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

Lindemann, KristinaOslo University Hospital, Norway; University of Sydney, Australia; Westmead Hospital, Australia (author)

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.

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kirurgi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Surgery hsv//eng
platinum-resistent ovarian cancer; chemotherapy; tamoxifen; quality of life; survival; phase III

Gibbs, EmmaUniversity of Sydney, Australia (author)
Åvall-Lundqvist, Elisabeth,1957-Karolinska Institutet,Linköpings universitet,Avdelningen för Kirurgi, Ortopedi och Onkologi,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US,Karolinska Institute, Sweden(Swepub:liu)eliav51 (author)
dePont Christensen, ReneUniversity of Southern Denmark, Denmark (author)
Woie, KathrineHaukeland Hospital, Norway (author)
Kalling, MartenSkåne University Hospital, Sweden (author)
Auranen, AnnikaTampere University Hospital, Finland (author)
Grenman, SeijaTurku University Hospital, Finland; University of Turku, Finland (author)
Hoegberg, ThomasSkåne University Hospital Lund, Sweden (author)
Rosenberg, PerLinköpings universitet,Avdelningen för kliniska vetenskaper,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US(Swepub:liu)perro95 (author)
Skeie-Jensen, ToneOslo University Hospital, Norway (author)
Hjerpe, ElisabetKarolinska Institutet,University of Southern Denmark, Denmark (author)
Dorum, AnneOslo University Hospital, Norway (author)
Gebski, ValUniversity of Sydney, Australia (author)
Kristensen, GunnarOslo University Hospital, Norway; University of Oslo, Norway (author)
Oslo University Hospital, Norway; University of Sydney, Australia; Westmead Hospital, AustraliaUniversity of Sydney, Australia (creator_code:org_t)

In:British Journal of Cancer: NATURE PUBLISHING GROUP116:4, s. 455-4630007-09201532-1827

By the author/editor: Lindemann, Krist ...; Gibbs, Emma; Åvall-Lundqvist, ...; dePont Christens ...; Woie, Kathrine; Kalling, Marten; show more...; Auranen, Annika; Grenman, Seija; Hoegberg, Thomas; Rosenberg, Per; Skeie-Jensen, To ...; Hjerpe, Elisabet; Dorum, Anne; Gebski, Val; Kristensen, Gunn ...; show less...

About the subject

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Surgery

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