A phase II trial of Neoadjuvant docetaxel and capecitabine for locally advanced breast cancer
A phase II trial of Neoadjuvant docetaxel and capecitabine for locally advanced breast cancer
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DOI：
10.1158/1078-0432.ccr-04-0976
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发表时间：
2004-10-15
影响因子：
11.5
通讯作者：
Zujewski, J
中科院分区：
文献类型：
--
作者：
Lebowitz, PF;Eng-Wong, J;Zujewski, J
目的：本研究评估了多西他赛/卡培他滨作为2/3期乳腺癌新辅助治疗的毒性和疗效。
实验设计：新诊断为浸润性2期和3期乳腺癌的患者符合条件。第一组患者接受A剂量的新辅助多西他赛（第1天静脉注射75mg/m²）和卡培他滨（第2 - 15天每日口服两次，每次1000mg/m²）治疗，共四个周期。第二组患者接受降低剂量的B剂量多西他赛（第1天静脉注射60mg/m²）和卡培他滨（第2 - 15天每日口服两次，每次937.5mg/m²）治疗。
结果：共招募了30名患者。接受A剂量治疗的10名患者中有8名因3级或4级毒性反应需要降低多西他赛或卡培他滨的剂量，这些毒性反应包括：黏膜炎（1例）、手足综合征（3例）、腹泻（2例）、直肠周围脓肿（1例）和中性粒细胞减少症（2例）。由于剂量降低率较高，接下来的20名患者接受B剂量治疗。多西他赛在A剂量和B剂量下的平均累积给药剂量分别为285mg/m²和231mg/m²。对于卡培他滨，A剂量和B剂量下的平均累积剂量分别为1585mg/m²/天和1627mg/m²/天，较为相似。总体临床缓解率为90%，其中31%的患者完全缓解，59%的患者部分缓解。在接受四个周期的多西他赛/卡培他滨治疗后，10%的患者实现了乳腺的病理完全缓解。
结论：多西他赛/卡培他滨在新辅助治疗中是一种高效的方案。推荐使用75mg/m²多西他赛和第2 - 15天1600mg/m²/天的卡培他滨进行新辅助治疗。
Purpose: This study evaluated the toxicity and efficacy of docetaxel/capecitabine as neoadjuvant treatment for stage 2/3 breast cancer.Experimental Design: Subjects with newly diagnosed invasive stage 2 and 3 breast cancer were eligible. The first cohort of patients was treated at dose A with neoadjuvant docetaxel (75 mg/m(2) i.v. day 1) and capecitabine (1000 mg/m(2) orally twice daily days 2-15) for four cycles. A second cohort of subjects was treated with a reduced dose, dose B, of docetaxel (60 mg/m(2) i.v. day 1) and capecitabine (937.5 mg/m(2) orally twice daily days 2-15).Results: Thirty patients were enrolled. Eight of 10 patients treated at dose A required dose reductions of either docetaxel or capecitabine secondary to grade 3 or 4 toxicities: mucositis (1), hand-foot syndrome (3), diarrhea (2), perirectal abscess (1), and neutropenia (2). Because of a high rate of dose reductions, the next 20 patients were treated at dose B. The mean cumulative administered dose of docetaxel was 285 and 231 mg/m(2) at dose A and dose B, respectively. For capecitabine, the mean cumulative dose at dose A and B were similar at 1585 and 1627 mg/m(2)/day, respectively. The overall clinical response rate was 90% with 31% of patients having a complete response and 59% having a partial response. A pathological complete response in the breast was achieved in 10% of patients after four cycles of docetaxel/capecitabine.Conclusions: Docetaxel/capecitabine is a highly active regimen in the neoadjuvant setting. Neoadjuvant therapy with 75 mg/m(2) docetaxel and 1600 mg/m(2)/day days 2-15 is recommended.