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

A. K. L. Reyners*, L. de Munck, F. L. G. Erdkamp, W. M. Smit, K. Hoekman, R. I. Lalisang, H. de Graaf, A. N. M. Wymenga, M. Polee, H. Hollema, M. A. T. M. van Vugt, M. Schaapveld, P. H. B. Willemse, DoCaCel Study Grp

*Corresponding author for this work

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29 Citations (Scopus)

Abstract

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.

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).

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.

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

Original languageEnglish
Pages (from-to)2896-2902
Number of pages7
JournalAnnals of Oncology
Volume23
Issue number11
DOIs
Publication statusPublished - Nov-2012

Keywords

  • carboplatin
  • celecoxib
  • docetaxel
  • epithelial ovarian cancer
  • first-line chemotherapy
  • randomized phase II study
  • CELL LUNG-CANCER
  • CYCLOOXYGENASE-2 EXPRESSION
  • TRIAL
  • PACLITAXEL
  • DOXORUBICIN
  • INTERGROUP
  • CISPLATIN
  • WOMEN
  • RISK

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