title: Phase II trials of single-agent activity of gemcitabine in patients with advanced non-small cell lung cancer: an overview.
abstract: A total of 361 patients have been entered into four phase II trials in which gemcitabine was given as a 30 min infusion in a schedule weekly x 3 q4W, at starting doses of 800-1250 mg/m2. Three of these trials produced response rates of 22.5%, 20% and 21.8% (all response rates were independently evaluated by an extramural Oncology Review Board). One small study of 30 evaluable patients produced a disappointing low response rate of 3%, but in this study the mean and median dose delivered was under 700 mg/m2. Gemcitabine was well tolerated with modest levels of traditional cytotoxicities such as myelosuppression, nausea and vomiting, and alopecia. Pooled data from two of the studies show improvement in a number of disease-related symptoms. Objective response rates by prognostic factor were determined: stage IIIa (30.5%), stage IIIb (18.8%), stage IV (19.5%); performance status 0 (31.8%), 1 (16.7%) and 2 (21.7%); female gender (23.5%), male (17.5%); age < 70 (18.6%), age > 70 (21.9%). Gemcitabine can be considered for use as a single agent in patients unable or unwilling to tolerate combination chemotherapy. Dose-response data suggest that a dose of 1000 mg/m2 or more is required for optimal therapeutic effect. The single-agent activity of gemcitabine together with its non-overlapping toxicity and novel mode of action suggest that this agent should also be investigated in combination with other active agents in non-small cell lung cancer.
authors.affiliation: Department of Medicine, Toronto Hospital, Ontario, Canada.
authors.forename: F A
authors.initials: FA
authors.lastname: Shepherd
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D017322:Clinical Trials, Phase II as Topic; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005060:Europe; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009656:North America; D013019:South Africa; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine