Novartis Pharmaceutical Corp, East Hanover, NJ
Xiting Cao , Derek Tang , Barbara Elizabeth Ratto , Austin Poole , Shoba Ravichandran , Lixian Jin , Wei Gao , Elyse Swallow , Nicholas J. Vogelzang
Background: In the first-line setting (1L), pazopanib (PAZ) is recommended by NCCN for treatment of advanced renal cell carcinoma (aRCC). In 2018, immuno-oncology (IO) therapy became commonly used 1L treatment option for aRCC. This study reports real-world clinical outcomes of PAZ following IO therapy among aRCC patients (pts) in an evolving treatment landscape. Methods: This retrospective chart review study used medical record data collected by medical oncologists. Included pts were those ≥ 18 at initiation of IO therapy who initiated 2L+ PAZ for clear cell aRCC before November 2017, and had complete medical records from the diagnosis of aRCC to discontinuation of PAZ, death, or the chart extraction date (May 2018), whichever occurred first. Primary outcome was PAZ duration of therapy (DOT). Secondary outcomes were progression-free survival (PFS) and overall survival (OS) since PAZ initiation, reasons for PAZ discontinuation, and adverse events (AEs). Time-to-event outcomes were analyzed by Kaplan-Meier method. Results: 258 eligible pts initiated the IO therapies before PAZ as follows: nivolumab (NIVO) (68%), NIVO+ipilimumab (IPI) (14%), pembrolizumab (12%), and IPI (3%). Ninety-seven (38%), 56 (22%), and 92 (36%) pts were grouped as favorable, intermediate, or poor risk by Heng criteria, respectively. Overall, the median PAZ DOT was 13.4 months (Ms) (95% confidence interval [CI] 10.1-16.0). When stratified by lines of therapy, pts who received PAZ as 2L (n=182) or 3L+ (n=76) had DOT of 13.4 Ms (95% CI 11.1-NR) and 9.6 Ms (95% CI 6.2-NR), respectively. The PFS and OS outcomes are shown in the Table. One hundred-nine (42%) pts reported an AE. The most frequently (>10%) reported AEs were fatigue (29%), diarrhea (14%), decreased appetite (14%), and hypertension (13%). Conclusions: In this real-world study, 2+L PAZ following prior IO therapy was well-tolerated, effective, and non-cross-resistant with IO therapy for aRCC pts.
Median PFS | Median OS | PFS Rates | OS Rates | |
---|---|---|---|---|
M (95% CI) | 12 M | |||
Overall | 13.5 (11.8-NR) | 16 (13.5-NR) | 0.6 | 0.9 |
2L PAZ (N=182) | 16.0 (11.8-NR) | 16 (16.0-NR) | 0.6 | 0.9 |
3L+ PAZ (N=76) | 13.5 (7.07-NR) | 13.5 (13.5-NR) | 0.5 | 0.8 |
NR=not reached
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