Source: Annual Congress 2002 - Thoracic oncology: clinical management
Disease area: Thoracic oncology

Abstract

Introduction: The aim of this study is to evaluate toxicity, safety and efficacy of this regimen with a new schedule in the treatment of MM cancer patients. The cisplatin, epirubicin, doxorubicin and high dose methotrexate are considered the agents which have demonstrated reproducible activity against MM. Some authors showed that GEM is active against MM in combination with CDDP or alone. CPT11 is a topoisomerase I inhibitor. We think that two drugs could have an additive-synergistic effect. Methods: From March 1999, 15 unselected patients were enrolled in the study, at present 14 pts were assessable for response and all for toxicity. 4 pts were diagnosed in stage IV and 3 pts in stage 3, 5 pts were diagnosed in stage 2. Median age was 60 years, median P.S.1. We administered a total numbers of 70 cycles and median 6, in 2 pts this schedule was the second line of therapy.The chemotherapy regimen consisted of GEM 1000mg/m2 on days 1 and 8, CPT11 200 mg/m2 on day 1.The cycles were repeated every 3 weeks. Results: All patients were valuable for toxicity. In all courses NCI- CTC grade 3 and 4 was as follows:1 case neutropenia grade 3, vomiting grade 4 in 1 pt, diarrhea grade 3 in 1 pt. 1 pt had dermatological toxicity grade 4. There was no treatment-related death, dose reduction to 50% in 5 % of cycles, dose reduction to 75% in 2 % of cycles.We observed 2/14 (14,2 %) PR, 6/14 MR/SD (42.8%), the median survival is13 (range 4 - 20 +) months and 8 pts are alive 1 year after the beginning of treatment. Conclusion: these data suggest that the combination is active in the dose and schedule used in the study. The agents of this investigation showed low toxicity. Accrual is ongoing.

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G. Rinaldi, V. Ferrari, A. Caprioli, G. Bozzola, G. Marini, G. F. Tassi (Brescia, Italy). A phase II study with gemcitabine (GEM) plus irinotecan (CPT11) in malignant mesothelioma (MM): preliminary report. Eur Respir J 2002; 20: Suppl. 38, 1188

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