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Phase II Trial of Paclitaxel by 96-Hour Continuous Infusion in Combination with Cisplatin for Patients with Advanced Non-Small Cell Lung Cancer

Medicine Branch [O. S. B., M. S. G., B. S. S., V. L., V. K., C. H. T., B. E. J.] and Biostatistics and Data Management Section [S. M. S.], Division of Clinical Sciences, National Cancer Institute/National Naval Medical Center, Bethesda, Maryland 20889; Departments of Radiology [P. P.] and Pulmonary Medicine [K. O.], National Naval Medical Center, Bethesda, Maryland 20889; and the Lowe Center for Thoracic Oncology, Department of Adult Oncology, Dana Farber Cancer Institute, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts 02115 [O. S. B., B. E. J.]

Our purpose was to determine the antitumor efficacy and safety profile of the combination of paclitaxel administered by 96-h continuous i.v. infusion followed by bolus cisplatin in patients with untreated advanced non-small cell lung cancer (NSCLC). Fifty-eight patients with untreated advanced or recurrent NSCLC were enrolled between October 1995 and December 1998. The median 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 NSCLC, 43 had stage IV disease, and 3 had recurrent disease after prior resection. Seven patients had received cranial irradiation for brain metastases, and 5 patients had received bone irradiation before enrollment. Patients were treated with paclitaxel (120 mg/m²/96 h) by continuous i.v. infusion followed by cisplatin (80 mg/m²) 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 received 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 progression-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 months, and the actuarial 1-year survival was 37% (95% confidence interval, 25.9–50.5%). This is the most extensive evaluation of prolonged continuous infusional paclitaxel in patients with advanced-stage cancer. In contrast to predictions from in vitro cytotoxicity models, the regimen does not appear to be obviously superior to shorter infusion times in the clinical setting. Additional trials of this regimen in patients with NSCLC are therefore of low priority.

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