Peking University Cancer Hospital and Institute, Beijing, China
Xinan Sheng , Jie Jin , Zhisong He , Yiran Huang , Ai-Ping Zhou , Jinwan Wang , Xiu-Bao Ren , Dingwei Ye , Xu Zhang , Shukui Qin , Fang-Jian Zhou , Yanfang Guo , Jun Guo
Background: A pooled analysis of treatment-naïve Chinese pts enrolled in the phase 3 COMPARZ studies VEG108844 (randomized, open-label, global study) and VEG113078 (sub-study to VEG108844 conducted in China, Korea and Taiwan) was carried out to compare the efficacy and safety of PAZ with SUN for advanced or metastatic RCC Methods: In both studies, pts were randomized (1:1) to receive PAZ 800 mg once daily continuously or SUN 50 mg once daily in 6-week cycles (4 weeks on/ 2 weeks off). Progression-free survival (PFS) was the primary endpoint. Secondary endpoints included overall response rate (ORR), overall survival (OS), and safety. PFS and ORR assessments were done by the independent review committee (IRC) and local investigators. Results: Of 209 pts (PAZ, 109; SUN, 100), 155 (74%) were male; median age was 57 years (range, 18-79). The median PFS was 13.9 months (mo) for PAZ vs 14.3 mo for SUN by investigator assessment and it was 8.3 mo in both arms by IRC assessment. The PFS HR was 1.17 (investigator) and 0.99 (IRC).The median OS was not reached in PAZ arm and was 29.5 mo in SUN arm. The ORR (complete response + partial response) in the PAZ arm was significantly higher than the SUN arm (investigator: 41% vs 23%, p = 0.005; IRC: 35% vs 20%, p = 0.02). Diarrhea and hair color changes were more frequent adverse events (AEs) in the PAZ arm compared to SUN; and decreased neutrophil, platelet count and thrombocytopenia were more common AEs in SUN arm compared to PAZ. Conclusions: This pooled analysis confirms that the efficacy was similar for PAZ and SUN in the Chinese population in terms of PFS and OS, consistent with the overall population of the COMPARZ study. ORR was higher in the PAZ arm than the SUN arm based on both investigator and IRC assessments. PAZ was generally well tolerated in the Chinese population with locally advanced or metastatic RCC. Clinical trial information: NCT00720941, NCT01147822
Parameter | Investigator assessment | IRC assessment | ||
---|---|---|---|---|
PAZ | SUN | PAZ | SUN | |
Median PFS, mo | 13.9 | 14.3 | 8.3 | 8.3 |
HR (95% CI) | 1.17 (0.792,1.727) | 0.99 (0.6760,1.4580) | ||
ORR, % | 41 | 23 | 35 | 20 |
Duration of response, mo | Not assessed | 8.3 | 21.8 | |
95% CI for difference P value | (5.9, 30.7) 0.005 | (3.0, 26.8) 0.02 |
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