与BEP/EP方案治疗相比，BOP/VIP-B强化诱导序贯化疗用于预后不良的转移性非精原细胞瘤性生殖细胞肿瘤：一项随机医学研究委员会/欧洲癌症研究与治疗组织的研究
Intensive induction-sequential chemotherapy with BOP/VIP-B compared with treatment with BEP/EP for poor-prognosis metastatic nonseminomatous germ cell tumor: a Randomized Medical Research Council/European Organization for Research and Treatment of Cancer study.
作者信息
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
机构信息
Cancer Research Campaign Department of Medical Oncology, University of Glasgow, Western Infirmary, UK.
出版信息
J Clin Oncol. 1998 Feb;16(2):692-701. doi: 10.1200/JCO.1998.16.2.692.
PURPOSE
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 AND METHODS
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.
RESULTS
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%]).
CONCLUSION
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.
目的
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。
患者与方法
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。
结果
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%]）。
结论
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。
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