James L E, Gower N H, Rudd R M, Spiro S G, Harper P G, Trask C W, Partridge M, Ruiz de Elvira M C, Souhami R L
Department of Oncology, University College London Medical School, Middlesex Hospital, UK.
Br J Cancer. 1996 Jun;73(12):1563-8. doi: 10.1038/bjc.1996.295.
We report the results of a randomised trial in extensive small-cell lung cancer (SCLC) of a novel approach to palliative chemotherapy. A widely used 3 weekly regimen was compared with the same drugs given at half the dose but twice the frequency with the same intended overall dose intensity (DI). A total of 167 patients defined as having extensive SCLC with adverse prognostic features were randomised to receive either a 3 weekly regimen of cisplatin 60 mg m-2 i.v. on day 1 and etoposide 120 mg m-2 i.v. on day 1 and 100 mg b.d. orally on days 2 and 3 alternating with cyclophosphamide 600 mg m-2 i.v., doxorubicin 50 mg m-2 i.v. and vincristine 2 mg i.v. all on day 1 for a maximum of six courses (3 weekly); or treatment with the same drugs but with each course consisting of half the 3 weekly dose given every 10 or 11 days for a maximum of 12 courses. In the 10/11 day regimen overall response rate was 58.9% (95% CI, 47.9-69.2%) with 12.8% complete responses (CR). For the 3 weekly treatment the overall response rate was 44.9% (95% CI, 35.0-55.5%) with 10.1% CR. Median survival was similar in the two arms at 6.4 months (95% CI, 4.9-7.3 months) and 5.8 months (95% CI, 4.0-6.6 months) respectively. Survival at 1 year was 9.9% (95% CI, 5.0-18.5%) and 8.9% (95% CI, 4.6-16.6%). The 95% CI for the difference in survival at 1 year is -7.09% to +9.09%. Haematological toxicity and treatment delays owing to infection were more frequent with the 10/11 day regimen but other toxicities were equal in both arms. Other aspects of quality of life were measured in a small representative cohort of patients using a daily diary card (DDC). There was a trend of improved quality of life on the 10/11 day arm, but there was little difference between the two treatments. The trial shows that a low-dose/high-frequency regimen with the same DI as conventionally scheduled chemotherapy gives similar response rates and survival. This and other modifications of the schedule may offer new approaches to palliative treatment of advanced cancer. However, in this trial there was no significant benefit in toxicity or other aspects of quality of life.
我们报告了一项针对广泛期小细胞肺癌（SCLC）姑息化疗新方法的随机试验结果。将一种广泛使用的每3周一次的方案与使用相同药物但剂量减半、给药频率加倍且总剂量强度（DI）相同的方案进行比较。共有167例被定义为具有不良预后特征的广泛期SCLC患者被随机分组，分别接受以下治疗：一种是每3周一次的方案，即第1天静脉注射顺铂60mg/m²，第1天和第2、3天口服依托泊苷120mg/m²，每日两次，每次100mg，与第1天静脉注射环磷酰胺600mg/m²、阿霉素50mg/m²和长春新碱2mg交替使用，最多6个疗程（每3周一次）；另一种是使用相同药物，但每个疗程由每10或11天给予3周方案剂量的一半，最多12个疗程。在10/11天方案组中，总缓解率为58.9%（95%CI，47.9 - 69.2%），完全缓解率（CR）为12.8%。对于每3周一次的治疗，总缓解率为44.9%（95%CI，35.0 - 55.5%），CR为1
