The prospective, multicenter study, PAZOREAL, is designed to examine the effectiveness, defined as primary time on drug (TD), safety, and quality of life in patients with mRCC treated with first-line pazopanib followed by second-line nivolumab or everolimus.
Following randomized clinical trials for new therapies, implementation of the therapies includes only a selection of patients treated with the options. Real-world evidence is the needed to monitor the translation of study findings into routine practice, potentially leading to improvements in cancer treatment and survival on a broader scale, according to Martin Boegemann, MD, and colleagues.
Dr. Boegemann presented results of the PAZOREAL study during a poster session at the ASCO 2019 Annual Meeting. The poster was titled Sequential Treatment with Pazopanib (PAZO) Followed by Nivolumab (NIVO) in Patients with Advanced or Metastatic Renal Cell Carcinoma (mRCC): Third Interim Results of the Non-interventional Study PAZOREAL.
A total of 421 patients were enrolled between December 2015 and September 2017. Of those, 402 started first-line treatment with pazopanib; 127 received nivolumab as second-line treatment and five received everolimus as second-line treatment. A total of 56 patients entered follow-up. As of the time of data-cut (November 8, 2018), median TD was 6.6 months (95% confidence interval [CI], 6.0-7.9) for first-line pazopanib and 4.1 months (95% CI, 3.205.8) for second-line nivolumab (all patients); median TD for trial eligible patients was 8.1 months (95% CI, 6.6-9.5) for pazopanib and 3.2 months (95% CI, 2.706.5) for nivolumab. Median TD for patients with or without prior nephrectomy was 7.6 months versus 4.5 months, respectively.
Based on investigator assessment, the clinical benefit of first-line treatment with pazopanib was 58.2% (95% CI, 53.3-62.9). Median overall survival on pazopanib was 29.5 months (95% CI, 23.6-NA) for all patients; median overall survival receiving nivolumab as second-line treatment was 28.2 months (95% CI, 22.2-NA).
The most commonly reported adverse events for pazopanib were diarrhea (35%), nausea (20.3%), hypertensive crisis (2.3%), and increase in gamma-glutamyltransferase level (1.8%).
Quality of life, as evaluated by the EQ-5D-5L scale, remained stable over different treatment lines.
“The interim results of the PAZOREAL study confirm a favorable overall survival in patients with mRCC treated with first-line pazopanib in a real-world setting, good benefit-risk profile of pazopanib, and sustained quality of life, monitored over several treatment lines. In Germany, nivolumab as second line treatment is commonly applied after first-line treatment with pazopanib,” the researchers said.
Source: Boegemann M, Bedke J, Schostak M, et al. Sequential treatment with pazopanib (PAZO) followed by nivolumab (NIVO) in patients with advanced or metastatic renal cell carcinoma (mRCC): Third interim results of the non-interventional study PAZOREAL. Abstract of a poster presented at the American Society of Clinical Oncology 2019 Annual Meeting, June 3, 2019, Chicago, Illinois.