| Background and purpose: Gastrointestinal stromal tumors(GISTs)are the most common mesenchymal tumors of the gastrointestinal tract,which originate from the Cajal stromal cells of the gastrointestinal tract.Molecular biology studies have found that the functional mutations of tyrosine kinase KIT,PDGFRA and other genes are the most important mechanism of GISTs,and thus opened a new era of molecular targeted therapy.Recently,Imatinib is the first-line drugs for advanced or metastatic gastrointestinal stromal tumors.With the emergence of imatinib resistance and intolerance,sunitinib is playing an important role as the second-line treatment for GISTs.In this study,56 cases treated by sunitinib were retrospectively analyzed,in order to evaluate the efficacy and safety of first-line treatment with sunitinib.Methods:In this study,the information of patients with gastrointestinal stromal tumors from June 2012 to June 2015 in the Affiliated Hospital of our school was retrospectively analyzed,followed up for 2 years.Using the Choi standard for objective evaluation of efficacy in the group of patients,and the survival condition of 1 years PFS,1 years OS and 2 years PFS,2 years OS,median OS,PFS were compared.Recorded the adverse events associated with treatment,and at the same time using non-parametric test,chi-square test,Kaplan-Meier survival analysis to process all the data.Results: 1.Underlying conditions of patients: A total of 124 patients,sunitinib group of 56 cases,34 male and 22 female,the median age was 57 years.The high-risk group of 9 cases,intermediate risk group of 15 cases,low risk group of 32 cases.Stage Ⅲ 24 cases,32 cases of stageⅣ.ECOG performance score 0 of 24 cases,score 1 of 26 cases,score 2 of 6 cases.Imatinib group of 68 cases,42 male and 26 female,and the median age was 54 years.53 cases had liver metastasis,and 36 cases of extrahepatic metastases.The high-risk group of 13 cases,intermediate risk group of 20 cases,35 cases of low risk group.Stage Ⅲ 32 cases,36 cases of stage IV.ECOG performance score 0 of 33 cases,score 1 of 22 cases,score 2 of 13 cases.2.The objective efficacy analysis: 56 cases of sunitinib group,after three months medication,CR 3 cases(5.36%),PR 26 cases(46.43%),SD 17 cases(30.36%),and PD 10 cases(17.86%).68 cases of imatinib group,after three months therapy,CR 1 case(1.47%),PR 31 cases(45.59%),SD 22 cases(32.35%),and PD 14人(20.59%).The ORR(CR+PR)and DCR(CR+PR+SD)in the sunitinib group were slightly higher than those in the imatinib group,but there was no significant difference between the two groups.The ORR respectively 49.15% and 47.05%,(p=0.600),DCR respectively 82.14% and 79.41%(p=0.702).3.Survival condition: The OS and PFS in the sunitinib group were slightly lower than those in the imatinib group,but there was no significant difference between the two groups.1-year OS% were 80.35%(45/56)and 82.35%(56/68),(p=0.776).1-year PFS% were 58.93%(33/56)and 61.76%(42/68),(p=0.748).The 2-year OS and 2-year PFS in the sunitinib group were significantly lower than those in the imatinib group.2-year OS% were 44.64%(25/56)and 67.65%(46/68),(p=0.010).2-year PFS% were 23.21%(13/56)and 41.17%(28/68),(p=0.010).Up to the end of follow-up,the median OS was 19.4 months in the sunitinib group,the median PFS13.9 was,and the median OS was not reached in the imatinib group,with a median PFS of up to 20.1 months.4.treatment-related adverse events: All the patients(100%)in sunitinib group had different degrees of adverse events,and 3-4 grade adverse reaction rate was 47.8%,mainly for fatigue(10%),followed by hypertension(8%),diarrhea(5%),and hand foot syndrome(5%).In addition there were some uncommon AEs,such as cardiac adverse events(1%)and hypothyroidism(2%).97.3% patients in Imatinib group had different AEs,and 3-4 grade adverse reaction rate was 20.5%.The most common side effect was the neutropenia(6.8%),followed by gastrointestinal bleeding(4.1%),others such as skin rash(2.7%)and liver injury(2.7%).5.Factor analysis of survival condition of sunitinib group: The efficacy of Sunitinib in gastrointestinal stromal tumor was related to the stage and risk level.The 1-year survival and 2-year survival of stage III were higher than those of stage IV.1-year OS% were 91.67%(22/24)and 71.88%(23/32),(p=0.031).1-year PFS% were 70.83%(17/24)and 50%(16/32),(p=0.031).2-year OS% were 62.50%(15/24)and 31.25%(10/32),(p=0.020).2-year PFS% were 37.50%(9/24)and 12.50%(4/32),(p=0.029).1-year survival and 1-year progression-free survival of the low-risk group were higher than the other groups.The OS% of three groups were 55.56 %(5/9),66.67%(10/15)and 93.75%(30/32).The PFS% of three groups were 22.22 %(2/9),40.00%(6/15)and 78.13%(25/32).The 2-year survival and 2-year PFS of low risk group were higher than the other groups.The OS% of three groups were 11.11%(1/9),26.67%(4/15)and 62.50%(20/32),2 years PFS% were 0 %(0/9),6.67%(1/15)and 34.38%(11/32).Conclusion: 1.the objective control rate of sunitinib in first-line gastrointestinal stromal tumors is similar to imatinib,and the 2-year survival rate is lower than imatinib.2.the objective control rate of stage III of gastrointestinal stromal tumors treated with sunitinib is higher than that of stage IV,and the low risk group is higher than the middle and high risk group.3.the incidence of adverse events of sunitinib in patients with gastrointestinal stromal tumors is higher than that of imatinib,which mainly include fatigue,hypertension,diarrhea and hand foot syndrome. |
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