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

doi:10.1093/annonc/mds107

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

Research output: Contribution to journal › Article › Academic › peer-review

39 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 language	English
Pages (from-to)	2896-2902
Number of pages	7
Journal	Annals of Oncology
Volume	23
Issue number	11
DOIs	https://doi.org/10.1093/annonc/mds107
Publication status	Published - 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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Reyners, A. K. L., de Munck, L., Erdkamp, F. L. G., Smit, W. M., Hoekman, K., Lalisang, R. I., de Graaf, H., Wymenga, A. N. M., Polee, M., Hollema, H., van Vugt, M. A. T. M., Schaapveld, M., Willemse, P. H. B., & DoCaCel Study Grp (2012). 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. Annals of Oncology, 23(11), 2896-2902. https://doi.org/10.1093/annonc/mds107

Reyners, A. K. L. ; de Munck, L. ; Erdkamp, F. L. G. et al. / 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. In: Annals of Oncology. 2012 ; Vol. 23, No. 11. pp. 2896-2902.

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title = "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",

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.",

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",

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

year = "2012",

month = nov,

doi = "10.1093/annonc/mds107",

language = "English",

volume = "23",

pages = "2896--2902",

journal = "Annals of Oncology",

issn = "0923-7534",

publisher = "Oxford University Press",

number = "11",

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Reyners, AKL, de Munck, L, Erdkamp, FLG, Smit, WM, Hoekman, K, Lalisang, RI, de Graaf, H, Wymenga, ANM, Polee, M, Hollema, H, van Vugt, MATM, Schaapveld, M, Willemse, PHB & DoCaCel Study Grp 2012, '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', Annals of Oncology, vol. 23, no. 11, pp. 2896-2902. https://doi.org/10.1093/annonc/mds107

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. / Reyners, A. K. L.; de Munck, L.; Erdkamp, F. L. G. et al.
In: Annals of Oncology, Vol. 23, No. 11, 11.2012, p. 2896-2902.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - 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

T2 - the DoCaCel study

AU - Reyners, A. K. L.

AU - de Munck, L.

AU - Erdkamp, F. L. G.

AU - Smit, W. M.

AU - Hoekman, K.

AU - Lalisang, R. I.

AU - de Graaf, H.

AU - Wymenga, A. N. M.

AU - Polee, M.

AU - Hollema, H.

AU - van Vugt, M. A. T. M.

AU - Schaapveld, M.

AU - Willemse, P. H. B.

AU - DoCaCel Study Grp

PY - 2012/11

Y1 - 2012/11

N2 - 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.

AB - 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.

KW - carboplatin

KW - celecoxib

KW - docetaxel

KW - epithelial ovarian cancer

KW - first-line chemotherapy

KW - randomized phase II study

KW - CELL LUNG-CANCER

KW - CYCLOOXYGENASE-2 EXPRESSION

KW - TRIAL

KW - PACLITAXEL

KW - DOXORUBICIN

KW - INTERGROUP

KW - CISPLATIN

KW - WOMEN

KW - RISK

U2 - 10.1093/annonc/mds107

DO - 10.1093/annonc/mds107

M3 - Article

SN - 0923-7534

VL - 23

SP - 2896

EP - 2902

JO - Annals of Oncology

JF - Annals of Oncology

IS - 11

ER -

Reyners AKL, de Munck L, Erdkamp FLG, Smit WM, Hoekman K, Lalisang RI et al. 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. Annals of Oncology. 2012 Nov;23(11):2896-2902. doi: 10.1093/annonc/mds107