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  • 1. Berhelsen, K
    et al.
    Hansen, S
    Rosenberg, Per
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Biomedicine and Surgery, Oncology. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Advanced epithelial ovarian cancer: 1998 consensus statement.1999In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 10, p. 87-92Article in journal (Refereed)
  • 2. Cullen, MH
    et al.
    Zatloukal, P
    Sörenson, Sverre
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Health Sciences, Pulmonary Medicine . Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Respiratory Medicine UHL.
    Novello, S
    Fischer, JR
    Joy, AA
    Zereu, M
    Peterson, P
    Visseren-Gruf, CM
    Iscoe, N
    A Randomized phase III trial comparing standard and high-dose pemetrexed as second-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer2008In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 19, no 5, p. 939-945Article in journal (Refereed)
    Abstract [en]

     Background: This phase III randomized trial compared pemetrexed 500 mg/m2 (P500) with pemetrexed 900 mg/m2 (P900) to determine whether higher dosing benefits non-small-cell lung cancer (NSCLC) patients as second-line therapy. Patients and methods: Patients with locally advanced or metastatic NSCLC, previously treated with platinum-based chemotherapy, were randomly assigned to receive i.v. P500 or P900 every 3 week. Results: Accrual was terminated with 588/600 patients enrolled because an interim analysis indicated a low probability of improved survival and numerically greater toxicity on the P900 arm. P900 patients were permitted to continue treatment at P500. No statistical difference was observed between the treatment arms (P500 versus P900) for median survival {6.7 versus 6.9 months, hazard ratio [HR] = 1.0132 [95% confidence interval (CI) 0.837-1.226]}, progression-free survival [2.6 versus 2.8 months, HR = 0.9681 (95% CI 0.817-1.147)], or best overall tumor response [7.1% versus 4.3% (P = 0.1616)]. The incidence of drug-related grade 3/4 toxicity was typically <5% on both treatment arms, but was numerically higher on the P900 arm for most toxicity categories. Conclusions: P900 did not improve any efficacy measure over P500. P500 i.v. every 3 week remains the standard pemetrexed dose for second-line treatment of platinum-pretreated advanced NSCLC.

  • 3. du Bois, A
    et al.
    Quinn, M
    Thigpen, T
    Vermorken, J
    Avall-Lundqvist, E
    Bookman, M
    Bowtell, D
    Brady, M
    Casado, A
    Cervantes, A
    Eisenhauer, E
    Friedlaender, M
    Fujiwara, K
    Grenman, S
    Guastalla, JP
    Harper, P
    Högberg, Thomas
    NSGO (Scandinavia).
    Kaye, S
    Kitchener, H
    Kristensen, G
    Mannel, R
    Meier, W
    Miller, B
    Neijt, JP
    Oza, S
    Ozols, R
    Parmar, M
    Pecorelli, S
    Pfisterer, J
    Poveda, A
    Provencher, D
    Pujade-Lauraine, E
    Randall, M
    Rochon, J
    Rustin, G
    Sagae, s
    Stehman, F
    Stuart, G
    Trimble, E
    Vasey, P
    Vergote, L
    Verheijen, R
    Wagner, U
    2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004)2005In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 16, no supplement 8, p. 36-38Article in journal (Refereed)
  • 4.
    du Bois, A
    et al.
    Department of Gynecology & Gynecologic Oncology, Wiesbaden, Germany..
    Quinn, M
    Thigpen, T
    Vermorken, J
    Åvall-Lundqvist, Elisabeth
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences.
    Bookman, M
    Bowtell, D
    Brady, M
    Casado, A
    Cervantes, A
    Eisenhauer, E
    Friedlaender, M
    Fujiwara, K
    Grenman, S
    Guastalla, J P
    Harper, P
    Hogberg, T
    Kaye, S
    Kitchener, H
    Kristensen, G
    Mannel, R
    Meier, W
    Miller, B
    Neijt, J P
    Oza, A
    Ozols, R
    Parmar, M
    Pecorelli, S
    Pfisterer, J
    Poveda, A
    Provencher, D
    Pujade-Lauraine, E
    Randall, M
    Rochon, J
    Rustin, G
    Sagae, S
    Stehman, F
    Stuart, G
    Trimble, E
    Vasey, P
    Vergote, I
    Verheijen, R
    Wagner, U
    2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004).2005In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 16, no 8, p. viii7-viii12Article in journal (Refereed)
  • 5.
    Duffy, S.W.
    et al.
    Queen Mary University of London, London, United Kingdom.
    Tabar, L.
    Falun Central Hospital, Falun, Sweden.
    Vitak, B.
    Östergötlands Läns Landsting, Centre for Medical Imaging, Department of Radiology UHL.
    Yen, M.F.
    Queen Mary University of London, London, United Kingdom.
    Warwick, J.
    Queen Mary University of London, London, United Kingdom.
    Smith, R.A.
    American Cancer Society, Atlanta, GA, United States.
    Chen, H.H.
    Institute of Preventive Medicine, National Taiwan University, Taipei, Taiwan.
    The Swedish two-county trial of mammographic screening: Cluster randomisation and end point evaluation2003In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 14, no 8, p. 1196-1198Article in journal (Refereed)
    Abstract [en]

    Background: The Swedish Two-County Trial has been criticised on the grounds of the cluster randomisation and alleged bias in classification of cause of death. Patients and methods: In the Two-County Trial, 77080 women were randomised to regular invitation to screening (active study population, ASP) and 55985 to no invitation (passive study population, PSP), in 45 geographical clusters. After ~7 years, the PSP was invited to screening and the trial closed. We analysed data using hierarchical statistical models to take account of cluster randomisation, and performed a conservative analysis assuming a systematic difference between ASP and PSP in baseline breast cancer mortality in one of the counties. We also analysed deaths from causes other than breast cancer and from all causes among breast cancer cases diagnosed in the ASP and PSP. Results: Taking account of the cluster randomisation there was a significant 30% reduction in breast cancer mortality in the ASP. Conservatively, assuming a systematic difference between ASP and PSP clusters in baseline breast cancer mortality, there was a significant 27% reduction in mortality in the ASP. Ignoring classification of cause of death, there was a significant 13% reduction in all-cause mortality in breast cancer cases in the ASP. Conclusions: Breast cancer mortality is a valid end point and mammographic screening does indeed reduce mortality from breast cancer. The criticisms of the Swedish Two-County Trial are unfounded.

  • 6. Emterling, A
    et al.
    Wallin, Åsa
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Biomedicine and Surgery, Oncology.
    Arbman, Gunnar
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Biomedicine and Surgery, Division of surgery. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Surgery in Östergötland.
    Sun, Xiao-Feng
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Biomedicine and Surgery, Oncology. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Clinicopathological significance of microsatellite instability and mutated RIZ in colorectal cancer2004In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 15, no 2, p. 242-246Article in journal (Refereed)
    Abstract [en]

    Background: Several studies have shown that microsatellite instability (MSI) is related to favourable survival in colorectal cancer patients but there are controversial results. Tumour suppressor gene RIZ is a susceptible mutational target of MSI. However, its clinicopathological significance has not been investigated. We investigated the prognostic significance of MSI in Swedish colorectal cancer patients and the clinicopathological significance of RIZ mutations. Patients and methods: We analysed 438 colorectal adenocarcinomas for MSI by microsatellite analysis. Among them, 29 MSI and 28 microsatellite stable (MSS) tumours were examined for RIZ mutations by DNA sequencing. Results: MSI (13% of 438 cases) was not associated with survival (rate ratio=0.97, 95% confidence interval =0.57-1.64, P=0.90), although it was related to proximal tumour (P <0.001), poor differentiation and mucinous carcinomas (P <0.001), multiple tumours (P=0.01) and negative/weak expression of hMLH1 (P=0.03). RIZ mutations were detected in 31% of 29 MSI tumours but in none of the 28 MSS tumours. The mutations were related to female (P=0.01), proximal tumour (P=0.01), stage B (P=0.01) and poor differentiation (P=0.047). Conclusions: MSI was not a prognostic factor in the Swedish patients included in this study. Clinicopathological variables associated with RIZ mutations might be a consequence of the MSI characteristics.

  • 7.
    Enblom, Anna
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medical and Health Sciences, Division of Nursing Science.
    Johnsson, Anna
    Department of Oncology, University Hospital, Lund, Sweden.
    Hammar, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences.
    Onelöv, Erik
    Department of Oncology-Pathology, Division of Clinical Cancer Epidemiology, Karolinska Institute, Stockholm, Sweden.
    Steineck, Gunnar
    Department of Oncology-Pathology, Division of Clinical Cancer Epidemiology, Karolinska Institute, Stockholm, Sweden.
    Börjeson, Sussanne
    Linköping University, Department of Medical and Health Sciences, Nursing Science. Linköping University, Faculty of Health Sciences.
    Acupuncture Compared To Placebo Acupuncture in Radiotherapy-induced Nausea: a Randomized Controlled Study2012In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 23, no 5, p. 1353-1361Article in journal (Refereed)
    Abstract [en]

    PURPOSE: To evaluate if verum (real) acupuncture is effective against nausea and vomiting during radiotherapy.

    PATIENTS AND METHODS: We randomised blinded cancer patients to verum; penetrating “deqi” creating acupuncture (n=109) in the antiemetic acupuncture point PC6 (three cm above the wrist), or sham (n=106) with a non-penetrating sham needle at a non-acupuncture point six cm above the wrist 2-3 times/week. The patients daily during the radiotherapy period documented nausea and vomiting. Primary endpoint was number of patients with at least one episode of nausea during the whole radiotherapy period. RESULTS: Data was provided by 205 patients (95 %). In the verum acupuncture group, 70 % experienced nausea at least once during the radiotherapy period (p=0.12 compared to the sham group) (mean number of days of 10.1), 25 % vomited and 42 % used antiemetic drugs at least once. In the sham group 62 % experienced nausea (mean number of days 8.7), 28 % vomited and 37 % consumed antiemetic drugs. Ninety five percent in the verum and 96 % in the sham acupuncture group believed that the treatment had been effective against nausea. In both groups 67 % experienced positive effects on relaxation, mood, sleep or pain-reduction, and 89 % wished to receive the treatment again.

    CONCLUSION: Acupuncture creating deqi is not more effective than sham in radiotherapy-induced nausea, but in this study nearly all patients in both groups experienced that the treatment was effective for nausea.

  • 8.
    Glimelius, B.
    et al.
    Department of Oncology, Radiology and Clinical Immunology, Uppsala University Hospital, SE-751 85 Uppsala, Sweden, Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.
    Sorbye, H.
    Sørbye, H., Department of Oncology, Haukeland University Hospital, Bergen, Norway.
    Balteskard, L.
    Department of Oncology, University Hospital, Tromsö, Norway.
    Bystrom, P.
    Byström, P., Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.
    Pfeiffer, P.
    Department of Oncology, University Hospital, Odense, Denmark.
    Tveit, K.
    Department of Oncology, Ullevål University Hospital, Oslo, Norway.
    Heikkila, R.
    Heikkilä, R., Department of Hemato-Oncology, Stavanger University Hospital, Stavanger, Norway.
    Keldsen, N.
    Department of Oncology, Central Hospital, Herning, Denmark.
    Albertsson, M.
    Department of Oncology, University Hospital, Malmö, Sweden.
    Starkhammar, Hans
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Oncology. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Garmo, H.
    Regional Oncologic Center, Uppsala, Sweden.
    Berglund, A.
    Berglund, Å., Department of Oncology, Radiology and Clinical Immunology, Uppsala University Hospital, SE-751 85 Uppsala, Sweden.
    A randomized phase III multicenter trial comparing irinotecan in combination with the Nordic bolus 5-FU and folinic acid schedule or the bolus/infused de Gramont schedule (Lv5FU2) in patients with metastatic colorectal cancer2008In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 19, no 5, p. 909-914Article in journal (Refereed)
    Abstract [en]

    Background: To compare irinotecan with the Nordic 5-fluorouracil (5-FU) and folinic acid (FA) bolus schedule [irinotecan 180 mg/m2 on day 1, 5-FU 500 mg/m2 and FA 60 mg/m2 on day 1 and 2 (FLIRI)] or the Lv5FU2 schedule [irinotecan 180 mg/m2 on day 1, FA 200 mg/m2, 5-FU bolus 400 mg/m2 and infused 5-FU 600 mg/m2 on day 1 and 2 (Lv5FU2-IRI)] due to uncertainties about how to administrate 5-FU with irinotecan. Patients and methods: Patients (n = 567) with metastatic colorectal cancer were randomly assigned to receive FLIRI or Lv5FU2-IRI. Primary end point was progression-free survival (PFS). Results: Patient characteristics were well balanced. PFS did not differ between groups (median 9 months, P = 0.22). Overall survival (OS) was also similar (median 19 months, P = 0.9). Fewer objective responses were seen in the FLIRI group (35% versus 49%, P = 0.001) but the metastatic resection rate did not differ (4% versus 6%, P = 0.3). Grade 3/4 neutropenia (11% versus 5%, P = 0.01) and grade 2 alopecia (18% versus 9%, P = 0.002) were more common in the FLIRI group. The 60-day mortality was 2.4% versus 2.1%. Conclusions: Irinotecan with the bolus Nordic schedule (FLIRI) is a convenient treatment with PFS and OS comparable to irinotecan with the Lv5FU2 schedule. Neutropenia and alopecia are more prevalent, but both regimens are equally well tolerated. © The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

  • 9.
    Hagman, H.
    et al.
    County Hospital Ryhov, Sweden.
    Frodin, J. -E.
    Karolinska University Hospital, Sweden.
    Berglund, A.
    University of Uppsala Hospital, Sweden.
    Sundberg, J.
    Skåne University Hospital, Sweden.
    Vestermark, L. W.
    Odense University Hospital, Denmark.
    Albertsson, Maria
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology.
    Fernebro, E.
    Vaxjo Hospital, Sweden.
    Johnsson, A.
    Skåne University Hospital, Sweden.
    A randomized study of KRAS-guided maintenance therapy with bevacizumab, erlotinib or metronomic capecitabine after first-line induction treatment of metastatic colorectal cancer: the Nordic ACT2 trial2016In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 27, no 1, p. 140-147Article in journal (Refereed)
    Abstract [en]

    Maintenance treatment (mt) with bevacizumab (bev) +/- erlotinib (erlo) has modest effect after induction chemotherapy in metastatic colorectal cancer (mCRC). We hypothesized the efficacy of erlo to be dependent on KRAS mutational status and investigated this by exploring mt strategies with bev +/- erlo and low-dose capecitabine (cap). Included patients had mCRC scheduled for first-line therapy, Eastern Cooperative Oncology Group (ECOG) 0-1 and no major comorbidities. Treatment with XELOX/FOLFOX or XELIRI/FOLFIRI + bev was given for 18 weeks. After induction, patients without progression were eligible for randomization to mt; KRAS wild-type (wt) patients were randomized to bev +/- erlo (arms wt-BE, N = 36 versus wt-B, N = 35), KRAS mutated (mut) patients were randomized to bev or metronomic cap (arms mut-B, N = 34 versus mut-C, N = 33). Primary end point was progression-free survival (PFS) rate (PFSr) at 3 months after start of mt. A pooled analysis of KRAS wt patients from the previous ACT study was performed. We included 233 patients. Median age was 64 years, 62% male, 68% ECOG 0, 52% with primary tumor in situ. A total of 138 patients started mt after randomization. PFSr was 64.7% versus 63.6% in wt-B versus wt-BE, P = 1.000; and 75% versus 66.7% in mut-B versus mut-C, P = 0.579, with no significant difference in median PFS and overall survival (OS). In the pooled cohort, median PFS was 3.7 months in wt-B (N = 64) and 5.7 months in wt-BE (N = 62) (hazard ratios 1.03, 95% confidence interval 0.70-1.50, P = 0.867). The frequency of any grade 3/4 toxicities during mt was: 28%/58%/18%/15% (wt-B/wt-BE/mut-B/mut-C). Addition of erlo to bev as mt in KRAS wt mCRC did not significantly improve PFS or OS, but it did increase toxicity. KRAS status does not seem to influence the outcome of treatment with erlotinib. Metronomic cap warrants further investigation in mt strategies, given our explorative results. NCT01229813.

  • 10. Iacopetta, B
    et al.
    Russo, A
    Bazan, V
    Dardanoni, G
    Gebbia, N
    Soussi, T
    Kerr, D
    Elsaleh, H
    Soong, R
    Kandioler, D
    Janschek, E
    Kappel, S
    Lung, M
    Leung, C-S S
    Ko, J M
    Sun, Xiao-Feng
    Linköping University, Department of Clinical and Experimental Medicine, Oncology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Jansson, Agneta
    Shorthouse, AJ
    Silverman, ML
    Kato, S
    Ishioka, C
    Functional categories of TP53 mutation in colorectal cancer: results of an International Collaborative Study2006In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 17, p. 842-847Article in journal (Refereed)
    Abstract [en]

         

  • 11.
    Lindemann, K
    et al.
    Department of Gynecological Cancer, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
    Christensen, R D
    Department of Medical Statistics, University of Southern Denmark, Odense, Denmark.
    Vergote, I
    Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven, Belgium .
    Stuart, G
    Department of Gynecologic Oncology, University of British Columbia, Vancouver, Canada.
    Izquierdo, M A
    Institute of Oncology, Catalán Hospital, Catalania, Spain.
    Kærn, J
    Department of Gynecological Cancer, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
    Havsteen, H
    Department of Oncology, Herlev University Hospital, Herlev, Denmark.
    Eisenhauer, E
    Department of Oncology, Queen’s University, Kingston, Ontario, Canada.
    Ridderheim, M
    Department of Gynecologic Oncology, Lund University Hospital, Lund, Sweden.
    Lopez, A B
    Department of Gynecologic Oncology, Queen Elizabeth Hospital, Gateshead, UK.
    Hirte, H
    Department of Oncology, Division of Medical Oncology, Juravinski Cancer Centre, Hamilton, Ontario, Canada.
    Åvall-Lundquvist, Elisabeth
    Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.
    Vrdoljak, E
    Department of Oncology, University Hospital, Split, Croatia.
    Green, J
    Department of Oncology, Clatterbridge Hospital, Wirral, UK.
    Kristensen, G B
    Department of Gynecological Cancer, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway / Department of Gynecological Cancer, Institute for Medical Informatics, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
    First-line treatment of advanced ovarian cancer with paclitaxel/carboplatin with or without epirubicin (TEC versus TC)--a gynecologic cancer intergroup study of the NSGO, EORTC GCG and NCIC CTG.2012In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 23, no 10, p. 2613-2619Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: The addition of anthracyclines to platinum-based chemotherapy may provide benefit in survival in ovarian cancer patients. We evaluated the effect on survival of adding epirubicin to standard carboplatin and paclitaxel.

    PATIENTS AND METHODS: We carried out a prospectively randomized phase III study comparing carboplatin plus paclitaxel (TC; area under the curve 5 and 175 mg/m(2)) with the same combination and epirubicin (TEC; 75 mg/m(2) i.v.). Between March 1999 and August 2001, 887 patients with epithelial ovarian, tubal or peritoneal cancer International Federation of Gynecology and Obstetrics stages IIB-IV were randomized to receive either TC (442 patients) or TEC (445 patients).

    RESULTS: Median time to progression was 16.4 months in the TEC arm and 16.0 months in the TC arm (hazard ratio 0.99; 95% confidence interval [CI]: 0.9-1.2). Median overall survival time was 42.4 months for the TEC arm and 40.2 for the TC arm (hazard ratio 0.96; 95% CI: 0.8-1.1). Grade 3/4 hematologic toxic effects and most grade 3/4 non-hematologic toxic effects were more frequent in the TEC arm. Accordingly, a quality-of-life analysis showed inferiority of TEC versus TC.

    CONCLUSION: The addition of epirubicin to standard carboplatin and paclitaxel treatment did not improve survival in patients with advanced ovarian, tubal or peritoneal cancer.

  • 12.
    Maddika, Subbareddy
    et al.
    Manitoba Institute of Cell Biology, Cancer Care Manitoba; Department of Biochemistry and Medical Genetics,University of Manitoba, Winnipeg, Canada .
    Kroczak, T.
    Manitoba Inst Cell Biol, Winnipeg, MB R3E 0V9, Canada.
    Los, Marek Jan
    Manitoba Institute of Cell Biology, Cancer Care Manitoba; Manitoba Institute of Child Health; Department of Biochemistry and Medical Genetics; Department of Human Anatomy and Cell Science, University Manitoba, Winnipeg, Canada, .
    Apoptin triggered apoptotic signaling in cancer cells2005In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 16, p. 36-36Article in journal (Refereed)
  • 13.
    Nordenskjold, A. E.
    et al.
    Southern Alvsborg Hospital, Sweden; Sahlgrens University Hospital, Sweden.
    Fohlin, Helena
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Region Östergötland, Center for Health and Developmental Care, Regional Cancer Center South East Sweden. Linköping University, Faculty of Medicine and Health Sciences. Regional Cancer Centre South East Sweden, Linkoping, Sweden.
    Albertsson, P.
    Sahlgrens University Hospital, Sweden.
    Arnesson, Lars-Gunnar
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Chamalidou, C.
    Southern Alvsborg Hospital, Sweden; Sahlgrens University Hospital, Sweden.
    Einbeigi, Z.
    Sahlgrens University Hospital, Sweden.
    Holmberg, E.
    Regional Cancer Centre, Sweden.
    Nordenskjöld, Bo
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology.
    Karlsson, P.
    Sahlgrens University Hospital, Sweden.
    No clear effect of postoperative radiotherapy on survival of breast cancer patients with one to three positive nodes: a population-based study2015In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 26, no 6, p. 1149-1154Article in journal (Refereed)
    Abstract [en]

    Background: In published radiotherapy trials, the failure rate in the control arm among patients with one to three positive nodes is high compared with that seen with modern adjuvant treatments. Therefore, the generalizability of the results has been questioned. The aim of the present study was to compare relative survival in breast cancer patients between two Swedish regions with screening mammography programs and adjuvant treatment guidelines similar with the exception of the indication of radiotherapy for patients with one to three positive nodes. Patients and methods: Between 1989 and 2006, breast cancer patients were managed very similarly in the west and southeast regions, except for indication for postoperative radiotherapy. In patients with one to three positive nodes, post-mastectomy radiotherapy was generally given in the southeast region (89% of all cases) and generally not given in the west region (15% of all cases). For patients with one to three positive nodes who underwent breast-conserving surgery, patients in the west region had breast radiotherapy only, while patients in the southeast region had both breast and lymph nodes irradiated. Results: The 10-year relative survival for patients with one to three positive lymph nodes was 78% in the west region and 77% in the southeast region (P = 0.12). Separate analyses depending on type of surgery, as well as number of examined nodes, also revealed similar relative survival. Conclusion: Locoregional postoperative radiotherapy has well-known side-effects, but in this population-based study, there was little or no influence of this type of radiotherapy on survival when one to three lymph nodes were involved.

  • 14.
    Oakman, C
    et al.
    Hospital Prato, Italy .
    Francis, P A.
    Peter MacCallum Cancer Centre, Australia .
    Crown, J
    Irish Clin Oncology Research Grp, Ireland .
    Quinaux, E
    Int Institute Drug Dev, Belgium .
    Buyse, M
    Int Institute Drug Dev, Belgium .
    De Azambuja, E
    University of Libre Brussels, Belgium .
    Margeli Vila, M
    Hospital Badalona Germans Trias and Pujol, Spain .
    Andersson, M
    Danish Breast Cancer Cooperat Grp, Denmark .
    Nordenskjöld, Bo
    Linköping University, Department of Clinical and Experimental Medicine, Oncology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology UHL.
    Jakesz, R
    Vienna Medical Sch, Austria .
    Thuerlimann, B
    Kantonsspital, Switzerland .
    Gutierrez, J
    Clin Las Condes, Chile .
    Harvey, V
    Auckland City Hospital, New Zealand .
    Punzalan, L
    University of Libre Brussels, Belgium .
    DellOrto, P
    University of Milan, Italy .
    Larsimont, D
    University of Libre Brussels, Belgium .
    Steinberg, I
    Sanofi Oncol, England .
    Gelber, R D.
    IBCSG, MA USA .
    Piccart-Gebhart, M
    University of Libre Brussels, Belgium .
    Viale, G
    University of Milan, Italy .
    Di Leo, A
    Hospital Prato, Italy .
    Overall survival benefit for sequential doxorubicin-docetaxel compared with concurrent doxorubicin and docetaxel in node-positive breast cancer-8-year results of the Breast International Group 02-98 phase III trial2013In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 24, no 5, p. 1203-1211Article in journal (Refereed)
    Abstract [en]

    Background: In women with node-positive breast cancer, the Breast International Group (BIG) 02-98 tested the incorporation of docetaxel (Taxotere) into doxorubicin (Adriamycin)-based chemotherapy, and compared sequential and concurrent docetaxel. At 5 years, there was a trend for improved disease-free survival (DFS) with docetaxel. We present results at 8-year median follow-up and exploratory analyses within biologically defined subtypes. less thanbrgreater than less thanbrgreater thanMethods: Patients were randomly assigned to one of four treatments: (i) sequential control: doxorubicin (A) (75 mg/m(2)) x 4 -andgt; classical cyclophosphamide, methotrexate, 5-fluorouracil (CMF); (ii) concurrent control: doxorubicin, cyclophosphamide (AC)(60/600 mg/m(2)) x 4 -andgt; CMF; (iii) sequential docetaxel: A (75 mg/m(2)) x3 -andgt; docetaxel (T) (100 mg/m(2)) x3. CMF and (iv) concurrent docetaxel: AT(50/75 mg/m(2)) x 4 -andgt; CMF. The primary comparison evaluated docetaxel efficacy regardless of the schedule. Exploratory analyses were undertaken within biologically defined subtypes. less thanbrgreater than less thanbrgreater thanResults: Two thousand eight hundred and eighty-seven patients were enrolled. After 93.4 months of median follow-up, there were 916 DFS events. For the primary comparison, there was no significant improvement in DFS from docetaxel [hazard ratio (HR) = 0.91, 95% confidence interval (CI) = 0.80-1.05, P = 0.187]. In secondary comparisons, sequential docetaxel significantly improved DFS compared with sequential control (HR = 0.81, 95% CI = 0.67-0.99, P = 0.036), and significantly improved DFS (HR = 0.84, 95% CI = 0.72-0.99, P = 0.035) and overall survival (OS) (HR = 0.79, 95% CI = 0.65-0.98, P = 0.028) compared with concurrent doxorubicin-docetaxel. Luminal-A disease had the best prognosis. HRs favored addition of sequential docetaxel in all subtypes, except luminal-A; but this observation was not statistically supported because of limited numbers. less thanbrgreater than less thanbrgreater thanConclusion: With further follow-up, the sequential docetaxel schedule resulted in significantly better OS than concurrent doxorubicin-docetaxel, and continued to show better DFS than sequential doxorubicin-based control.

  • 15. Pestalozzi, B. C.
    et al.
    Francis, P.
    Quinaux, E.
    Dolci, S.
    Azambuja, E.
    Gelber, R. D.
    Viale, G.
    Balil, A.
    Andersson, M.
    Nordenskjöld, Bo
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Oncology . Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Gnant, M.
    Gutierrez, J.
    Láng, I.
    Crown, J. P. A.
    Piccart-Gebhart, M.
    Is risk of central nervous system (CNS) relapse related to adjuvant taxane treatment in node-positive breast cancer? Results of the CNS substudy in the intergroup phase III BIG 02-98 trial2008In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 19, no 11, p. 1837-1841Article in journal (Refereed)
    Abstract [en]

    Background: Breast cancer central nervous system (CNS) metastases are an increasingly important problem because of high CNS relapse rates in patients treated with trastuzumab and/or taxanes. Patients and methods: We evaluated data from 2887 node-positive breast cancer patients randomised in the BIG 02-98 trial comparing anthracycline-based adjuvant chemotherapy (control arms) to anthracycline-docetaxel-based sequential or concurrent chemotherapy (experimental arms). After a median follow-up of 5 years, 403 patients had died and detailed information on CNS relapse was collected for these patients. Results: CNS relapse occurred in 4.0% of control patients and3.7% of docetaxel-treated patients. CNS relapse occurred in 27% of deceased patients in both treatment groups. CNS relapse was usually accompanied by neurologic symptoms (90%), and 25% of patients with CNS relapse died without evidence of extra-CNS relapse. Only 20% of patients survived 1 year from the diagnosis of CNS relapse. Prognosis of CNS relapse was worse for patients with meningeal carcinomatosis when compared with brain metastases. Unexpected findings included a higher rate of positive cerebrospinal fluid cytology (8% versus 3%) and more frequent use of magnetic resonance imaging for diagnosis (47% versus 30%) in the docetaxel-treated patients. Conclusion: There is no evidence that adjuvant docetaxel treatment is associated with an increased frequency of CNS relapse. © The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

  • 16. Pfeiffer, P
    et al.
    Sörbye, H
    Ehrsson, H
    Fokstuen, T
    Mortensen, JP
    Baltesgard, L
    Tveit, KM
    Ögreid, D
    Starkhammar, Hans
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Biomedicine and Surgery, Oncology. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Wallin, I
    Qvortrup, C
    Glimelius, B
    Short-time infusion of oxaliplatin in combination with capecitabine (XELOX30) as second-line therapy in patients with advanced colorectal cancer after failure to irinotecan and 5-fluorouracil2006In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 17, no 2, p. 252-258Article in journal (Refereed)
    Abstract [en]

    Background: The efficacy of oxaliplatin combined with capecitabine (XELOX) as second-line therapy in patients with advanced colorectal cancer (ACRC) resistant to irinotecan is not well established. Oxaliplatin induces acute, cold-induced neuropathy in most patients. The incidence is claimed to be infusion rate-dependent and therefore a 2-h infusion is recommended. Patients and methods: For practical and economic reasons, but also for patient's convenience, we performed a phase II study to examine XELOX30 (capecitabine 1000 mg/m2 orally twice daily on days 1-14 and oxaliplatin 130 mg/m2 as a 30 min infusion on day 1) in patients with ACRC resistant to irinotecan. In addition the pharmacokinetics of oxaliplatin was studied. Results: From November 2002 to September 2003, 70 patients with ACRC were treated with XELOX30. Median age was 62 (range 33-74 years) years and median performance status was 1 (range 0-2). The median number of courses was four (range 1-12) and median cumulative dose of oxaliplatin was 530 (range 125-1560) mg/m2. The response rate was 17% (95% CI 10-23), median time to progression (TTP) was 5.4 months (95% CI 4.6-6.4) and median survival 9.5 months (95% CI 8.5-11.2). White blood cell count (WBC) and performance status were significantly correlated to TTP. Neurotoxicity was moderate: grade 1 56%, grade 2 17% and grade 3 6%. Other grade 3 toxicities were nausea/ vomiting 9%, diarrhoea 14% and PPE 8%. The maximum blood concentration and total body clearance of oxaliplatin was higher than previously reported in studies examining 2-h infusions, but the volume of distribution and terminal half-life was in close agreement with previous results. Conclusion: XELOX30 is a very convenient second-line regimen in ACRC with an activity and safety profile similar to other oxaliplatin schedules. © 2005 European Society for Medical Oncology.

  • 17. Quinn, M
    et al.
    Pfisterer, J
    Åvall-Lundqvist, Elisabeth
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences.
    Bookman, M
    Bowtell, D
    Casado, A
    Cervantes, A
    Grenman, S
    Harper, P
    Oza, A
    Pecorelli, S
    Pujade-Lauraine, E
    Trimble, E
    Vasey, P
    Wagner, U
    Integration of new or experimental treatment options and new approaches to clinical trials.2005In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 16, no 8, p. viii30-viii35Article in journal (Refereed)
  • 18. Quinn, M
    et al.
    Åvall-Lundqvist, Elisabeth
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences.
    du Bois, A
    Vermorken, J
    Parmar, M
    Pfisterer, J
    Stuart, G
    Thigpen, T
    Neijt, J
    University Medical Center Utrecht, Utrecht, The Netherlands.
    History, scope and methodology of the 3rd International Consensus Workshop on Ovarian Cancer 2004.2005In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 16, no 8, p. viii5-viii6Article in journal (Refereed)
    Abstract [en]

    This document reports the history of the two previous ovarian cancer consensus meetings and the scope and methodology of the 3rd International Ovarian Cancer Consensus Conference, which was held by the GCIG from 5–9 September 2004 in Baden-Baden, Germany. This conference was supported by an unrestricted grant from Bristol-Myers-Squibb. Selection of participants, agenda and deliberations were not influenced by the financial support provider.

  • 19.
    Qvortrup, C.
    et al.
    Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, Odense C 5000, Denmark, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
    Yilmaz, M.
    Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.
    Ogreid, D.
    Department of Oncology, Rogaland Central Hospital, Stavanger, Norway.
    Berglund, A.
    Department of Oncology, Radiology and Clinical Immunology, University Hospital, Uppsala University Hospital, Uppsala, Sweden.
    Balteskard, L.
    Department of Oncology, Tromso University Hospital, Tromso, Norway.
    Ploen, J.
    Department of Oncology, Vejle Hospital, Vejle, Denmark.
    Fokstuen, T.
    Department of Oncology and Pathology, Karolinska Hospital, Stockholm, Sweden.
    Starkhammar, Hans
    Linköping University, Department of Clinical and Experimental Medicine, Oncology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Sorbye, H.
    Sørbye, H., Department of Oncology, Haukeland University Hospital, Bergen, Norway.
    Tveit, K.
    Department of Oncology, Ullevål University Hospital, Oslo, Norway.
    Pfeiffer, P.
    Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, Odense C 5000, Denmark.
    Chronomodulated capecitabine in combination with short-time oxaliplatin: A Nordic phase II study of second-line therapy in patients with metastatic colorectal cancer after failure to irinotecan and 5-flourouracil2008In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 19, no 6, p. 1154-1159Article in journal (Refereed)
    Abstract [en]

    Background: Oxaliplatin in combination with capecitabine prolongs survival in patients with metastatic colorectal cancer (mCRC). Chronomodulation might reduce toxicity and improve efficacy. Patients and methods: A phase II study examining chronomodulated XELOX30 (XELOX30chron): oxaliplatin: 130 mg/m2 on day 1, as a 30-min infusion between 1 and 3 p.m. Capecitabine: total daily dose of 2000 mg/m2, 20% of the dose between 7 and 9 a.m. and 80% of the dose between 6 and 8 p.m. in patients with mCRC resistant to irinotecan. Seventy-one patients were enrolled. Response rate was 18%, median progression-free survival 5.1 months and median overall survival (OS) 10.2 months. Platelet count and performance status were significantly correlated to OS in multivariate analyses. Neurotoxicity grade 2 and 3 was seen in 25% and 2% of patients, respectively, other grade 3 toxic effects were as follows: nausea 6%, vomiting 3%, diarrhoea 12% (3% experienced grade 4) and palmoplantart erytem 9%. Conclusion: XELOX30chron is a convenient second-line regimen with efficacy and safety profile similar to other oxaliplatin schedules. To further investigate chronomodulated XELOX, we have started a Nordic randomised phase II study comparing XELOX30 and XELOX30chron as first-line therapy in patients with mCRC. © The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

  • 20.
    Roila, F.
    et al.
    Medical Oncology Division, Silvestrini Hospital, 06156S Andrea delle Fratte, Perugia, Italy.
    Aapro, M.
    Institut Multidisciplinaire d'Oncologie, Genolier, Switzerland.
    Ballatori, E.
    Statistics Unit, L'Aquila, Italy.
    Borjeson, S.
    Division of Nursing Science, Linkoping University, Linkoping, Sweden.
    Clark-Snow, R.A.
    University of Kansas Cancer Center, Kansas City, KS, United States.
    Del, Favero A.
    Del Favero, A., Department of Internal Medicine and Oncological Sciences, Perugia, Italy.
    Einhorn, L.H.
    Walther Cancer Institute, Indianapolis, IN, United States.
    Feyer, P.
    Viventes Clinics Berlin-Neukölln, Berlin, Germany.
    Gralla, R.J.
    New York Lung Cancer Alliance, New York, NY, United States.
    Grunberg, S.M.
    University of Vermont, Burlington, VT, United States.
    Herrstedt, J.
    Copenhagen University Hospital, Copenhagen, Denmark.
    Hesketh, P.J.
    Caritas St. Elizabeth's Medical Center, Boston, MA, United States.
    Kaiser, R.
    University Clinic, Goettingen, Germany.
    Koeller, J.
    University of Texas Health Science Center, San Antonio, TX, United States.
    Kris, M.G.
    Memorial Sloan-Kettering Cancer Center, New York, NY, United States.
    Maranzano, E.
    Radiation Oncology Center, 'S.S. Maria' Hospital, Terni, Italy.
    Molassiotis, A.
    School of Nursing, University of Manchester, Manchester, United Kingdom.
    Olver, I.
    Royal Adelaide Hospital Cancer Center, Adelaide, SA, Australia.
    Osoba, D.
    QOL Consulting, West Vancouver, BC, Canada.
    Rapoport, B.L.
    The Medical Oncology Centre of Rosebank, Johannesburg, South Africa.
    Rittenberg, C.
    Rittenberg Oncology Consulting, Metaire, LA, United States.
    Tonato, M.
    Perugia Regional Cancer Center, Perugia, Italy.
    Warr, D.
    Princess Margaret Hospital, University of Toronto, Toronto, Ont., Canada.
    Prevention of chemotherapy- and radiotherapy-induced emesis: Results of the 2004 Perugia International Antiemetic Consensus Conference2006In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 17, no 1, p. 20-28Article, review/survey (Refereed)
    Abstract [en]

    Background: In the late 1990s, several professional organizations convened antiemetic guideline groups and published the findings of these expert panels. Each of these documents was based on analyses of the available published trials and provided nearly similar recommendations. Nonetheless, small differences in emetic risk categories and treatment recommendations led to confusion in antiemetics selection. With the emergence of new findings and agents since the guidelines were initially published, many of the oncology professional societies have updated the antiemetic guidelines. Materials and methods: A literature review up to March 2004 was carried out using MEDLINE with evaluation of the evidence by an expert panel composed of 23 oncology professionals in clinical medicine, medical oncology, radiation oncology, oncology nursing, statistics, pharmacy, medical policy and decision making, and pharmacology. The experts represented nine oncology professional societies and came from 11 different countries on four continents. Results: Recommendations on antiemetic regimens to prevent emesis induced by high, moderate, low and minimal risk chemotherapy were suggested as well as management of anticipatory emesis. Furthermore, recommendations for refractory emesis, emesis induced by high-dose chemotherapy and radiotherapy and for antiemetics in children receiving chemotherapy were elaborated. Conclusions: Recommendations about antiemetic prophylaxis in patients receiving treatment with chemo- and radiotherapy have been updated by representatives of nine oncological organizations. © 2005 European Society for Medical Oncology.

  • 21. Stuart, G
    et al.
    Åvall-Lundqvist, Elisabeth
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences.
    du Bois, A
    Bookman, M
    Bowtell, D
    Brady, M
    Casado, A
    Cervantes, A
    Eisenhauer, E
    Friedlaender, M
    Fujuwara, K
    Grenman, S
    Guastalla, JP
    Harper, P
    Högberg, Thomas
    NSGO (Scandinavia).
    Kaye, S
    Kitchener, H
    Kristensen, G
    Mannel, R
    Meier, W
    Miller, B
    Oza, A
    Ozols, R
    Parmar, M
    Pfisterer, J
    Poveda, A
    Provencher, D
    Pujade-Lauraine, E
    Quinn, M
    Randall, M
    Rochon, J
    Rustin, G
    Sagae, S
    Stehman, F
    Trimble, E
    Thigpen, T
    Vasey, P
    Vergote, I
    Verheijen, R
    Vermorken, J
    Wagner, U
    3rd international ovarian cancer consensus conference: outstanding issues for future consideration2005In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 16, no supplement 8, p. viii36-viii38Article in journal (Refereed)
  • 22.
    Stål, Olle
    et al.
    Linköping University, Department of Biomedicine and Surgery, Oncology. Linköping University, Faculty of Health Sciences.
    Borg, Å
    Department of Oncology, University Hospital Lund, Sweden.
    Fernö, M
    Department of Oncology, University Hospital Lund, Sweden.
    Källström, Ann-Christine
    Linköping University, Department of Biomedicine and Surgery, Oncology. Linköping University, Faculty of Health Sciences.
    Malmström, P
    Department of Oncology, University Hospital Lund, Sweden.
    Nordenskjöld, Bo
    Linköping University, Department of Biomedicine and Surgery, Oncology. Linköping University, Faculty of Health Sciences.
    ErbB2 status and the benefit from two or five years of adjuvant tamoxifen in postmenopausal early stage breast cancer2000In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 11, no 12, p. 1545-1550Article in journal (Refereed)
    Abstract [en]

    Aim:We aimed to study the importance of erbB2 status in early stage postmenopausal breast cancer for patients who participated in a trial of five vs. two years of adjuvant tamoxifen.

    Patients and methods: We analysed the erbB2 status of the tumours from 577 patients participating in the trial, either by a DNA amplification assay (n=181) or by measurement of the protein level with flow cytometry (n=396).

    Results: ErbB2 was overexpressed or gene amplified in 102 of the patients (18%). Overall, erbB2-positive patients had a significantly lower recurrence-free probability than others, 62% at five years as compared to 83%, and showed a significantly decreased breast cancer survival rate (P=0.0007). ErbB2 status was significantly associated with recurrence and death in Cox multivariate analysis, adjusting for nodal status, tumour size and estrogen receptor status. The relative risk of recurrence (RR) for five vs. two years of tamoxifen was analysed in relation to erbB2 status for patients still disease-free two years after surgery. Whereas erbB2-negative patients showed significant benefit from prolonged treatment (RR=0.62, 95% confidence interval (95% CI): 0.42–0.93), no benefit was evident for erbB2-positive patients (RR=1.1, 95% CI: 0.41–3.2). When the same analysis was restricted to ER-positive patients a similar difference in relative hazard was obtained but the difference was not strictly significant (P=0.065).

    Conclusions: For early stage breast cancer patients treated with adjuvant tamoxifen, overexpression of erbB2 is an independent marker of poor prognosis. The results suggest that overexpression decreases the benefit from prolonged tamoxifen treatment.

  • 23.
    Tandstad, T.
    et al.
    St Olavs University Hospital, Norway.
    Stahl, O.
    Skåne University Hospital, Sweden.
    Dahl, O.
    University of Bergen, Norway; Haukeland Hospital, Norway.
    Haugnes, H. S.
    University of Tromso, Norway; University Hospital North Norway, Norway.
    Håkansson, U.
    Skåne University Hospital, Sweden.
    Karlsdottir, A.
    Haukeland Hospital, Norway.
    Kjellman, A.
    Karolinska University Hospital, Sweden.
    Langberg, C. W.
    Oslo University Hospital, Norway.
    Laurell, A.
    University of Uppsala Hospital, Sweden.
    Oldenburg, J.
    Akershus University Hospital, Norway; University of Oslo, Norway.
    Solberg, A.
    St Olavs University Hospital, Norway.
    Söderström, K.
    Norrland University Hospital, Sweden.
    Stierner, U.
    Sahlgrens University Hospital, Sweden; University of Gothenburg, Sweden.
    Cavallin-Stahl, E.
    Skåne University Hospital, Sweden.
    Wahlqvist, R.
    Oslo University Hospital, Norway.
    Wall, Najme
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology. Linköping University, Faculty of Medicine and Health Sciences.
    Cohn-Cedermark, G.
    Karolinska Institute, Sweden; Karolinska University Hospital, Sweden.
    Treatment of stage I seminoma, with one course of adjuvant carboplatin or surveillance, risk-adapted recommendations implementing patient autonomy: a report from the Swedish and Norwegian Testicular Cancer Group (SWENOTECA)2016In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 27, no 7, p. 1299-1304Article in journal (Refereed)
    Abstract [en]

    A total of 1118 patients with clinical stage I seminoma one course of adjuvant carboplatin or managed by surveillance were included. Stromal invasion of rete testis and tumor size amp;gt; 4 cm are confirmed as risk factors predicting relapse. Relapse rates following one course of adjuvant carboplatin is high and there is need to explore more effective adjuvant treatment options in patients with seminoma.The purpose of the protocol was to reduce the treatment burden in clinical stage I (CSI) seminoma by offering risk-adapted treatment. The protocol aimed to prospectively validate the proposed risk factors for relapse, stromal invasion of the rete testis and tumor diameter amp;gt; 4 cm, and to evaluate the efficacy of one course of adjuvant carboplatin. From 2007 to 2010, 897 patients were included in a prospective, population-based, risk-adapted treatment protocol implementing one course of adjuvant carboplatin AUC7 (amp;gt;n = 469) or surveillance (amp;gt;n = 422). In addition, results from 221 patients receiving carboplatin between 2004 and 2007 are reported. At a median follow-up of 5.6 years, 69 relapses have occurred. Stromal invasion of the rete testis [hazard ratio (HR) 1.9, amp;gt;P = 0.011] and tumor diameter amp;gt; 4 cm (HR 2.7, amp;gt;P amp;lt; 0.001) were identified as risk factors predicting relapse. In patients without risk factors, the relapse rate (RR) was 4.0% for patients managed by surveillance and 2.2% in patients receiving adjuvant carboplatin. In patients with one or two risk factors, the RR was 15.5% in patients managed by surveillance and 9.3% in patients receiving adjuvant carboplatin. We found no increased RR in patients receiving carboplatin amp;lt; 7 x AUC compared with that in patients receiving a parts per thousand yen7 x AUC. Stromal invasion in the rete testis and tumor diameter amp;gt; 4 cm are risk factors for relapse in CSI seminoma. Patients without risk factors have a low RR and adjuvant therapy is not justified in these patients. The efficacy of adjuvant carboplatin is relatively low and there is need to explore more effective adjuvant treatment options in patients with high-risk seminoma. The data do not support the concept of a steep dose response for adjuvant carboplatin.

  • 24.
    Tandstad, T.
    et al.
    St Olavs University Hospital, Norway.
    Stahl, O.
    Skåne University Hospital, Sweden.
    Hakansson, U.
    Skåne University Hospital, Sweden.
    Dahl, O.
    University of Bergen, Norway; Haukeland Hospital, Norway.
    Haugnes, H. S.
    University of Tromso, Norway; University Hospital North Norway, Norway.
    Klepp, O. H.
    Alesund Hospital, Norway.
    Langberg, C. W.
    Oslo University Hospital, Norway.
    Laurell, A.
    University of Uppsala Hospital, Sweden.
    Oldenburg, J.
    Oslo University Hospital, Norway.
    Solberg, A.
    St Olavs University Hospital, Norway.
    Soderstrom, K.
    Norrland University Hospital, Sweden.
    Cavallin-Stahl, E.
    Skåne University Hospital, Sweden.
    Stierner, U.
    Sahlgrens University Hospital, Sweden.
    Wahlquist, R.
    Oslo University Hospital, Norway.
    Wall, Najme
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology.
    Cohn-Cedermark, G.
    Karolinska Institute, Sweden; Karolinska University Hospital, Sweden.
    One course of adjuvant BEP in clinical stage I nonseminoma mature and expanded results from the SWENOTECA group2014In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 25, no 11, p. 2167-2172Article in journal (Refereed)
    Abstract [en]

    The SWENOTECA group treated 517 clinical stage I nonseminoma patients with one course of adjuvant BEP in a prospective study. The median follow-up is 7.9 years. One course of adjuvant BEP reduced the risk of relapse by over 90%. The relapse rates were 1.6% in low-risk disease and 3.2% in high-risk disease. One course of adjuvant BEP should be considered a standard adjuvant treatment option.SWENOTECA has since 1998 offered patients with clinical stage I (CS I) nonseminoma, adjuvant chemotherapy with one course of bleomycin, etoposide and cisplatin (BEP). The aim has been to reduce the risk of relapse, sparing patients the need of toxic salvage treatment. Initial results on 312 patients treated with one course of adjuvant BEP, with a median follow-up of 4.5 years, have been previously published. We now report mature and expanded results. In a prospective, binational, population-based risk-adapted treatment protocol, 517 Norwegian and Swedish patients with CS I nonseminoma received one course of adjuvant BEP. Patients with lymphovascular invasion (LVI) in the primary testicular tumor were recommended one course of adjuvant BEP. Patients without LVI could choose between surveillance and one course of adjuvant BEP. Data for patients receiving one course of BEP are presented in this study. At a median follow-up of 7.9 years, 12 relapses have occurred, all with IGCCC good prognosis. The latest relapse occurred 3.3 years after adjuvant treatment. The relapse rate at 5 years was 3.2% for patients with LVI and 1.6% for patients without LVI. Five-year cause-specific survival was 100%. The updated and expanded results confirm a low relapse rate following one course of adjuvant BEP in CS I nonseminoma. One course of adjuvant BEP should be considered a standard treatment in CS I nonseminoma with LVI. For patients with CS I nonseminoma without LVI, one course of adjuvant BEP is also a treatment option.

  • 25.
    Tobin, N. P.
    et al.
    Karolinska Institute, Sweden; University Hospital, Sweden.
    Harrell, J. C.
    University of N Carolina, NC 27599 USA.
    Lovrot, J.
    Karolinska Institute, Sweden; University Hospital, Sweden.
    Egyhazi Brage, S.
    Karolinska Institute, Sweden; University Hospital, Sweden.
    Frostvik Stolt, M.
    Karolinska Institute, Sweden; University Hospital, Sweden.
    Carlsson, L.
    Sundsvall Gen Hospital, Sweden.
    Einbeigi, Z.
    Sahlgrens University Hospital, Sweden.
    Linderholm, B.
    Karolinska Institute, Sweden; University Hospital, Sweden; Sahlgrens University Hospital, Sweden.
    Loman, N.
    Skåne University Hospital, Sweden.
    Malmberg, M.
    Skåne University Hospital, Sweden.
    Walz, Thomas
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology. Karolinska Institute, Sweden; University Hospital, Sweden.
    Ferno, M.
    Lund University, Sweden.
    Perou, C. M.
    University of N Carolina, NC 27599 USA.
    Bergh, J.
    Karolinska Institute, Sweden; University Hospital, Sweden.
    Hatschek, T.
    Karolinska Institute, Sweden; University Hospital, Sweden.
    Lindstrom, L. S.
    University Hospital, Sweden; University of Calif San Francisco, CA USA; Karolinska Institute, Sweden.
    Molecular subtype and tumor characteristics of breast cancer metastases as assessed by gene expression significantly influence patient post-relapse survival2015In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 26, no 1, p. 81-88Article in journal (Refereed)
    Abstract [en]

    We and others have recently shown that tumor characteristics are altered throughout tumor progression. These findings emphasize the need for re-examination of tumor characteristics at relapse and have led to recommendations from ESMO and the Swedish Breast Cancer group. Here, we aim to determine whether tumor characteristics and molecular subtypes in breast cancer metastases confer clinically relevant prognostic information for patients. The translational aspect of the Swedish multicenter randomized trial called TEX included 111 patients with at least one biopsy from a morphologically confirmed locoregional or distant breast cancer metastasis diagnosed from December 2002 until June 2007. All patients had detailed clinical information, complete follow-up, and metastasis gene expression information (Affymetrix array GPL10379). We assessed the previously published gene expression modules describing biological processes [proliferation, apoptosis, human epidermal receptor 2 (HER2) and estrogen (ER) signaling, tumor invasion, immune response, and angiogenesis] and pathways (Ras, MAPK, PTEN, AKT-MTOR, PI3KCA, IGF1, Src, Myc, E2F3, and beta-catenin) and the intrinsic subtypes (PAM50). Furthermore, by contrasting genes expressed in the metastases in relation to survival, we derived a poor metastasis survival signature. A significant reduction in post-relapse breast cancer-specific survival was associated with low-ER receptor signaling and apoptosis gene module scores, and high AKT-MTOR, Ras, and beta-catenin module scores. Similarly, intrinsic subtyping of the metastases provided statistically significant post-relapse survival information with the worst survival outcome in the basal-like [hazard ratio (HR) 3.7; 95% confidence interval (CI) 1.3-10.9] and HER2-enriched (HR 4.4; 95% CI 1.5-12.8) subtypes compared with the luminal A subtype. Overall, 25% of the metastases were basal-like, 32% HER2-enriched, 10% luminal A, 28% luminal B, and 5% normal-like. We show that tumor characteristics and molecular subtypes of breast cancer metastases significantly influence post-relapse patient survival, emphasizing that molecular investigations at relapse provide prognostic and clinically relevant information.

  • 26. Tropé, C
    et al.
    Kaern, J
    Hogberg, T
    Abeler, V
    Hagen, B
    Kristensen, G
    Onsrud, M
    Pettersen, E
    Rosenberg, Per
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Biomedicine and Surgery, Oncology. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Sandvei, R
    Sundfor, K
    Vergote, I
    Randomized study on adjuvant chemotherapy in stage I high-risk ovarian cancer with evaluation of DNA-ploidy as prognostic instrument.2000In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 11, p. 281-288Article in journal (Refereed)
  • 27.
    Vermorken, J B
    et al.
    Department of Medical Oncology, University Hospital Antwerp, Edegem, Belgium.
    Åvall-Lundqvist, Elisabeth
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Department of Gynecological Oncology, Karolinska University Hospital, Sweden.
    Pfisterer, J
    Universitätsklinikum, Klinik für Gynäkologie und Geburtshilfe, Kiel, Germany.
    Bacon, M
    NCIC Clinical Trial Group, Queen’s University, Kingston, Ontario, Canada.
    The Gynecologic Cancer Intergroup (GCIG): history and current status.2005In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 16, no 8, p. viii39-viii42Article in journal (Refereed)
    Abstract [en]

    Randomized trials are considered the definitive source of evidence for guiding decisions in clinical practice, especially when the magnitude of the expected treatment difference is at best moderate. Goals of these trials are (i) to determine the effectiveness of a treatment relative to the best current standard of care, or (ii) to assess whether a new treatment is as effective as the standard, but associated with less toxicity, cost or better quality of life. The design, execution and analysis of such trials must be based on sound scientific and ethical criteria, but it is also crucial that they have sufficient statistical power to detect a realistic and clinically important difference in overall or progression-free survival [1]. Lack of statistical power owing to small numbers of enrolled patients has been a serious problem in ovarian cancer trials in the past. Both progression-free and overall survival can be considered as important end points (although progressionfree survival is also often considered as a surrogate end point for survival) and are of obvious clinical relevance for the patients, just as are quality of life or symptoms scores

  • 28.
    Vermorken, JB
    et al.
    EORTC (Europe).
    Parmar, MKB
    MRC/NCRI (UK).
    Brady, MF
    GOG (USA).
    Eisenhauer, EA
    NCIC-CTG (Canada).
    Högberg, Thomas
    NSGO (Scandinavia).
    Ozols, RF
    GOG (USA).
    Rochon, J
    AGO-OVAR (Germany).
    Rustin, GJS
    MRC/NCRI (UK).
    Sagae, S
    Verheijen, RHM
    EORTC (Europe).
    Clinical trials in ovarian carcinoma: study methodology2005In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 16, no S8, p. 20-29Article in journal (Refereed)
  • 29.
    Weiner, Maria
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Oncology. Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Health Sciences.
    Skoog, L
    Karolinska Institute, Sweden.
    Fornander, T
    Karolinska Institute, Sweden.
    Nordenskjöld, Bo
    Linköping University, Department of Clinical and Experimental Medicine, Oncology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology.
    Sgroi, D C.
    Massachusetts General Hospital, Boston, USA.
    Stål, Olle
    Linköping University, Department of Clinical and Experimental Medicine, Oncology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology.
    Oestrogen receptor co-activator AIB1 is a marker of tamoxifen benefit in postmenopausal breast cancer2013In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 24, no 8, p. 1994-1999Article in journal (Refereed)
    Abstract [en]

    Background The oestrogen receptor (ER) co-activator amplified in breast cancer 1 (AIB1) has been suggested as a treatment predictive and prognostic marker in breast cancer. Studies have however not been unanimous.

    Patients and methods AIB1 protein expression was analysed by immunohistochemistry on tissue micro-arrays with tumour samples from 910 postmenopausal women randomised to tamoxifen treatment or no adjuvant treatment. Associations between AIB1 expression, clinical outcome in the two arms and other clinicopathological variables were examined.

    Results In patients with ER-positive breast cancer expressing low tumour levels of AIB1 (<75%), we found no significant difference in recurrence-free survival (RFS) or breast cancer-specific survival (BCS) between tamoxifen treated and untreated patients. In patients with high AIB1 expression (>75%), there was a significant decrease in recurrence rate (HR 0.40, 95% CI 0.26–0.61, P < 0.001) and breast cancer mortality rate (HR 0.38, 95% CI 0.21–0.69, P = 0.0015) with tamoxifen treatment. In the untreated arm, we found high expression of AIB1 to be significantly associated with lower RFS (HR 1.74, 95% CI 1.20–2.53, P = 0.0038).

    Conclusion Our results suggest that high AIB1 is a predictive marker of good response to tamoxifen treatment in postmenopausal women and a prognostic marker of decreased RFS in systemically untreated patients.

  • 30.
    Wilking, N.
    et al.
    Department of Oncology, Karolinska Institutet, Stockholm, Sweden, Radiumhemmet Karolinska Hospital, Stockholm, Sweden.
    Lidbrink, E.
    Radiumhemmet, Karolinska Institutet and University Hospital, Solna, S-171 76 Stockholm, Sweden.
    Wiklund, T.
    Roche OY, Espoo, Finland, Department of Oncology, University Hospital, Helsinki, Finland.
    Erikstein, B.
    Southern Norway Regional Health Authority, Skien, Norway, The Norwegian Radiumhospital, Oslo, Norway.
    Lindman, H.
    Department of Oncology, Akademiska Hospital, Uppsala, Sweden.
    Malmstrom, P.
    Malmström, P., Department of Oncology, University Hospital, Lund, Sweden.
    Kellokumpu-Lehtinen, P.
    Department of Oncology, Tampere University, University Hospital, Tampere, Finland.
    Bengtsson, N.-O.
    Department of Oncology, University Hospital, Umeå, Sweden.
    Söderlund, G.
    Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Anker, G.
    Department of Oncology, Haukeland University Hospital, Bergen, Norway, Department of Oncology, Haukeland Hospital, Bergen, Norway.
    Wist, E.
    Department of Oncology, Ullevål University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway, Department of Oncology, Regional Hospital, Tromsø, Norway.
    Ottosson, S.
    Department of Oncology, NÄL, Trollhättan, Sweden.
    Salminen, E.
    Department of Oncology, Turku University Hospital, Turku, Finland.
    Ljungman, P.
    Haematology Centre, Karolinska University Hospital, Stockholm, Sweden, Department of Hematology, Huddinge Hospital, Stockholm, Sweden.
    Holte, H.
    Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway, Hematology Section, The Norwegian Radiumhospital, Oslo, Norway.
    Nilsson, J.
    Trial Form Support AB, Stockholm, Sweden.
    Blomqvist, C.
    Department of Oncology, University Hospital, Helsinki, Finland.
    Bergh, J.
    Department of Oncology, Karolinska Institutet, Stockholm, Sweden, Radiumhemmet, Karolinska Institutet and University Hospital, Solna, S-171 76 Stockholm, Sweden, Radiumhemmet Karolinska Hospital, Stockholm, Sweden.
    Hoglund, M.
    Höglund, M., Department of Hematology, University Hospital, Uppsala, Sweden.
    Bengtsson, M.
    Department of Clinical Immunology, University Hospital, Uppsala, Sweden.
    Gruber, A.
    Department of Hematology, Karolinska Hospital, Stockholm, Sweden.
    Fornander, T.
    Department of Oncology, Södersjukhuset,, Stockholm, Sweden.
    Petterson-Skold, D.
    Petterson-Sköld, D., Department of Oncology, Danderyd Hospital, Stockholm, Sweden.
    Lofvenberg, E.
    Löfvenberg, E., Department of Hematology, University Hospital, Umeå, Sweden.
    Villman, K.
    Department of Oncology, Örebro Hospital, Örebro, Sweden.
    Karlsson, Katarina
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Health Sciences, Nursing Science.
    Hultborn, R.
    Department of Oncology, Sahlgrenska Hospital, Göteborg, Sweden.
    Ottoson, S.
    Department of Oncology, Sahlgrenska Hospital, Göteborg, Sweden.
    Mattson, J.
    Department of Surgery, Sahlgrenska Hospital, Göteborg, Sweden.
    Jansson, S.
    Department of Surgery, Sahlgrenska Hospital, Göteborg, Sweden.
    Braide, I.
    Department of Hematology, Sahlgrenska Hospital, Göteborg, Sweden.
    Carlsson, G.
    Department of Oncology, Östra Hospital, Göteborg, Sweden.
    Rodjer, S.
    Rödjer, S., Department of Hematology, Östra Hospital, Göteborg, Sweden.
    Sallerfors, B.
    Department of Hematology, University Hospital, Lund, Sweden.
    Ahlgren, J.
    Department of Oncology, Gävle Hospital, Gävle, Sweden.
    Gawelin, A.
    Department of Oncology, Gävle Hospital, Gävle, Sweden.
    Solderberg, M.
    Sölderberg, M., Department of Oncology, Karlstad Hospital, Karlstad, Sweden.
    Hansen, J.
    Department of Oncology, Västerås Hospital, Västerås, Sweden.
    Stenstam, B.
    Department of Oncology, Mälarsjukhuset, Eskilstuna, Sweden.
    Svensson, J.-H.
    Mälarsjukhuset Eskilstuna of Oncology, Borås Hospital, Borås, Sweden.
    Norberg, B.
    Department of Oncology, Ryhov Hospital, Jönköping, Sweden.
    Kvalheim, G.
    Department of Medicine, The Norwegian Radiumhospital, Oslo, Norway.
    Sommer, H.H.
    Department of Oncology, Ullevål Hospital, Oslo, Norway.
    Tangen, J.M.
    Department of Hematology, Ullevål Hospital, Oslo, Norway.
    Lundgren, S.
    Department of Oncology, Regional Hospital, Trondheim, Norway.
    Remes, K.
    Department of Internal Medicine, University Hospital, Turku, Finland.
    Lehtinen, M.
    Department of Clinical Chemistry, Division of Hematology, University Hospital, Tampere, Finland.
    Koivinen, E.
    Department of Clinical Chemistry, Division of Hematology, University Hospital, Tampere, Finland.
    Turpeenniemi-Hujanen, T.
    Department of Oncology, Oulu University Hospital, Oulu, Finland.
    Kuittinen, O.
    Department of Oncology, Oulu University Hospital, Oulu, Finland.
    Voutilainen, L.
    Department of Oncology, Kuopio University Hospital, Kuopio, Finland.
    Mirza, M.R.
    Department of Oncology, University Hospital, Odense, Denmark.
    Rose, C.
    Department of Oncology, University Hospital, Odense, Denmark.
    Long-term follow-up of the SBG 9401 study comparing tailored FEC-based therapy versus marrow-supported high-dose therapy2007In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 18, no 4, p. 694-700Article in journal (Refereed)
    Abstract [en]

    Background: The purpose was to investigate adjuvant marrow-supportive high-dose chemotherapy compared with an equitoxicity-tailored comparator arm. Patients and methods: Five hundred and twenty-five women below theage of 60 years with operated high-risk primary breast cancer were randomised to nine cycles of granulocyte colony-stimulating factor supported and individually tailored FEC (5-fluorouracil, epirubicin, cyclophosphamide), (n = 251) or standard FEC followed by marrow-supported high-dose therapy with CTCb (cyclophosphamide, thiotepa, carboplatin) therapy (n = 274), followed by locoregional radiotherapy and tamoxifen for 5 years. Results: There were 104 breast cancer relapses in the tailored FEC group versus 139 in the CTCb group (double triangular method by Whitehead, P = 0.046), with a median follow-up of all included patients of 60.8 months. The event-free survival demonstrated 121 and 150 events in the tailored FEC- and CTCb group, respectively [P = 0.074, hazard ratio (HR) 0.804, 95% confidence interval (CI) 0.633-1.022]. Ten patients in the tailored FEC regimen developed acute myeloid leukaemia (AML)/myelodysplasia (MDS). One hundred deaths occurred in the tailored FEC group and 121 in the CTCb group (P = 0.287, HR 0.866, 95% CI 0.665-1.129). Conclusion: The update of this study shows an improved outcome linked to the tailored FEC treatment in relation to breast cancer relapse, but also an increased incidence of AML/MDS. © 2007 Oxford University Press.

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