A Systemic Hyperthermia Oncologic Working Group trial. Ifosfamide, carboplatin, and etoposide combined with 41.8 degrees C whole-body hyperthermia for metastatic soft tissue sarcoma.

Abstract

BACKGROUND:

Based on earlier clinical and preclinical studies, we conducted a phase II trial in metastatic sarcoma patients of the combination of 41.8 degrees C (x60 min) radiant heat (Aquatherm) 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 approximately 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.

• Authors: A M Westermann, G J Wiedemann, E Jager, D Jager, D M Katschinski, A Knuth, P Z Vörde Sive Vörding, J D P Van Dijk, J Finet, A Neumann, W Longo, A Bakhshandeh, C L Tiggelaar, W Gillis, H Bailey, S O Peters, H I Robins, Systemic Hyperthermia Oncologic Working Group
• Journal: Oncology (Oncology) Vol. 64 Issue 4 Pg. 312-21 ( 2003) ISSN: 0030-2414 [Print] Switzerland
• PMID: 12759526 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
• Copyright: Copyright 2003 S. Karger AG, Basel

Chemical References

• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• Etoposide
• Lenograstim
• Carboplatin
• Filgrastim
• Ifosfamide

Topics

• Adolescent
• Adult
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Carboplatin (administration & dosage)
• Combined Modality Therapy
• Etoposide (administration & dosage)
• Female
• Filgrastim
• Granulocyte Colony-Stimulating Factor (therapeutic use)
• Humans
• Hyperthermia, Induced
• Ifosfamide (administration & dosage)
• Lenograstim
• Male
• Middle Aged
• Recombinant Proteins (therapeutic use)
• Sarcoma (drug therapy, therapy)
• Survival Analysis
• Treatment Outcome