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Comparison of six cycles of epirubicin andpaclitaxel (ET) versus four cycles of epirubicin and cyclophosphamide, followedby four cycles of paclitaxel (EC-T) as adjuvant therapy for operable breastcancer in women with positive axillary nodes. Sub-category: Cytotoxic Chemotherapy Category: Breast Cancer -Triple-Negative/Cytotoxics/Local Therapy Meeting: 2014 ASCO Annual Meeting Abstract No: 1042 Citation: J Clin Oncol 32:5s, 2014 (suppl;abstr 1042) Author(s): Peng Yuan, Jiayu Wang, Fei Ma,Ying Fan, Yang Luo, Ruigang Cai, Pin Zhang, Qing Li, Binghe Xu; Department ofMedical Oncology, Cancer Institute and Hospital, Chinese Academy of MedicalSciences and Peking Union Medical College, Beijing, China; Cancer Hospital& Institute, Chinese Academy of Medical Sciences & Peking Union MedicalCollege, Beijing, China; Department of Medical Oncology, Cancer Hospital(Institute), Chinese Academy of Medical, Beijing, China; Cancer Hospital,Chinese Academy of Medical Sciences, Beijing, China Abstract Disclosures Abstract: Background: To determine if 6 cycles of EThas similar efficacy to 4 cycles of EC followed by 4 cycles of T, but withshorter treatment time and reduced toxicity. Methods: Patients with operablebreast cancer and positive lymph nodes were enrolled and randomized to receiveET (75/175 mg/m2 X 6 every 21 days) or EC (90/600 mg/m2 X 4 every 21 days)followed by T (175 mg/m2 X4 every 14 days). The primary end point was DFS. Thetrial was designed to detect the upper limits of the 95% confidence interval ofthe hazard ratio of ET versus an EC-T < 1.30. A sample size of 905 patientswas required to detect the difference (a=0.05, β=80%). Assuming a drop-out rateof 10%, 996 patients were required. The first analysis of DFS was planned atthe time when 50% of patients were enrolled. Results: Between August 2009 andOctober 2013, 496 patients were enrolled in the study and 445 patientscompleted the study treatment protocol, among which 214 patients were in theEC-T arm and 231 patients were in the ET arm. The patient characteristics werewell-matched between the two arms. The median age was 49 years in both groups.Of the patients in the EC-T and ET arms, 87.4% and 92.2% were ER/PR-positive,respectively. After a median follow-up of 35.5 months, 28 events were observed(14 each in both arms). The 4-year DFS was 91.3% in the EC-T arm and 91.4% inthe ET arm (log-rank p= 0.719,HR = 0.873, 95%CI = 0.416-1.832). Both regimenswere well-tolerated. Of the patients in the EC-T and ET groups, 92.1% and88.7%, respectively, completed all treatment cycles per protocol. Dosereductions were required in 24.8% and 35.5% of the patients in the EC-T and ETarms, respectively. The most frequent grade 3 / 4 toxicities were neutropenia,nausea, and anemia, with no significant difference between the two regimens.Conclusions: The toxicity from six cycles of ET were similar to eight cycles ofEC-T in patients with node-positive early breast cancer. The efficacy of thetwo chemotherapy regimens should await the enrollment of additional patientsand a longer follow-up. |
