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  • 1.
    Baumann, P.
    et al.
    Divisions of Oncology, Hospital Physics, Radiumhemment, Sweden.
    Nyman, J.
    Department of Oncology and Radiation Physics, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Hoyer, M.
    Divisions of Oncology and Medical Physics, Aarhus University Hospital, Denmark.
    Gagliardi, G.
    Divisions of Oncology, Hospital Physics, Radiumhemment, Sweden.
    Lax, I.
    Divisions of Oncology, Hospital Physics, Radiumhemment, Sweden.
    Wennberg, B.
    Divisions of Oncology, Hospital Physics, Radiumhemment, Sweden.
    Drugge, N.
    Department of Oncology and Radiation Physics, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Ekberg, L.
    Divisions of Oncology, Hospital Physics, Malmö University Hospital, Sweden.
    Friesland, S.
    Divisions of Oncology, Hospital Physics, Radiumhemment, Sweden.
    Johansson, K.-A.
    Department of Oncology and Radiation Physics, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Lund, J.-A.
    Lund, J.-Å., Department of Oncology, Trondheim University Hospital, Norway.
    Morhed, E.
    Department of Oncology and Radiotherapy, Akademiska University Hospital, Uppsala, Sweden.
    Nilsson, K.
    Department of Oncology and Radiotherapy, Akademiska University Hospital, Uppsala, Sweden.
    Levin, N.
    Department of Oncology, Trondheim University Hospital, Norway.
    Paludan, M.
    Divisions of Oncology and Medical Physics, Aarhus University Hospital, Denmark.
    Sederholm, Christer
    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.
    Traberg, A.
    Divisions of Oncology and Medical Physics, Aarhus University Hospital, Denmark.
    Wittgren, L.
    Divisions of Oncology, Hospital Physics, Malmö University Hospital, Sweden.
    Lewensohn, R.
    Divisions of Oncology, Hospital Physics, Radiumhemment, Sweden.
    Stereotactic body radiotherapy for medically inoperable patients with stage I non-small cell lung cancer - A first report of toxicity related to COPD/CVD in a non-randomized prospective phase II study2008In: Radiotherapy and Oncology, ISSN 0167-8140, E-ISSN 1879-0887, Vol. 88, no 3, p. 359-367Article in journal (Refereed)
    Abstract [en]

    Background and Aims: In a retrospective study using stereotactic body radiotherapy (SBRT) in medically inoperable patients with stage I NSCLC we previously reported a local control rate of 88% utilizing a median dose of 15 Gy × 3. This report records the toxicity encountered in a prospective phase II trial, and its relation to coexisting chronic obstructive pulmonary disease (COPD) and cardio vascular disease (CVD). Material and methods: Sixty patients were entered in the study between August 2003 and September 2005. Fifty-seven patients (T1 65%, T2 35%) with a median age of 75 years (59-87 years) were evaluable. The baseline mean FEV1% was 64% and median Karnofsky index was 80. A total dose of 45 Gy was delivered in three fractions at the 67% isodose of the PTV. Clinical, pulmonary and radiological evaluations were made at 6 weeks, 3, 6, 9, 12, 18, and 36 months post-SBRT. Toxicity was graded according to CTC v2.0 and performance status was graded according to the Karnofsky scale. Results: At a median follow-up of 23 months, 2 patients had relapsed locally. No grade 4 or 5 toxicity was reported. Grade 3 toxicity was seen in 12 patients (21%). There was no significant decline of FEV1% during follow-up. Low grade pneumonitis developed to the same extent in the CVD 3/17 (18%) and COPD 7/40 (18%) groups. The incidence of fibrosis was 9/17 (53%) and pleural effusions was 8/17 (47%) in the CVD group compared with 13/40 (33%) and 5/40 (13%) in the COPD group. Conclusion: SBRT for stage I NSCLC patients who are medically inoperable because of COPD and CVD results in a favourable local control rate with a low incidence of grade 3 and no grade 4 or 5 toxicity. © 2008 Elsevier Ireland Ltd. All rights reserved.

  • 2. Baumann, Pia
    et al.
    Nyman, Jan
    Hoyer, Morten
    Wennberg, Berit
    Gagliardi, Giovanna
    Lax, Ingmar
    Drugge, Ninni
    Ekberg, Lars
    Friesland, Signe
    Johansson, Karl-Axel
    Lund, Jo-Asmund
    Morhed, Elisabeth
    Nilsson, Kristina
    Levin, Nina
    Paludan, Merete
    Sederholm, Christer
    Linköping University, Department of Medicine and Health Sciences, Pulmonary Medicine . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Respiratory Medicine UHL.
    Traberg, Anders
    Wittgren, Lena
    Lewensohn, Rolf
    Outcome in a Prospective Phase II Trial of Medically Inoperable Stage I Non-Small-Cell Lung Cancer Patients Treated With Stereotactic Body Radiotherapy2009In: JOURNAL OF CLINICAL ONCOLOGY, ISSN 0732-183X, Vol. 27, no 20, p. 3290-3296Article in journal (Refereed)
    Abstract [en]

    Purpose The impact of stereotactic body radiotherapy (SBRT) on 3-year progression-free survival of medically inoperable patients with stage I non-small-cell lung cancer (NSCLC) was analyzed in a prospective phase II study. Patients and Methods Fifty-seven patients with T1NOMO (70%) and T2N0M0 (30%) were included between August 2003 and September 2005 at seven different centers in Sweden, Norway, and Denmark and observed up to 36 months. SBRT was delivered with 15 Gy times three at the 67% isodose of the planning target volume. Results Progression-free survival at 3 years was 52%. Overall- and cancer-specific survival at 1, 2, and 3 years was 86%, 65%, 60%, and 93%, 88%, 88%, respectively. There was no statistically significant difference in survival between patients with T1 or T2 tumors. At a median follow-up of 35 months (range, 4 to 47 months), 27 patients (47%) were deceased, seven as a result of lung cancer and 20 as a result of concurrent disease. Kaplan-Meier estimated local control at 3 years was 92%. Local relapse was observed in four patients (7%). Regional relapse was observed in three patients (5%). Nine patients (16%) developed distant metastases. The estimated risk of all failure (local, regional, or distant metastases) was increased in patients with T2 (41%) compared with those with T1 (18%) tumors (P = .027). Conclusion With a 3-year local tumor control rate higher than 90% with limited toxicity, SBRT emerges as state-of-the-art treatment for medically inoperable stage I NSCLC and may even challenge surgery in operable instances.

  • 3.
    Dittrich, Christian
    et al.
    Kaiser Franz Josef Spital, Austria Kaiser Franz Josef Spital, Austria .
    Papai-Szekely, Zsolt
    St George Hospital Fejer County, Hungary .
    Vinolas, Nuria
    Hospital Clin Barcelona, Spain .
    Sederholm, Christer
    Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Respiratory Medicine.
    Hartmann, Joerg T.
    Department Internal Medical II Hematol and Medical Oncol, Germany Catholic Hospital Consortium Ostwestfalen, Germany .
    Behringer, Dirk
    Clin Hematol and Oncol, Germany .
    Kazeem, Gbenga
    Eli Lilly UK, England .
    Desaiah, Durisala
    Eli Lilly Corp Centre, IN USA .
    Leschinger, Monika I.
    Lilly Deutschland GmbH, Germany .
    von Pawel, Joachim
    Asklepios Hospital Munchen Gauting, Germany .
    A randomised phase II study of pemetrexed versus pemetrexed plus erlotinib as second-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer2014In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 50, no 9, p. 1571-1580Article in journal (Refereed)
    Abstract [en]

    Introduction: Pemetrexed and erlotinib have been approved as second-line monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC). This multicentre, randomised, open-label, parallel phase II study assessed efficacy and safety of pemetrexed versus pemetrexed + erlotinib in patients with advanced non-squamous NSCLC. Methods: NSCLC stage III-IV patients who failed one prior platinum-based chemotherapy regimen, greater than= 1 measurable lesion by Response Evaluation Criteria in Solid Tumors, and Eastern Cooperative Oncology Group performance status less than= 2 were eligible. Patients received pemetrexed 500 mg/m(2) with vitamin B-12 and folic acid q3w alone or combined with erlotinib 150 mg daily. The primary end-point was progression-free survival (PFS). Secondary end-points were overall survival (OS), time-to-treatment failure (TTTF), response and toxicity. Results: Of 165 randomised non-squamous patients, 159 were treated (pemetrexed: 83; pemetrexed + erlotinib: 76). The median PFS (months; 95% CI) was 2.89 (1.94, 3.38) for pemetrexed versus 3.19 (2.86, 4.70) for pemetrexed + erlotinib (hazard ratio [HR] 0.63; 95% CI: (0.44, 0.90); P = 0.0047). The median OS (months; 95% CI) was 7.75 (5.29, 10.41) for pemetrexed versus 11.83 (8.18, 16.66) for pemetrexed + erlotinib (HR: 0.68; 95% CI: 0.46, 0.98; P = 0.019). The median TTTF (months: 95% CI) was 2.4 (1.74, 2.99) for pemetrexed versus 3.0 (2.23, 4.07) for pemetrexed + erlotinib (HR 0.64; 95% CI: 0.46, 0.89; P = 0.0034). One patient died in pemetrexed + erlotinib arm due to febrile neutropenia. Grades 3/4 drug-related toxicities (in greater than= 5% of patients) in pemetrexed/pemetrexed + erlotinib were febrile neutropenia (2.4%/10.5%), diarrhoea (1.2%/5.3%), rash (1.2%/9.2%); anaemia (6%/11.8%), leukopenia (9.6%/23.7%), neutropenia (9.6%/25.0%), and thrombocytopenia (4.8%/14.5%). Conclusions: Pemetrexed + erlotinib treatment significantly improved PFS, OS and TTTF in 2nd line non-squamous NSCLC and was associated with an increase in grade 3/4 toxicities compared with pemetrexed alone.

  • 4.
    Hallqvist, A
    et al.
    Gothenburg University.
    Wagenius, G
    Akad University Hospital.
    Rylander, H
    Gothenburg University.
    Brodin, O
    Karolinska University Hospital.
    Holmberg, E
    Gothenburg University.
    Loden, B
    Karlstad Central Hospital.
    -B Ewers, S
    University Lund Hospital.
    Bergstrom, S
    Gavle Central Hospital.
    Wichardt-Johansson, G
    Karolinska University Hospital.
    Nilsson, K
    Akad University Hospital.
    Ekberg, L
    University Hospital MAS.
    Sederholm, Christer
    Linköping University, Department of Medicine and Health Sciences, Pulmonary Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Respiratory Medicine UHL.
    Nyman, J
    Gothenburg University.
    Concurrent cetuximab and radiotherapy after docetaxel-cisplatin induction chemotherapy in stage III NSCLC: Satellite-A phase II study from the Swedish Lung Cancer Study Group2011In: LUNG CANCER, ISSN 0169-5002, Vol. 71, no 2, p. 166-172Article in journal (Refereed)
    Abstract [en]

    Background: Several attempts to increase the locoregional control in locally advanced lung cancer including concurrent chemotherapy, accelerated fractionation and dose escalation have been made during the last years. As the EGFR directed antibody cetuximab has shown activity concurrent with radiotherapy in squamous cell carcinoma of the head and neck, as well as in stage IV NSCLC combined with chemotherapy, we wanted to investigate radiotherapy with concurrent cetuximab in locally advanced NSCLC, a tumour type often over expressing the EGF-receptor. Methods: Between February 2006 and August 2007 75 patients in stage Ill NSCLC with good performance status (PS 0 or 1) and adequate lung function (FEV1 andgt; 1.0) were enrolled in this phase II study at eight institutions. Treatment consisted of 2 cycles of induction chemotherapy, docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2) with 3 weeks interval. An initial dose of cetuximab 400 mg/m(2) was given before start of 3D-CRT to 68 Gy with 2 Gy per fraction in 7 weeks concurrent with weekly cetuximab 250 mg/m(2). Toxicity was scored weekly during radiotherapy (CTC 3.0), and after treatment the patients were followed every third month with CT-scans, toxicity scoring and QLQ. Results: Seventy-one patients were eligible for analysis as four were incorrectly enrolled. Histology: adenocarcinoma 49%, squamous cell carcinoma 39% and other NSCLC 12%. The majority had PS 0 (62.5%), median age 62.2 (42-81), 50% were women and 37% had a pre-treatment weight loss andgt; 5%. Toxicity: esophagitis grade 1-2: 72%; grade 3:1.4%. Hypersensitivity reactions grade 3-4: 5.6%. Febrile neutropenia grade 3-4: 15.4%. Skin reactions grade 1-2: 74%; grade 3: 4.2%. Diarrhoea grade 1-2: 38%; grade 3: 11.3%. Pneumonitis grade 1-2: 26.8%; grade 3: 4.2%; grade 5:1.4%. The median follow-up was 39 months for patients alive and the median survival was 17 months with a 1-, 2- and 3-year OS of 66%, 37% and 29% respectively. Until now local or regional failure has occurred in 20 patients and 22 patients have developed distant metastases. Weight loss, PS and stage were predictive for survival in univariate as well as in multivariate analysis. Conclusion: Induction chemotherapy followed by concurrent cetuximab and RT to 68 Gy is clearly feasible with promising survival. Toxicity, e.g. pneumonitis and esophagitis is low compared to most schedules with concurrent chemotherapy. This treatment strategy should be evaluated in a randomised manner vs. concurrent chemoradiotherapy to find out if it is a valid treatment option.

  • 5.
    Hillerdal, Gunnar
    et al.
    Karolinska University Hospital.
    Sederholm, Christer
    Linköping University, Department of Medicine and Health Sciences, Pulmonary Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Respiratory Medicine UHL.
    Andersson, Kerstin
    University Lund Hospital.
    Randomized phase II study of gemcitabine and carboplatin +/- sequential docetaxel in non-small cell lung cancer2011In: LUNG CANCER, ISSN 0169-5002, Vol. 71, no 2, p. 178-181Article in journal (Refereed)
    Abstract [en]

    Sequential administration of chemotherapeutic drugs might have advantages: additive toxicity is avoided and the individual drugs can be given in full dosages. The Swedish group earlier found the combination of gemcitabine and carboplatin to be effective and with acceptable toxicity. The group therefore decided to add docetaxel in a sequential way in a randomized phase II study. Patients were randomized to either gemcitabine or carboplatin for six cycles or the same regimen for three cycles followed by weekly single agent docetaxel. The primary objective was time to progression (UP). One hundred and twenty-three patients with performance status WHO 0-2 and with earlier un-treated non-small cell lung cancer with measurable stage IIIB disease, not amenable to curative treatment, or stage IV disease without known metastatic spread to the CNS, were enrolled. Hematological toxicity was more common in the GC group but clinically significant bleeding or leucopenic fever occurred only in a minority of patients. No complete responses were noted. Partial response (PR) was observed in 19.3% and 20.8% in the GC and GCD group, respectively. Progression-free survival was 5.6 and 4.8 months and overall survival time 10.6 and 10.1 months in the GC and GCD groups, respectively. Thus, sequential treatment with docetaxel after treatment with gemcitabine and carboplatin did not improve time to progression, response rates, or overall survival.

  • 6.
    Koch, Andrea
    et al.
    Linköping University, Department of Medical and Health Sciences, Internal Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Centre, Allergy Centre UHL.
    Bergman, Bengt
    Department of Respiratory Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Holmberg, Erik
    Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden.
    Sederholm, Christer
    Linköping University, Department of Medical and Health Sciences, Pulmonary Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Surgery, Orthopaedics and Cancer Treatment, Department of Respiratory Medicine UHL.
    Ek, Lars
    Department of Respiratory Medicine and Allergology, Skåne University Hospital, Lund, Sweden.
    Kosieradzki, Jaroslaw
    Department of Respiratory Medicine and Allergology, Skåne University Hospital, Malmö, Sweden.
    Lamberg, Kristina
    Department of Pulmonary Medicine, Uppsala University Hospital, Uppsala, Sweden.
    Thaning, Lars
    Department of Pulmonary Medicine, University Hospital, Örebro, Sweden.
    Ydreborg, Sven-Olof
    Department of Medicine, County Hospital Ryhov, 551 85 Jönköping, Sweden.
    Sörenson, Sverre
    Linköping University, Department of Medical and Health Sciences, Pulmonary Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Surgery, Orthopaedics and Cancer Treatment, Department of Respiratory Medicine UHL.
    Effect of celecoxib on survival in patients with advanced non-small cell lung cancer: A double blind randomised clinical phase III trial (CYCLUS study) by the Swedish Lung Cancer Study Group2011In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 47, no 10, p. 1546-1555Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Increased expression of cyclooxygenase-2 (COX-2) is common in non-small cell lung cancer (NSCLC) and has been associated with poor prognosis. Experimental and clinical phase II trials have indicated that the addition of the COX-2 inhibitor celecoxib to palliative chemotherapy might increase survival time in patients with advanced NSCLC.

    METHODS: We performed a double-blind, placebo-controlled multicentre phase III trial at 13 centres in Sweden. Three hundred and nineteen patients with advanced NSCLC stage IIIB-IV and performance status 0-2 were randomised to receive celecoxib 400mg b.i.d. or placebo in addition to palliative chemotherapy. The primary objective was to compare overall survival. Other end-points were quality of life, progression-free survival, toxicity, cardiovascular events and biological markers. The trial is registered with ClinicalTrials.gov, No. NCT00300729.

    FINDINGS: Three hundred and sixteen patients were included in the analysis, 158 in each treatment group. Median survival time was 8.5months. There was no survival difference between the treatment arms. Small but not statistically significant differences in global quality of life and pain were seen favouring the celecoxib group. No increased incidence of cardiovascular events was observed in the celecoxib group.

    INTERPRETATION: This study failed to demonstrate a survival benefit of the addition of celecoxib to palliative chemotherapy.

  • 7.
    M Wennberg, Berit
    et al.
    Karolinska University Hospital, Stockholm.
    Baumann, Pia
    Karolinska University Hospital, Stockholm.
    Gagliardi, Giovanna
    Karolinska University Hospital, Stockholm.
    Nyman, Jan
    Sahlgrens University Hospital, Gothenburg.
    Drugge, Ninni
    Sahlgrens University Hospital, Gothenburg.
    Hoyer, Morten
    Aarhus University Hospital, Aarhus, Denmark.
    Traberg, Anders
    Aarhus University Hospital, Aarhus, Denmark.
    Nilsson, Kristina
    Uppsala University Hospital, Uppsala.
    Morhed, Elisabeth
    Uppsala University Hospital, Uppsala.
    Ekberg, Lars
    Malmo University Hospital, Malmo.
    Wittgren, Lena
    Malmo University Hospital, Malmo.
    Lund, Jo-Asmund
    University Trondheim Hospital, Trondheim Norway.
    Levin, Nina
    University Trondheim Hospital, Trondheim Norway.
    Sederholm, Christer
    Linköping University, Department of Medical and Health Sciences, Pulmonary Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Surgery, Orthopaedics and Cancer Treatment, Department of Respiratory Medicine UHL.
    Lewensohn, Rolf
    Karolinska University Hospital, Stockholm.
    Lax, Ingmar
    Karolinska University Hospital, Stockholm.
    NTCP modelling of lung toxicity after SBRT comparing the universal survival curve and the linear quadratic model for fractionation correction2011In: ACTA ONCOLOGICA, ISSN 0284-186X, Vol. 50, no 4, p. 518-527Article in journal (Refereed)
    Abstract [en]

    Background. In SBRT of lung tumours no established relationship between dose-volume parameters and the incidence of lung toxicity is found. The aim of this study is to compare the LQ model and the universal survival curve (USC) to calculate biologically equivalent doses in SBRT to see if this will improve knowledge on this relationship. Material and methods. Toxicity data on radiation pneumonitis grade 2 or more (RP2+) from 57 patients were used, 10.5% were diagnosed with RP2+. The lung DVHs were corrected for fractionation (LQ and USC) and analysed with the Lyman-Kutcher-Burman (LKB) model. In the LQ-correction alpha/beta = 3 Gy was used and the USC parameters used were: alpha/beta = 3 Gy, D-0 = 1.0 Gy, (n) over bar = 10, alpha = 0.206 Gy(-1) and d(T) = 5.8 Gy. In order to understand the relative contribution of different dose levels to the calculated NTCP the concept of fractional NTCP was used. This might give an insight to the questions of whether "high doses to small volumes" or "low doses to large volumes" are most important for lung toxicity. Results and Discussion. NTCP analysis with the LKB-model using parameters m = 0.4, D-50 = 30 Gy resulted for the volume dependence parameter (n) with LQ correction n = 0.87 and with USC correction n = 0.71. Using parameters m = 0.3, D-50 = 20 Gy n = 0.93 with LQ correction and n = 0.83 with USC correction. In SBRT of lung tumours, NTCP modelling of lung toxicity comparing models (LQ, USC) for fractionation correction, shows that low dose contribute less and high dose more to the NTCP when using the USC-model. Comparing NTCP modelling of SBRT data and data from breast cancer, lung cancer and whole lung irradiation implies that the response of the lung is treatment specific. More data are however needed in order to have a more reliable modelling.

  • 8.
    Nyman, J
    et al.
    Sahlgrens University Hospital.
    Friesland, S
    Sahlgrens University Hospital.
    Hallqvist, A
    Sahlgrens University Hospital.
    Seke, M
    University Hospital MAS.
    Bergstrom, S
    Gävle Central Hospital.
    Thaning, L
    Örebro University Hospital.
    Loden, B
    Karlstad Central Hospital.
    Sederholm, Christer
    Linköping University, Department of Medicine and Health Sciences, Pulmonary Medicine . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Respiratory Medicine UHL.
    Wagenius, G
    Akad University Hospital.
    How to improve loco-regional control in stages IIIa-b NSCLC? Results of a three-armed randomized trial from the Swedish Lung Cancer Study Group2009In: LUNG CANCER, ISSN 0169-5002, Vol. 65, no 1, p. 62-67Article in journal (Refereed)
    Abstract [en]

    Background: A combination of chemotherapy and radiotherapy is the treatment base for locally advanced non-small cell lung cancer (NSCLC). However, both loco-regional and distant failure is frequent. Attempts to improve the loco-regional control were made in three separate phase 11 studies in Swedish University Hospitals, where accelerated radiotherapy or concurrent daily or weekly chemotherapy with conventional radiotherapy were tested. Comparatively good results from these studies lead to this national randomized phase 11 study, the RAKET-study, where the different concepts were investigated on a wider basis for further phase III studies. Methods: Inoperable stage III non-small cell lung cancer patients in good performance status (PS andlt; 2) were equally randomized to either of three arms in eight institutions. All arms started with two cycles of induction chemotherapy: paclitaxel 200 mg/m(2) and carboplatin AUC6. Arm A: a third identical cycle was given concomitant with start of accelerated radiotherapy, 1.7 Gy BID to 64.6 Gy in 4.5 weeks. Arm B consisted of daily concomitant paclitaxel 12 mg/m(2) with conventionally fractionated radiotherapy: 2 Gy to 60 Gy in 6 weeks. Arm C: weekly concomitant paclitaxel 60 mg/m2 and identical radiotherapy to 60 Gy. Primary endpoint: TTP. Secondary: OS, toxicity, QL and relapse pattern. Results: Between June 2002 and May 2005 152 patients were randomized and of them 151 were evaluable: 78 men and 73 women, median age 62 years (43-78), 55% had performance status 0 and 45% PS 1. Thirty-four percent had stage IIIa and 66% IIIb. Histology: adenocarcinoma 48%, squamous cell carcinoma 32% and 20% non-small cell carcinoma. The three arms were well balanced. Toxicity was manageable with 12% grades 3-4 esophagitis, 1% grades 3-4 pneumonitis and there was no clear difference between the arms. The QL data did not differ either. Median time to progression was 9.8 (8.3-12.7) months (8.8, 10.3 and 9.3 months for arms A, B and C, respectively). Median survival was 17.8 (14.4-23.7) months (17.7, 17.7 and 20.6 months for A, B and C, respectively). The 1-, 3- and 5-year overall survival was 63, 31 and 24%. Sixty-nine percent of the patients relapsed with distant metastases initially and 31% had loco-regional tumor progression, without significant differences between treatment arms. Thirty-four percent developed brain metastases. Conclusions: Treatment results are quite equal by intensifying the loco-regional treatment either by accelerated fractionated radiotherapy or daily or weekly concomitant chemo-radiotherapy both in terms of

  • 9.
    Nyman, Jan
    et al.
    Sahlgrens University Hospital.
    Hallqvist, Andreas
    Sahlgrens University Hospital.
    Brodin, Ola
    Karolinska University Hospital.
    Nilsson, Kristina
    Akad Hospital, Uppsala.
    Bergstrom, Stefan
    Gävle Central Hospital.
    Loden, Britta
    Central Hospital Karlstad.
    Ewers, Sven-Borje
    Lund University Hospital.
    Ekberg, Lars
    University Hospital MAS.
    Rylander, Hillevi
    Sahlgrens University Hospital.
    Sederholm, Christer
    Linköping University, Department of Medicine and Health Sciences, Pulmonary Medicine . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Respiratory Medicine UHL.
    Wagenius, Gunnar
    Akad Hospital, Uppsala.
    Concurrent cetuximab and radiotherapy after docetaxel-cisplatin induction chemotherapy in stage III NSCLC: a phase II study from the Swedish Lung Cancer Study Group2009In: in JOURNAL OF THORACIC ONCOLOGY, vol 4, issue 9, 2009, Vol. 4, no 9, p. S373-S373Conference paper (Refereed)
    Abstract [en]

    n/a

  • 10.
    Sederholm, Christer
    et al.
    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.
    Hillerdal, G.
    Hillerdal, G..
    Lamberg, K.
    Lamberg, K..
    Kolbeck, K.
    Kölbeck, K..
    Dufmats, M.
    Dufmats, M..
    Westberg, R.
    Westberg, R..
    Gawande, S.R.
    Gawande, S.R..
    Phase III trial of gemcitabine plus carboplatin versus single-agent gemcitabine in the treatment of locally advanced or metastatic non-small-cell lung cancer: The Swedish Lung Cancer Study Group2005In: Journal of Clinical Oncology, ISSN 0732-183X, E-ISSN 1527-7755, Vol. 23, no 33, p. 8380-8388Article in journal (Refereed)
    Abstract [en]

    Purpose: This phase III study compared overall survival in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) when treated with single-agent gemcitabine versus gemcitabine/carboplatin. Secondary objectives were to compare response, time to progression, toxicity, and quality of life. Patients and Methods: Chemotherapy-naive patients received either gemcitabine alone (1,250 mg/m2 on days 1 and 8, gemcitabine arm) or with carboplatin (area under the curve 5 on day 1, GC arm) every 21 days. Results: Demographics and disease characteristics of 334 randomly assigned patients were comparable on both arms. An intent-to-treat analysis showed significantly better overall survival (log-rank P = .0205) and 2-year survival (15% v 5%, P = .009) favoring the GC arm. Per Cox multivariate analysis, only two covariates, treatment arm (GC v G) and baseline performance status (0 or 1 v 2), independently influenced survival. Per-protocol analyses showed significantly longer median time to progression (5.7 v 3.9 months, P = .0001) and significantly higher objective response rate (29.6 v 11.3%, P < .0001) in the GC arm. Grade 3 to 4 leucopenia and thrombocytopenia were significantly more pronounced in the GC arm (P for both variables < .001) but importantly without associated increases in fever, infection, bleeding, or hospitalizations. There was no discernible difference in global quality-of-life patterns between treatment arms. Conclusion: In advanced NSCLC, gemcitabine/carboplatin therapy resulted in significant survival benefit compared with single-agent gemcitabine without undue increase in toxicity. © 2005 by American Society of Clinical Oncology.

  • 11.
    Sörenson, Sverre
    et al.
    Linköping University, Department of Medical and Health Sciences, Pulmonary Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Respiratory Medicine. Östergötlands Läns Landsting, Heart and Medicine Center, Allergy Center.
    Fohlin, Helena
    Linköping University, Department of Clinical and Experimental Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Health and Developmental Care, Regional Cancer Center South East Sweden.
    Lindgren, Andrea
    Linköping University, Department of Medical and Health Sciences, Internal Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Center, Allergy Center.
    Lindskog, Magnus
    Uppsala University, Sweden .
    Bergman, Bengt
    Sahlgrens University Hospital, Sweden .
    Sederholm, Christer
    Linköping University, Department of Medical and Health Sciences, Pulmonary Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Respiratory Medicine.
    Ek, Lars
    Skåne University Hospital, Sweden .
    Lamberg, Kristina
    University of Uppsala Hospital, Sweden .
    Clinchy, Birgitta
    Linköping University, Department of Clinical and Experimental Medicine. Linköping University, Faculty of Health Sciences.
    Predictive role of plasma vascular endothelial growth factor for the effect of celecoxib in advanced non-small cell lung cancer treated with chemotherapy2013In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 49, no 1, p. 115-120Article in journal (Refereed)
    Abstract [en]

    Aim of the study: The primary purpose of this study is to investigate if pretreatment plasma levels of vascular endothelial growth factor (VEGF) are predictive of the effect of celecoxib on survival in advanced non-small cell lung cancer (NSCLC) treated with palliative chemotherapy. A secondary objective is to describe the course of plasma VEGF levels during and after treatment with cytotoxic chemotherapy combined with celecoxib or placebo. less thanbrgreater than less thanbrgreater thanMethods: In a previously published double-blind multicenter phase III trial, 316 patients with NSCLC stage IIIB or IV and World Health Organisation (WHO) performance status 0-2 were randomised to receive celecoxib 400 mg b.i.d. or placebo in combination with two-drug platinum-based chemotherapy. Chemotherapy cycle length was three weeks and planned duration of chemotherapy was four cycles. Celecoxib was given for a maximum of one year but was stopped earlier in case of disease progression or prohibitive toxicity. In a subset of patients, plasma VEGF levels were examined at onset of treatment and at 6, 12 and 20 weeks. less thanbrgreater than less thanbrgreater thanResults: VEGF levels at start of treatment were obtained in 107 patients at four study sites. The median value was 70 pg/ml. Mean values declined during the first 12 weeks and then increased at 20 weeks. A subpopulation treatment effect pattern plot (STEPP) analysis showed an inverse relationship between initial plasma VEGF and the impact of celecoxib on survival with zero effect at 200 pg/ml. The effect on survival by celecoxib in the whole subset of patients was positive (hazard ratio (HR)=0.64 [confidence interval (CI) 0.43-0.95], p=0.028). less thanbrgreater than less thanbrgreater thanConclusion: Low pretreatment plasma levels of VEGF appear to be predictive of a positive effect of celecoxib on survival.

  • 12.
    Tell, Roger
    et al.
    Karolinska University Hospital.
    Sederholm, Christer
    Linköping University, Department of Medical and Health Sciences, Pulmonary Medicine. Linköping University, Faculty of Health Sciences.
    Klintenberg, Claes
    Linköping University, Department of Clinical and Experimental Medicine, Oncology. Linköping University, Faculty of Health Sciences.
    Franksson, Lars
    Karolinska University Hospital.
    Branden, Eva
    Karolinska University Hospital.
    Hillerdal, Gunnar
    Karolinska University Hospital.
    Lonn, Ulf
    Gävle City Hospital.
    Linden, Carl-Johan
    Lund University Hospital.
    Ewers, Sven-Borje
    Lund University Hospital.
    Lamberg, Kristina
    Västerås Hospital.
    Mrazek, Eva
    Västerås Hospital.
    Loden, Britta
    Karlstad Central Hospital.
    Sjogren, Anders
    Karlstad Central Hospital.
    Linne, Thomas
    Bristol Myers Squibb AB.
    Friesland, Signe
    Karolinska University Hospital.
    Sirzen, Florin
    Karolinska University Hospital.
    Multicentre Phase II Trial of Paclitaxel and Carboplatin with Concurrent Radiotherapy in Locally Advanced Non-small Cell Lung Cancer2008In: Anticancer Research, ISSN 0250-7005, E-ISSN 1791-7530, Vol. 28, no 5B, p. 2851-2857Article in journal (Refereed)
    Abstract [en]

    Aim: To evaluate weekly, induction chemotherapy followed by weekly concomitant chemoradiotherapy in a multicentre phase II study of patients with wiresectable stage III non-small cell lung cancer (NSCLC; stage wet IIIB excluded). Patients (aid Methods: Eligible patients received three weekly cycles of paclitaxel 100 mg/m(2) and carboplatin AUC2 followed by six weekly cycles of paclitaxel 60 mg/m(2) and carboplatin AUC2 in combination with thoracic radiotherapy (2 Gy per fraction and day to a total (lose of 60 Gy), Results: Sixty-four patients (40 males and 24 females) with a median age of 63 Years (range, 43-79 years) entered the study. T and N stage were distributed as follows: T1 2 patients (3.2%). T2 10 patients (15.6%), T3 15 patients (23.4%). T4 37 patients (57.8%), N0 10 patients (15.6%). N1 1 patient (1.6%), N2 26 patients (40.6%), N3 26 patients (40.6%), and N missing I patient (1.6%). Seven patients (10.9%) suffered from grade 314 oesophagitis. Grade 112 oesophagitis occurred in 36 patients (56.3%) and pneumonitis grade 112 occurred in 10 patients (15.6%). Sixty-three patients were evaluated on an intent-to-treat basis. The overall response rate was 74.6%. The median time to progression was 247 days and median overall survival was 461 days. According to subgroup analyses, no statistically signicant differences were noted according to gender, age (<65 vs. >= 65 years), perfromance status, histology, or study centre. Conclusion: Induction chemotherapy followed by concurrent chemoradiotherapy with weekly cycles of paclitaxel and carboplatin is feasible and generates moderate toxicity. Efficacy is comparable to other recently published regimens. However, prognosis remains, ill general, poor for this group of patients and further work to develop better therapy is required.

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