Efficacy Of First-line Treatment Of Chemotherapy And Chemotherapy Plus Targeting Agents For MCRC

Background:Colorectal cancer is one of the most common gastrointestinal malignant tumor,about 20% of the patients were metastatic at the time of first diagnosis.Chemotherapy and chemotherapy plus targeting agents are effective clinical strategies with metastatic colorectal cancer(m CRC)at present.The aim of this study was to compare the efficacy and safety of first line treatment of chemotherapy plus targeting agents and chemotherapy alone for m CRC.Materials and methods:A total of 133 patients with m CRC were collected,who were relapsed after radical resection with or without adjuvant therapy,or initially diagnosed with m CRC without any history of palliative chemotherapy or radiotherapy.According to regimen they were divided into chemo plus targeting group,which consist of chemo-Cetuximab group(n=25)and chemo-Bevacizumab group(n=20),and chemo alone group,which consist of FOLFOX group(n=34),FOLFIRI group(n=10),other regimen group(n=44).Accessing criteria of treatment outcomes was based on Response Evaluation Criteria In Solid Tumors(RECIST)version 1.1,and grading criteria of adverse events was in accordance with Common Terminology Criteria for Adverse Events(CTCAE)version 3.0.The main outcome measures included curative effect,which was objective response rate(ORR),disease control rate(DCR),overall survival(OS),progression free survival(PFS),and safety profile,which was the classification and grade of adverse effect.The follow-up was done with consulting the medical records and paying phone calls,the end date was Jan.1st 2016.Statistical analysis was performed by SPSS 21.0.Results:1.The ORR of chemo-targeting group and chemo alone group was 22.2% and 9.1% respectively,which is statistically significant(P=0.036).Within the chemo-targeting group,ORR of chemo-C225 group and chemo-Avastin group were 20% and 25%respectively,which is not statistically different(P=0.053).Within the chemo alone group,the ORR of FOLFIRI ? FOLFOX and other regimen group were significantly10%?2.9%?15.9%,respectively,P=0.053.The DCR of chemo-targeting group and chemo alone group was 71.1% and 60.2% respectively,which is not statistically significant(P=0.216).Within the chemo-targeting group,DCR of chemo-C225 group and chemo-Avastin group were 84% and 55%respectively,which is statistically different(P=0.033).Within the chemo alone group,the DCR of FOLFIRI?FOLFOX and other regimen group were significantly 10%?2.9%?15.9%,respectively P=0.053.2.The PFS of chemo-targeting group and chemo alone group were 9.0months and 6.4months respectively,which is statistically significant(P=0.046).Within the chemo-targeting group,PFS of chemo-C225 group and chemo-Avastin group were 9.2ms and 8.6m respectively,which is not statistically significant(P=0.847).Within the chemo alone group,the PFS of FOLFIRI?FOLFOX and other regimen group were 7.6m?6.4m?5.6m,respectively,which is not significant(P=0.737).3.The OS of chemo-targeting group and chemo alone group were 24.2months and 17.8months respectively,which is statistically significant(P=0.015).Within the chemo-targeting group,OS of chemo-C225 group and chemo-Avastin group were 22.5m and 17.8m respectively,which is not statistically different(P=0.778).Within the chemo alone group,the OS of FOLFIRI?FOLFOX and other regimen group were 17.3m?17.2m?16.2m,respectively,which is not statistically significant(P=0.506).4.In the univariable analysis for OS and PFS,ECOG was significantly associated with OS(ECOG 2:HR=2.673,P=0.028).Other factors were not observed to have significant effect on either OS or PFS.5.In terms of hematological toxicity,the incidence of grade 1-2 in the chemo-targeting group and chemo alone group were 32% and 48.6%,respectively;the incidence of grade 3-4 were 4% and 8.1%,respectively,which was not significantly different(P=0.74).While in the aspect of non-hematological toxicity,the incidence of grade 1-2 in the chemo-targeting group and chemo alone group were 64.1% and 40.5%,respectively;the incidence of grade 3-4 were 8% and 2.7%,respectively,which was not significantly different(P=0.391).Conclusions:1.Chemotherapy in combination with targeting agents,both anti-EGFR and anti-VEGF,had a higher objective response rate,PFS and OS compared with chemotherapy alone in first line treatment of m CRC.2.Chemotherapy with or without targeting agents had a similar safety profile.3.ECOG performance status was significant associated with prognosis for patients of m CRC.These results,derived from “real world” practice,suggest the combination of targeting agents might have had a significant contribution to these outcomes,and therefore support the current practice of adding targeting agents to first line treatment of m CRC.