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Br J Cancer. 2017 Feb 14;116(4):455-463. doi: 10.1038/bjc.2016.435. Epub 2017 Jan 24.

Chemotherapy vs tamoxifen in platinum-resistant ovarian cancer: a phase III, randomised, multicentre trial (Ovaresist).

Author information

1
Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
2
NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.
3
Department of Medical Oncology, Westmead Hospital, Crown Princess Mary Cancer Centre, Wentworthville, NSW, Australia.
4
NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW 2050, Australia.
5
Department of Oncology and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
6
Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.
7
Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense, Denmark.
8
Department of Gynecologic Oncology, Haukeland University Hospital, Bergen, Norway.
9
Department of Gynecologic Oncology, Skane University Hospital, Lund, Sweden.
10
Department of Obstetrics and Gynecology, Tampere University Hospital, Tampere, Finland.
11
Department of Obstetrics and Gynecology, Turku University Hospital, Turku, Finland.
12
University of Turku, Turku, Finland.
13
Department of Cancer Epidemiology, Skane University Hospital Lund, Lund, Sweden.
14
Department of Oncology, Linköping University Hospital, Linköping, Sweden.
15
Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo and University of Oslo, Oslo, Norway.

Abstract

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 40 mg 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.

PMID:
28118323
PMCID:
PMC5318972
DOI:
10.1038/bjc.2016.435
[Indexed for MEDLINE]
Free PMC Article

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