Immunotherapy: real-world outcomes do not measure up to clinical trial results

  • La J & al.
  • JCO Clin Cancer Inform
  • 1 Oct 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Real-world survival outcomes for patients with cancer receiving immune checkpoint inhibitors (ICIs) are inferior to outcomes reported in patients in clinical trials of ICIs.

Why this matters

  • Authors: “patients receiving ICIs in real-world practice differ from those enrolled in trials in a variety of ways, including age, race, performance status, and comorbidity burden.”

Study design

  • Study of 11,888 patients with cancer who received ICIs.
  • Funding: VA Office of Research and Development.

Key results

  • The patients were treated for NSCLC (51.1%), melanoma (14.4%), renal cell carcinoma (RCC; 8.1%), squamous cell carcinoma of the head and neck (6.8%), urothelial cancer (6.4%), hepatocellular carcinoma (4.5%), and other less common cancer types (8.8%).
  • Median real-world OS was inferior to median clinical trial OS for:
    • RCC:
      • Second line or higher (2L+): 16.3 months.
      • First-line ipilimumab and nivolumab: 14 months.
    • NSCLC:
      • First-line pembrolizumab: 10.6 months.
      • First-line pembrolizumab and platinum-based chemotherapy: 9.1 months.
    • Urothelial cancer (2L+ ICIs): 6.7 months.
  • The following settings showed similar OS between the real-world and trial data. 
    • Melanoma: first-line nivolumab in melanoma, 25.5 months.
    • NSCLC: 2L+ pembrolizumab or nivolumab, 9.9 months.

Limitations

  • Retrospective.