TY - JOUR
T1 - Gemcitabine monotherapy in elderly patients with advanced non-small cell lung cancer
T2 - A multicenter phase II study
AU - Ricci, S.
AU - Antonuzzo, A.
AU - Galli, L.
AU - Tibaldi, C.
AU - Bertuccelli, M.
AU - Lopes Pegna, A.
AU - Petruzzelli, S.
AU - Algeri, R.
AU - Bonifazi, V.
AU - Fioretto, M. L.
AU - Orlandini, C.
AU - Conte, P. F.
PY - 2000/2/1
Y1 - 2000/2/1
N2 - 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.
AB - 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.
KW - Advanced non-small cell lung cancer
KW - Elderly patients
KW - Gemcitabine monotherapy
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U2 - 10.1016/S0169-5002(99)00098-7
DO - 10.1016/S0169-5002(99)00098-7
M3 - Article
C2 - 10688490
AN - SCOPUS:0033955531
VL - 27
SP - 75
EP - 80
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - 2
ER -