KEY TAKEAWAYS
- Longitudinal symptomatic adverse events during clinical trials must be summarized to understand treatment tolerability.
- The PRO-CTCAE is a valuable tool to assess treatment tolerability in clinical trials.
- The toxicity index can be used to evaluate the PRO-CTCAE data obtained from the COMET-2 clinical trial in conjunction with the highest attainable score.
- The toxicity index is a useful approach to stratify patients based on the severity of their symptomatic adverse event load, ranging from minimal to maximal.
- The toxicity index and severity level proportions exhibited analogous outcomes in inter-group statistical variations.
- Additional research is required to establish a definitive clinical or patient-oriented explanation of the toxicity index.
Summarizing longitudinal symptomatic adverse events during clinical trials is imperative to comprehend treatment tolerability. Utilizing the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) offers valuable information for assessing treatment tolerability in clinical trials. In medical literature and during patient consultations, it is common to employ tolerability summary measures, such as the maximum score, to convey the possible adverse symptoms. Typically, the ratios of prevalent and acute symptomatic unfavorable occurrences are utilized and disclosed between therapeutic groups across categories of unfavorable occurrences.
The toxicity index is a measure that has been utilized in the past to summarize clinician-reported Common Terminology Criteria for Adverse Events (CTCAE) data. The researchers utilize the toxicity index to evaluate the PRO-CTCAE data obtained from the COMET-2 clinical trial in conjunction with the highest attainable score. Subsequently, they provide an overview and analysis of the factors that must be considered while employing the toxicity index as a comprehensive metric for conveying the degree of tolerability to both patients and healthcare providers. The maximum severity levels of PRO-CTCAE and the median toxicity index were calculated for each arm, considering all trial data and adjusting for baseline symptoms.
The inter-group statistical variations exhibited analogous outcomes, regardless of whether the severity level proportions or the toxicity index were employed. Baseline symptom adjustment’s observed effects were comparable when assessing arms based on severity rates or the toxicity index. The employment of the toxicity index is a valuable approach in the stratification of patients based on the severity of their symptomatic adverse event load, ranging from minimal to maximal. The present investigation has demonstrated the feasibility of utilizing the toxicity index in the context of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. While the tolerability summary measure is useful, additional research is required to establish a definitive clinical or patient-oriented explanation of the toxicity index.
Source: https://pubmed.ncbi.nlm.nih.gov/34371138/
Clinical Trail: https://clinicaltrials.gov/ct2/show/NCT01522443
Langlais B, Mazza GL, Thanarajasingam G, Rogak LJ, Ginos B, Heon N, Scher HI, Schwab G, Ganz PA, Basch E, Dueck AC. Evaluating Treatment Tolerability Using the Toxicity Index With Patient-Reported Outcomes Data. J Pain Symptom Manage. 2022 Feb;63(2):311-320. doi: 10.1016/j.jpainsymman.2021.07.031. Epub 2021 Aug 8. PMID: 34371138; PMCID: PMC8816875.
