Randomized Phase III Trial Comparing Epirubicin/ Doxorubicin Plus Docetaxel and Epirubicin/ Doxorubicin Plus Paclitaxel as First Line Treatment in Women with Advanced Breast Cancer

R. Guru Nirmal Raj, Aditya Kumar, Prachi Sood, Roshan Kumar, Vinod Rana
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引用次数: 6

Abstract

This study aimed to examine the efficacy of docetaxel plus epirubicin against docetaxel plus capecitabine as first-line therapy for women with advanced breast cancer (ABC). Patients with ABC who had not been treated in the past were split into two groups: those who received docetaxel and epirubicin (DE) on day 1 and those who received docetaxel and capecitabine (DC) on day 1 and twice daily on days 1-14 of each 21-day cycle. Prior neoadjuvant treatment with anthracyclines was permitted if it had been finished more than a year prior to enrolment. The study's major aim was to evaluate the difference in time to disease progression (TTP). Median TTP for DE was 10.6 months and for DC it was 11.0 months (P = 0.7), with each arm treating 170 women. Using the RECIST criterion, we found that the rates of complete responses were higher in DC (61%) than in DE (11%), and that the rates of partial responses were lower in DC (40%) than in DE (45%) (P = 0.8). Grade 3-4 neutropenia was more common with DE than DC (57% vs. 46%, P = 0.07), as were febrile neutropenia (11% vs. 8%, P = 0.4), hand-foot syndrome (0% vs. 4%, P = 0.02), grade 2-3 anemia (20% vs. 7%, P = 0.001), and asthenia (12% vs. 6%, P = 0.09).
比较表柔比星/阿霉素+多西他赛和表柔比星/阿霉素+紫杉醇作为晚期乳腺癌妇女一线治疗的随机III期试验
本研究旨在探讨多西他赛联合表柔比星与多西他赛联合卡培他滨作为一线治疗晚期乳腺癌(ABC)的疗效。过去未接受过治疗的ABC患者分为两组:第1天接受多西他赛和表柔比星(DE)治疗的患者和第1天接受多西他赛和卡培他滨(DC)治疗的患者,每21天周期的第1-14天每天两次。如果在入组前一年以上完成蒽环类药物的新辅助治疗,则允许使用蒽环类药物。该研究的主要目的是评估疾病进展时间(TTP)的差异。DE的中位TTP为10.6个月,DC的中位TTP为11.0个月(P = 0.7),每组治疗170名妇女。使用RECIST标准,我们发现DC患者的完全缓解率(61%)高于DE患者(11%),DC患者的部分缓解率(40%)低于DE患者(45%)(P = 0.8)。3-4级中性粒细胞减少症在DE患者中比DC患者更常见(57%比46%,P = 0.07),发热性中性粒细胞减少症(11%比8%,P = 0.4)、手足综合征(0%比4%,P = 0.02)、2-3级贫血(20%比7%,P = 0.001)和虚弱(12%比6%,P = 0.09)也是如此。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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