Williams S D, Birch R, Einhorn L H, Irwin L, Greco F A, Loehrer P J
N Engl J Med. 1987 Jun 4;316(23):1435-40. doi: 10.1056/NEJM198706043162302.
Standard chemotherapy for disseminated germ-cell tumors includes a combination of cisplatin, vinblastine, and bleomycin, but this regimen produces substantial neuromuscular toxicity. In a randomized clinical trial in 261 men with disseminated germ-cell tumors, we substituted etoposide for the vinblastine in this regimen in half the patients to compare the efficacy and toxicity of the two treatments. Among 244 patients who could be evaluated for a response, 74 percent of those receiving the regimen including vinblastine and 83 percent of those receiving the regimen including etoposide became disease-free with or without subsequent surgery (P not significant). Among the 157 patients with high tumor volume, 61 percent became disease-free on the regimen that included vinblastine, as compared with 77 percent on the regimen that included etoposide (P less than 0.05). Survival among the patients who received etoposide was higher (P = 0.048). The regimens were similar in terms of myelosuppressive effects and pulmonary toxicity. However, the etoposide regimen caused substantially fewer paresthesias (P = 0.02), abdominal cramps (P = 0.0008), and myalgias (P = 0.00002). We conclude that etoposide with cisplatin and bleomycin is superior to vinblastine with cisplatin and bleomycin in the treatment of disseminated germ-cell tumors because of diminished neuromuscular toxicity and, among patients with advanced disease, better efficacy.
转移性生殖细胞肿瘤的标准化疗方案包括顺铂、长春碱和博来霉素联合使用,但该方案会产生严重的神经肌肉毒性。在一项针对261例转移性生殖细胞肿瘤男性患者的随机临床试验中,我们将一半患者该方案中的长春碱替换为依托泊苷,以比较两种治疗方法的疗效和毒性。在244例可评估疗效的患者中,接受含长春碱方案治疗的患者有74%、接受含依托泊苷方案治疗的患者有83%无论是否进行后续手术均实现疾病缓解(P值无统计学意义)。在157例肿瘤体积较大的患者中,接受含长春碱方案治疗的患者有61%实现疾病缓解,而接受含依托泊苷方案治疗的患者这一比例为77%(P值小于0.05)。接受依托泊苷治疗的患者生存率更高(P = 0.048)。两种方案在骨髓抑制作用和肺部毒性方面相似。然而,依托泊苷方案导致的感觉异常(P = 0.02)、腹部绞痛(P = 0.0008)和肌痛(P = 0.00002)明显更少。我们得出结论,在转移性生殖细胞肿瘤的治疗中,依托泊苷联合顺铂和博来霉素优于长春碱联合顺铂和博来霉素,因为前者神经肌肉毒性更小,且在晚期疾病患者中疗效更好。