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

被引：40

作者：

Lindemann, Kristina ^{[1
,2
,3
]}

Gibbs, Emma ^{[4
]}

Avall-Lundqvist, Elisabeth ^{[5
,6
,7
]}

Christensen, Rene dePont ^{[8
]}

Woie, Kathrine ^{[9
]}

Kalling, Marten ^{[10
]}

Auranen, Annika ^{[11
]}

Grenman, Seija ^{[12
,13
]}

Hoegberg, Thomas ^{[14
]}

Rosenberg, Per ^{[15
]}

Skeie-Jensen, Tone ^{[1
]}

Hjerpe, Elisabet ^{[8
]}

Dorum, Anne ^{[1
]}

Gebski, Val ^{[4
]}

Kristensen, Gunnar ^{[1
,16
,17
]}

机构：

[1] Oslo Univ Hosp, Norwegian Radium Hosp, Dept Gynecol Oncol, Oslo, Norway

[2] Univ Sydney, NHMRC Clin Trials Ctr, Camperdown, NSW, Australia

[3] Westmead Hosp, Dept Med Oncol, Crown Princess Mary Canc Ctr, Wentworthville, NSW, Australia

[4] Univ Sydney, NHMRC Clin Trials Ctr, Camperdown, NSW 2050, Australia

[5] Linkoping Univ, Dept Oncol, Linkoping, Sweden

[6] Linkoping Univ, Dept Clin & Expt Med, Linkoping, Sweden

[7] Karolinska Inst, Dept Pathol & Oncol, Stockholm, Sweden

[8] Univ Southern Denmark, Inst Publ Hlth, Res Unit Gen Practice, Odense, Denmark

[9] Haukeland Hosp, Dept Gynecol Oncol, Bergen, Norway

[10] Skane Univ Hosp, Dept Gynecol Oncol, Lund, Sweden

[11] Tampere Univ Hosp, Dept Obstet & Gynecol, Tampere, Finland

[12] Turku Univ Hosp, Turku, Finland

[13] Univ Turku, Turku, Finland

[14] Skane Univ Hosp Lund, Dept Canc Epidemiol, Lund, Sweden

[15] Linkoping Univ Hosp, Dept Oncol, Linkoping, Sweden

[16] Oslo Univ Hosp, Inst Canc Genet & Informat, Oslo, Norway

[17] Univ Oslo, Oslo, Norway

来源：

BRITISH JOURNAL OF CANCER | 2017年 / 116卷 / 04期

关键词：

platinum-resistent ovarian cancer; chemotherapy; tamoxifen; quality of life; survival; phase III; PEGYLATED LIPOSOMAL DOXORUBICIN; QUALITY-OF-LIFE; SINGLE-AGENT; WEEKLY PACLITAXEL; AURELIA TRIAL; TOPOTECAN; THERAPY; COMBINATION; CARCINOMA; CARBOPLATIN;

D O I：

10.1038/bjc.2016.435

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：455 / 463

页数：9

共 31 条

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