Muhonen T, Jantunen I, Pertovaara H, Voutilainen L, Maiche A, Blomqvist C, Pyrhönen S, Kellokumpu-Lehtinen P
Department of Radiotherapy and Oncology, Helsinki University Central Hospital, Finland.
Am J Clin Oncol. 1996 Jun;19(3):232-4. doi: 10.1097/00000421-199606000-00004.
Patients with metastatic breast cancer were randomly assigned to receive as second-line chemotherapy either MMM (mitomycin 8 mg/m2 day 1; mitoxantrone 8 mg/m2 days 1 and 22; methotrexate 35 mg/m2 days 1 and 22) alone or in combination with filgrastim (5 micrograms/kg s.c. days 4-17, 24-37). The courses were repeated every 42 days for a maximum of six courses. Thirty-one patients are evaluable for safety and efficacy. The 16 patients in the filgrastim arm received a total of 42 cycles compared with 34 cycles in the 15 control patients. Tumor responses were few in both patient groups (one partial response in the filgrastim group and two partial responses in control group). Nevertheless, a difference in survival was seen (filgrastim median 10.7 months, control median 6.5 months; p = 0.02 log rank). The treatment was well tolerated. Doses were reduced six times in the filgrastim arm and eleven times in the control arm. Grade IV neutropenia was seen in four patients in the filgrastim arm and in twelve patients in the control arm. The observed survival benefit needs to be confirmed in a larger patient group.
转移性乳腺癌患者被随机分配接受二线化疗，要么单独使用MMM方案（丝裂霉素8mg/m²，第1天；米托蒽醌8mg/m²，第1天和第22天；甲氨蝶呤35mg/m²，第1天和第22天），要么联合非格司亭（5μg/kg皮下注射，第4 - 17天、第24 - 37天）。疗程每42天重复一次，最多进行六个疗程。31例患者可进行安全性和疗效评估。非格司亭组的16例患者共接受了42个周期的治疗，而15例对照组患者接受了34个周期的治疗。两组患者的肿瘤反应均较少（非格司亭组1例部分缓解，对照组2例部分缓解）。然而，观察到了生存差异（非格司亭组中位生存期10.7个月，对照组中位生存期6.5个月；对数秩检验p = 0.02）。该治疗耐受性良好。非格司亭组剂量降低了6次，对照组剂量降低了11次。非格司亭组有4例患者出现IV级中性粒细胞减少，对照组有12例患者出现IV级中性粒细胞减少。观察到的生存获益需要在更大规模的患者群体中得到证实。
