Phase II study of paclitaxel plus gemcitabine salvage chemotherapy for germ cell tumors after progression following high-dose chemotherapy with tandem transplant
Phase II study of paclitaxel plus gemcitabine salvage chemotherapy for germ cell tumors after progression following high-dose chemotherapy with tandem transplant
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DOI：
10.1200/jco.2006.07.7271
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发表时间：
2007-02-10
影响因子：
45.3
通讯作者：
Williams, Stephen D.
中科院分区：
文献类型：
--
作者：
Einhorn, Lawrence H.;Brames, Mary J.;Williams, Stephen D.
目的探讨顺铂联合化疗及后续大剂量化疗串联移植进展后紫杉醇加吉西他滨补救性化疗的长期生存率和潜在治愈率。患者与方法1996年2月至2004年12月，184例患者在印第安纳大学（Indianapolis， IN）接受了恢复性大剂量化疗。在进一步证据表明疾病进展后，32例患者随后接受紫杉醇100 mg/n(2)超过1小时的治疗加上吉西他滨1000 mg/m(2)超过30分钟的治疗，每4周第1、8和15天，最多6个疗程。这是对患者群体的回顾性研究。评估患者的反应、反应持续时间和生存率。如果患者先前接受过紫杉醇或吉西他滨，则不合格。结果32例患者中有10例（31%）达到客观缓解，包括4例部分缓解（持续时间2 ~ 6个月）和6例完全缓解（cr）。这6例CRs中有4例（占总患者人数的12.5%）分别在紫杉醇加吉西他滨治疗开始后超过20、40、44和57个月，紫杉醇加吉西他滨连续无病（NED）（无化疗后手术）。目前，在紫杉醇加吉西他滨治疗后超过63个月又发生了一例CR，随后进行了两次癌切除术。结论紫杉醇联合吉西他滨治疗在大剂量化疗后进展，且之前未接受过紫杉醇或吉西他滨治疗的患者群体中可以实现长期无病生存。
PurposeTo determine long-term survival and potential cure with salvage chemotherapy with paclitaxel plus gemcitabine after progression after both cisplatin combination chemotherapy and subsequent high-dose chemotherapy with tandem transplantation.Patients and MethodsOne hundred eighty-four patients received salvage high-dose chemotherapy at Indiana University ( Indianapolis, IN) from February 1996 to December 2004. After further evidence of progressive disease, 32 patients were subsequently treated with paclitaxel 100 mg/n(2) over 1 hour plus gemcitabine 1,000 mg/m(2) over 30 minutes, days 1, 8, and 15 every 4 weeks for a maximum of six courses. This is a retrospective review of this patient population. Patients were evaluated for response, duration of response, and survival. Patients were ineligible if they received prior paclitaxel or gemcitabine.ResultsTen (31%) of 32 patients achieved objective response, including four partial remissions (2- to 6-month duration) and six complete responses (CRs). Four of these six CRs (12.5% of total patient population) are continuously disease free (NED) with paclitaxel plus gemcitabine alone ( no postchemotherapy surgery) at more than 20, 40, 44, and 57 months from start of paclitaxel plus gemcitabine, respectively. One additional CR is currently NED more than 63 months after paclitaxel plus gemcitabine with two subsequent resections of carcinoma.ConclusionLong-term disease-free survival is possible with paclitaxel plus gemcitabine in this patient population that progressed after high-dose chemotherapy, and had not received prior paclitaxel or gemcitabine.