临床时讯 ＞ 临床研究
为了研究卡培他滨和多西他赛（XT）在改善乳腺癌手术治疗后的无复发生存率（RFS）上是否优于紫杉醇周疗（WP），美国安德森癌症中心进行了一项随机临床试验。研究结果已在线发表在《临床肿瘤学杂志》（Journal of Clinical Oncology）上。
在这项研究中，受试者按1∶1的比例被随机分为WP组（WP 80mg/m²，共12个星期，然后予以氟尿嘧啶500mg/m²、表阿霉素100mg/m²加环磷酰胺500mg/m²的FEC-100化疗，每3周为1个周期，共4个周期）和XT组（第1天：XT 75mg/m²，第1～14天：XT 1500mg/m²，每3周1个周期，共4个周期，然后再给予4个周期的FEC。
J Clin Oncol. 2012 Feb 13. [Epub ahead of print]
Phase III Trial Evaluating Weekly Paclitaxel Versus Docetaxel in Combination With Capecitabine in Operable Breast Cancer.
Kelly CM, Green MC, Broglio K, Thomas ES, Brewster AM, Valero V, Ibrahim NK, Gonzalez-Angulo AM, Booser DJ, Walters RS, Hunt KK, Hortobagyi GN, Buzdar AU.
The University of Texas MD Anderson Cancer Center, Houston, TX.
PURPOSE: We investigated whether capecitabine and docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) or weekly paclitaxel (WP) followed by FEC would improve relapse-free survival (RFS) in operable breast cancer. PATIENTS AND METHODS: In this single-institution study, patients with clinical stages I to IIIC breast cancer were randomly assigned on a 1:1 basis to WP 80 mg/m(2) for 12 weeks followed by fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), and cyclophosphamide 500 mg/m(2) (FEC-100) every 3 weeks for four cycles or docetaxel 75 mg/m(2) on day 1 and capecitabine (XT) 1,500 mg/m(2) on days 1 through 14 every 3 weeks for four cycles followed by FEC for four cycles and stratified by timing of chemotherapy (preoperative v adjuvant). Accrual was stopped short of 930 patients on the basis of a Bayesian predictive calculation that additional accrual would be unlikely to change the qualitative comparison of the two regimens. Results: After enrollment of 601 patients and a median follow-up of 50 months, we observed no improvement in RFS between XT (87.5%; 95% CI, 82.7% to 91.1%) and WP (90.7%; 95% CI, 86.4% to 93.7%; P = .51). In the preoperative group, the pathologic complete response rate was 19.8% and 16.4% in the XT and WP arms, respectively (P = .45). Rates of breast-conserving surgery were similar between the two groups (P = .48). The XT arm had a significantly higher incidence of stomatitis (P < .001), hand-foot syndrome (P < .001), and neutropenic infection (P < .001). CONCLUSION: There was no difference in efficacy between WP and XT as used in this randomized phase III trial. XT was associated with higher GI, skin, and neutropenic-related toxicities.