Literature DB >> 10688490

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

S Ricci1, 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.   

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.

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Year:  2000        PMID: 10688490     DOI: 10.1016/s0169-5002(99)00098-7

Source DB:  PubMed          Journal:  Lung Cancer        ISSN: 0169-5002            Impact factor:   5.705


  19 in total

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