Sculier J P, Bureau G, Giner V, Thiriaux J, Michel J, Berchier M C, Van Cutsem O, Küstner U, Kroll F, Mommen P
Department of Medicine, Institut Jules Bordet, Brussels, Belgium.
Semin Oncol. 1995 Feb;22(1 Suppl 2):18-22.
Prospective trials comparing drug analogues in the treatment of small cell lung cancer are rare. The European Lung Cancer Working Party has conducted a randomized trial with a primary end point of determining the effect on survival of maintenance chemotherapy and a secondary end point of comparing doxorubicin (45 mg/m2) with a bioequivalent epirubicin dose (60 mg/m2) in one set of patients, and a standard with a high epirubicin dose (60 v 90 mg/m2) in a second set of patients. Anthracycline was given on day 1 of induction chemotherapy in combination with ifosfamide (1.5 g/m2 intravenously days 1 through 3) and etoposide (80 mg/m2 intravenously days 1 through 3). Six courses were given at 3-week intervals. In all, 235 eligible previously untreated patients with pathologically proven small cell lung cancer were randomized: 106 to the comparison of doxorubicin and epirubicin and 129 to the comparison of standard-dose versus high-dose epirubicin. There was no difference between the regimens in terms of objective response rate or survival, and the regimen containing the lower (60 mg/m2) epirubicin dose was better tolerated, with fewer toxic deaths and less need for dose and schedule adjustments.
比较药物类似物治疗小细胞肺癌的前瞻性试验很少见。欧洲肺癌工作组进行了一项随机试验，主要终点是确定维持化疗对生存率的影响，次要终点是在一组患者中比较阿霉素（45mg/m²）与生物等效表柔比星剂量（60mg/m²），在另一组患者中比较标准剂量与高剂量表柔比星（60对90mg/m²）。蒽环类药物在诱导化疗的第1天给予，与异环磷酰胺（1.5g/m²静脉滴注，第1至3天）和依托泊苷（80mg/m²静脉滴注，第1至3天）联合使用。每3周给予6个疗程。总共235例符合条件的既往未治疗的经病理证实的小细胞肺癌患者被随机分组：106例接受阿霉素和表柔比星的比较，129例接受标准剂量与高剂量表柔比星的比较。各治疗方案在客观缓解率或生存率方面没有差异，含较低（60mg/m²）表柔比星剂量的方案耐受性更好，毒性死亡更少，剂量和疗程调整的需求也更少。
