围手术期化疗在非小细胞肺癌中的应用探讨

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

The study of peri-operative chemotherapy in stage I-IIIa NSCLC

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 or= 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 >or= 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 >or= 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, >or= 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.