Phase II trial of docetaxel with dexamethasone premedication in patients with advanced non-small cell lung cancer : the Canadian experience

We performed a Phase II trial to evaluate the activity and tolerability of docetaxel as a single agent in the treatment of advanced non-small cell lung cancer (NSCLC). Forty-four patients with metastatic and/or locally advanced NSCLC received i.v. docetaxel 100 mg/m2 every 3 weeks for a median of 4...

Full description

Saved in:
Bibliographic Details
Published in:Investigational new drugs 1998-01, Vol.16 (3), p.265-270
Main Authors: LATREILLE, J, GELMON, K. A, HIRSH, V, LABERGE, F, MAKSYMIUK, A. W, SHEPHERD, F. A, DELORME, F, BERILLE, J
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic agents
Antineoplastic Agents, Phytogenic - therapeutic use
Biological and medical sciences
Bone marrow
Canada
Cancer therapies
Carcinoma, Non-Small-Cell Lung - drug therapy
Carcinoma, Non-Small-Cell Lung - secondary
Chemotherapy
Dexamethasone - therapeutic use
Female
Glucocorticoids - therapeutic use
Hematology
Humans
Hypotheses
Infections
Lung cancer
Lung Neoplasms - drug therapy
Lung Neoplasms - pathology
Male
Medical prognosis
Medical sciences
Metastasis
Middle Aged
Neutropenia
Paclitaxel - analogs & derivatives
Paclitaxel - therapeutic use
Patients
Pharmacology. Drug treatments
Premedication
Radiation therapy
Response rates
Steroids
Survival Analysis
Taxoids
Toxicity
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:We performed a Phase II trial to evaluate the activity and tolerability of docetaxel as a single agent in the treatment of advanced non-small cell lung cancer (NSCLC). Forty-four patients with metastatic and/or locally advanced NSCLC received i.v. docetaxel 100 mg/m2 every 3 weeks for a median of 4 (range 1-11) cycles. All patients received premedication with oral dexamethasone 8 mg twice daily for 5 days starting the day before chemotherapy. Seven partial responses were observed among 35 evaluable patients, and the overall response rate was 20% (95% CI 8-37). The median response duration was 5 months, median survival time was 10 months and the estimated 1-year survival rate was 42%. Treatment was generally well tolerated. Febrile neutropenia occurred in 10 patients (23%); neutropenic infection occurred in 4 patients, and led to 2 toxic deaths (both patients had borderline exclusion criteria). The corticosteroid premedication effectively reduced the overall incidence (34%) and severity (4% severe) of fluid retention, and delayed the median time to onset from cycle 4 to cycle 7. This study shows the promising efficacy of docetaxel as monotherapy in advanced NSCLC, and combination chemotherapy regimens incorporating docetaxel are now being evaluated in this clinical setting.
ISSN:0167-6997
1573-0646
DOI:10.1023/A:1006126505910