Abstract P3-10-05: Phase III trial evaluating paclitaxel plus carboplatin versus paclitaxel plus epirubicin as first-line treatment for metastatic breast cancer
Authors: Tong Zhongsheng , Li Shufen , Shi Yehui , Wang Xu , Hao Chunfang , He Lihong , Dong Guolei , Wang Xiaorui , Jia Yongsheng , Zhang Li 
Published: May 2015

Abstract
Background: To compare survival and side-effects between patients with metastatic breast cancer (MBC) treated with paclitaxel/carboplatin (TP) or paclitaxel/epirubicin (TE) chemotherapy.
Patients and methods: From June 2009 to April 2012, 121patients were randomly assigned, 61 of whom were randomized to TP and 60 to TE. Baseline characteristics were relatively well-balanced in the two treatment arms.
Table 1 Baseline patient characteristicsCharacteristicTP(n=61)TE(n=60)P(χ2 test)Median age,years(range)53.5(35-68)51.8(32-69)0.614ECOG performance status &lt;261(100%)60(100%)Node positive at first diagnosis27(44.3%)25(41.7%)0.773ER/PR-positive42(68.9%)43(71.7%)0.735HER2-positive18(29.5%)15(25.0%)0.578Metastatic sites≥233(58.1%)35(55.2%)0.639Visceral40(65.6%)42(70.0%)0.602Lymph25(41.0%)28 (46.7%)0.529HistologyLobular12(19.7%)11(18.3%)0.851Ductal44(72.1%)42(70.0%)0.796Other5(8.2)7(11.7%)0.523Adjuvant endocrine therapyYes28(45.9%)25(41.7%)0.639No33(54.1%)35(58.3%)Adjuvant radiotherapyYes13(21.3%)11 (18.3%)0.681No48(78.7%)49(81.7%)
Results: After a median follow-up of 21.3 months, there was no significant difference between the two treatment arms in objective response rate(ORR) (68.5 % vs. 73.3%, respectively;). And both the progression-free survival (P=0.704)and overall survival (P=0.403)were very similar between the two arms. Both regimens were well tolerated. The main toxicities were myelosuppression, gastrointestinal reactions and alopecia. There was more grades 3–4 alopecia and more nausea with TE(p&lt;0.05). For the QLQ-C30 questionnaire statistically significant changes after treatment were fatigue(0.031) in TP, nausea/vomiting(p=0.041) and lose of appetite(p=0.048) in TE.
Table 2 Summary of adverse events per patient; p-values are given overallTP (n=61)TE (n=60)P valueAdverse eventsGrades 1-4Grades 3-4Grades 1-4Grades 3-4Neutropenia46133870.149Leukopenis50114070.054Anemia40410.981Thrombocytopenia41300.714Lymphocytopenia20410.391Vomiting1532060.289Nausea2724150.010Diarrhea40300.714Alopecia441560310.000Cardiotoxicity30600.523Hypersensitivity reaction0000-ALT increase50700.523Peripheral neurotoxicity2001900.895Overall p value for the comparison of grades 1-4 are given
Conclusion: This study did not found significant differences in ORR, PFS and OS between TP and TE arms. Both arms were well tolerated. TP has some advantages in less side-effects, especially alopecia and nausea.This combination can be safely prescribed to patients in which anthracyclines have the potential of being harmful such as those previously exposed to anthracyclines in the adjuvant setting.
Citation Format: Zhongsheng Tong, Shufen Li, Yehui Shi, Xu Wang, Chunfang Hao, Lihong He, Guolei Dong, Xiaorui Wang, Yongsheng Jia, Li Zhang. Phase III trial evaluating paclitaxel plus carboplatin versus paclitaxel plus epirubicin as first-line treatment for metastatic breast cancer [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-10-05.