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长春花碱/博来霉素与阿霉素/顺二氯二氨铂(II)序贯联合化疗治疗非精原细胞瘤性睾丸癌。I. 71例播散性疾病(IV期)患者的前瞻性随机III期研究结果(作者译)

[Sequential combination chemotherapy with vinblastine/bleomycin and adriamycin/cis-dichlorodiammineplatinum (II) in non-seminomatous testicular cancer. I. Results of a prospective randomized phase III-study with 71 patients with disseminated disease (stage IV) (author's transl)].

作者信息

Scheulen M E, Higi M, Schilcher R B, Meier C R, Seeber S, Schmidt C G

出版信息

Klin Wochenschr. 1980 Aug 15;58(16):811-21. doi: 10.1007/BF01491101.

Abstract

74 patients with disseminated non-seminomatous testicular cancer were randomly entered on a prospective sequential combination chemotherapy regimen with mandatory crossover, consisting of either vinblastine/bleomycin or adriamycin/cis-dichlorodiammineplatinum (II) (DDP) as initial therapy. Independent of the randomization the overall remission rate in 71 evaluable patients was 89% including 54% complete remissions. 35% of the patients remained disease-free at 2+ to 28+ months with a median of 12 months. By additional surgical removal of residual pulmonary metastases in two patients the complete remission rate was increased to 40/71 (56%), and the number of patients with no evidence of disease to 27/71 (38%). According to the life-table method the two-years survival rates were 63% for complete responders and 29% for all other patients, which was significantly lower. 53 patients (75%) were alive at 3 to 28 months with a median of 9 months. Additional advanced abdominal disease, initially elevated beta-HCG and LDH and extension of pulmonary disease were of significant negative influence on the prognosis. The evaluation of single chemotherapy courses revealed equal efficacy of both combinations. However, response to adriamycin/DDP occurred in 46% of the courses, when vinblastine/bleomycin had failed, while response to vinblastine/bleomycin occurred only in 21% of the courses when adriamycin/DDP had failed. Thus different patterns of cross-resistance between these alternative regimens may exist.

摘要

74例播散性非精原细胞瘤性睾丸癌患者被随机纳入一项前瞻性序贯联合化疗方案,该方案有强制交叉,初始治疗采用长春碱/博来霉素或阿霉素/顺二氯二氨铂(II)(顺铂)。与随机分组无关,71例可评估患者的总体缓解率为89%,其中完全缓解率为54%。35%的患者在2至28个月内无疾病,中位时间为12个月。通过额外手术切除两名患者残留的肺转移灶,完全缓解率提高到40/71(56%),无疾病证据的患者数量增加到27/71(38%)。根据寿命表法,完全缓解者的两年生存率为63%,所有其他患者为29%,后者显著更低。53例患者(75%)在3至28个月存活,中位时间为9个月。额外的晚期腹部疾病、最初升高的β-HCG和乳酸脱氢酶以及肺部疾病的扩展对预后有显著负面影响。对单一化疗疗程的评估显示两种联合方案疗效相当。然而,当长春碱/博来霉素治疗失败时,46%的疗程对阿霉素/顺铂有反应,而当阿霉素/顺铂治疗失败时,长春碱/博来霉素治疗只有21%的疗程有反应。因此,这些替代方案之间可能存在不同的交叉耐药模式。

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