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Clinical Trial
. 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)

Kristina Lindemann  1   2   3 , Emma Gibbs  4 , Elisabeth Åvall-Lundqvist  5   6 , Rene dePont Christensen  7 , Kathrine Woie  8 , Marten Kalling  9 , Annika Auranen  10 , Seija Grenman  11   12 , Thomas Hoegberg  13 , Per Rosenberg  14 , Tone Skeie-Jensen  1 , Elisabet Hjerpe  7 , Anne Dørum  1 , Val Gebski  4 , Gunnar Kristensen  1   15
Affiliations
Clinical Trial

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

Kristina Lindemann et al. Br J Cancer. .

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.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
CONSORT diagram: enrolment, randomization and treatment.
Figure 2
Figure 2
Kaplan–Meier estimates of progression-free and OS according to treatment arm.
Figure 3
Figure 3
Baseline and scores from a mixed model for health-related quality of life function scales in both treatment arms. Error bars represent 95% confidence interval for the estimated mean values. *Subscales derived from the EORTC_QLQ-C30; †Subscales derived from EORTC-OV-28.
Figure 4
Figure 4
HQOL response proportions at 8 weeks (15% cutoff).
See this image and copyright information in PMC

References

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