Bleehen N M, Girling D J, Machin D, Stephens R J
Br J Cancer. 1993 Dec;68(6):1150-6. doi: 10.1038/bjc.1993.496.
A total of 458 eligible patients, from 21 centres, with histologically or cytologically confirmed SCLC were allocated at random to three chemotherapy regimens, each given at 3-week intervals. In two regimens, etoposide, cyclophosphamide, methotrexate and vincristine were given for a total of either three courses (ECMV3) or six courses (ECMV6). In the third regimen, etoposide and ifosfamide were given for six courses (EI6). Patients with limited disease (56% of the total) also received radiotherapy to the primary site after the third course of chemotherapy in all three groups. A partial response occurred in 45% of 144 ECMV3 patients, 48% of 141 ECMV6, and 53% of 141 EI6 patients assessed, and a complete response in a further 15%, 9%, and 13% respectively, giving total response rates of 60%, 57%, and 67%, respectively. There was no overall survival advantage to any of the three regimens. At 1 year, 24%, 29%, and 30% of patients were alive, and at 2 years 7%, 8%, and 9%, respectively. The median survival time was 7.4 months in the ECMV3 group, 8.6 months in the ECMV6 group and 8.8 months in the EI6 group. The individual factors: poor performance status, extensive disease, the presence of dysphagia and a raised white blood cell count on admission adversely affected prognosis. The results do not exclude the possibility of a minor survival advantage with the two 6-course regimens. The findings on quality of life are presented in the companion paper (MRC Lung Cancer Working Party, 1993b).
来自21个中心的总共458例经组织学或细胞学确诊的小细胞肺癌患者被随机分配到三种化疗方案中,每种方案每3周给药一次。在两种方案中,依托泊苷、环磷酰胺、甲氨蝶呤和长春新碱总共给药三个疗程(ECMV3)或六个疗程(ECMV6)。在第三种方案中,依托泊苷和异环磷酰胺给药六个疗程(EI6)。所有三组中,局限期疾病患者(占总数的56%)在第三个化疗疗程后也接受了原发部位的放疗。在接受评估的144例ECMV3患者中,45%出现部分缓解,141例ECMV6患者中为48%,141例EI6患者中为53%,另有15%、9%和13%分别出现完全缓解,总缓解率分别为60%、57%和67%。三种方案中任何一种均无总体生存优势。1年时,患者的生存率分别为24%、29%和30%,2年时分别为7%、8%和9%。ECMV3组的中位生存时间为7.4个月,ECMV6组为8.6个月,EI6组为8.8个月。个体因素:身体状况差、广泛期疾病、存在吞咽困难以及入院时白细胞计数升高均对预后产生不利影响。结果不排除两种六个疗程方案有轻微生存优势的可能性。生活质量的研究结果见配套论文(MRC肺癌工作组,1993b)。