| ObjectiveThe aim of our study was to observe the efficacy and adverse events of regorafenib in third-line treatment of metastatic colorectal cancer with standard chemotherapy failure,and to explore the correlation between baseline characteristics of patients and the efficacy of regorafenib,in order to search for possible predictive factors of efficacy.MethodsThe clinical data of patients with metastatic colorectal cancer treated by oral administration of regorafenib as third-line treatment in Jiangsu Cancer Hospital from March 2017 to October 2019 were collected by referring to electronic medical records and telephone follow-up.The patients were treated with different initial doses of regorafenib once a day for 21 days,28 days as a cycle.CT was reviewed every two periods.The efficacy of regorafenib was evaluated according to the RECIST(Response Evaluation Criteria in Solid Tumors)version 1.1.ORR(Objective response rate)and DCR(disease control rate)were calculated.The adverse events were graded according to CTCAE(Common Terminology Criteria for Adverse Events)version 5.0.The data were analyzed by SPSS 26.0 software.Chi-square test was used to compare the differences of ORR,DCR and the incidence of adverse events in different initial doses of regorafenib.Kaplan-Meier was used to draw the survival curves,Log-Rank test was used to analyze the correlation between baseline characteristics and PFS(progression-free survival)and OS(overall survival).COX regression model was used for multivariate analysis.P<0.05 was considered that the difference was statistically significant.Results1.A total of 76 eligible patients were included,and the efficacy of 74 patients were evaluable at the end of follow-up.No patients had a complete response,only 2(2.7%)patients had a partial response,21(28.4%)patients had stable disease,and 51(68.9%)patients had progressive disease.The overall ORR was 2.7%and DCR was31.1%.The ORR of 160mg initial dose group and<160mg initial dose group was 0.0%vs 4.9%,respectively(P=0.499),and the DCR was 21.2%vs 39.0%,respectively(?~2=2.708,P=0.100),the differences were not statistically significant.2.The median PFS was 2.8 months.Patients with an ECOG(Eastern Cooperative Oncology Group)score of 0～1 had a longer median PFS(3.0 months vs 2.3 months,P=0.004)and a 53.7%lower risk of disease progression(HR=0.463,95%CI:0.264～0.811,P=0.007)than those with a score of 2.Patients with baseline CA125?35U/m L had a longer median PFS(3.0 months vs 2.7 months,P=0.014)and a48.2%lower risk of disease progression(HR=0.518,95%CI:0.294～0.911,P=0.022)than those with baseline CA125>35U/m L.3.The median OS was 7.9 months.Patients with baseline CA125?35U/m L had a longer median OS(8.6 months vs 7.0 months,P=0.042)and a 50.3%lower risk of death(HR=0.497,95%CI:0.250～0.990,P=0.047)than those with baseline CA125>35U/m L.4.During the treatment,a total of 72(94.7%)patients had adverse events such as HFSR(hand–foot skin reaction),AST(aspartate aminotransferase)elevation,ALT(alanine aminotransferase)elevation,proteinuria,fatigue,anemia,hypophosphatemia,hyperbilirubinemia,hypertension,thrombocytopenia,diarrhea,anorexia,leukopenia and so on.Most of the adverse events were grade 1～2.The incidence of any grade adverse events in the 160mg initial dose group and<160mg initial dose group was100.0%vs 90.7%,respectively(P=0.128),and the incidence of grade 3～4 adverse events in these two groups was 42.4%vs 25.6%,respectively(?~2=2.399,P=0.121),the differences were not statistically significant.Conclusion1.Regorafenib can improve the efficacy and prolong the survival of patients with metastatic colorectal cancer who failed standard second-line chemotherapy.There was no significant difference in the efficacy of different initial doses.2.Patients with an ECOG score of 0～1 and patients with normal baseline CA125were more likely to benefit from regorafenib.3.The adverse events of regorafenib were generally controllable,and the incidence of adverse events was independent of the initial dose. |
PDF Full Text Request