Conference Paper
Critical Analysis of Electromagnetic Hyperthermia Randomized Trials: Dubious Effect and Multiple Biases
Table 14
Randomized trials on whole-body hyperthermia.
| | Authors | Bakhshandeh et al. 2003 [39] | Bakhshandeh et al. 2004 [40] |
| | Phase | II | III | | Design | Prospective, monocenter, single-arm | Prospective, randomized, controlled | | | TChT | TChT | ChT | | Whole-body hyperthermia | Extreme | | | Interval between sessions | 3-4 weeks | | | Number of procedures | 4 | | | Temperature on plateau | 41.8°C | | | Time on plateau | 60′ | | | Heating method | IR-C | | | Unit | Aquatherm | | | Anesthesia | IV deep sedation | | | Artificial ventilation | No | | | Chemotherapy | ICE: ifosfamide 5 g/m2, carboplatin 300 mg/m2, etoposide 150 mg/m2 every 4 weeks |
ICE: ifosfamide 4.5 g/m2, carboplatin 270 mg/m2, etoposide 135 mg/m2 every 4 weeks | |
Number of patients |
27 | 31 (27 randomized) | | 14 | 13 | | Median age | 18–65 | 58 | | Disease | Pleural mesothelioma | Pleural mesothelioma | | Stage | I–III | 0–II | | Prior chemotherapy | 0% | 0% | | Metastases | 0% | 0% | | Immediate efficacy (CR + PR) | 20% | 15% | 31% | | Complete remission (CR) | 0% | 0% | 0% | | Partial remission (PR) | 20% | 15% | 31% | | Stable disease (SD) | 56% | 57% | 38% | | Progression of disease (PD) | 24% | 28% | 31% | | Time to progression | 6.9 months | 5.6 months | 9.2 months | | Overall survival | 17.9 months | 11.5 months | 15 months | | 1 year | 68% | | | | 2 years | 20% | | | | Toxicity Grade III-IV | | | | | Neutropenia | 74% | 36% | 30% | | Thrombocytopenia | 33% | 37.7% | 15.3% | | Treatment-related deaths | 1 (3.7%), sepsis | | |
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