Saxman S B, Finch D, Gonin R, Einhorn L H
Department of Medicine, Indiana University School of Medicine, Indianapolis 46202, USA.
J Clin Oncol. 1998 Feb;16(2):702-6. doi: 10.1200/JCO.1998.16.2.702.
In a previously reported randomized Southeastern Cancer Study Group (SECSG) trial, three cycles of chemotherapy were found to be equivalent to four cycles in patients with favorable-prognosis germ-cell cancer. We have conducted a follow-up analysis of patients treated at Indiana University (Indianapolis, IN) to compare long-term survival between the two groups and to examine factors associated with survival.
Sixty-nine patients with minimal-stage and 49 patients with moderate-stage disseminated germ-cell tumors were randomized to either three or four courses of bleomycin, etoposide, and cisplatin (BEP) administered every 3 weeks. Median follow-up time is 10.1 years (range, 7 months to 12.6 years). Ninety-two percent of patients have an actual follow-up time of > 5 years, and 97.5% of patients have an actual follow-up time of > 3 years.
Survival analysis shows no significant difference between the two treatment groups in terms of overall (P = .80) or disease-free (P = .93) survival. Several clinical variables were examined by univariate analysis; only serum human chorionic gonadotropin (HCG) had an impact on survival. There were two disease-related deaths in 104 patients with HCG < or = 1,000 mIU/mL and five disease-related deaths in 14 patients with HCG greater than 1,000 mIU/mL (P < .001). Ninety-eight percent (95% CI, 95.2 to 100) of patients with favorable prognosis germ-cell tumor with an initial HCG of < or = 1,000 mIU/mL are alive without evidence of disease at 5+ years.
With long-term follow-up, there is no statistically significant difference in survival between three or four cycles of BEP chemotherapy in patients with favorable prognosis germ-cell carcinoma. Serum HCG elevation of greater than 1,000 mIU/mL is a significant predictor of poor outcome in patients with otherwise good-risk disease.
在先前报道的一项东南部癌症研究组（SECSG）随机试验中，发现对于预后良好的生殖细胞癌患者，三个周期的化疗与四个周期的化疗效果相当。我们对印第安纳大学（印第安纳波利斯，印第安纳州）治疗的患者进行了随访分析，以比较两组患者的长期生存率，并研究与生存相关的因素。
69例微小分期和49例中度播散期生殖细胞肿瘤患者被随机分为接受每3周一次的三个疗程或四个疗程的博来霉素、依托泊苷和顺铂（BEP）化疗。中位随访时间为10.1年（范围：7个月至12.6年）。92%的患者实际随访时间超过5年，97.5%的患者实际随访时间超过3年。
生存分析显示，两组在总生存（P = 0.80）或无病生存（P = 0.93）方面无显著差异。通过单因素分析研究了几个临床变量；只有血清人绒毛膜促性腺激素（HCG）对生存有影响。在104例HCG≤1000 mIU/mL的患者中有2例与疾病相关的死亡，在14例HCG大于1000 mIU/mL的患者中有5例与疾病相关的死亡（P < 0.001）。初始HCG≤1000 mIU/mL的预后良好的生殖细胞肿瘤患者中，98%（95% CI，95.2至100）在5年以上时存活且无疾病证据。
经过长期随访，对于预后良好的生殖细胞癌患者，三个周期或四个周期的BEP化疗在生存率方面无统计学显著差异。血清HCG升高超过1000 mIU/mL是其他方面风险良好的疾病患者预后不良的重要预测指标。
