Adjuvant pembrolizumab well tolerated in high-risk renal cell carcinoma
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NASHVILLE, Tenn. — Adjuvant pembrolizumab appeared well tolerated among patients with high-risk renal cell carcinoma after nephrectomy, according to study results.
The findings of the real-world analysis — presented at International Kidney Cancer Symposium: North America — highlight the critical importance of risk-benefit discussions, particularly in the context of potentially life-altering toxicities, researchers concluded.
“Multicenter analyses are needed to determine practice patterns and outcomes for patients with disease progression on adjuvant pembrolizumab,” Allison Martin, PA-C, physician assistant at Cleveland Clinic Taussig Cancer Institute, and colleagues wrote. "Optimal treatment for patients with progressive disease on adjuvant pembrolizumab requires further study.”
Results of the KEYNOTE-564 trial showed 1 year of adjuvant pembrolizumab (Keytruda, Merck) — an anti-PD-1 antibody — extended DFS by 1 year compared with placebo among patients with resected high-risk renal cell carcinoma.
Based on these results, the FDA approved adjuvant pembrolizumab for this indication in November 2021.
Although nearly 2 years have passed since then, real-world evidence about toxicity and treatment upon disease progression in this setting is limited, according to study background.
Martin and colleagues identified patients treated at Cleveland Clinic who received adjuvant pembrolizumab for high-risk clear cell renal cell carcinoma or sarcomatoid renal cell carcinoma. They gathered data about baseline and disease characteristics, risk group per KEYNOTE-564 criteria, toxicity and treatment after progressive disease.
The cohort included 20 patients (median age, 67 years; range, 44-76; 75% men). Nineteen patients (95%) had clear cell histology, three (15%) had sarcomatoid features and six (30%) had rhabdoid features.
The majority had pT3 staging (85%), whereas three (15%) had pT1 staging. Three (15%) had node-positive disease.
Two-thirds (65%) had intermediate/high-risk disease per KEYNOTE-564 criteria, three (15%) had high-risk disease and four (20%) had M1-NED disease.
Five patients (25%) completed 1 year of therapy and nine (45%) were still in their year of treatment at data cutoff. Six patients (30%) discontinued therapy within a year — three due to progressive disease and three due to toxicity.
Six patients (30%) required corticosteroids for immune-related adverse events— two for dermatitis and one each for nephritis, ototoxicity, arthralgia and polymyalgia rheumatica/elevated troponin.
Median steroid duration was 3 weeks (range, 2-19). All patients stopped corticosteroids with toxicity resolution reduced to grade 1 or less.
The cases of ototoxicity and elevated troponin resolved rapidly with steroids and no long-term sequelae, Martin and colleagues reported.
Three patients — the single cases of nephritis, polymyalgia rheumatic/troponin leak and arthralgia — permanently discontinued pembrolizumab due to their immune-related adverse events.
Four patients (20%) developed progressive disease during adjuvant therapy with pembrolizumab, with median time to progressive disease of 6 months. One patient underwent stereotactic radiosurgery to an oligometastatic lesion and remained on therapy. The other three changed systemic therapy.
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Martin A, et al. Abstract 66. Presented at: IKCS: North America; Nov. 9-11, 2023; Nashville, Tenn.
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