Comparison of Mucin Patterns in Colonic Pathologies by Histochemistry

[摘要] On the 15 November 2018, the Committee for MedicinalProducts for Human Use adopted an extension to anexisting indication for the use of nivolumab (Opdivo) incombination with ipilimumab (Yervoy) for the first-linetreatment of adult patients with intermediate/poor-riskadvanced renal cell carcinoma (RCC). The approvalwas based on results from the Pivotal CA209214 study,a randomised, open-label, phase III study, comparingnivolumab +ipilimumab with sunitinib in subjects≥18years of age with previously untreated advanced RCC(not amenable for surgery or radiotherapy) or metastaticRCC, with a clear-cell component. A total of 1096 patientswere randomised in the trial, of which 847 patients hadintermediate/poor-risk RCC and received either nivolumab(n=425) in combination with ipilimumab administeredevery 3 weeks for 4 doses followed by nivolumabmonotherapy 3mg/kg every 2 weeks or sunitinib (n=422)administered orally for 4 weeks followed by 2 weeks off,every cycle. A statistically significant difference in overallsurvival (OS) was observed in the nivolumab + ipilimumabgroup compared with the sunitinib group in intermediate/poor-risk subjects (HR 0.63 (99.8% CI 0.44 to 0.89);stratified log-rank 2-sided p-value<0.0001). The medianOS was not reached for the nivolumab + ipilimumab groupand was 25.95 months for the sunitinib group. The OSrates were 89.5% and 86.2% at 6 months, and 80.1% and72.1% at 12 months in the nivolumab +ipilimumab andthe sunitinib groups, respectively. K-M curves separatedafter approximately 3 months, favouring nivolumab +ipilimumab. This was not mirrored in the favourable-riskpatients where no statistically significant difference wasobserved between nivolumab + ipilimumab and sunitinibin favourable-risk patients (HR 1.45 (descriptive 99.8%CI0.51 to 4.12), p =0.2715).

[学科分类] 生理学与病理学