Phase II trial of paclitaxel by 96-hour continuous infusion in combinationwith cisplatin for patients with advanced non-small cell lung cancer

Our purpose was to determine the antitumor efficacy and safety profile of t he combination of paclitaxel administered by 96-h continuous i,v, infusion followed by bolus cisplatin in patients with untreated advanced non-small c ell lung cancer (NSCLC), Fifty-eight patients with untreated advanced or re current NSCLC were enrolled between October 1995 and December 1998, The med ian patient age was 60 years (age range, 34-75 years). Twenty-four patients were female. The majority of patients (n = 52) had an Eastern Cooperative Oncology Group performance status of 0/1, Twelve patients had stage IIIB NS CLC, 43 had stage IV disease, and 3 had recurrent disease after prior resec tion, Seven patients had received cranial irradiation for brain metastases, and 5 patients had received bone irradiation before enrollment. Patients,w ere treated with paclitaxel (120 mg/m(2)/96 h) by continuous i,v, infusion followed by cisplatin (80 mg/m(2)) on day 5, Therapy was administered every 3 weeks as tolerated until disease progression or a maximum of six cycles. A total of 264 cycles of therapy were administered. Twenty-nine patients r eceived all six cycles, Forty-six patients had measurable disease, with 20 patients achieving a partial response, and no complete responses were seen (overall response rate, 43%; 95% confidence interval, 29-60%), The median p rogression-free survival was 5.5 months. At a median potential follow-up of 27.2 months, the median survival for all 58 enrolled patients was 8.5 mont hs, and the actuarial 1-year survival was 37% (95% confidence interval, 25. 9-50.5%). This is the most extensive evaluation of prolonged continuous inf usional paclitaxel in patients,vith advanced-stage cancer. In contrast to p redictions from in vitro cytotoxicity models, the regimen does not appear t o be obviously superior to shorter infusion times in the clinical setting. Additional trials of this regimen in patients with NSCLC are therefore of l ow priority.