# Neoadjuvant-Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma

Source: https://onco.cc/key-papers/paper-swog-s1801-n-engl-j-med-2023/  
OnCo record `paper-swog-s1801-n-engl-j-med-2023` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Published report from the SWOG S1801 trial registered as NCT03698019, in New England Journal of Medicine (2023), chosen as the most cited paper whose own text cites the registry id.

## Summary

Background: Whether pembrolizumab given both before surgery (neoadjuvant therapy) and after surgery (adjuvant therapy), as compared with pembrolizumab given as adjuvant therapy alone, would increase event-free survival among patients with resectable stage III or IV melanoma is unknown.

Methods: In a phase 2 trial, we randomly assigned patients with clinically detectable, measurable stage IIIB to IVC melanoma that was amenable to surgical resection to three doses of neoadjuvant pembrolizumab, surgery, and 15 doses of adjuvant pembrolizumab (neoadjuvant-adjuvant group) or to surgery followed by pembrolizumab (200 mg intravenously every 3 weeks for a total of 18 doses) for approximately 1 year or until disease recurred or unacceptable toxic effects developed (adjuvant-only group). The primary end point was event-free survival in the intention-to-treat population. Events were defined as disease progression or toxic effects that precluded surgery; the inability to resect all gross disease; disease progression, surgical complications, or toxic effects of treatment that precluded the initiation of adjuvant therapy within 84 days after surgery; recurrence of melanoma after surgery; or death from any cause. Safety was also evaluated.

Results: At a median follow-up of 14.7 months, the neoadjuvant-adjuvant group (154 patients) had significantly longer event-free survival than the adjuvant-only group (159 patients) (P = 0.004 by the log-rank test). In a landmark analysis, event-free survival at 2 years was 72% (95% confidence interval [CI], 64 to 80) in the neoadjuvant-adjuvant group and 49% (95% CI, 41 to 59) in the adjuvant-only group. The percentage of patients with treatment-related adverse events of grades 3 or higher during therapy was 12% in the neoadjuvant-adjuvant group and 14% in the adjuvant-only group.

Conclusions: Among patients with resectable stage III or IV melanoma, event-free survival was significantly longer among those who received pembrolizumab both before and after surgery than among those who received adjuvant pembrolizumab alone. No new toxic effects were identified. (Funded by the National Cancer Institute and Merck Sharp and Dohme; S1801 ClinicalTrials.gov number, NCT03698019.).

Indexed on Europe PMC as PubMed record 36856617 (DOI 10.1056/nejmoa2211437). Its abstract cites the registry id NCT03698019, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: New England Journal of Medicine
- Year: 2023
- DOI: 10.1056/nejmoa2211437
- Authors: Patel SP, Othus M, Chen Y, et al.
- What it means: This is the paper Europe PMC returns for registry id NCT03698019 with the most citations, so it is the natural first reading for anyone following the SWOG S1801 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.

## Sources

- N Engl J Med 2023: https://doi.org/10.1056/nejmoa2211437
- PubMed: https://pubmed.ncbi.nlm.nih.gov/36856617/
- Europe PMC: https://europepmc.org/article/MED/36856617
- ClinicalTrials.gov NCT03698019: https://clinicaltrials.gov/study/NCT03698019

## Connected records

- trials: [SWOG S1801](https://onco.cc/trials/swog-s1801/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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