RESUMEN
In a retrospective evaluation of patients taking part for 2 months in a postmarketing surveillance study on the effectiveness and safety of Harpagophytum procumbens, associations were found to known explanators of pain, disability and depression. Therefore, treatment non-responders might best be referred to a multimodal pain relief program that deals with fear avoidance beliefs, enhances experiences that decrease perceptions linking disability and pain and forces the patients to rethink the way they deal with the problem. However, during treatment with the aqueous Harpagophytum extract, this decision might reasonably be postponed to the end of month 4, since it has been shown that the maximum pain relief occurs after 3-4 months.
Asunto(s)
Analgésicos/uso terapéutico , Dolor/tratamiento farmacológico , Dolor/psicología , Fitoterapia , Extractos Vegetales/uso terapéutico , Adaptación Psicológica , Anciano , Depresión/psicología , Evaluación de Medicamentos , Miedo , Femenino , Harpagophytum/química , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Hipertermia Inducida , Neoplasias Pleurales/terapia , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Carboplatino/administración & dosificación , Etopósido/administración & dosificación , Humanos , Hipertermia Inducida/efectos adversos , Ifosfamida/administración & dosificación , Mesotelioma/mortalidad , Mesotelioma/terapia , Neoplasias Pleurales/mortalidad , Sobrevida , SobrevivientesRESUMEN
We performed a phase II study combining 41.8 degrees C whole body hyperthermia with ICE chemotherapy, i.e. ifosfamide (5 g/m(2)), carboplatin (300 mg/m(2)) and etoposide (150 mg/m(2) on days 2 and 3), administered every 4 weeks, for patients with malignant pleural mesothelioma. Of 27 chemonäive, non-metastatic patients enrolled, 25 patients were evaluable for response. Overall response rate was 20% (five partial remissions; 95% CI 8.9-39.1%). Median survival time from the start of treatment for all patients was 76.6 weeks (95% CI 65.4-87.8 weeks). Progression free survival for all patients measured 29.6 weeks (95% CI 24.4-34.7 weeks). One year overall survival was 68% and 2 year overall survival was 20%. Major treatment toxicities included grade 3/4 neutropenia and thrombocytopenia in 74 and 33% of treatment cycles, respectively. One patient died due to sepsis. These promising results are consistent with continued clinical investigation; a phase III clinical trial with whole body hyperthermia as the independent variable has been initiated.