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顺铂和依托泊苷联合或不联合异环磷酰胺治疗转移性精原细胞瘤的风险适应性研究:GETUG S99 多中心前瞻性研究结果。

A risk-adapted study of cisplatin and etoposide, with or without ifosfamide, in patients with metastatic seminoma: results of the GETUG S99 multicenter prospective study.

机构信息

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

Department of Medical Oncology, Centre Paul Papin, Angers, France.

出版信息

Eur Urol. 2014 Feb;65(2):381-6. doi: 10.1016/j.eururo.2013.09.004. Epub 2013 Sep 13.

Abstract

BACKGROUND

Whether patients with good prognosis and intermediate/poor prognosis advanced seminoma should be treated differently has not been defined.

OBJECTIVE

To assess a risk-adapted chemotherapy regimen in patients with advanced seminoma.

DESIGN, SETTING, AND PARTICIPANTS: A total of 132 patients were included in this prospective study. Patients with a good prognosis according to the International Germ Cell Cancer Collaboration Group (IGGCCG) were treated with four cycles of cisplatin-etoposide (EP). Patients with an intermediate prognosis according to the IGCCCG (or a poor prognosis according to the Medical Research Council classification) were treated with four cycles of VIP (EP and ifosfamide) and granulocyte colony-stimulating factor (G-CSF).

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Survival curves were estimated using the Kaplan-Meier method.

RESULTS AND LIMITATIONS

The median follow-up was 4.5 yr (range: 0.4-11.6 yr). Among 108 patients (82%) with a good prognosis who received EP, grade 3-4 toxicity included neutropenia (47%) and neutropenic fever (12%). Among the 24 patients (18%) with an intermediate/poor prognosis who received VIP plus G-CSF, toxicity included grade 3-4 neutropenia (36%), neutropenic fever (23%), thrombocytopenia (23%), anemia (23%), and a toxicity-related death (n=1; 4%). The 3-yr progression-free survival (PFS) rate was 93% (range: 85-97%) in the good prognosis group and 83% (range: 63-93%) in the intermediate/poor prognosis group (p=0.03 for PFS). The 3-yr overall survival (OS) rate was 99% (range: 92-100%) and 87% (range: 67-95%), respectively (p<0.005 for OS). Only four patients died of seminoma or its treatment.

CONCLUSIONS

A risk-adapted chemotherapy policy for advanced seminoma yielded an excellent outcome with a 3-yr OS rate of 96%.

摘要

背景

预后良好和中/差预后的晚期精原细胞瘤患者是否应采用不同的治疗方法尚未明确。

目的

评估晚期精原细胞瘤患者的风险适应化疗方案。

设计、地点和参与者:这项前瞻性研究共纳入了 132 例患者。根据国际生殖细胞癌协作组(IGGCCG)预后良好的患者接受 4 个周期顺铂-依托泊苷(EP)治疗。根据 IGGGCCG 预后中等(或根据医学研究委员会分类预后较差)的患者接受 4 个周期 VIP(EP 和异环磷酰胺)和粒细胞集落刺激因子(G-CSF)治疗。

观察指标和统计学分析

使用 Kaplan-Meier 法估计生存曲线。

结果和局限性

中位随访时间为 4.5 年(范围:0.4-11.6 年)。在接受 EP 治疗的 108 例(82%)预后良好的患者中,3-4 级毒性包括中性粒细胞减少症(47%)和中性粒细胞减少症发热(12%)。在接受 VIP 加 G-CSF 治疗的 24 例(18%)中/预后不良的患者中,毒性包括 3-4 级中性粒细胞减少症(36%)、中性粒细胞减少症发热(23%)、血小板减少症(23%)、贫血(23%)和与毒性相关的死亡(n=1;4%)。在预后良好的组中,3 年无进展生存率(PFS)为 93%(范围:85-97%),在中/预后不良的组中为 83%(范围:63-93%)(PFS 为 0.03)。3 年总生存率(OS)分别为 99%(范围:92-100%)和 87%(范围:67-95%)(OS 为<0.005)。只有 4 例患者死于精原细胞瘤或其治疗。

结论

晚期精原细胞瘤的风险适应化疗方案获得了极好的结果,3 年 OS 率为 96%。

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