PMID- 25572687 OWN - NLM STAT- MEDLINE DCOM- 20160512 LR - 20150811 IS - 1534-4681 (Electronic) IS - 1068-9265 (Linking) VI - 22 IP - 9 DP - 2015 Sep TI - Preoperative carboplatin-paclitaxel-bevacizumab in triple-negative breast cancer: final results of the phase II Ca.Pa.Be study. PG - 2881-7 LID - 10.1245/s10434-015-4371-0 [doi] AB - PURPOSE: The phase II Ca.Pa.Be trial evaluated preoperative carboplatin-paclitaxel in combination with bevacizumab in triple-negative breast cancer patients with previously untreated stage II-III disease. The primary aim was the assessment of the rate of pathologic complete response (pCR). Secondary aims included safety, breast-conserving surgery rate, and early response assessment with dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). METHODS: Patients with hormone receptor-negative, HER-2-negative stage II-III breast cancer were eligible. Treatment included paclitaxel 80 mg/mq + carboplatin area under the curve (AUC) 2 on days 1, 8, and 15, combined with bevacizumab 10 mg/kg on days 1 and 15 each 28 days, for 5 courses. At baseline, patients underwent breast DCE-MRI, followed by a single dose of bevacizumab 5 mg/kg (day -6). DCE-MRI was repeated before the initiation of chemotherapy. RESULTS: Forty-four patients were enrolled. Forty-three patients underwent surgery, and 22 (50 %) received breast-conserving surgery (conversion rate from mastectomy indication at baseline, 34.4 %). A pCR in breast and axillary lymph nodes occurred in 22 patients (50 %). Bevacizumab-associated adverse events (AEs) were mild: G1-2 hypertension and bleeding occurred in 6 (13.6 %) and 12 (27 %) patients, respectively. No G4 nonhematologic AEs were recorded. More frequent G3 AEs were liver function test abnormalities (6.8 %), and diarrhea and fatigue (4.5 % each). The only G3-4 hematologic toxicity was neutropenia (G3, 25 %; G4, 9 %). Early assessed DCE-MRI response parameters failed to predict pCR. CONCLUSIONS: The neoadjuvant anthracycline-free combination of weekly paclitaxel and carboplatin plus bevacizumab is active and safe in triple-negative breast cancer, and the rate of pCR is comparable to that observed with more intensive carboplatin- and bevacizumab-containing regimens. Further investigation is warranted. FAU - Guarneri, Valentina AU - Guarneri V AD - Department of Surgery, Oncology, and Gastroenterology, University of Padova, Padua, Italy, valentina.guarneri@unipd.it. FAU - Dieci, Maria Vittoria AU - Dieci MV FAU - Bisagni, Giancarlo AU - Bisagni G FAU - Boni, Corrado AU - Boni C FAU - Cagossi, Katia AU - Cagossi K FAU - Puglisi, Fabio AU - Puglisi F FAU - Pecchi, Annarita AU - Pecchi A FAU - Piacentini, Federico AU - Piacentini F FAU - Conte, PierFranco AU - Conte P LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20150109 PL - United States TA - Ann Surg Oncol JT - Annals of surgical oncology JID - 9420840 RN - 0 (Contrast Media) RN - 2S9ZZM9Q9V (Bevacizumab) RN - BG3F62OND5 (Carboplatin) RN - P88XT4IS4D (Paclitaxel) SB - IM MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Bevacizumab/administration & dosage MH - Carboplatin/administration & dosage MH - Carcinoma, Ductal, Breast/*drug therapy/pathology MH - Contrast Media/*administration & dosage MH - Female MH - Follow-Up Studies MH - Humans MH - Magnetic Resonance Imaging/*methods MH - Middle Aged MH - Neoadjuvant Therapy MH - Neoplasm Grading MH - Neoplasm Staging MH - Paclitaxel/administration & dosage MH - Preoperative Care MH - Prognosis MH - Triple Negative Breast Neoplasms/*drug therapy/pathology EDAT- 2015/01/13 06:00 MHDA- 2016/05/14 06:00 CRDT- 2015/01/10 06:00 PHST- 2014/10/31 00:00 [received] PHST- 2015/01/10 06:00 [entrez] PHST- 2015/01/13 06:00 [pubmed] PHST- 2016/05/14 06:00 [medline] AID - 10.1245/s10434-015-4371-0 [doi] PST - ppublish SO - Ann Surg Oncol. 2015 Sep;22(9):2881-7. doi: 10.1245/s10434-015-4371-0. Epub 2015 Jan 9.