Kaye S B, Mead G M, Fossa S, Cullen M, deWit R, Bodrogi I, van Groeningen C, Sylvester R, Collette L, Stenning S, De Prijck L, Lallemand E, deMulder P
Cancer Research Campaign Department of Medical Oncology, University of Glasgow, Western Infirmary, UK.
J Clin Oncol. 1998 Feb;16(2):692-701. doi: 10.1200/JCO.1998.16.2.692.
The aim of this randomized trial was to assess the potential therapeutic advantage of an intensive induction-sequential chemotherapy schedule (bleomycin, vincristine, cisplatin [BOP])/etoposide, ifosfamide, cisplatin, and bleomycin [VIP-B]), compared with a regimen based on bleomycin, etoposide, and cisplatin (BEP) (BEP/etoposide and cisplatin [EP]) for the treatment of patients with poor-prognosis metastatic nonseminomatous germ cell tumors (NSGCTs).
Patients had one or more of the following: a retroperitoneal mass > or = 10 cm in diameter; mediastinal or supraclavicular mass > or = 5 cm in diameter; at least 20 lung metastases (any size); liver, bone, or brain metastases; and serum beta human chorionic gonadotropin (betaHCG) > or = 10,000 IU/L or alfa fetoprotein (AFP) > or = 1,000 IU/L. A total of 380 patients were accrued between May 1990 and June 1994 into this joint Medical Research Council (MRC)/European Organization for Research and Treatment of Cancer (EORTC) trial; of these, nine patients were deemed ineligible.
There was no significant difference between the two arms in the proportion of patients who achieved a complete response (CR) with chemotherapy alone, ie, 79 of 185 assessable patients (57%) with BEP/EP and 72 of 186 (54%) with BOP/VIP-B (P = 0.687). With a median follow-up of 3.1 years (maximum, 5.8), a total of 107 patients (28%) had progressive disease. There was no significant difference in time to first disease progression, or failure-free or overall survival between the two arms (P = 0.21, 0.101, and 0.190, respectively). The 1-year failure-free survival rates for BEP/EP and BOP/VIP-B were 60% (95% confidence interval [CI], 53% to 67%) and 53% (95% CI, 47% to 61%). Grade 3 or 4 myelosuppression, febrile neutropenia, and weight loss were more pronounced with BOP/VIP-B than with BEP/EP, and there were more toxic deaths with BOP/VIP-B than BEP/EP (18 [9%] v nine [5%]).
The intensive BOP/VIP-B therapy was associated with more toxicity, but there was no evidence of an improvement in response rate or survival compared with treatment with BEP/EP.
本随机试验旨在评估与基于博来霉素、依托泊苷和顺铂（BEP）（BEP/依托泊苷和顺铂[EP]）的方案相比，强化诱导序贯化疗方案（博来霉素、长春新碱、顺铂[BOP]）/依托泊苷、异环磷酰胺、顺铂和博来霉素[VIP - B]）治疗预后不良的转移性非精原细胞性生殖细胞肿瘤（NSGCT）患者的潜在治疗优势。
患者具备以下一项或多项情况：直径≥10 cm的腹膜后肿块；直径≥5 cm的纵隔或锁骨上肿块；至少20个肺转移灶（任何大小）；肝、骨或脑转移；血清β人绒毛膜促性腺激素（βHCG）≥10,000 IU/L或甲胎蛋白（AFP）≥1,000 IU/L。1990年5月至1994年6月期间，共有380例患者纳入了这项联合医学研究委员会（MRC）/欧洲癌症研究与治疗组织（EORTC）的试验；其中，9例患者被判定不符合入组条件。
两组仅接受化疗达到完全缓解（CR）的患者比例无显著差异，即185例可评估的接受BEP/EP治疗的患者中有79例（57%），186例接受BOP/VIP - B治疗的患者中有72例（54%）（P = 0.687）。中位随访3.1年（最长5.8年），共有107例患者（28%）出现疾病进展。两组在首次疾病进展时间、无失败生存期或总生存期方面无显著差异（P分别为0.21、0.101和0.190）。BEP/EP和BOP/VIP - B的1年无失败生存率分别为60%（95%置信区间[CI]，53%至67%）和53%（95%CI，47%至61%）。BOP/VIP - B组3或4级骨髓抑制、发热性中性粒细胞减少和体重减轻比BEP/EP组更明显，且BOP/VIP - B组的毒性死亡病例比BEP/EP组更多（18例[9%]对9例[5%]）。
强化BOP/VIP - B治疗的毒性更大，但与BEP/EP治疗相比，没有证据表明缓解率或生存率有所改善。
