Niiranen A, Holsti P, Salmo M
Department of Radiotherapy and Oncology, Helsinki University Central Hospital, Finland.
Acta Oncol. 1989;28(4):501-5. doi: 10.3109/02841868909092258.
Fifty-five patients with untreated small cell lung cancer were allocated randomly to receive either a standard 2-drug or a 4-drug chemotherapy regimen. The patients were further randomized to receive or not to receive prophylactic cranial irradiation (PCI) 40 Gy/20 fractions/4 weeks. Each patient also received split-course irradiation against the primary tumour (55 Gy/25 fractions/8 weeks), the mediastinum, and the supraclavicular areas. The standard 2-drug regimen consisted of cyclophosphamide 10 mg/kg i.v. days 1-4 and vincristine 1 mg i.v. days 1 + 4; every 4 weeks. The 4-drug regimen comprised cyclophosphamide 10 mg/kg i.v. days 1-3, vincristine 2 mg i.v. day 1 and 1 mg i.v. day 5, methotrexate 30 mg i.v. days 3 and 5, CCNU 80 mg/m2 i.v. day 2; every 7 weeks. The total treatment time for both protocols was 9 to 12 months. Objective response after 2 cycles of chemotherapy was seen in 46% of patients with the 2-drug regimen and in 56% with the 4-drug regimen. Local radiotherapy increased the response rates to 58% and 90% respectively. The median survival time was 12 months with the 2-drug regimen and 14 months with the 4-drug regimen. The 2-year and 3-year survival rates were 11% and 0% in the 2-drug group and 19% and 15% in the 4-drug group respectively. Toxicity was more severe in the 4-drug group with 4 deaths due to myelosuppression. Altogether, 25 patients received PCI. This did not in any subgroup increase median survival significantly but a reduction of relapses in the central nervous system was seen. Median survival was 13 months with versus 10 months without PCI; 2-year survival rates were 15% and 6% respectively. Morbidity due to PCI did not occur. Although no statistically significant survival advantage could be documented, there was obviously a higher rate of complete responses with multidrug therapy, and longer median duration of remission, median survival and maximal survival.
55例未经治疗的小细胞肺癌患者被随机分配接受标准两药或四药化疗方案。患者进一步随机分为接受或不接受40 Gy/20次/4周的预防性颅脑照射（PCI）。每位患者还接受针对原发肿瘤（55 Gy/25次/8周）、纵隔和锁骨上区域的分段照射。标准两药方案包括环磷酰胺10 mg/kg静脉注射第1 - 4天和长春新碱1 mg静脉注射第1天和第4天；每4周一次。四药方案包括环磷酰胺10 mg/kg静脉注射第1 - 3天，长春新碱2 mg静脉注射第1天和1 mg静脉注射第5天，甲氨蝶呤30 mg静脉注射第3天和第5天，洛莫司汀80 mg/m²静脉注射第2天；每7周一次。两种方案的总治疗时间均为9至12个月。两药方案组46%的患者在2周期化疗后出现客观缓解，四药方案组为56%。局部放疗使缓解率分别提高到58%和90%。两药方案组的中位生存时间为12个月，四药方案组为14个月。两药组的2年和3年生存率分别为11%和0%，四药组分别为19%和15%。四药组毒性更严重，有4例因骨髓抑制死亡。共有25例患者接受了PCI。这在任何亚组中均未显著提高中位生存时间，但可见中枢神经系统复发减少。接受PCI的中位生存时间为13个月，未接受PCI的为10个月；2年生存率分别为15%和6%。未发生PCI相关的发病率。虽然未记录到统计学上显著的生存优势，但多药治疗显然有更高的完全缓解率、更长的中位缓解持续时间、中位生存时间和最大生存时间。
