Phase II trial of docetaxel in patients with stage III and IV non-small-cell lung cancer Journal Article


Authors: Francis, P. A.; Rigas, J. R.; Kris, M. G.; Pisters, K. M. W.; Orazem, J. P.; Woolley, K. J.; Heelan, R. T.
Article Title: Phase II trial of docetaxel in patients with stage III and IV non-small-cell lung cancer
Abstract: Purpose: This phase II study was conducted to evaluate the efficacy and toxicity of docetaxel in the treatment of patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Docetaxel was administered to 29 patients with unresectable stage III and IV NSCLC at a dose of TOO mg/m2 intravenously (IV) over 1 hour every 21 days. No premedication was given to the first 16 patients. Premedication with diphenhydramine was instituted for the remainder. No patient had previously received chemotherapy. Seven patients had undergone prior radiation therapy. Results: All patients were assessable for response and toxicity. Eleven of 29 patients (38%) had a major objective response (95% confidence interval, 21% to 58%). The median duration of response was 5.3 months. Febrile neutropenia occurred in 41% of patients and in 11 % of 134 courses of docetaxel. Nonhematologic toxicities included infusion-related hypersensitivity reactions, fluid retention, rash, alopecia, and sensory neuropathy. Premedication with diphenhydramine did not decrease the incidence of infusion-related hypersensitivity reactions. Conclusion: At this dose and schedule, docetaxel demonstrates significant antitumor activity in patients with advanced NSCLC. Further investigations of this agent in NSCLC are indicated. © 1994 by American Society of Clinical Oncology.
Keywords: adult; cancer chemotherapy; clinical article; aged; clinical trial; neutropenia; advanced cancer; drug efficacy; paclitaxel; phase 2 clinical trial; sensory neuropathy; gastrointestinal symptom; lung non small cell cancer; carcinoma, non-small-cell lung; lung neoplasms; antineoplastic agents, phytogenic; dexamethasone; antineoplastic activity; docetaxel; drug hypersensitivity; rash; drug response; alopecia; drug induced disease; intravenous drug administration; fluid retention; diphenhydramine; premedication; middle age; human; male; female; priority journal; article; support, non-u.s. gov't
Journal Title: Journal of Clinical Oncology
Volume: 12
Issue: 6
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1994-06-01
Start Page: 1232
End Page: 1237
Language: English
PROVIDER: scopus
PUBMED: 7911159
DOI: 10.1200/JCO.1994.12.6.1232
DOI/URL:
Notes: Article -- Source: Scopus
Altmetric Score
MSK Authors
  1. Mark Kris
    612 Kris
  2. Robert T Heelan
    85 Heelan
  3. James R. Rigas
    29 Rigas