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对于低风险转移性睾丸生殖细胞肿瘤患者,博来霉素、依托泊苷和顺铂的3个周期方案与依托泊苷和顺铂的4个周期方案是否为等效的最佳方案?是否需要进行一项随机试验?

Are 3 cycles of bleomycin, etoposide and cisplatin or 4 cycles of etoposide and cisplatin equivalent optimal regimens for patients with good risk metastatic germ cell tumors of the testis? The need for a randomized trial.

作者信息

Culine S, Theodore C, Terrier-Lacombe M J, Droz J P

机构信息

Department of Medicine, Institut Gustave Roussy, Villejuif, France.

出版信息

J Urol. 1997 Mar;157(3):855-8; discussion 858-9.

PMID:9072585
Abstract

PURPOSE

Standard chemotherapy for good prognosis metastatic nonseminomatous germ cell tumors of the testis currently includes etoposide and cisplatin. The optimal number of cycles and the need for bleomycin remain matters of debate. Three cycles of bleomycin, etoposide and cisplatin (BEP) or 4 cycles of etoposide and cisplatin are supposed to represent equivalent optimal regimens.

MATERIALS AND METHODS

We analyzed the therapeutic outcome of 75 patients with good risk metastatic nonseminomatous germ cell tumor of the testis who were routinely treated at our institute. The chemotherapy regimens consisted of 4 cycles of BEP in 17 patients, 3 cycles of BEP in 23 patients, and 4 cycles of etoposide and cisplatin in 35 patients.

RESULTS

All 75 patients achieved a complete or partial response with normal serum tumor markers. After a median followup of 3.5 years (range 2 to 7.5) the overall no evidence of disease rate was 91% (100, 96 and 83% in patients treated with 4 cycles of BEP, 3 cycles of BEP, and 4 cycles of etoposide and cisplatin, respectively). When considering the number of adverse events in each treatment group, that is the number of surgical complete responses or relapses after complete remission, results appeared similar with 3 or 4 cycles of BEP (2 and 3, respectively) but lower in patients who received 4 cycles of etoposide and cisplatin (11 adverse events). Of the 35 patients treated with etoposide and cisplatin 4 (11%) died of disease while only 1 of the 40 (3%) treated with BEP died of disease.

CONCLUSIONS

Four cycles of etoposide and cisplatin could yield inferior results compared to 3 cycles of BEP in patients with good risk nonseminomatous germ cell tumor of the testis. Our results highlight the need for a randomized trial addressing the question of therapeutic equivalence between these 2 chemotherapy regimens.

摘要

目的

目前,针对预后良好的转移性睾丸非精原细胞瘤的标准化疗方案包括依托泊苷和顺铂。最佳化疗周期数以及是否需要博来霉素仍存在争议。三个周期的博来霉素、依托泊苷和顺铂(BEP)方案或四个周期的依托泊苷和顺铂方案被认为是等效的最佳方案。

材料与方法

我们分析了在我院接受常规治疗的75例低危转移性睾丸非精原细胞瘤患者的治疗结果。化疗方案包括:17例患者接受四个周期的BEP方案,23例患者接受三个周期的BEP方案,35例患者接受四个周期的依托泊苷和顺铂方案。

结果

所有75例患者均实现了血清肿瘤标志物正常的完全或部分缓解。中位随访3.5年(范围2至7.5年)后,总体无疾病证据率为91%(接受四个周期BEP方案、三个周期BEP方案和四个周期依托泊苷和顺铂方案治疗的患者分别为100%、96%和83%)。考虑每个治疗组的不良事件数量,即手术完全缓解或完全缓解后复发的数量,三个或四个周期BEP方案的结果相似(分别为2例和3例),但接受四个周期依托泊苷和顺铂方案的患者不良事件数量较少(11例不良事件)。在接受依托泊苷和顺铂方案治疗的35例患者中,4例(11%)死于疾病,而在接受BEP方案治疗的40例患者中,只有1例(3%)死于疾病。

结论

对于低危转移性睾丸非精原细胞瘤患者,四个周期的依托泊苷和顺铂方案可能比三个周期的BEP方案效果差。我们的结果强调需要进行一项随机试验,以解决这两种化疗方案治疗等效性的问题。

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