摘要
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.
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/m^2 （day 1 and 8） cisplating 75 mgim2 （day 1） every three weeks. Twenty seven non-progressive patients after 4 cycles of chemotherapy were randomized either to receive oral etoposide 50 mg/m^2 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.
