A systemic hyperthermia oncologic working group trial -: Ifosfamide, carboplatin, and etoposide combined with 41.8°C whole-body hyperthermia for metastatic soft tissue sarcoma

被引:19
作者
Westermann, AM
Wiedemann, GJ
Jager, E
Jager, D
Katschinski, DM
Knuth, A
Vörding, PZVS
Van Dijk, JDP
Finet, J
Neumann, A
Longo, W
Bakhshandeh, A
Tiggelaar, CL
Gillis, W
Bailey, H
Peters, SO
Robins, HI
机构
[1] Univ Wisconsin, Ctr Comprehens Canc, Madison, WI 53792 USA
[2] Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands
[3] Krankenhaus Nordw, Frankfurt, Germany
[4] Med Univ Lubeck, D-23538 Lubeck, Germany
关键词
whole-body hyperthermia; sarcoma; ifosfamide; carboplatin;
D O I
10.1159/000070287
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background. Based on earlier clinical and preclinical studies, we conducted a phase 11 trial in metastatic sarcoma patients of the combination of 41.8degreesC (x60 min) radiant heat (Aquatherm(R)) whole-body hyperthermia (WBH) with 'ICE' chemotherapy. The ICE regimen consists of ifosfamide (5 g/m(2)), carboplatin (300 mg/m(2)) and etoposide (100 mg/m(2)), concurrent with WBH, with etoposide also on days 2 and 3 post-WBH. Methods: Therapy was delivered every 4 weeks for a maximum of 4 cycles. All patients received filgrastim or lenograstim. Results: Of 108 patients enrolled as of September 2001, 95 are evaluable for response. Of the evaluable patients (mean ECOG performance status similar to 1; mean age 42.3; 58% male) 33 had no prior therapy for metastatic disease, and 62 were pretreated (mean: 1.5 prior regimens). The overall response rate was 28.4% (4 complete remissions and 23 partial remissions) with stable disease (SD) in 31 patients. For no prior therapy, the response rate was 36%; in pretreated patients it was 24%. The median overall survival by Kaplan-Meier estimates was 393 days (95% CI 327, 496); the median time to treatment failure was 123 days (95% CI 77, 164). The major toxicity (287 cycles) was grade 3 or 4 neutropenia and thrombocytopenia seen in 79.7 and 60.6% of treatments respectively; there were 7 episodes of infection (grade 3/4) with 2 treatment-related deaths, bot involving disease progression and ureteral obstruction. Conclusion: These results are consistent with continued clinical investigation of this combined modality approach.
引用
收藏
页码:312 / 321
页数:10
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