Disease State: Cutaneous Toxicities to Anti-Cancer Therapy

Background

Mucocutaneous reactions are common adverse events seen in the care of the oncologic patient. These toxicities result in significant symptomology and impact patient quality of life. Instruments such as the NCI Common Terminology Criteria for Adverse Events (CTCAE) and the Skindex-16/Dermatology Life Quality Index (DLQI) are most frequently utilized to measure the severity of such toxicities from both the clinician and patient perspective. While such tools have been helpful in the assessment of toxicities, they also have some important shortcomings. The clinician reported outcome measures (ClinROs) often use non-specific nomenclature (i.e., “rash”, “skin toxicity”). Moreover, grade of toxicity frequently misaligns with the patient’s subjective drug tolerance and subsequent decisions on treatment continuation. The patient reported outcomes used in clinical trials were developed to assess chronic general skin diseases rather than specific mucocutaneous toxicities to anticancer therapy. Use of well developed and tested measures of toxicity in trials is crucial to supporting anti-neoplastic drug development programs which result in therapies with toxicities that can be reliably recognized and managed, and that appropriately inform clinical decision making.

Project Goal

COAST aims to evaluate existing ClinRO and PRO measures with the goal of improving performance and, where necessary, develop new measures for specific mucocutaneous toxicities.

Project Leads

Allireza Alloo

Sheila Shaigany

Key Project Team Members:

In progress

C³ Methods Partner:

Amit Garg

Contact:

Allireza Alloo (aalloo@northwell.edu)

Sheila Shaigany (sshaigany@northwell.edu)

Publications:

Shaigany S, Mastacouris N, Tannenbaum R, Strunk A, Luan C, Burshtein J, Burshtein A, Carvajal R, Garg A, Alloo A. Outcome Measurement Instruments Used to Evaluate Dermatologic Adverse Events in Cancer Trials: A Systematic Review. JAMA Dermatol. 2024 Mar 20. doi: 10.1001/jamadermatol.2024.0053. Epub ahead of print. PMID: 38506826. https://pubmed.ncbi.nlm.nih.gov/38506826/

Updated on May 1, 2022