Gemcitabine monotherapy in elderly patients with advanced non-small cell lung cancer: A multicenter phase II study

Background: This trial investigated the activity and toxicity of gemcitabine in previously untreated elderly (>70 years) patients with advanced (stage IIIB-IV) non-small cell lung cancer (NSCLC). Patients and methods: From January 1997 to July 1998, 46 patients with advanced NSCLC aged over 70 ye...

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Bibliographic Details
Published in:	Lung cancer (Amsterdam, Netherlands) Vol. 27; no. 2; pp. 75 - 80
Main Authors:	Ricci, S, Antonuzzo, A, Galli, L, Tibaldi, C, Bertuccelli, M, Lopes Pegna, A, Petruzzelli, S, Algeri, R, Bonifazi, V, Fioretto, M.L, Orlandini, C, Conte, P.F
Format:	Journal Article
Language:	English
Published:	Shannon Elsevier Ireland Ltd 01-02-2000 Elsevier Science
Subjects:	Advanced non-small cell lung cancer Aged Aged, 80 and over Antimetabolites, Antineoplastic - pharmacology Antimetabolites, Antineoplastic - therapeutic use Antineoplastic agents Biological and medical sciences Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - pathology Chemotherapy Deoxycytidine - analogs & derivatives Deoxycytidine - pharmacology Deoxycytidine - therapeutic use Disease Progression Elderly patients Female Gemcitabine monotherapy Humans Infusions, Intravenous Lung Neoplasms - drug therapy Lung Neoplasms - pathology Male Medical sciences Pharmacology. Drug treatments Survival Analysis Treatment Outcome Gemcitabine monotherapy Elderly patients Advanced non-small cell lung cancer Antineoplastic agent Human Gemcitabine Toxicity Treatment efficiency Multicenter study Malignant tumor Chemotherapy Treatment Antimetabolic Advanced stage Fluorine Organic compounds Therapeutic protocol Elderly Pyrimidine nucleoside Non small cell carcinoma
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Summary:	Background: This trial investigated the activity and toxicity of gemcitabine in previously untreated elderly (>70 years) patients with advanced (stage IIIB-IV) non-small cell lung cancer (NSCLC). Patients and methods: From January 1997 to July 1998, 46 patients with advanced NSCLC aged over 70 years with a performance status of 0–2 were entered into the study. Gemcitabine 1000 mg/m 2 was administered as a 30-min infusion once a week for 3 weeks followed by a week of rest; cycles were repeated every 4 weeks. Results: Forty-four patients were evaluable for response. One complete response and nine partial responses were observed, for an overall response rate of 22.2% (95% C.I.: 11.3–37.5). The median time to disease progression was 5.1 months (95% C.I.: 3.5–6.7), the median duration of response was 6.3 months, and the median overall survival time 6.75 months (95% C.I.: 5.3–8.2). All patients were evaluable for toxicity (184 cycles, median=3 cycles/patient) and no grade 4 hematologic toxicities were reported. WHO grade 3 leukopenia, neutropenia and anemia occurred in 3.3, 0.5 and 1.1% of cycles, respectively. Grade 3 skin rash occurred in 4.3% of patients. These side effects led to treatment discontinuation in two patients. Conclusion: Our data show that gemcitabine is active and well tolerated in patients aged over 70 years with advanced NSCLC.
ISSN:	0169-5002 1872-8332
DOI:	10.1016/S0169-5002(99)00098-7