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

Abstract

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/m2 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.

• Authors: S Ricci, A Antonuzzo, L Galli, C Tibaldi, M Bertuccelli, A Lopes Pegna, S Petruzzelli, R Algeri, V Bonifazi, M L Fioretto, C Orlandini, P F Conte
• Journal: Lung cancer (Amsterdam, Netherlands) (Lung Cancer) Vol. 27 Issue 2 Pg. 75-80 (Feb 2000) ISSN: 0169-5002 [Print] Ireland
• PMID: 10688490 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Antimetabolites, Antineoplastic
• Deoxycytidine
• Gemcitabine

Topics

• Aged
• Aged, 80 and over
• Antimetabolites, Antineoplastic (pharmacology, therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, pathology)
• Deoxycytidine (analogs & derivatives, pharmacology, therapeutic use)
• Disease Progression
• Female
• Humans
• Infusions, Intravenous
• Lung Neoplasms (drug therapy, pathology)
• Male
• Survival Analysis
• Treatment Outcome
• Gemcitabine