Quality of life assessments in oncology trials often don’t — but should — go ‘well beyond treatment’
Most oncology clinical trials that assess quality of life do so only during or shortly after the treatment or intervention rather than continuing after disease progression or until death, according to results of a cross-sectional analysis published in JAMA Network Open.
The majority of studies that evaluated quality-of-life outcomes until death reported worse outcomes among those who received an intervention compared with controls.
“The main goal of treating incurable cancers should be to lengthen the amount of time that people can survive. Sometimes, though, oncology drugs are approved on less important outcomes, such as response rate or PFS, but they either do not improve OS or they lead to only marginal gains in OS,” Alyson Haslam, PhD, senior research scientist at Oregon Health & Science University, told Healio. “In these situations, we also need to consider quality of life throughout the duration of the patient’s life and not just during treatment, because improvement in quality of life during treatment may be offset by worse declines in quality of life after treatment.”
Haslam and colleagues sought to examine the timing of assessment of quality of life measures in 149 randomized clinical trials published in three high-impact oncology journals — The Lancet Oncology, Journal of Clinical Oncology and JAMA Oncology — between July 2015 and June 2018.
The researchers pooled data from all studies on timing of quality-of-life assessments, quality-of-life metrics, whether quality-of-life assessment was done during the intervention and results of quality-of-life outcome.
About half (49.7%) of all studies included patients with metastatic, advanced or incurable cancers, whereas 28.2% included patients with cancers that were not metastatic, advanced or incurable, and 22.1% examined interventions not designed to improve survival.
Of the studies that included patients with metastatic, advanced or incurable cancers, only two (4.1%) had quality of life as the primary outcome, compared with nine (10.8%) of those that included patients without such cancers.
Among all studies, results showed overall quality-of-life assessment was highest during treatment (69.8%), followed by during follow-up (54.4%) and after the end of the intervention (45.6%).
Only five studies (3.4%) assessed quality of life until death, including just one of the 74 studies that included patients with metastatic or incurable cancers.
Quality-of-life assessment occurred during the intervention in 89.2% of studies that included patients with metastatic disease vs. 50.7% of studies that included patients with nonmetastatic disease; at the end of intervention in 44.6% vs. 46.7% of studies; and during follow-up in 43.2% vs. 65.3% of studies.
Researchers reported low rates of quality-of-life assessment until the time of death both in studies that included patients with metastatic disease (1.4%) and nonmetastatic disease (5.3%).
Positive quality-of-life outcomes were reported in 56.7% of studies that measured this outcome during treatment, 51.5% that measured it at the end of treatment, 51.9% that measured it after follow-up, 57.1% that measured it upon progression and only one (20%) that measured it until death.
“[Although] most studies measure quality of life during treatment and even shortly after treatment, they rarely measure quality of life for the duration of the patient’s life,” Haslam told Healio. “For those studies that did measure quality of life throughout the duration of the patient’s life, only 20% found an improvement in quality of life from the intervention treatment.
“The lesson that we can take from this study is that researchers need to include quality-of-life measurements well beyond treatment so that patients and physicians can have honest discussions about patients’ values and priorities regarding treatment and follow-up in oncology settings.”
Researchers acknowledged study limitations, including limited generalizability of the findings. They noted that not all quality-of-life metrics measured the same facets of quality of life, and that it was sometimes difficult to determine when measurements were conducted because of unclear or insufficient reporting of methods.
“A discussion on quality of life is not unique to the medical discipline of oncology, which is why researchers and physicians should evaluate quality of life in all other medical disciplines where treatment is not designed to cure, but rather to only modestly prolong life,” Haslam told Healio.
Measuring quality of life is a challenge, Hilde M. Buiting, PhD, researcher at Netherlands Cancer Institute, and Gert Olthuis, PhD, assistant professor in the department of medical ethics at Radboud Institute for Molecular Life Sciences, wrote in an accompanying editorial.
“It could be argued whether the current procedure to evaluate quality of life is the right approach. Criteria on toxic effects guide physicians to evaluate whether patients can continue with trial. A patient’s quality of life possibly fluctuates daily,” Buiting and Olthuis wrote. “Moreover, quality-of-life data probably become available after the patient reported their experiences about the treatment or trial. This delay limits the option for physicians to provide advice to patients with respect to their quality of life.
“In accordance with the suggestions of Haslam [and colleagues], we recommend use of different outcome measures to evaluate patients’ well-being,” the editorial authors wrote. “We believe that by doing this, quality of life can be measured and monitored broadly to guarantee patients’ quality of life with awareness of personal and biographical variety.” – by Jennifer Southall
For more information:
Alyson Haslam, PhD, can be reached at Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239; email: firstname.lastname@example.org.
Disclosures: Haslam reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures. Buiting and Olthuis report no relevant financial disclosures.