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= 75, KPS >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.
RCT Entities:
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= 75, KPS >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.