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Predictive value of immune-related adverse events during pembrolizumab treatment in non-small cell lung cancer
  1. Carmen Maria Valencia Soto1,
  2. María Victoria Villacañas Palomares1,
  3. Adela Garcia-Avello Fernández-Cueto1,
  4. Sara Barbadillo Villanueva1,
  5. Virginia Martínez Callejo1,
  6. María Ochagavía Sufrategui1,
  7. Pedro Muñoz Cacho2,
  8. Marta Valero Domínguez1
  1. 1Pharmacy, Hospital Universitario Marques de Valdecilla Servicio de Farmacia, Santander, Cantabria, Spain
  2. 2Unidad Docente de Medicina familiar y comunitaria, Idival, Santander, Cantabria, Spain
  1. Correspondence to Carmen Maria Valencia Soto, Pharmacy, Hospital Universitario Marques de Valdecilla Servicio de Farmacia, 39008 Santander, Cantabria, Spain; carmenmaria.valencia{at}


Objectives Several studies have reported the role of immune-related adverse events as a predictor of clinical benefit, but few have properly described these findings in advanced or metastatic non-small cell lung cancer treated with pembrolizumab. This study aimed to evaluate the association between immune-related adverse events development and clinical outcomes in the aforementioned group of patients.

Methods We conducted a retrospective study in patients with advanced or metastatic non-small cell lung cancer treated with pembrolizumab. Overall response rate, progression-free survival and overall survival were evaluated according to the appearance, subtype and number of immune-related adverse events developed. We report the results of the immune-related adverse events analysis and the potential correlation between immune-related adverse events and clinical outcomes. Univariate and multivariate analyses were performed to evaluate this relationship.

Results A total of 94 patients were analysed; 60 of them developed immune-related adverse events. Patients with immune-related adverse events had a significantly higher overall response rate compared with the non-immune-related adverse events group (34% vs 8.5%, χ2=0.005). Median progression-free survival was statistically significant in favour of patients with at least one immune-related adverse event (p=0.015). Median overall survival was not reached in patients with ≥1 immune-related adverse events, compared with 8 months (95% CI 0.6 to 15.4 months) in those without immune-related adverse events. Patients who developed ≥2 immune-related adverse events had longer median progression-free survival (11 vs 4 months, not statistically significant) and overall survival (not reached vs 11, p=0.022) compared with those with ≤1 immune-related adverse events.

Conclusions Obtained data showed that patients with immune-related adverse events occurrence had significantly better overall response rate and longer progression-free survival and overall survival. This study highlights the role of immune-related adverse events as a predictor of survival in a real-life setting.

  • Antineoplastic agents
  • Respiratory Tract Neoplasms
  • Evidence-Based Medicine

Data availability statement

Data are available in a public, open access repository.

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