‘Positive impact’ on quality of life reported with immunotherapy for solid tumors
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Immune checkpoint inhibitors had a favorable impact on patient-reported quality-of-life compared with other standard therapies across a variety of advanced solid tumor types, data from a meta-analysis showed.
The research — published in JAMA Network Open — also revealed immune checkpoint inhibitors do not worsen quality of life when combined with other anticancer agents.
Background
The emergence of immune checkpoint inhibitors (ICIs) has fundamentally altered the treatment paradigm for patients with certain advanced solid tumors, according to Laura Pala, MD, medical oncologist at Humanitas Gavazzeni in Bergamo, Italy, who helped conduct the research while serving as a medical oncologist at European Institute of Oncology in Milan.
“Both the efficacy and toxicity profiles of ICIs meaningfully differ from those of other classes of anticancer treatments,” she told Healio. “Although the efficacy of ICIs has been widely investigated, their impact on a patient’s quality of life — compared with that of other available anticancer treatments — has been less explored.”
Methodology
To determine the effect of ICI use on patients’ health-related quality of life, Pala and colleagues conducted a systematic review and random-effects meta-analysis of randomized clinical trials listed on PubMed, MEDLINE, Embase or Scopus. The analysis also included review of abstracts from major medical meetings from Jan. 1, 2010, to June 1, 2021.
The investigators found 2,259 randomized clinical trials that evaluated ICIs as monotherapy or in combination with chemotherapy, another ICI or other targeted therapy for the treatment of advanced solid tumors.
Studies included in the analysis assessed patient-reported outcomes using either the Global Health Status scale or the EuroQol Health-Related Quality of Life 5-Dimension, 3-Level visual analog scale.
Primary objectives for the analysis included evaluating mean change in patient-reported quality-of-life outcome scores from baseline and at 12 and 24 weeks of follow up, in addition to the pooled differences among treatment groups in time to deterioration of patient-reported quality-of-life scores.
Key findings
Researchers identified 34 randomized clinical trials, including 18,709 patients, that met the study’s selection criteria.
Nineteen randomized clinical trials that tested ICIs as monotherapy demonstrated a pooled between-groups difference of mean change in patient-reported quality-of-life scores of 4.6 (95% CI, 2.8-6.4) at 12 weeks of follow up and of 6.1 (95% CI, 4.2-8.1) at 24 weeks, both of which significantly favored ICIs.
Eight trials evaluating ICIs combined with chemotherapy showed a pooled mean difference in patient-reported quality-of-life scores of 1.4 (95% CI, 0.4 to 3.2) at week 12 of follow-up and 2.5 (95% CI, 0.8 to 5.9) at week 24 of follow-up.
The remaining eight trials evaluating ICIs in combination with other targeted therapies demonstrated a pooled mean difference in scores of 2.1 (95% CI, 0.8 to 5) at week 12 and 2.1 (95% CI, 0.4 to 4.5) at week 24 of follow-up.
Investigators observed significantly longer time to deterioration of patient-reported quality-of-life outcomes among groups who received immunotherapy alone or in combination regimens compared with control groups among the studies included in the analysis (HR = 0.8 [95% CI, 0.7-0.91] for ICIs as monotherapy; HR = 0.89 [95% CI, 0.78-1] for ICIs plus chemotherapy; and HR = 0.78 [95% CI, 0.63-0.96] for ICI-containing combinations).
Clinical implications
The study’s findings “robustly confirm the supposed positive impact of immunotherapy on patients’ quality of life” and support the use of ICIs as the “preferred drug option” for patients when available, Pala said.
“Our results also showed that ICIs can be combined with several other classes of anticancer drugs — particularly chemotherapy — without worsening patients’ quality of life,” Pala told Healio.
Pala noted that none of the randomized clinical trials included in her group’s analysis included health-related quality-of-life measures as a primary study endpoint and that such assessments had only been conducted in secondary or later reports. The absence of these measurements in primary analyses, in her estimation, highlights the lack of importance placed on patient-reported outcomes in the field.
“We think analysis of quality of life should be mandatory as one of the primary objectives of clinical trials,” she said. “Moreover, greater attention should be given to endpoints that jointly assess efficacy and tolerability of treatments, to concretely develop a patient-centered model of care.”
For more information:
Laura Pala, MD, can be reached at laura.pala@gavazzeni.it.
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