A randomized phase III study of cisplatin with or without raltitrexed in patients (pts) with malignant pleural mesothelioma (MPM): an intergroup study of the EORTC Lung Cancer Group and NCIC

摘要: 7021 Background: MPM is characterized by an increasing incidence and refractoriness to available cytostatic drugs. Phase I II trials in mesothelioma pts using raltitrexed- a thymidine synthase inhibitor- with without platinum showed ORR of 20–35% (Fizazi, 2000 2003) 21%(Baas, respectively provide the rationale for design this randomized study. Methods: Eligible had have histologically proven unresectable MPM, not pretreated chemotherapy, WHO PS ≤ 2, adequate hematological, renal hepatic function. Stratification was institution, (0 vs.1–2) WBC (< 8.3 109/l vs. ≥ 109/l). After written informed consent, were between cisplatin 80 mg/m2 iv on day 1, (Arm A) or B) preceding infusion raltitrexed 3 mg/m2. Treatment continued q3 weeks unless refusal, progression unacceptable toxicity occurred. Appropriate dose reductions made case toxicity. In measurable disease, response moni...