P4-20-01: Multicentric Phase II PACS 09/Beverly1 Trial: First Efficacy and Safety Results of Neoadjuvant Chemotherapy Combined with Bevacizumab in HER2−Negative Patients with Non-Metastatic Inflammatory Breast Cancer
| العنوان: | P4-20-01: Multicentric Phase II PACS 09/Beverly1 Trial: First Efficacy and Safety Results of Neoadjuvant Chemotherapy Combined with Bevacizumab in HER2−Negative Patients with Non-Metastatic Inflammatory Breast Cancer |
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| المؤلفون: | M-A Mouret-Reynier, Thierry Petit, J-Y Pierga, Jérôme Lemonnier, Thomas Bachelot, T. Delozier, Patrick Soulié, Florence Lerebours, J. Bonneterre, E Charafe-Jauffret, J-M Ferrero, A-C. Hardy-Bessard, J.M. Boher, Bernard Asselain, P. Kerbrat, Gilles Romieu, J-C Eymard, A-L Martin, Florence Dalenc, M Deblock, Alain Lortholary, F Andre, Patrice Viens |
| المصدر: | Cancer Research. 71:P4-20 |
| بيانات النشر: | American Association for Cancer Research (AACR), 2011. |
| سنة النشر: | 2011 |
| مصطلحات موضوعية: | Oncology, Cancer Research, medicine.medical_specialty, Bevacizumab, business.industry, medicine.medical_treatment, medicine.disease, Inflammatory breast cancer, Surgery, Radiation therapy, Breast cancer, Docetaxel, Internal medicine, medicine, Adjuvant therapy, business, Febrile neutropenia, Neoadjuvant therapy, medicine.drug |
| الوصف: | Background: Inflammatory breast cancer (IBC) is a relatively rare form of breast cancer. Because this disease exhibits angiogenic properties, bevacizumab (BEV) may improves the efficacy of neoadjuvant chemotherapy (CT) in IBC. Methods: Pts with HER2−negative IBC (IHC 0 or 1+ or FISH/CISH-, T4d, any N) were included to receive 4 cycles of FEC100 + BEV 15 mg/kg, d1 q3w, followed by 4 cycles of Docetaxel 100 mg/m2 + BEV 15 mg/kg q3w. Complete surgery was performed 4–6 weeks after the last dose of CT, followed by radiotherapy and endocrine therapy for hormone receptor positive (HR+) pts. BEV was re-introduced as adjuvant therapy for 10 cycles, giving a total of 18 cycles of BEV. The primary endpoint of the PACS09/Beverly1 trial was to evaluate the pathologic complete response (pCR; Sataloff classification) rate in HER2−negative non-metastatic IBC patients(pts). Results: Between Jan 2009 and Sep 2010, 101 pts were included (100 pts were evaluable). Main baseline characteristics were: median age 49 years; postmenopausal status, 39 pts; SBR 2, 32 pts SBR3 61 pts, both HR-negative, 55 pts. 85 pts completed neoadjuvant therapy according to the protocol, ***.90 pts underwent complete mastectomy, 4 had a breast-conservative surgery. After neoadjuvant treatment, investigator-assessed pCR rate was 27% (18%-36%, CI 95%). Interestingly, a significantly greater proportion of pCR rate was observed in the HR-negative group compared to HR-positive group (38% vs 13% respectively; p=0.007). Results from central review of pCR are currently in progress. Main Grade 3,4 toxicities were: neutropenia (61 pts),febrile neutropenia (36 pts),mucitis (23 pts) Neither gr3/4 HTA nor cardiac failure or proteinuria was reported. There were no treatment-related deaths. Conclusions: These data suggest that the use of BEV with neoadjuvant CT is active in HER2−negative IBC (pCR rate 27%), with an acceptable safety profile. Interestingly, the HR-negative subgroup is significantly more responsive than the HR-positive subgroup. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P4-20-01. |
| تدمد: | 1538-7445 0008-5472 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::1b55a24ff6064bade2fe8843f063424a https://doi.org/10.1158/0008-5472.sabcs11-p4-20-01 |
| رقم الأكسشن: | edsair.doi...........1b55a24ff6064bade2fe8843f063424a |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15387445 00085472 |
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