Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma |
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Authors: | van Haarst J M W Baas P Manegold Ch Schouwink J H Burgers J A de Bruin H G Mooi W J van Klaveren R J de Jonge M J A van Meerbeeck J P |
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Institution: | Rotterdam Oncological Thoracic Studygroup (ROTS), Department of Pulmonology, University Hospital Rotterdam, PO Box 5201, 3008 AE Rotterdam, The Netherlands. |
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Abstract: | Malignant pleural mesothelioma is a notoriously chemoresistant tumour. However, a recent single institution study showed an impressive activity of gemcitabine and cisplatin. Our aim is to investigate the efficacy and toxicity of a gemcitabine and cisplatin combination in selected and chemo-naive patients with histologically proven malignant pleural mesothelioma. METHOD: Gemcitabine 1250 mg m(-2) was administered on day 1 and day 8 and cisplatin 80 mg m(-2) was administered on day 1 in a 3-week cycle with a maximum of six cycles. Response and toxicity evaluations were performed according to WHO and NCIC-CTC criteria. Pathology and radiology were centrally reviewed. Results show that in 25 evaluable patients, four PR were observed (ORR 16%, 95% CI 1-31%). Responses of seven patients were unevaluable. No unexpected toxicity occurred. Time to progression was 6 months (5-7 months) with a median survival from registration of 9.6 months (95% CI 8-12 months). In conclusion this trial excludes with 90% power a response rate of greater than 30% in patients with malignant pleural mesothelioma using a combination of gemcitabine and cisplatin at the proposed dose and schedule. |
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Keywords: | malignant pleural mesothelioma cisplatin gemcitabine phase II study |
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