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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Immune checkpoint inhibitors (ICIs) do not appear to increase fracture risk in cancer patients. Further research with longer observation periods is needed to confirm these findings.

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Area of Science:

  • Oncology
  • Immunology
  • Orthopedics

Background:

  • Immune checkpoint inhibitors (ICIs) treat various cancers but can cause immune-related adverse events (irAEs).
  • While fractures aren't typical irAEs, ICIs might activate osteoclasts, potentially increasing fracture risk.
  • Existing data on ICI therapy and fracture risk are limited.

Purpose of the Study:

  • To systematically evaluate the association between ICI therapy and fracture risk.
  • To analyze fracture data from randomized controlled trials (RCTs) in patients with solid malignancies.

Main Methods:

  • A systematic literature review of phase II and III ICI RCTs was performed using PubMed and Embase.
  • Fracture outcomes (any, osteoporotic, pathologic) were extracted and analyzed using pooled analysis, random-effects meta-analysis, and meta-regression.
  • Subgroup analyses were conducted on studies without active comparators and those with longer ICI treatment durations.

Main Results:

  • 35 RCTs with 23,404 patients were included. No significant association was found between ICI therapy and the risk of any fracture (OR: 1.10), osteoporotic fracture (OR: 1.14), or pathologic fracture (OR: 0.84).
  • Meta-analysis and meta-regression did not identify significant differences or risk factors.
  • Statistical heterogeneity was non-significant (I2 = 0.0%).

Conclusions:

  • Current evidence from RCTs does not indicate an increased risk of fractures with ICI therapy.
  • The limited number of studies and short observation periods highlight the need for comprehensive, long-term fracture-adverse-event reporting in future ICI trials.