Phase 3 clinical trials for cancer are underreporting safety and efficacy data for elderly patients, according to a systematic review of 159 articles.
Roughly 40% of articles reporting efficacy data and 9% of articles reporting safety data had results stratified by age, Karlynn BrintzenhofeSzoc, PhD, of the University of Cincinnati, and colleagues noted in the Journal of Geriatric Oncology.
“Results of our systematic review suggest that there is inadequate reporting of treatment efficacy and adverse events as well as discrepancies as to how older age is defined, considered, and reported,” the investigators wrote. “This sparse and varied reporting critically limits the evidence base for treating older patients with cancer.”
This study was inspired by the American Society of Clinical Oncology, which turned a spotlight on the age-specific data shortage in 2015, when it published a statement that called for inclusion of more elderly patients in cancer trials (J Clin Oncol. 2015 Nov 10;33[32]:3826-33).
According to Tammy Hshieh, MD, a geriatrician at Dana-Farber Cancer Institute in Boston, data for elderly patients with cancer are needed more than ever.
Dr. Tammy Hshieh
“Cancer care has become, increasingly, a field where precision medicine is at its strongest,” Dr. Hshieh said in an interview. “[Oncologists] have a lot of data on patients that allow them to tailor their care to each individual patient’s profile, and so the fact that there is not a lot of evidence looking at toxicities and side effects for older patients makes it basically harder for oncologists to practice evidence-based medicine for this vulnerable but growing population.” This leads to poorer and more variable outcomes, Dr. Hshieh said. When data aren’t available, clinicians must rely on experience and recognize that patient age isn’t as simple as date of birth.
“Oncologists looking at older patients really have to trust their gestalt and their experience in determining how to provide the best care for their older patients,” she said. “They have to look at the chronological age of the patient and try to determine whether that actually matches more of what we’re saying is the physiological age of the patient and use that to guide their treatment.”
Study details
The study included phase 3 clinical trials of adult cancer patients that were conducted from mid-2016 through mid-2017. After identifying 929 manuscripts, the investigators removed duplicates and those that did not meet criteria. This left 159 articles published in 36 journals and covering 25 cancer types.
Of the 159 articles, 73.6% included age-specific medians (in addition to age means), and 47.2% had data stratified by age.
Efficacy was often reported (96.2%), but only 39.9% of articles specified age when describing effectiveness. Although most articles (84.9%) included safety data, only 8.9% had safety findings stratified by age.
In article discussion sections, age was mentioned infrequently in relation to treatment efficacy (13.8%) and rarely in relation to complications and adverse events (5.7%).Beyond underreporting of age-specific data, the investigators found that age categories themselves may be an area in need of improvement.“When outcomes pertaining to older adults were reported, the results were inconsistent as evidenced by the array of age distributions and varying categorization of ‘older adults,’” the investigators wrote. “There is a significant and timely need to design all clinical trials to include older adults and utilize a broad array of geriatric-specific outcomes.” Dr. Hshieh said these findings are concerning, but the study itself suggests the medical community is making efforts to correct the data shortage.“It was actually an important study, even though the results are a little discouraging,” Dr. Hshieh said. “What I’m hoping is that [these findings], combined with all the other literature that’s starting to come out about the need for more research in older patients with cancer, is going to be an impetus for us to do more research, and to be more open to treating older patients, and not to be afraid to confront this head on.”When asked about strategies for managing elderly patients, Dr. Hshieh first recommended the 2018 ASCO Guideline for Geriatric Oncology (J Clin Oncol. 2018 Aug 1;36[22]:2326-47).
“It’s very well written,” she said. “It is clear and user-friendly.”
Dr. Hshieh also offered some simple principles that may help guide clinical decision making.“I’m thinking of three things that an oncologist in the community would want to look at when they see an older patient and they’re trying to determine their treatment plan,” she said. “I would say [the oncologist] should look at [the patient’s] function; their psychosocial status, which includes mood and the support that they have in the community; and cognition.”
Dr. Hshieh and the study authors reported no conflicts of interest.
SOURCE: BrintzenhofeSzoc K et al. J Geriatr Oncol. 2020 Jan 10. pii: S1879-4068(19)30501-6.