A phase II trial of TIP (paclitaxel, ifosfamide and cisplatin) given as second-line (post-BEP) salvage chemotherapy for patients with metastatic germ cell cancer: a medical research council trial

被引:94
作者
Mead, GM
Cullen, MH
Huddart, R
Harper, P
Rustin, GJS
Cook, PA
Stenning, SP
Mason, M
机构
[1] Southampton Gen Hosp, Med Oncol Unit, Southampton SO16 6YD, Hants, England
[2] Univ Hosp Birmingham NHS Fdn Trust, Birmingham B15 2TH, W Midlands, England
[3] Royal Marsden Hosp, Sutton SM2 5PT, Surrey, England
[4] Guys Hosp, London SE1 9RT, England
[5] Mt Vernon Hosp, Northwood HA6 2RN, Middx, England
[6] MRC, Clin Trials Unit, London NW1 2DA, England
[7] Velindre Hosp, Cardiff CF4 7XL, Wales
关键词
cisplatin; ifosfamide; metastatic germ cell cancer; paclitaxel; salvage chemotherapy;
D O I
10.1038/sj.bjc.6602682
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
This phase II trial describes the use of TIP chemotherapy ( paclitaxel, ifosfamide and cisplatin) as salvage for patients with metastatic germ cell cancer (GCC) who have failed initial BEP (bleomycin, etoposide and cisplatin) chemotherapy. Patients with first relapse following BEP for metastatic GCC, confirmed by biopsy or sequentially rising markers, received four courses of TIP ( paclitaxel 175 mg m(-2) day 1, followed on days 1-5 by ifosfamide 1 gm(-2) intravenously (i.v.) and cisplatin 20 mg(2) i.v.) at 3-weekly intervals. The primary outcome measure was response to TIP. In all, 51 patients were registered, of whom 43 were eligible for response assessment. Eight achieved complete remission (CR) and 18 a partial remission with negative markers (PR-ve); favourable response rate (FRR = CR + PR-ve) 60%, 95% CI (44-75%); survival at 1 year was 70% (56-84%) and failure-free survival 36% (22-50%). In the group of 26 patients meeting the `good-risk' criteria described by the Memorial Hospital, the FRR was 73% (52-88%) compared with 41% (18-67%) for the 17 `poor-risk' patients. These results are inferior to those previously reported for TIP in a single-centre study when it was given more intensively, at higher dose and with growth factor support. Nonetheless, TIP as described here can cure a substantial proportion of patients. (c) 2005 Cancer Research UK.
引用
收藏
页码:178 / 184
页数:7
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