Nav: Home

Reporting of adverse events in targeted therapy and immunotherapy trials is 'suboptimal'

October 05, 2016

LUGANO-COPENHAGEN, 5 October, 2016 - A significant number of trials of targeted therapies and immunotherapies in recent years show suboptimal reporting of adverse events, particularly the reporting of recurrent or late toxicities and the duration of the adverse events, researchers have told the ESMO 2016 Congress in Copenhagen.

"Reporting adverse events from clinical trials with new agents is a crucial point, as this will inform physicians and patients regarding the safety profile of that drug and what to expect when starting this therapy in a new patient in everyday clinical practice," said principal investigator Dr Paolo Bossi, from the Head & Neck Unit at the Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan.

In this study, researchers reviewed publications from 81 trials of targeted therapies and immunotherapies approved by the US Food and Drug Administration between 2000-2015 for solid malignancies in adult patients. Each publication was assessed according to a 24-point score card based on the Consolidated Standards of Reporting Trials (CONSORT) guidance.

More than 90% of trials scored poorly in their reporting of recurrent and late toxicities, and in reporting the duration of adverse events; 86% of trials did not adequately report on the time of the adverse event occurrence; and 75% of trials only reported on adverse events that occurred at a frequency above a fixed threshold.

More than half of the analysed papers showed limitations in the method for presenting adverse events, in describing the toxicities leading to therapy withdrawal, and in the follow-up interval assessment, while dose reductions due to adverse events were not reported in one-third of trials.

"Toxicities of targeted agents and immunotherapy are obviously different from the toxicities we are used to observing and treating due to chemotherapy, and there are some aspects of the toxicities of these newer agents that we are not so well informed about," Dr Bossi said.

He highlighted the issue of duration of an adverse event - the so-called 'third axis' (the other being severity and frequency) in the evaluation of toxicities - which is not regularly considered with a new drug comes to market.

Dr Bossi said that it was encouraging to see a trend towards improved adverse event reporting in recent years. Moreover, there are new instruments available that can help physicians to improve the quality of adverse event reporting and help them discuss potential toxicities with their patients.

"The most important and innovative one is the PRO-CTCAE form, which is the patient-reported outcome version of the common toxicity criteria of adverse events, and which will allow physicians to collect the symptoms as reported by the patients, considering also the severity, intensity and influence of the symptoms on their quality of life."

Commenting on the study, Dr Nathan Cherny from the Shaare Zedek Medical Center in Jerusalem, said, "it ought to be remembered that there is pre-existing evidence that toxicity reporting based upon clinician reports, rather than patient reported data, consistently leads to underreporting of adverse events and the severity of those events."

"These findings lend further support to the proposal to radically re-evaluate the collection and reporting of adverse event data to give weighting to patient-reported data," Dr Cherny said.

He concluded: "It is worth noting however, that the published reports of studies represent a summary of a dataset that may not necessarily represent the full data set submitted to licensing authorities for purposes of drug approval and registration."
-end-


European Society for Medical Oncology

Related Physicians Articles:

Types and distribution of payments from industry to physicians
In 2015, nearly half of physicians were reported to have received a total of $2.4 billion in industry-related payments, primarily involving general payments (including consulting fees and food and beverage), with a higher likelihood and value of payments to physicians in surgical than primary care specialties and to male than female physicians, according to a study published by JAMA in a theme issue on conflict of interest.
Is higher health care spending by physicians associated with better outcomes?
Higher health care utilization spending by physicians was not associated with better outcomes for hospitalized Medicare beneficiaries in a new article published online by JAMA Internal Medicine.
Time for physicians to prepare for impending appropriate use mandate
Within a year, the Centers for Medicare & Medicaid Services (CMS) will implement a provision in the Protecting Access to Medicare Act that requires physicians to consult appropriate use criteria using CMS-approved computer-based clinical decision support mechanisms when ordering advanced imaging procedures.
Four Loyola physicians named to Who's Who in Hispanic Chicago
Four Loyola Medicine physicians have been named to Negocios Now's 2016 'Who's Who in Hispanic Chicago.' Loyola has more physicians on the list than any other medical center.
Physicians are more likely to use hospice and intensive care at end of life
New research suggests that US physicians are more likely to use hospice and intensive or critical care units in the last months of life than non-physicians.
Professional burnout associated with physicians limiting practice
At a time when the nation is facing projected physician shortages, a Mayo Clinic study shows an association between burnout and declining professional satisfaction with physicians reducing the number of hours they devote to clinical practice.
By asking, 'what's the worst part of this?' physicians can ease suffering
When patients suffer, doctors tend to want to fix things and if they cannot many doctors then withdraw emotionally.
Physicians in training at high risk for depression
New research from Brigham and Women's Hospital finds that 28.8 percent of trainees screen positive for depression during their residency.
Physicians and burnout: It's getting worse
Burnout among US physicians is getting worse. An update from a three-year study evaluating burnout and work-life balance shows that American physicians are worse off today than they were three years earlier.
American College of Physicians urges physicians to oppose mass deportation
The American College of Physicians (ACP) today called on physicians, individually and collectively, to speak out against proposals to deport the 12 million US residents who lack documentation of legal residency status, citing the adverse impact that mass deportation would have on individuals and the health of the public.

Related Physicians Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Anthropomorphic
Do animals grieve? Do they have language or consciousness? For a long time, scientists resisted the urge to look for human qualities in animals. This hour, TED speakers explore how that is changing. Guests include biological anthropologist Barbara King, dolphin researcher Denise Herzing, primatologist Frans de Waal, and ecologist Carl Safina.
Now Playing: Science for the People

#SB2 2019 Science Birthday Minisode: Mary Golda Ross
Our second annual Science Birthday is here, and this year we celebrate the wonderful Mary Golda Ross, born 9 August 1908. She died in 2008 at age 99, but left a lasting mark on the science of rocketry and space exploration as an early woman in engineering, and one of the first Native Americans in engineering. Join Rachelle and Bethany for this very special birthday minisode celebrating Mary and her achievements. Thanks to our Patreons who make this show possible! Read more about Mary G. Ross: Interview with Mary Ross on Lash Publications International, by Laurel Sheppard Meet Mary Golda...