Jouve M, Palangie T, Belli L, Dorval T, Garcia-Giralt E, Beuzeboc P, Scholl S, Mosseri V, Livartowski A, Vedrenne J
Service de médecine oncologique, Institut Curie, Paris, France.
Bull Cancer. 1989;76(6):643-52.
Ninety-four patients with metastatic breast cancer were entered in a prospective randomised trial comparing 2 schedules of the same combination chemotherapy. Group I consisted of 46 patients, treated in a monthly three day course with adriamycin (ADM), cyclophosphamide (CPM), vindesine (VDS) and 5 fluoro-uracil (5 FU). Group II included 48 patients who received the same total monthly doses in 4 injections of ADM, CPM, VDS on days 2, 5, 16, 19 of each month together with a continuous infusion of 5 FU over a total of 10 days (days 1-5 and 15 and 19). Patient characteristics in the 2 groups as regards essential prognostic parameters were identical. We observed no difference in myelosuppression between the 2 groups. There were fewer gastrointestinal side effects in group II. Whereas complete alopecia occurred in 100% of patients in group I, only 33% of patients with the fractionated schedule totally lost their hair. The objective response rates at 8 months were 75 and 74% respectively, but the complete response rates (17.5 versus 28%) showed an advantage for group II. This advantage was not statistically significant. Durations of response were 15 months (group I) and 18 months (group II) and the median survival was 27 months in both. We conclude that prolonged low dose and fractionated administration of chemotherapy over 2 five day courses per month improves the therapeutic index and diminishes side effects.
94例转移性乳腺癌患者进入一项前瞻性随机试验,比较相同联合化疗的两种方案。第一组由46例患者组成,采用每月为期3天的疗程,使用阿霉素(ADM)、环磷酰胺(CPM)、长春地辛(VDS)和5-氟尿嘧啶(5-FU)进行治疗。第二组包括48例患者,他们在每月的第2、5、16、19天接受4次注射ADM、CPM、VDS,总月剂量相同,同时持续输注5-FU共10天(第1-5天以及第15和19天)。两组患者在基本预后参数方面的特征相同。我们观察到两组之间在骨髓抑制方面没有差异。第二组的胃肠道副作用较少。第一组100%的患者出现完全脱发,而采用分次给药方案的患者中只有33%完全脱发。8个月时的客观缓解率分别为75%和74%,但完全缓解率(17.5%对28%)显示第二组具有优势。这种优势没有统计学意义。缓解持续时间分别为15个月(第一组)和18个月(第二组),两组的中位生存期均为27个月。我们得出结论,每月分两个5天疗程进行延长的低剂量和分次化疗可提高治疗指数并减少副作用。