Results from clinical trials of adjuvant anti-PD-1 therapy may not reflect the real-world experience of patients with resected stage III or IV melanoma, according to research published in the European Journal of Cancer.

Researchers found the rate of premature treatment discontinuation among real-world patients was “remarkably” higher than discontinuation rates observed in clinical trials. 

The researchers evaluated real-world data from the Dutch Melanoma Treatment Registry, which included 641 patients with resected stage III or IV melanoma who received adjuvant anti-PD-1 therapy. 


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The patients’ median age was 62 years (range, 19-90 years), and 56.5% of them were men. Most patients (93.3%) had cutaneous melanoma, and 6.9% of patients had stage IV disease. More patients received nivolumab (83.3%) than pembrolizumab (16.7%).  

The median follow-up was 12.8 months, and 367 patients had 1-year follow-up data.

The rate of grade 3 or higher treatment-related adverse events was 18.2%, which is slightly higher than the 14.4% rate seen in CheckMate-238 (ClinicalTrials.gov Identifier: NCT02388906) and the 14.7% rate seen in the KEYNOTE-054 trial (ClinicalTrials.gov Identifier: NCT02362594), the researchers noted.

In the current study, 61% of patients discontinued treatment prematurely. This rate is substantially higher than 1-year discontinuation rates reported in CheckMate-238 and KEYNOTE-054 — 39.2% and 44.6%, respectively — according to the researchers.

On the other hand, the relapse-free survival (RFS) rate in the current study was similar to that seen in clinical trials. The 12-month RFS rate was 70.6% overall, 87.0% for patients with stage IIIA disease, 76.5% for stage IIIB, 60.3% for stage IIIC, and 69.1% for stage IV disease. 

“Despite similar patient characteristics, premature discontinuation of adjuvant anti-PD-1 in daily clinical practice occurs more often than reported in clinical trials, while toxicity rates also appear slightly higher,” the researchers wrote. “Nevertheless, recurrence-free survival at 12 months is similar between daily clinical practice and trial patients.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.  

Referencede Meza MM, Ismail RK, Rauwerdink D, et al. Adjuvant treatment for melanoma in clinical practice – Trial versus reality. Eur J Cancer. Published online September 29, 2021. doi:10.1016/j.ejca.2021.08.044