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首页> 外文期刊>Journal of the advanced practitioner in oncology >Genitourinary (Non-Prostate) Cancers: 2021 ASCO Annual Meeting Highlights for the Advanced Practitioner: The Advanced Practitioner Perspective: KEYNOTE-564: Adjuvant Pembrolizumab Extends Disease-Free Survival in High-Risk Renal Cell Carcinoma, By Alice Goodman
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Genitourinary (Non-Prostate) Cancers: 2021 ASCO Annual Meeting Highlights for the Advanced Practitioner: The Advanced Practitioner Perspective: KEYNOTE-564: Adjuvant Pembrolizumab Extends Disease-Free Survival in High-Risk Renal Cell Carcinoma, By Alice Goodman

机译：Genitourinary (Non-Prostate) Cancers: 2021 ASCO Annual Meeting Highlights for the Advanced Practitioner: The Advanced Practitioner Perspective: KEYNOTE-564: Adjuvant Pembrolizumab Extends Disease-Free Survival in High-Risk Renal Cell Carcinoma, By Alice Goodman

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Adjuvant pembrolizumab following surgery significantly improved disease-free survival compared with placebo among patients with high-risk clear cell renal cell carcinoma (RCC), according to the international phase III KEYNOTE-564 study presented at the Plenary session during the 2021 ASCO Annual Meeting.1 The addition of the immune checkpoint inhibitor as adjuvant therapy led to a 32% reduction in the risk of disease recurrence or death compared with placebo. “KEYNOTE-564 is the first phase III study to show an improvement in disease-free survival with adjuvant immunotherapy in patients with high-risk, fully resected clear cell RCC, the most common type of kidney cancer. The improvement in disease-free survival was statistically significant and clinically meaningful. KEYNOTE-564's disease-free survival supports pembrolizumab as a potential new standard of care in renal cell carcinoma,” said lead author Toni K. Choueiri, MD, of Dana-Farber Cancer Hospital, Boston. The Advanced Practitioner Perspective: Despite the FDA approval for adjuvant sunitinib (Sutent) for patients with high-risk renal cell carcinoma (RCC), the excitement for adjuvant therapies has been lackluster given the absence of overall survival (OS) benefit coupled with significant toxicity. The results of KEYNOTE-564 have the potential to be practice changing given the impact on disease-free survival (DFS) and acceptable toxicity profile. KEYNOTE-564 is a phase III, multicenter trial of pembrolizumab vs. placebo in patients with intermediate-high risk, high-risk, or M1 no evidence of disease (NED) clear cell RCC following nephrectomy. Patients were randomized to either placebo or pembrolizumab within 12 weeks following nephrectomy, and treatment was given for up to 17 cycles (roughly 1 year). The primary endpoint, DFS, was 77.3% in the pembrolizumab arm vs. 68.1% in the placebo arm at 24 months. Follow-up is planned to report on OS—a key secondary outcome. This is the first reported adjuvant trial for clear cell RCC with a checkpoint inhibitor. The inclusion of M1 NED patients is notable and addresses an unmet need in adjuvant trials given the role of metastasectomy in M1 RCC. In the current era of immunotherapy, advanced practitioners are well versed in managing these therapies and their side effects, making this a seamless addition to day-to-day practice should FDA approval be granted. However, questions remain, primarily on the impact on OS, as well as how adjuvant immunotherapy might impact future immunotherapy use in the metastatic setting. Advanced practitioners should be familiar with DFS and the ideal patient population in which adjuvant therapy should be considered.

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