A phase III trial to evaluate oral chemotherapy with capecitabine versus standard chemotherapy with CMF for advanced breast cancer (ANZ 0001 Capecitebine)

323 eligible women were randomly assigned to capecitabine adminis-tered intermittently (1,000 mg/m2 twice daily for 14 of every 21 days; n = 107) or continuously (650 mg/m2 twice daily for 21 of every 21 days; n = 107), or to classical CMF (oral cyclophos-phamide 100 mg/m2 days 1 to 14 with intravenous methotrexate 40 mg/m2 and fluorouracil 600 mg/m2 on days 1 and 8 every 28 days; n = 109). The primary end point was quality-adjusted progression-free survival (PFS); secondary end points included PFS, overall survival (OS), objective tumor response, and adverse events. Intermittent and continuous capecitabine were to be compared first and, if similar (P >.05), combined for definitive comparisons versus CMF.

323名符合入组标准的女性患者被随机分配至三组：间歇给药卡培他滨（capecitabine）组（每21天周期内连续14天给药，1000mg/m²，每日两次；n=107）、持续给药卡培他滨组（每21天周期内连续21天给药，650mg/m²，每日两次；n=107），或经典CMF化疗方案组（每28天为一化疗周期，第1~14天口服环磷酰胺100mg/m²，第1天和第8天静脉给予甲氨蝶呤40mg/m²与氟尿嘧啶600mg/m²；n=109）。本研究的主要终点为质量校正无进展生存期（quality-adjusted progression-free survival, PFS）；次要终点包括无进展生存期（progression-free survival, PFS）、总生存期（overall survival, OS）、客观肿瘤应答及不良事件。研究首先比较间歇与持续卡培他滨给药方案，若二者疗效相似（P>0.05），则将两组合并后与CMF方案开展确证性对比分析。