吉西他滨和奥沙利铂联合或不联合紫杉醇治疗且二次手术治疗顺铂耐药和/或多次复发生殖细胞肿瘤患者的长期生存。

Long-term survival after treatment with gemcitabine and oxaliplatin with and without paclitaxel plus secondary surgery in patients with cisplatin-refractory and/or multiply relapsed germ cell tumors.

机构信息

Department of Oncology/Hematology/Bone Marrow Transplantation/Pneumology, University Medical Center Eppendorf, Hamburg, Germany.

出版信息

Eur Urol. 2011 Oct;60(4):850-5. doi: 10.1016/j.eururo.2011.06.019. Epub 2011 Jun 24.

DOI:10.1016/j.eururo.2011.06.019

PMID:21704446

Abstract

BACKGROUND

Chemotherapy including gemcitabine, oxaliplatin, and/or paclitaxel has shown efficacy in germ cell tumor patients after progression during cisplatin-based chemotherapy or relapse after high-dose chemotherapy including complete responses in 5-15%.

OBJECTIVE

Most studies have been published with a short follow-up. We present the long-term outcome of two previously reported trials.

DESIGN, SETTING, AND PARTICIPANTS: Two phase 2 trials have evaluated chemotherapy with gemcitabine plus oxaliplatin alone (GO) or plus paclitaxel (GOP) including a total of 76 patients (35 GO and 41 GOP). At first publication, 29 patients were still alive and 9 patients (12%) were free of disease after chemotherapy with or without surgery: GO, 3 of 35 (9%) and GOP, 6 of 41 (15%).

MEASUREMENTS

Survival and follow-up time were calculated using the Kaplan-Meier method from the beginning of study treatment until the date of death or the date of the last follow-up.

RESULTS AND LIMITATIONS

After a median follow-up of 19 mo (2-86 mo) for the 29 patients still alive, 11% of all patients (8 of 76) were free of disease for >2 yr: 1 of 35 patients (3%) after GO and 7 of 41 patients (17%) after GOP. Three patients with complete remission (CR), two after GO and one after GOP, relapsed. Two others treated with GOP were rendered disease free: One patient with partial remission and short follow-up underwent secondary surgery, and another patient, who had relapsed 2 mo after GOP, achieved a CR after salvage treatment. Overall survival time is ≥33 mo (range: ≥ 28-59 mo) in these eight patients.

CONCLUSIONS

Long-term survival can be achieved in about 10-15% of patients with cisplatin-refractory or multiply relapsed germ cell tumor with GO(P) chemotherapy. Aggressive secondary surgery following partial remission is a crucial part of this salvage treatment.

摘要

背景

在顺铂为基础的化疗中进展或大剂量化疗后复发的生殖细胞瘤患者中，吉西他滨、奥沙利铂和/或紫杉醇联合化疗显示出疗效，完全缓解率为 5-15%。

目的

大多数研究的随访时间都较短。我们报告了两项先前报道的试验的长期结果。

设计、地点和参与者：两项 2 期试验评估了吉西他滨联合奥沙利铂（GO）或联合紫杉醇（GOP）的化疗，共纳入 76 例患者（GO 组 35 例，GOP 组 41 例）。首次发表时，29 例患者仍存活，9 例（12%）患者在接受化疗加或不加手术治疗后无疾病：GO 组 3 例（9%），GOP 组 6 例（15%）。

测量

从研究治疗开始到死亡或最后一次随访日期，使用 Kaplan-Meier 方法计算生存和随访时间。

结果和局限性

在仍存活的 29 例患者的中位随访时间为 19 个月（2-86 个月）后，所有患者中有 11%（76 例中的 8 例）无疾病超过 2 年：GO 组 1 例（3%），GOP 组 7 例（17%）。3 例完全缓解（CR）患者，GO 组 2 例，GOP 组 1 例，复发。另外 2 例接受 GOP 治疗的患者无疾病：1 例部分缓解且随访时间较短的患者接受了二次手术，另 1 例 GOP 后 2 个月复发的患者在挽救治疗后获得了 CR。这 8 例患者的总生存时间≥33 个月（范围：≥28-59 个月）。