Kondagunta G Varuni, Bacik Jennifer, Sheinfeld Joel, Bajorin Dean, Bains Manjit, Reich Lillian, Deluca John, Budnick Amy, Ishill Nicole, Mazumdar Madhu, Bosl George J, Motzer Robert J
Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
J Clin Oncol. 2007 Jan 1;25(1):85-90. doi: 10.1200/JCO.2006.06.9401.
To evaluate the optimal dose of carboplatin as well as the efficacy and tolerability of sequential, dose-intense chemotherapy with paclitaxel and ifosfamide followed by carboplatin and etoposide (TICE) plus peripheral-blood stem-cell (PBSC) support in patients with germ cell tumors (GCT) who are likely to experience treatment failure with conventional-dose salvage treatment. This prospective trial followed a similarly designed report of TICE, which used a different means of carboplatin dosing.
The 48 patients entered onto this trial had progressive GCT and unfavorable prognostic features after chemotherapy. Two cycles of paclitaxel plus ifosfamide were administered with leukapheresis, followed by three cycles of carboplatin plus etoposide with reinfusion of PBSC.
Twenty-three (49%) of 47 assessable patients achieved a complete response (CR) to chemotherapy. An additional three patients (6%) achieved a CR to chemotherapy and surgery. The CR rate was 55%. Six patients experienced relapse, but 24 patients (51%) are alive and free of disease at a median follow-up time of 40 months. Four patients who experienced relapse or achieved an incomplete response were rendered disease free by salvage surgical resection. When combined with results of the prior trial of similar design, TICE chemotherapy yielded an overall CR of 56% (n = 84), with 50% of patients alive with no evidence of disease.
TICE is an effective and tolerable dose-intense treatment for patients with previously treated metastatic GCT who have a poor predicted outcome to conventional-dose salvage chemotherapy.
评估卡铂的最佳剂量,以及对于可能在接受传统剂量挽救性治疗时出现治疗失败的生殖细胞肿瘤(GCT)患者,采用紫杉醇和异环磷酰胺序贯、剂量密集化疗,随后进行卡铂和依托泊苷(TICE)联合外周血干细胞(PBSC)支持治疗的疗效和耐受性。这项前瞻性试验遵循了一项设计相似的TICE报告,该报告采用了不同的卡铂给药方式。
入组该试验的48例患者在化疗后患有进展期GCT且预后不良。给予两个周期的紫杉醇加异环磷酰胺并进行白细胞单采,随后给予三个周期的卡铂加依托泊苷并回输PBSC。
47例可评估患者中有23例(49%)对化疗达到完全缓解(CR)。另外3例患者(6%)对化疗和手术达到CR。CR率为55%。6例患者出现复发,但24例患者(51%)在中位随访时间40个月时存活且无疾病。4例出现复发或未达到完全缓解的患者通过挽救性手术切除实现无病生存。当与先前类似设计试验的结果相结合时,TICE化疗的总体CR率为56%(n = 84),50%的患者存活且无疾病证据。
对于先前接受过治疗的转移性GCT患者,若预测其对传统剂量挽救性化疗预后不佳,TICE是一种有效且耐受性良好的剂量密集治疗方法。