| Objective:To investigate the clinically efficacy and safety in advanced non-smallcell lung cancer, it can provide a theoretical basis for the maintenance treatment ofadvanced non-small cell lung cancer.Methods:One hundred patients who were diagnosed with advanced non-small celllung cancer in the First Affiliated Hospital of Dalian Medical University from2007to2012were enrolled in this study. After4-6cycles of the first-line standard treatment,thetreatment conditions did not progress,and they were divided into continuationmaintenance therapy group(n=33),switch maintenance therapy group(n=31) and the bestsupport care group(n=36).Continuation maintenance therapy group and the best supportcare group accepted CT examination of measurable lesions every2cycles.Switchmaintenance therapy group underwent CT examination one month after the start ofmedication and then every two months.The primary end point was progression-freesurvival time(PFS). The second end point was objective response rate (ORR), diseasecontrol rate (DCR), overall survival time(OS) and drug safety.Clinical evaluation inaccordance with the RECIST Solid Tumors evaluation criteria, divided into completeresponse (CR), partial response (PR), stable disease (SD) and progressive disease (PD).Adverse effects by the U.S. National Cancer Institute (NCI) anticancer drugs acute andsubacute toxicity indexing standards were evaluated into0-Ⅳ degree.Results:1.The clinically efficacy of continuation maintenance therapy group,switchmaintenance therapy group and the best support care groupThe ORR of continuation maintenance therapy group,switch maintenance therapygroup and the best support care group were12.1%,19.4%and0.The DCR were45.4%,41.9%and19.4%,The PFS were5.3months,7.1months and3.7months.The OS were13.8months,17.4months and12.7months. The difference of three groups ORR was statistically significant (P <0.05); There were significant differences of DCR and PFS(P<0.01). The difference of OS was not statistically significant (P>0.05).2.The clinically efficacy of subgroup2.1Continuation maintenance therapy group was divided into chemotherapy drugpemetrexed, docetaxel and gemcitabine:The ORR of pemetrexed docetaxel and gemcitabine were23.0%,8.3%and0.TheDCR were61.5%,41.7%and25.0%.The PFS were8.0months,3.6months and3.4months.The OS were14.7months,13.6months and12.7months. The differences ofthree groups ORR,DCR and OS were not statistically significant (P>0.05).There issignificant difference of PFS in three groups(P <0.05).2.2Switch maintenance therapy group was divided into gefitinib.erlotinib andicotinib:The ORR of gefitinib,erlotinib and icotinib were16.7%,28.6%and16.7%.TheDCR were44.4%,57.2%and16.7%.The PFS were8.0months,7.1months and4.0months.The OS were17.5months,17.4months and15.1months. The differences ofthree groups ORR,DCR,PFS and OS were not statistically significant (P>0.05).3.Adverse reactionsThe major adverse reaction of continuation maintenance therapy group were bonemarrow suppression and gastrointestinal reactions. The incidence of I-II degree were45.5%and30.3%.The incidence of III-IV degree were12.1%and15.2%;The major adverse reaction of switch maintenance therapy group were rash anddiarrhea. I-II degree of rash and diarrhea rates were48.4%and22.6%, III-IV degree ofincidence were both of12.9%;The difference of the two main groups of adverse reactions was statisticallysignificant (P <0.05).Conclusion:1.Maintenance therapy can improve the ORR and DCR of advanced non-small celllung cancer and prolong PFS and well tolerated.2.There were no differences in improving patient ORR, DCR, PFS and OS in twomodes of continuation maintenance therapy group and switch maintenance therapygroup.3.Continuation maintenance therapy with pemetrexed can significantly prolongPFS of the advanced non-small cell lung cancer patients compared with docetaxel andgemcitabine.And pemetrexed had well tolerated. 4.Gefitinib,erlotinib and icotinibin improving patients DCR, ORR, PFS andadverse drug reactions were similar. |
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