Prevalence of symptomatic toxicities for novel therapies in adult oncology trials: A scoping review.

Background: Patients' self-report of their symptoms can provide important data for the evaluation of treatment benefit and tolerability of oncology drugs. Contemporary treatment approaches, including immunotherapy and molecular targeted therapies, have unique toxicities based on their novel mechanisms of action. This scoping review aimed to summarize evidence from existing reviews and clinical practice guidelines to examine the type and prevalence of toxicities including symptomatic adverse events (sympAEs) for adult cancer patients to inform clinical care and therapeutic trials.

Methods: A systematic search of PubMed, Web of Science, and Embase was performed using predefined eligibility criteria. Thirty-one literature reviews and 3 clinical practice guidelines met inclusion criteria and were selected for review and data abstraction.

Results: Findings from this scoping review demonstrated several leading sympAEs that were reported across immunotherapy and targeted therapy drugs, including fatigue, diarrhea and rash. In addition to these more prevalent sympAEs, there were some less frequently reported class-specific sympAEs, which had potential for significant harm or disability to the patient if not properly identified and treated. Many studies reported toxicities as AEs or syndromes solely using data reported by clinicians without additional self-report from patients.

Conclusion: We identified several core sympAEs experienced by patients participating in oncology trials using immunotherapy and targeted therapy agents, which has implications for future trial design and drug labeling. Future cancer trials should assess patient-reported sympAEs based on identified drug mechanism to inform the tolerability of these newer agents and enhance patient safety during trial participation and clinical care.