[Evaluation of the therapeutic benefit of 41.8 degrees C whole body hyperthermia plus ifosfamide, carboplatin and etoposide (ICE) for patients with malignant pleural mesothelioma using the Modified Brunner-Score (MBS)]
ABSTRACT
BACKGROUND: We performed a phase-II-study combining 41.8 degrees C whole body hyperthermia with ICE chemotherapy, i. e., ifosfamide (5 g/m (2) on day 1), carboplatin (300 mg/m (2) on day 1) and etoposide (150 mg/m (2) on days 2 and 3), administered every 4 weeks, to assess the treatment benefit for patients with malignant pleural mesothelioma. To date this is mainly done by measurement of response rates and overall survival, as it can be widely found in the literature. In fewer cases there is also a quality of life assessment. Here we describe an instrument well-capable for a more comprehensive statement on the therapeutic benefit by linking several study end points including quality of life assessment, the Modified Brunner-Score (MBS).
MATERIAL AND METHODS: The Modified Brunner Score (MBS) was used for this assessment. MBS integrates progression free survival, change of physical performance (WHO-index), a quality of life self-assessment by the patient and toxicity. A positive score means a therapy benefit and vice versa.
RESULTS AND CONCLUSIONS: Of 27 chemonäive, non-metastatic patients enrolled, 22 were evaluable for assessment. Overall survival and progression free survival for all patients was 76 weeks (95 % CI 65.4 weeks – 87.8 weeks) and 29.6 weeks (95 % CI 24.4 weeks – 34.7 weeks) respectively. Major treatment toxicities included grade 3/4 neutropenia and thrombocytopenia and affection of the GI tract, like mucositis, nausea and vomiting. Mean Improvement of Performance Index (WHO) was 0.29 points. The MBS showed a score of 4.21 points (- 4.43 – 16.45 range) for the overall study group. 16 of 22 evaluable patients achieved a positive score. MBS is a suitable tool to evaluate the treatment benefit especially in non-standard therapy approaches. For WBH plus ICE, it showed a beneficial effect on overall quality of life in the majority of patients.