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Ann Oncol. 2012 Nov;23(11):2896-902. doi: 10.1093/annonc/mds107. Epub 2012 Jun 11.

A randomized phase II study investigating the addition of the specific COX-2 inhibitor celecoxib to docetaxel plus carboplatin as first-line chemotherapy for stage IC to IV epithelial ovarian cancer, Fallopian tube or primary peritoneal carcinomas: the DoCaCel study.

Author information

1
Department of Medical Oncology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. a.k.l.reyners@umcg.nl

Abstract

BACKGROUND:

In ovarian cancer, cyclooxygenase-2 (COX-2) overexpression is prognostic for poor survival. We investigated the efficacy of celecoxib (C), a selective COX-2 inhibitor, added to docetaxel (Taxotere)/carboplatin (DC) in advanced ovarian cancer.

PATIENTS AND METHODS:

In a phase II, randomized study, 400 mg celecoxib b.i.d. was added to first-line DC treatment (DCC). Celecoxib was to be continued after DC termination up to 3 years. Study end points were tolerability, progression-free survival (PFS) and overall survival (OS).

RESULTS:

151 of 196 eligible patients were diagnosed with stage IIIC/IV disease. Median follow-up for patients alive was 32.3 months. Celecoxib was used during a mean of 8.5 months. Twenty-three of 97 DCC patients stopped celecoxib prematurely, mainly due to skin reactions. Complete biochemical response was achieved in 51/78 DC patients (65%) versus 57/78 DCC patients (75%, not significant). In both study arms, median PFS was 14.3 months and median OS 34 months. COX-2 was expressed in 82% of 120 tumor samples retrospectively recovered. The PFS and OS of patients with intermediate/high COX-2 expression were similar to that in the other patients.

CONCLUSION:

Celecoxib did not influence PFS and OS, but interpretation of results is hampered by premature celecoxib discontinuation.

PMID:
22689176
DOI:
10.1093/annonc/mds107
[Indexed for MEDLINE]

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