Phase II trial of a 75-mg/m2 dose of docetaxel with prednisone premedication for patients with advanced non-small cell lung cancer

✍ Scribed by Vincent A. Miller; James R. Rigas; Prudence A. Francis; Stefan C. Grant; Katherine M. W. Pisters; Mark G. Kris; Karen Woolley; Ennapadam S. Venkatraman; Robert T. Heelan

• Publisher: John Wiley and Sons
• Year: 1995
• Tongue: English
• Weight: 493 KB
• Volume: 75
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/1097-0142(19950215)75:4<968::aid-cncr2820750411>3.0.co;2-y

✦ Synopsis

Background.

A prior Phase I1 study of a 100-mg/m2 dose of docetaxel conducted at the Memorial Sloan-Kettering Cancer Center (New York, NY) demonstrated a 38% response rate with grade 3 or 4 neutropenia in 76% of the patients and a grade 2 or greater rash or infusionrelated reaction in 41% and 34% of the patients, respectively. The current Phase I1 study sought to determine the activity of a 75-mg/mz dose of docetaxel to establish whether this lower dose, combined with prednisone, ameliorates toxicity.

Methods. Twenty untreated patients with advanced non-small cell lung cancer (NSCLC) received a 1-hour 75- mg/m2 dose of docetaxel every 21 days. Fifty milligrams of prednisone were administered twice the day before chemotherapy and once each of the next 3 days. Patients' disease-related symptoms were assessed prospectively using the Lung Cancer Symptom Scale (LCSS).

Results. All patients were assessable for response and toxicity. Five patients had a major objective response (25%; 95% confidence interval, 11-50%). The median duration of response was 9.1 months. The projected 1-year From the