围手术期化疗在非小细胞肺癌中的应用探讨

The study of peri-operative chemotherapy in stage Ⅰ-Ⅲa NSCLC

目的 探讨围术期化疗对NSCLC生存率预后因素的影响。方法 1 995年 2月至 1 997年 7月Ⅰ Ⅲa期根治性手术的NSCLC ,随机分为术前先行化疗和先行手术二组 ,以Kaplan Meier曲线统计累积生存率及LogRank检验 ,Cox单因素和多因素分析生存率影响因素。 结果 全组 2 1 1例 ,术前先行化疗组 1 0 8例 ,先行手术组 1 0 3例。累积年生存率、Cox单多因素分析未见二组有统计学差异 ,P >0 0 5 ,如 5年生存率为 31 98%∶36 68% ,MST绝对值虽以先化疗组低于先手术组 36个月∶48个月 ,但P >0 0 5。Ⅱ期术前先化疗组累积年生存率、MST和Cox单因素分析明显差于先手术组 ,如 5年生存率为 2 0 %∶65 2 % ,MST为 2 4个月∶48个月 ,P =0 0 4 2 ,Ⅰ、Ⅲ期中也未见两组生存率差异有显著意义。Cox多因素分析各参数中见期别及术后化疗与生存率有显著相关 ,P均为 0 0 0 0。此外 ,术前化疗有效者生存率优于无效者 ;化疗后临床和病理学相比“T”降期和“T”不变病员的年生存率、MST均明显高于“T”升期组 ,提示术前化疗有效可获较好结果。Ⅱ、Ⅲa期术后化疗≤ 2周期者年生存率明显低于 3 4周期和 >4周期 ,Cox单、多因素分析均见明显差异。结论 术前化疗用于Ⅰ、Ⅱ期和可根治性切除的Ⅲa期NSCLC生存率差异无显著意义 ,Ⅱ期先?

Objective A number of studies had evaluated the benefit of neoadjuvant chemotherapy combined surgery on stage Ⅲa Ⅲb NSCLC, survival benefit was found in several papers We attempt to evaluate the survival and prognosis of cisplatinum based schedule as peri operative CT for resectable stage I Ⅲa NSCLC Methods A prospective, randomized, multicenter study was conducted by Shanghai Lung Cancer Team (supported by Shanghai Branch of Discipline Foundation) since 1995 1997 for 211 cases of stage I Ⅲa NSCLC with curative resection (99 stage I, 47 stage Ⅱ, 65 stage Ⅲ), age of ≤75, KPS≥80, staged by 1997 AJC TNM Criteria They were randomized to be 103 cases with 1 2 cycles of pre operative CT and 108 cases with no pre operative CT, 2 4 cycles of post operative CT were used for stage II and stage Ⅲa NSCLC, it was totally 4 cycles of MVP or MOP CT schedule each case Follow up team had been trained, the follow up rate should be≥95%, last follow up date was March of 2002 Lobectomy was performed for most patients Accumulated survival, log rank, MST, Cox uni variance and multi variance analyses were used as statistics for evaluation Results The two arms were well balanced for baseline demographic and clinical characteristics ( P >0 05 for all) Stage I NSCLC had the best year survival in whole patients No statistical survival difference was found between the group with pre op CT and with no pre op CT, P =0 074, 0 087 and 0 097, respectively, 5 year survival rates were of 31 98%: 36 68% In various stage, a statistical survival difference was only shown in stage ⅡNSCLC, P =0 042, 5 year survival rates and MST were worse in the group with pre operation CT, 20%∶65 2% and 24 months∶48 months, respectively, but no difference was seen in stage I and stage Ⅲa NSCLC Stage and post operation CT were the only two meaningful parameters with statistical survival difference calculated by multi variance analyses, P =0 000 all, but no difference was found in others 4 parameters (age, sex, type and pre operation CT) The response rate of pre operation CT was of 50% Though there was no statistical difference, the responders were with slightly better year survival rates than MR+NR patients, 38 9% and 33 3%, respectively In the cases with pathological 'T' down stage and 'T' unchanged after pre operation CT had a better yr survival rates than 'T' up stage, P =0 03, 5 year survival rates were of 41 67%, 40 51% and 11 76%, respectively, thus, effective chemotherapy might be beneficial to survival Besides, in the cases with ≥3 cycles of post operation CT have better survival rates than less cycles Conclusion A prospective, randomized , multicenter peri operation CT study for stage I Ⅲa NSCLC conducted in Shanghai, China , it showed there had no benefit in survival between with pre operation CT arm and with no pre operation CT arm In stage Ⅱ NSCLC, pre operation CT cases had a worse year survival than with no pre operation CT, P =0 042, but no difference was seen in stage I and stage Ⅲa NSCLC The responder of CT and 'T' down stage,'T' unchanged had better survival rates than those of not response and 'T' up stage From multivariate analyses, stage and post operation CT were the two meaningful parameters to year survival, ≥3 4 cycles of post operation CT had a better statistical higher year survival than less cycles Nutrition, supportive treatment, immunity status and prevention of toxicity might be the next study worthy to conduct, for CT combined with OP