BACKGROUND: A previously published prospective randomized phase 3 trial showed that administration of 24 weeks of primary systemic chemotherapy (PST) with paclitaxel and FEC(75) (fluorouracil, epirubicin, cyclophosphamide) concurrently with trastuzumab in patients with HER2-positive primary breast cancer resulted in a 60% pathologic complete response rate (PCR) with no associated severe cardiac toxicity. The purpose of this study was to review the efficacy and safety of a similar regimen outside the setting of a clinical trial. METHODS:Patients with HER2-positive breast cancer (defined as either immunohistochemical 3+ or fluorescence in situ hybridization-positive) that had received 24 weeks ofneoadjuvant trastuzumab concurrently with taxane and anthracycline-based chemotherapy between 2004 and 2006 were included in the analysis. PST chemotherapy consisted of paclitaxel (80 mg/m(2)) weekly for 12 weeks followed by 4 cycles of FEC(75) (500 mg/m(2), 75 mg/m(2), and 500 mg/m(2), respectively). RESULTS:Forty patients were identified. The median age was 48 years (range, 29-81). In all, 60% of patients had stage III disease and 4 had inflammatory breast cancer. The PCR rate was 55% (95% confidence interval [CI], 38.5%-70.7%). At a median follow-up of 19 months. 5 patients had a recurrence, of which 4 did not achieve a PCR. No severe cardiac events were observed. CONCLUSIONS:Stage II and III HER2-positive breast cancer patients achieved a high rate of PCR with trastuzumab given concurrently with paclitaxel and FEC(75) chemotherapy. No severe cardiac events were observed with the regimen. The data concur with the results of a previously published trial. (c) 2007 American Cancer Society.
RCT Entities:
BACKGROUND: A previously published prospective randomized phase 3 trial showed that administration of 24 weeks of primary systemic chemotherapy (PST) with paclitaxel and FEC(75) (fluorouracil, epirubicin, cyclophosphamide) concurrently with trastuzumab in patients with HER2-positive primary breast cancer resulted in a 60% pathologic complete response rate (PCR) with no associated severe cardiac toxicity. The purpose of this study was to review the efficacy and safety of a similar regimen outside the setting of a clinical trial. METHODS:Patients with HER2-positive breast cancer (defined as either immunohistochemical 3+ or fluorescence in situ hybridization-positive) that had received 24 weeks of neoadjuvant trastuzumab concurrently with taxane and anthracycline-based chemotherapy between 2004 and 2006 were included in the analysis. PST chemotherapy consisted of paclitaxel (80 mg/m(2)) weekly for 12 weeks followed by 4 cycles of FEC(75) (500 mg/m(2), 75 mg/m(2), and 500 mg/m(2), respectively). RESULTS: Forty patients were identified. The median age was 48 years (range, 29-81). In all, 60% of patients had stage III disease and 4 had inflammatory breast cancer. The PCR rate was 55% (95% confidence interval [CI], 38.5%-70.7%). At a median follow-up of 19 months. 5 patients had a recurrence, of which 4 did not achieve a PCR. No severe cardiac events were observed. CONCLUSIONS: Stage II and III HER2-positive breast cancerpatients achieved a high rate of PCR with trastuzumab given concurrently with paclitaxel and FEC(75) chemotherapy. No severe cardiac events were observed with the regimen. The data concur with the results of a previously published trial. (c) 2007 American Cancer Society.
Authors: Emmanuelle Charafe-Jauffret; Christophe Ginestier; Flora Iovino; Carole Tarpin; Mark Diebel; Benjamin Esterni; Gilles Houvenaeghel; Jean-Marc Extra; François Bertucci; Jocelyne Jacquemier; Luc Xerri; Gabriela Dontu; Giorgio Stassi; Yi Xiao; Sanford H Barsky; Daniel Birnbaum; Patrice Viens; Max S Wicha Journal: Clin Cancer Res Date: 2009-12-22 Impact factor: 12.531
Authors: Joan Albanell; Xavier Andreu; María José Calasanz; Angel Concha; José María Corominas; Tomás García-Caballero; José Antonio López; Fernando López-Ríos; Santiago Ramón y Cajal; Francisco J Vera-Sempere; Ramón Colomer; Miguel Martín; Emilio Alba; Antonio González-Martín; Antonio Llombart; Ana Lluch; José Palacios Journal: Clin Transl Oncol Date: 2009-06 Impact factor: 3.405
Authors: J F Cueva; S Antolín; L Calvo; I Fernández; M Ramos; L de Paz; J G Mata; R López; M Constenla; E Pérez; A González; M L Pellón; S Varela; T López Journal: Clin Transl Oncol Date: 2017-03-24 Impact factor: 3.405