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

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

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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. (C) 2000 Elsevier Science Ireland Ltd.

Original languageEnglish
Pages (from-to)75-80
Number of pages6
JournalLung Cancer
Issue number2
Publication statusPublished - Feb 1 2000


  • Advanced non-small cell lung cancer
  • Elderly patients
  • Gemcitabine monotherapy

ASJC Scopus subject areas

  • Oncology


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