Einhorn L H, Crawford J, Birch R, Omura G, Johnson D H, Greco F A
Department of Medicine, Indiana University, Indianapolis.
J Clin Oncol. 1988 Mar;6(3):451-6. doi: 10.1200/JCO.1988.6.3.451.
From June 1982 through October 1985, the Southeastern Cancer Study Group randomized patients with limited small-cell lung cancer (SCLC) to cyclophosphamide plus doxorubicin (Adriamycin, Adria Laboratories, Columbus, OH) plus vincristine (CAV) for six cycles v CAV plus concomitant thoracic irradiation as induction therapy. Patients achieving either a complete or partial response and remaining in remission after completion of induction therapy were subsequently randomized to consolidation chemotherapy consisting of cisplatin 20 mg/m2 X 4 plus etoposide (VP-16) 100 mg/m2 X 4 every 4 weeks for two courses v no further therapy. There were 160 patients entered on the consolidation phase and 148 were fully evaluable. The median survival for patients randomized to cisplatin plus VP-16 (PVP16) from start of CAV chemotherapy was 97.7 weeks, compared with 68 weeks for the no-consolidation arm (P = .0094). PVP16 consolidation also significantly increased the duration of remission, with median durations of 49 weeks v 28 weeks (P = .0008). The median durations for partial remission were 41 weeks v 23 weeks (P = .013), and for complete remission, 52 weeks v 30.5 weeks (P = .0091). Furthermore, 18 patients on PVP16 consolidation remain in a continuous complete remission for 12+ months and 13 of these are continuously disease free 2+ years. Eight patients randomized to no consolidation remain in a continuous complete remission, with only four patients disease free 2+ years. PVP16 consolidation has significantly improved the duration of remission and overall survival and appears capable of improving the cure rate in limited SCLC.
从1982年6月至1985年10月，东南癌症研究组将局限性小细胞肺癌（SCLC）患者随机分为两组，一组接受环磷酰胺加阿霉素（阿霉素，阿德里亚实验室，俄亥俄州哥伦布市）加长春新碱（CAV），共六个周期，另一组接受CAV加同期胸部放疗作为诱导治疗。诱导治疗完成后达到完全缓解或部分缓解且仍处于缓解期的患者，随后被随机分为巩固化疗组，即每4周给予顺铂20mg/m²×4加依托泊苷（VP - 16）100mg/m²×4，共两个疗程，另一组则不再接受进一步治疗。有160例患者进入巩固治疗阶段，其中148例可进行全面评估。从开始CAV化疗起，随机接受顺铂加VP - 16（PVP16）治疗的患者中位生存期为97.7周，而未进行巩固治疗组为68周（P = 0.0094）。PVP16巩固治疗还显著延长了缓解期，中位缓解期分别为49周和28周（P = 0.0008）。部分缓解的中位持续时间分别为41周和23周（P = 0.013），完全缓解的中位持续时间分别为52周和30.5周（P = 图0091）。此外，接受PVP16巩固治疗的18例患者持续完全缓解达12个月以上，其中13例持续无病生存2年以上。随机分配至未进行巩固治疗组的8例患者持续完全缓解，但只有4例患者无病生存2年以上。PVP16巩固治疗显著改善了缓解期和总生存期，似乎能够提高局限性SCLC的治愈率。
