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Multicenter Interspecialty Consensus on Experimental Oncology Drug-Related Ocular Adverse Event Reporting.

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Summary

New ocular grading scales improve the reporting of adverse events (AEs) in patients receiving experimental oncology drugs. These standardized scales enhance patient safety and guide the development of novel cancer therapies.

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Area of Science:

  • Ophthalmology
  • Oncology
  • Clinical Trials

Background:

  • Current ocular Common Terminology Criteria for Adverse Events (CTCAE) lack standardization, mixing signs and symptoms, and omitting dose modification guidance.
  • Robust reporting of ocular adverse events (AEs) is crucial for patient safety and developing effective oncology drugs.

Purpose of the Study:

  • To develop improved ocular AE grading scales for evaluating AEs in patients undergoing experimental oncology drug therapy.
  • To provide clear drug dose modification recommendations for ocular AEs.

Main Methods:

  • A collaborative multicenter working group of oncologists and ophthalmologists was formed in February 2023.
  • Expert consensus was reached on novel experimental oncology drug-related ocular AE grading scales, which were released in June 2023.

Main Results:

  • Six novel ocular AE grading scales were developed for antibody-drug conjugate clinical trials: visual acuity, eye symptoms, cornea, conjunctiva/sclera, anterior chamber, and retina/posterior segment.
  • These scales incorporate standardized clinical photographs where applicable.

Conclusions:

  • The new scales are more concise than previous CTCAE and include clear drug dose modification recommendations.
  • These grading scales promote objective and consistent measurement of ocular AEs, aiding safe testing of novel oncology agents.