Celecoxib and exemestane versus placebo and exemestane in postmenopausal metastatic breast cancer patients: a double-blind phase III GINECO study

C. Falandry 1, 2 M. Debled 3 Thomas Bachelot 4 T. Delozier 5 J. Crétin 6, 7 P. Romestaing 2 D. Mille 8 Benoit You 2 L. Mauriac 3 E. Pujade-Lauraine 9 G. Freyer 1, 2, *
* Auteur correspondant
1 Université de Lyon
2 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
3 Plateforme de génétique moléculaire des cancers d'Aquitaine
4 Centre Léon Bérard [Lyon]
5 CRLC François Baclesse - Centre Régional de Lutte contre le Cancer François Baclesse
6 Clinique Valdegour
7 Clinique Bonnefon
8 Institut de Cancérologie de la Loire Lucien Neuwirth
9 Hôpital Hôtel-Dieu
Abstract : The aim of this study was to evaluate antitumor effects of cyclooxygenase-2 inhibitors in breast carcinoma and their ability to act synergistically with aromatase inhibitors (AIs). Postmenopausal metastatic breast cancer patients without previous adjuvant AI treatment received exemestane 25 mg/days plus either celecoxib 400 mg twice daily or placebo. The primary endpoint was progression-free survival (PFS). This trial was prematurely terminated ( = 157 of 342 planned) after cardiovascular toxicity was reported in other celecoxib trials. Although no PFS difference was observed between the two arms (9.8 months for both,  = 0.72), a trend favoring celecoxib was observed in 60 tamoxifen-resistant patients (9.6 vs. 5.1 months;  = 0.14) and in 126 patients treated ≥3 months before study termination (12.2 vs. 9.8 months;  = 0.09). No severe adverse events were reported. Cyclooxygenase-2 inhibitors seemingly contribute to reverse endocrine resistance in breast cancer patients, although further study is necessary to allow development of a new therapeutic strategy.
keyword : Breast cancer Celecoxib Exemestane Aromatase Cyclooxygenase-2 Clinical trial
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Soumis le : vendredi 30 avril 2010 - 14:28:34
Dernière modification le : jeudi 12 décembre 2019 - 09:58:02
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C. Falandry, M. Debled, Thomas Bachelot, T. Delozier, J. Crétin, et al.. Celecoxib and exemestane versus placebo and exemestane in postmenopausal metastatic breast cancer patients: a double-blind phase III GINECO study. Breast Cancer Research and Treatment, Springer Verlag, 2008, 116 (3), pp.501-508. ⟨10.1007/s10549-008-0229-5⟩. ⟨hal-00478277⟩

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