Universitäts-Frauenklinik Frankfurt, German Breast Group Forschungs GmbH, Martin-Behaim-Strasse 12, 63263 Neu-Isenburg, Germany.
J Clin Oncol. 2010 Apr 20;28(12):2015-23. doi: 10.1200/JCO.2009.23.8303. Epub 2010 Mar 22.
PURPOSE Capecitabine can be integrated either concomitantly or sequentially to anthracycline-plus-taxane-based regimens. PATIENTS AND METHODS Patients with large operable or locally advanced tumors, with hormone receptor-negative tumors, or with receptor-positive tumors but also clinically node-positive disease were recruited to receive preoperatively four cycles of epirubicin plus cyclophosphamide (EC; epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2)). Patients were then randomly assigned to four cycles of docetaxel (100 mg/m(2)), four cycles of docetaxel + capecitabine (TX; docetaxel 75 mg/m(2) plus capecitabine 1,800 mg/m(2)), or four cycles of docetaxel (75 mg/m(2)) followed by four cycles of capecitabine (1,800 mg/m(2); T-X). Patients with human epidermal growth factor receptor 2 (HER-2) -positive tumors received trastuzumab concomitantly with all cycles. Primary objectives were to assess the effect of docetaxel by comparing EC plus docetaxel versus EC plus TX and to assess the effect of duration by comparing EC plus TX versus EC plus T-X on pathologic complete response (pCR, without invasive/noninvasive breast tumor, regardless of nodal status) at surgery, irrespective of trastuzumab treatment. Results Of 1,509 patients starting EC, 1,421 were randomly assigned to docetaxel (n = 471), TX (n = 471), or T-X (n = 479). At surgery, pCR rates were 22.3%, 19.5%, and 22.3%, respectively; the difference for docetaxel (EC plus docetaxel v EC plus TX) was 2.8% (95% CI, -2.4% to 8.0%; P = .298).The difference for duration was -2.8% (95% CI, -8.0% to 2.4%; P = .298). Breast conservation rates were 70.1%, 68.4%, and 65.3%, respectively (P = .781 for docetaxel; P = .270 for duration). Concomitant but not sequential treatment with docetaxel was associated with more diarrhea; nail changes, and hand-foot-syndrome, but it was associated with less edema. CONCLUSION Adding capecitabine to or prolonging duration of neoadjuvant EC plus docetaxel does not result in higher efficacy at surgery.
卡培他滨可与蒽环类药物联合紫杉烷类药物同时或序贯给药。
招募了患有大型可手术或局部晚期肿瘤、激素受体阴性肿瘤或受体阳性但临床淋巴结阳性疾病的患者，接受术前 4 个周期表柔比星加环磷酰胺（EC；表柔比星 90mg/m²和环磷酰胺 600mg/m²）治疗。然后，患者被随机分配接受 4 个周期的多西他赛（100mg/m²）、4 个周期的多西他赛加卡培他滨（TX；多西他赛 75mg/m²加卡培他滨 1800mg/m²）或 4 个周期的多西他赛（75mg/m²）后加 4 个周期的卡培他滨（1800mg/m²；T-X）。HER-2 阳性肿瘤患者接受曲妥珠单抗联合所有周期治疗。主要目的是通过比较 EC 联合多西他赛与 EC 联合 TX，评估多西他赛的疗效，并通过比较 EC 联合 TX 与 EC 联合 T-X 来评估持续时间对手术时病理完全缓解（pCR，无浸润性/非浸润性乳腺肿瘤，无论淋巴结状态如何）的影响，而不考虑曲妥珠单抗的治疗。
在开始接受 EC 的 1509 例患者中，有 1421 例患者被随机分配接受多西他赛（n=471）、TX（n=471）或 T-X（n=479）。手术时，pCR 率分别为 22.3%、19.5%和 22.3%；多西他赛（EC 联合多西他赛与 EC 联合 TX）的差异为 2.8%（95%CI，-2.4%至 8.0%；P=0.298）。持续时间的差异为-2.8%（95%CI，-8.0%至 2.4%；P=0.298）。保乳率分别为 70.1%、68.4%和 65.3%（多西他赛的 P=0.781；持续时间的 P=0.270）。多西他赛联合治疗而非序贯治疗与腹泻、指甲改变和手足综合征有关，但与水肿有关。
卡培他滨联合或延长新辅助 EC 联合多西他赛的持续时间不会导致手术时更高的疗效。
