Pazopanib versus sunitinib in Chinese patients with locally advanced or metastatic renal cell carcinoma: pooled subgroup analysis from the randomized, COMPARZ studies

BackgroundWe performed a pooled analysis of the COMPARZ study assessing efficacy and safety of pazopanib versus sunitinib in treatment-naive Chinese patients with locally advanced and/or metastatic renal cell carcinoma (a/mRCC).MethodsIn the COMPARZ study, patients were randomized (1:1) to receive pazopanib 800mg once daily (QD) continuously or sunitinib 50mg QD in 6-weekcycles (4weeks on, 2weeks off). The primary endpoint was progression-free survival (PFS); secondary endpoints included overall response rate (ORR), overall survival (OS), and safety. PFS and ORR were assessed by independent review committee (IRC) and local investigators.ResultsOf the 209 Chinese patients (pazopanib, [n=109] and sunitinib, [n=100]), 155 (74%) were males and median age was 57years (range, 18-79). Median PFS was 13.9months for pazopanib versus 14.3months for sunitinib per investigator assessment and 8.3months in both arms per IRC assessment; PFS hazard ratio was 1.17 (investigator) and 0.99 (IRC). Median OS was not reached in pazopanib arm and was 29.5months in sunitinib arm. ORR was significantly higher in pazopanib arm versus sunitinib arm (investigator: 41% versus 23% [P=0.0052]; IRC: 35% versus 20% [P=0.0203]). Pazopanib was generally well tolerated in Chinese patients with a/mRCC. Most frequent AEs in the pazopanib arm were diarrhea and hair color changes whereas the most frequent AEs in the sunitinib arm were decreased platelets, decreased neutrophil count, and thrombocytopenia.ConclusionThe results of the pooled analysis were consistent with the overall population in the COMPARZ study, and confirmed similar PFS and OS of pazopanib and sunitinib in the Chinese patients.Trial registrationclinical trials.gov, NCT00720941 (August 14, 2008) and NCT01147822 (May 19, 2010).