TY - JOUR
T1 - Gemcitabine plus vinorelbine yields better survival outcome than vinorelbine alone in elderly patients with advanced non-small cell lung cancer. A Southern Italy Cooperative Oncology Group (SICOG) phase III trial
AU - Frasci, Giuseppe
AU - Lorusso, Vito
AU - Panza, Nicola
AU - Comella, Pasquale
AU - Nicolella, Gianpaolo
AU - Bianco, Andrea
AU - DeCataldis, Giuseppe
AU - Belli, Mario
AU - Iannelli, Nunzio
AU - Massidda, Bruno
AU - Mascia, Vittorio
AU - Comella, Giuseppe
AU - De Lena, Mario
PY - 2001
Y1 - 2001
N2 - Objective: This phase III study was aimed at evaluating whether the addition of gemcitabine (G) to vinorelbine (V) could improve the survival and quality of life (QoL) of elderly patients with advanced NSCLC. Patients and methods: Patients with advanced NSCLC, aged ≥70 years, were randomly allocated to receive V 30 mg/m2 on days 1 and 8 every 3 weeks or G 1200 mg/m2 plus V 30 mg/m2 on days 1 and 8 every 3 weeks. Survival was the main end point of the study. The estimated sample size was 120 patients per arm, but an interim analysis of survival was planned on the first 60 patients per arm. Results: In May 1999, an interim analysis was performed with the survival data of the first 120 eligible patients (Varm=60, G+Varm=60). Forty-nine patients had stage IIIB disease and 71 patients stage IV disease, median potential follow-up of 14 months (range; 3-22), 93 patients had died (G+Varm=41, Varm=52). Median survival time (MST) was 29 weeks and projected 1-year survival was 30% in the G+Varm; these values were 18 weeks and 13% in the Varm. At multivariate Cox analysis, the risk of death in the G+Varm compared with Varm was 0.48 (95% C1=0.29-0.79; Parms, respectively. Toxicity was not irrelevant in both arms. Conclusions: G+V treatment is associated with a significantly better survival than V alone in elderly NSCLC patients. The magnitude of the difference justifies the early closure of the study. The G+V regimen is now the SICOG reference regimen in this type of patients.
AB - Objective: This phase III study was aimed at evaluating whether the addition of gemcitabine (G) to vinorelbine (V) could improve the survival and quality of life (QoL) of elderly patients with advanced NSCLC. Patients and methods: Patients with advanced NSCLC, aged ≥70 years, were randomly allocated to receive V 30 mg/m2 on days 1 and 8 every 3 weeks or G 1200 mg/m2 plus V 30 mg/m2 on days 1 and 8 every 3 weeks. Survival was the main end point of the study. The estimated sample size was 120 patients per arm, but an interim analysis of survival was planned on the first 60 patients per arm. Results: In May 1999, an interim analysis was performed with the survival data of the first 120 eligible patients (Varm=60, G+Varm=60). Forty-nine patients had stage IIIB disease and 71 patients stage IV disease, median potential follow-up of 14 months (range; 3-22), 93 patients had died (G+Varm=41, Varm=52). Median survival time (MST) was 29 weeks and projected 1-year survival was 30% in the G+Varm; these values were 18 weeks and 13% in the Varm. At multivariate Cox analysis, the risk of death in the G+Varm compared with Varm was 0.48 (95% C1=0.29-0.79; Parms, respectively. Toxicity was not irrelevant in both arms. Conclusions: G+V treatment is associated with a significantly better survival than V alone in elderly NSCLC patients. The magnitude of the difference justifies the early closure of the study. The G+V regimen is now the SICOG reference regimen in this type of patients.
KW - Elderly patients
KW - Gemcitabine
KW - Non-small cell lung cancer
KW - Phase III trial
KW - Vinorelbine
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M3 - Article
C2 - 11742706
AN - SCOPUS:0035195433
VL - 34
SP - 65
EP - 69
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - SUPPL. 4
ER -