| Background and purpose: Clear cell carcinoma is a commonhistological type of renal cell carcinoma, accounts for kidney cancer80%-85%. For inoperable or postoperative recurrence of metastatic renal cellcarcinoma is called advanced renal cell carcinoma，including distantmetastasis, pathologic stage T≥3and/or lymph node involvement.Cytokine-based biological treatment was the standard treatment foradvanced renal cell carcinoma. With the deeper study of the molecularmechanisms of pathogenesis of kidney cancers, targeted therapy forangiogenesis inhibitors and tyrosine kinase has been applied in advancedrenal cell carcinoma therapy，Global Ⅲ clinical trials have shown thatsunitinib prolong disease-free survival of nearly six months comparedwith interferon. In May2008, China Food and Drug Administration(SFDA) approved sunitinib domestic market, whether the efficacy andside effects of Ⅳtrials in domestic sunitinib clinical is consistent withforeign countries, the present study rarely reported. To compared thedifferences in efficacy between sunitinib and biological treatment, andanalyzed the impact of the efficacy and toxicity of sorafenib-relatedfactors，in this study,63cases treated by sunitinib and96cases treated bycytokines with advanced clear cell carcinoma from the center wereanalyzed retrospectively. Methods: In this study, the information of patients of advanced renal cellcarcinoma patients from July2008to March2013Affiliated Hospital ofJilin University was statistically analysed, telephone follow-up, and fillout the survey. Using RECIST criteria to assess the efficacy,1yearprogression-free survival rate and1year survival rates to compare thesurvival conditions, classified and record incidence of adverse events. Atthe same time using non-parametric test, chi-square test, Kaplan-Meiersurvival analysis to process all the data.Results:1.Underlying conditions of patients: A total of159cases ofpatients, including sunitinib group of63cases, male47cases, female16cases, maximum71years old, minimum37years old, with a median ageof55(55.3±10.27) years. Primary lesions were unilateral in61cases,bilateral in2cases. Clinical stage of Ⅲ13cases, stage Ⅳ50cases.MSKCC score high-risk group of12cases, intermediate risk group of23cases,28cases of low-risk group. Cytokines group of96cases, male72cases, female24cases, maximum73years old, minimum34years old,with a median age of56(56.07±10.74) years. Primary lesions wereunilateral in91cases, bilateral in5cases. Clinical stage of Ⅲ29cases,stage Ⅳ67cases. MSKCC score high-risk group20cases, intermediaterisk group of31cases,45cases of low-risk group.2.The objectiveefficacy analysis:63cases of sunitinib group, after taking three cycles (18weeks), complete remission (CR)1cases (1.59%), partial remission (PR)10cases (15.87%), stable disease (SD)38cases (60.32%), progressivedisease (PD)14(22.22%). Objective response rate (ORR)(CR+PR) was17.46%(11/63), disease control rate (DCR)(CR+PR+SD) was77.78%(49/63).96cases of cytokine group, after18weeks medication, completeremission (CR)0cases (0%), partial remission (PR)7cases (7.29%),stable disease (SD)26cases (27.08%), progressive disease (PD)63 (65.63%). Objective response rate (ORR)(CR+PR) was7.29%(7/96),disease control rate (DCR)(CR+PR+SD) was34.38%(33/96).Sunitinib group ORR (CR+PR) and DCR (CR+PR+SD) weresignificantly higher than the cytokine group, ORR were17.46%and7.29%, P=0.0079, DCR were77.78%and34.38%, P=0.014.3. Survivalcondition: Sunitinib group of63cases, with a median follow-up time of2.3years,50cases of1-year survival，of which45cases no diseaseprogression. Cytokines group96cases, with a median follow-up time of1.9years,29cases of1-year survival, of which21cases no diseaseprogression. When compared the two groups with1year PFS%, sunitinibtreatment group was also better than the cytokine group,71.43%（45/63）and21.88%（21/96） respectively， P=0.011.1year OS%, sunitinibtreatment group was higher than the cytokine group,79.37%（50/63）and30.21%（29/96）respectively，P=0.019.4. Factor analysis of objectiveresponse effects of sunitinib group:13cases of stage Ⅲ patients，withcomplete remission (CR)1cases, partial remission (PR)3cases，stabledisease (SD)6cases，progressive disease (PD)3cases.50cases of stageⅣ patients, no cases of complete remission (CR), partial response (PR)7cases，stable disease (SD)32cases，progressive disease (PD)11cases, theORR of stage Ⅲ was significantly higher than stage Ⅳ，30.77%and14.00%respectively，P=0.0091. According to MSKCC score,12cases ofhigh-risk group, no cases of complete remission (CR), only one cases ofpartial remission (PR), stable disease (SD)6cases, progressive disease(PD)5cases.23cases of intermediate-risk group, also no completeremission (CR), partial remission (PR)3cases, stable disease (SD)15cases, progressive disease (PD)5cases.28cases of low-risk group,complete remission (CR)1cases, partial remission (PR)6cases, stable disease (SD)17cases, progressive disease (PD)43cases. The ORR of thelow-risk group was significantly higher than the high-risk groups,25.00%and8.33%respectively, P=0.0039.5. Factor analysis of survival conditionof sunitinib group: clinical staging and MSKCC score wree closelyrelated to prognosis. A total of13cases of patients with stage Ⅲ, with10cases1year progression-free survival（76.92%，10/13）, and50cases ofⅣ patients for35cases1year progression-free surviva（l70.00%，35/50）,P=0.0031. stage Ⅲ13cases of patients with1-year survival (100%,13/13), and stage Ⅳ50cases was74.00%,(37/50), P=0.0071. MSKCCscore high, medium and low risk group1-year progression-free survivalrates were50.00%(6/12),65.22%(15/23),85.71%(24/28) respectively,the low-risk group was significantly higher than that in high-risk group(all P <0.05).1-year survival rate was58.33%(7/12),73.91%(17/23),92.86%(26/28) respectively, the low-risk group was significantly higherthan in medium and high-risk groups (both P<0.05).1-year survival ratewas highest in low-risk groups, there was the significant differencesbetween groups when compared low-risk group with medium andhigh-risk groups (all P<0.05). Alone accounted for13cases of lungmetastases, which ORR, DCR was23.08%(3/13) and69.23%(9/13);1year PFS rate and1year OS rate was69.23%(9/13) and69.23%(9/13)respectively. Alone accounted for5cases of liver metastasis, which ORR,DCR was20.00%(1/5) and80.00%(4/5) respectively;1year PFS rateand OS rate was60.00%(3/5) and60.00%(3/5) respectively. Aloneaccounted for12cases of bone metastasis, the ORR, DCR was25.00%(3/12) and83.33%(10/12) respectively;1year PFS rate and1year OSrate was83.33%(10/12) and91.67%(11/12), respectively. Two or moremetastasis accounted for20cases, which ORR was0, DCR was80.00%(16/20);1year PFS rate and1year OS rate was65.00%(13/20) and 70.00%(14/20) respectively.6.Toxicity and side effect which wereevaluated in sunitinib group: hand-foot syndrome22cases (34.92%),diarrhea14cases (22.22%), asthenia10cases (15.87%), hypertension12cases (19.05%), mucosal ulceration8cases (12.70%), hypothyroidism3cases (4.76%), mostly grade1to2level， but they were improved byrelated drug reductions，no drug-related deaths. Grade3to4toxicityoccurred in10cases, they were bleeding in3cases (2cases ofgastrointestinal tract, one case of respiratory tract) and7cases of severediarrhea, and were alleviated by positive symptomatic treatment and doseadjustment.Conclusion:1. For renal cell carcinoma, the objective response rate，1-year progression-free survival,1-year survival rate in Sunitinib groupwas significantly higher than those in the cytokine therapy group.2. Theefficacy of Sunitinib was relevant to the stage of renal clear cellcarcinoma, MSKCC score level. Stage III objective response rate,1-yearprogression-free survival and1-year survival rate was significantly higherthan stage Ⅳ and MSKCC low-risk group higher than that inintermediate and high-risk group.3. Hand-foot syndrome, pancytopenia,and cardiac toxicity, diarrhea, hypertension, hand-foot skin reaction arecommon side effects of sunitinib，most of them can be tolerated.Minoritycases should prohibit its application because of gastrointestinal orrespiratory tract bleeding and severe diarrhea. |
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