Novel Toxicity Examinations for Patients Treated With Targeted Therapies

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Instead of analyzing adverse events in the traditional fashion, we ought to consider alternatives in this new era of personalized medicine.
Instead of analyzing adverse events in the traditional fashion, we ought to consider alternatives in this new era of personalized medicine.

Editor's Note: A previous version of this article referred to a source as "Dr Pratt." This was changed to Dr Patt.

Oncologists need better ways of measuring toxicity with targeted therapies, according to a report in the Annals of Oncology.1 Instead of analyzing adverse events (AEs) in the traditional fashion, the new era of personalized medicine should offer alternative options.

AEs have traditionally been reported in terms of frequency and intensity. This may not, however, be adequate with molecularly targeted therapies (MTTs) and immunotherapies, according to Thomas Filleron, MD, of the Institut Claudius Regaud, IUCT-Oncopole, Bureau des Essais Cliniques in France, and colleagues. The researchers suggest 2 methods: prevalence and quality-adjusted time without symptoms or toxicity (Q-TWiST).

Prevalence assesses the rate of toxicity over time and can tease out some AEs that are resolved by medical intervention or spontaneous improvement with time. Q-TWiST can help evaluate the tradeoffs between toxicity and survival. This tool looks at toxicity, time without symptom and toxicity, and relapse. The researchers highlighted the strengths of these approaches in a phase 2 trial and a hypothetical simulated clinical trial.

The researchers believe that the 2 methods may be able to capture different effects and help better guide clinicians in making therapeutic decisions. They believe that these methods should be considered for future clinical trials with MTTs and for analyzing published data from randomized clinical trials.

Igor Puzanov, MD, director of the Center for Early Phase Clinical Trials and Developmental Therapeutics and professor of oncology at the Department of Medicine at Roswell Park Cancer Institute in Buffalo, New York, said prevalence has been typically used to report toxicities over time for clinical oncology trials with targeted therapies. He added that there is a need for a method to describe a patient's experience with a given drug over time, and, further, that such a method may help guide clinicians on how to best sequence and manage checkpoint inhibitors and other MMTs.

RELATED: Targeted Therapy Has Led to Better Survival Among African Americans, Caucasians

“The Q-TWiST method is able to incorporate individual patient experiences with the drug therapies over time, including incorporation of quality of life. This may become a preferred method as we try to weigh the value of new oncology therapies,” Dr Puzanov told Cancer Therapy Advisor.

“As the drugs become more successful at keeping our patients alive, we need to move towards not just prolonging life itself, but also prolonging life's quality. The current system has its limitations as described in this and other articles, and the Q-TWiST system may be one of the alternative measures of the symptoms.”

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