TIRAPAZAMINE WITH CISPLATIN IN PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG-CANCER - A PHASE-II STUDY

Purpose: A phase II study was conducted to evaluate the safety and eff icacy of tirapazamine combined with cisplatin for the treatment of pat ients with advanced non-small-cell lung cancer (NSCLC). Patients and M ethods: Forty-four patients with stage IIIB/IV NSCLC were treated with a combination of tirapazamine and cisplatin. Patients received tirapa zamine 260 mg/m(2) administered intravenously over 2 hours, followed 1 hour later by cisplatin 75 mg/m(2) administered over an additional ho ur, repeated every 21 days. The duration of therapy was meant to be li mited to four cycles for nonresponders and eight cycles for responders . Results: Ten of 44 patients (23%) showed a partial response. The est imated median survival for all patients was 37 weeks. Toxicities were treatable and included grade 3 nausea or vomiting (25%), fatigue (27.3 %), and muscle cramps (4.5%). No dose reductions were necessary. Concl usion: The results show that tirapazamine can safely be added to cispl atin. Both the median survival and response rate observed strongly sug gest that tirapazamine with cisplatin is more active than cisplatin al one. (C) 1998 by American Society of Clinical Oncology.