Phase II study of docetaxel for recurrent or metastatic non-small-cell lung cancer

Frank V. Fossella, Jin Soo Lee, William K. Murphy, Scott M. Lippman, Maria Calayag, Arlita Pang, Marvin Chasen, Dong M. Shin, Bonnie Glisson, Steven Benner, Martin Huber, Roman Perez-Soler, Waun Ki Hong, Martin Raber

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232 Scopus citations


Purpose: We conducted a phase II study to determine the response and toxicity of docetaxel (Taxotere; Rhone-Poulenc Rorer Pharmaceuticals, Inc, Collegeville, PA) in chemotherapy-naive patients with advanced non-small- cell lung cancer. Patients and Methods: We treated 41 chemotherapy-naive patients who had stage IIIb or IV non-small-cell lung cancer with 100 mg/m2 of docetaxel intravenously over 1 hour every 3 weeks. Responses were assessed after every one to two treatment courses. Responses of 39 of 41 patients were assessable. The patients' median age was 63 years; 90% of patients had a Zubrod performance status of 0 or 1. The predominant histology was adenocarcinoma (54%), and 90% of patients had stage IV disease. Results: Thirteen patients (33%) achieved a partial response to treatment, and the median response duration was 14 weeks. Grade 3 or 4 neutropenia occurred in 97% of patients; this was usually of brief duration and was associated with serious infection in 17% of patients. Other acute toxic effects included easily treated hypersensitivity reactions (36% of patients) and dermatitis (74%). We also observed fluid retention (with peripheral edema or pleural effusion or both) in 54% of patients. This was a cumulative side effect that generally occurred late in treatment. Conclusion: Docetaxel administered at 100 mg/m2 intravenously every 3 weeks has significant activity against non- small-cell lung cancer, with a 33% major response rate. Primary toxicities were neutropenia, hypersensitivity, and fluid retention.

Original languageEnglish (US)
Pages (from-to)1238-1244
Number of pages7
JournalJournal of Clinical Oncology
Issue number6
StatePublished - Jun 1994
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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