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Chemotherapy vs tamoxifen in platinum-resistant ovarian cancer: a phase III, randomised, multicentre trial (Ovaresist)
Oslo University Hospital, Norway; University of Sydney, Australia; Westmead Hospital, Australia.
University of Sydney, Australia.
Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Karolinska Institute, Sweden.
University of Southern Denmark, Denmark.
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2017 (English)In: British Journal of Cancer, ISSN 0007-0920, E-ISSN 1532-1827, Vol. 116, no 4, 455-463 p.Article in journal (Refereed) Published
Abstract [en]

Background: Chemotherapy in platinum-resistant ovarian cancer (PROC) aims for palliation and prolonging of progression-free survival (PFS). This study compares Health-related Quality of Life (HRQoL) and efficacy between single-agent chemotherapy and tamoxifen in PROC. Methods: Patients with PROC were randomised (2 : 1) to chemotherapy (weekly paclitaxel 80 mg m(-2) or four weekly pegylated liposomal doxorubicin 40 mg m(-2)) or tamoxifen 40mg daily. The primary end point was HRQoL. Secondary end points were PFS by RECIST and overall survival (OS). Results: Between March 2002 and December 2007, 156 and 82 patients were randomised to chemotherapy and tamoxifen, respectively. In the chemotherapy arm, a significantly larger proportion of patients experienced a worsening in their social functioning. There was no difference in the proportion of patients experiencing improvement of gastrointestinal symptoms. Median PFS on tamoxifen was 8.3 weeks (95% CI, 8.0-10.4) compared with 12.7 weeks (95% CI, 9.0-16.3) on chemotherapy (HR, 1.54; 95% CI, 1.16-2.05; log-rank P = 0.003). There was no difference in OS between the treatment arms. Conclusions: Patients on chemotherapy had longer PFS but experienced more toxicity and poorer HRQoL compared with tamoxifen. Control over gastrointestinal symptoms was not better on chemotherapy. These data are important for patient counselling and highlight the need to incorporate HRQoL end points in studies of PROC.

Place, publisher, year, edition, pages
NATURE PUBLISHING GROUP , 2017. Vol. 116, no 4, 455-463 p.
Keyword [en]
platinum-resistent ovarian cancer; chemotherapy; tamoxifen; quality of life; survival; phase III
National Category
Surgery
Identifiers
URN: urn:nbn:se:liu:diva-136169DOI: 10.1038/bjc.2016.435ISI: 000394446600006PubMedID: 28118323OAI: oai:DiVA.org:liu-136169DiVA: diva2:1086658
Available from: 2017-04-03 Created: 2017-04-03 Last updated: 2017-04-11

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Åvall Lundqvist, ElisabethRosenberg, Per
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Division of Surgery, Orthopedics and OncologyFaculty of Medicine and Health SciencesDepartment of OncologyDivision of Clinical Sciences
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