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

Lindemann, Kristina; Gibbs, Emma; Åvall Lundqvist, Elisabeth; Depont Christensen, Rene; Woie, Kathrine; Kalling, Marten; Auranen, Annika; Grenman, Seija; Hoegberg, Thomas LU and Rosenberg, Per, et al. (2017) In British Journal of Cancer 116(4). p.455-463
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... (More)

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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British Journal of Cancer
volume
116
issue
4
pages
9 pages
publisher
Nature Publishing Group
external identifiers
  • scopus:85010867680
ISSN
0007-0920
DOI
10.1038/bjc.2016.435
language
English
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no
id
3eaa5f96-922e-43af-87a7-f7ac1f4e2c56
date added to LUP
2017-02-27 12:55:46
date last changed
2018-01-07 11:53:01
@article{3eaa5f96-922e-43af-87a7-f7ac1f4e2c56,
  abstract     = {<p>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.</p>},
  author       = {Lindemann, Kristina and Gibbs, Emma and Åvall Lundqvist, Elisabeth and Depont Christensen, Rene and Woie, Kathrine and Kalling, Marten and Auranen, Annika and Grenman, Seija and Hoegberg, Thomas and Rosenberg, Per and Skeie-Jensen, Tone and Hjerpe, Elisabet and Dørum, Anne and Gebski, Val and Kristensen, Gunnar},
  issn         = {0007-0920},
  language     = {eng},
  month        = {02},
  number       = {4},
  pages        = {455--463},
  publisher    = {Nature Publishing Group},
  series       = {British Journal of Cancer},
  title        = {Chemotherapy vs tamoxifen in platinum-resistant ovarian cancer : A phase III, randomised, multicentre trial (Ovaresist)},
  url          = {http://dx.doi.org/10.1038/bjc.2016.435},
  volume       = {116},
  year         = {2017},
}