Objective:The aim of our study was to evaluate the response and tolerability to treatment when using gemcitabine-cisplatin combination(GC),followed by maintenance therapy of oral etoposide for non-progressive patients...Objective:The aim of our study was to evaluate the response and tolerability to treatment when using gemcitabine-cisplatin combination(GC),followed by maintenance therapy of oral etoposide for non-progressive patients in trial to improve progression free survival and overall survival.Methods:Thirty nine patients with extensive small cell lung cancer(SCLC) and ECOG ≤ 2 received 4 cycles of chemotherapy consisting of gemcitabine 1000 mg/m2(day 1 and 8) cisplating 75 mg/m2(day 1) every three weeks.Twenty seven non-progressive patients after 4 cycles of chemotherapy were randomized either to receive oral etoposide 50 mg/m2 for consecutive 15 days every 3 weeks vs no therapy for three months or progression.Results:Thirty nine eligible patients treated with GC,27 non progressive patients were subsequently randomized to oral etoposide or observation.Median follow-up was 18 months.The overall response rate to GC was 59% and toxicity to oral etoposide was mild.There was improvement in median progression-free survival(PFS) favoring the maintenance arm of 10.5 months vs 7 months(P < 0.05).Median overall survival(OS) had improved towards the maintenance arm(13 vs 11.5 months).One year survival(60% vs 24%),18 months survival(20% vs 5%) favoring the maintenance.Multivariate analysis revealed that age,performance status,maintenance therapy,and response to treatment were independent prognostic factors for OS.Age,maintenance therapy,and response to treatment were highly significant factors for PFS.Conclusion:Gemcitabine-cisplatin is an effective and tolerable regiment for extensive disease of SCLC.The addition of 3 months of oral etoposide in non progressing patients was associated with a significant improvement of PFS and longer OS.展开更多
文摘Objective:The aim of our study was to evaluate the response and tolerability to treatment when using gemcitabine-cisplatin combination(GC),followed by maintenance therapy of oral etoposide for non-progressive patients in trial to improve progression free survival and overall survival.Methods:Thirty nine patients with extensive small cell lung cancer(SCLC) and ECOG ≤ 2 received 4 cycles of chemotherapy consisting of gemcitabine 1000 mg/m2(day 1 and 8) cisplating 75 mg/m2(day 1) every three weeks.Twenty seven non-progressive patients after 4 cycles of chemotherapy were randomized either to receive oral etoposide 50 mg/m2 for consecutive 15 days every 3 weeks vs no therapy for three months or progression.Results:Thirty nine eligible patients treated with GC,27 non progressive patients were subsequently randomized to oral etoposide or observation.Median follow-up was 18 months.The overall response rate to GC was 59% and toxicity to oral etoposide was mild.There was improvement in median progression-free survival(PFS) favoring the maintenance arm of 10.5 months vs 7 months(P < 0.05).Median overall survival(OS) had improved towards the maintenance arm(13 vs 11.5 months).One year survival(60% vs 24%),18 months survival(20% vs 5%) favoring the maintenance.Multivariate analysis revealed that age,performance status,maintenance therapy,and response to treatment were independent prognostic factors for OS.Age,maintenance therapy,and response to treatment were highly significant factors for PFS.Conclusion:Gemcitabine-cisplatin is an effective and tolerable regiment for extensive disease of SCLC.The addition of 3 months of oral etoposide in non progressing patients was associated with a significant improvement of PFS and longer OS.
