UNICANCER-PEGASE 07 study: a randomized phase 3 trial evaluating post-operative docetaxel-5FU regimen after neo-adjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer
Mené en France sur 174 patientes atteintes d'un cancer inflammatoire du sein traité entre 2001 et 2005 (durée médiane de suivi : 59,6 mois), cet essai de phase III évalue, du point de vue du taux de survie sans maladie et du taux de réponse pathologique complète à 5 ans, l'intérêt d'une chimiothérapie à base de 5 fluorouracile-docétaxel après un traitement comportant une chimiothérapie à forte dose d'épirubicine et de cyclophosphamide, une mastectomie avec curage ganglionnaire axillaire puis une radiothérapie
Résumé en anglais
Background Inflammatory breast cancer (IBC) : is a rare and aggressive disease requiring a multimodal treatment. We evaluated the benefit of adding docetaxel-5 fluorouracil (D-5FU) regimen after pre-operative dose-intense epirubicin-cyclophosphamide (EC) and loco-regional treatment in IBC patients
Patients and methods : PEGASE 07 was a national randomized phase 3 open-label study involving 14 hospitals in France. Women with non-metastatic IBC were eligible and randomly assigned to receive either 4 cycles of dose-intense EC (E150 mg/m² and C 4000 mg/m² every 3 weeks with repeated hematopoietic stem cell support), then mastectomy with axillary lymph node dissection, and radiotherapy (Arm A) or the same treatment followed by 4 cycles of D-5FU (D 85 mg/m², day 1 and 5FU 750 mg/m²/day continuous infusion, days 1-5 every 3 weeks) administered post-radiotherapy (Arm B). Patients with hormone receptor positive tumors received hormonal therapy. Disease-free survival (DFS) was the primary endpoint. Secondary endpoints included tolerance, pathological complete response (pCR) rate, and overall survival (OS).
Results : Between January 2001 and May 2005, 174 patients were enrolled and treated (87 in each arm). Median follow-up was similar in both arms: 59.6 months (95%CI: 58.4-60.3) in arm A and 60·5 months (95%CI: 58.3-61.4) in arm B. The estimated 5-year DFS rates were not different: 55% (95%CI: 43.9-64.7) in arm A and 55·5% (95%CI: 44.3-65.3) in arm B (hazard ratio, HR =0.94 [0.61-1.48]; p=0.81). Identical results were observed for 5-year OS: 70.2% (95%CI: 59.1-78.8) in arm A and 70% (95%CI: 58.8-78.7) in arm B (HR= 0.93 [0.55-1.60]; p=0.814). Following dose-intense EC induction, in-breast and global (breast plus nodes) pCR were 28.9% and 20.1%, respectively. Estrogen receptor and pCR status were independently associated with survival.
Conclusion : The addition of D-5FU after pre-operative dose-intense EC and standard local therapy did not improve DFS in IBC.
