Study: Immune checkpoint inhibitors found to improve quality of life PROs

Regulatory NewsRegulatory News | 16 August 2022 |  By 

Immune checkpoint inhibitors (ICIs) improve patient-reported outcomes (PROs) if they are used alone or together with other anticancer drugs, according to recent research published in JAMA Network Open.
“The results of this meta-analysis demonstrate a favorable association of ICIs with patient quality of life compared with control groups that did not contain immunotherapy across a large spectrum of solid tumors,” Laura Pala, MD, of the division of melanoma, sarcomas, and rare tumors at the European Institute of Oncology in Milan, Italy, and colleagues wrote in their study. “The benefit was particularly evident when ICIs were administered as monotherapy.”
Pala and colleagues performed a systematic review and meta-analysis of 34 randomized controlled trials (RCTs) with 18,709 patients identified in PubMed, MEDLINE, Embase, and Scopus databases up to June 2021 that included programmed cell death receptor 1, programmed cell death ligand 1 (PD-L1), and cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) inhibitors in patients with advanced solid tumors. The studies included in the analysis evaluated these inhibitors alone (19 RCTs), with chemotherapy (8 RCTs), and together with other ICIs or anticancer drugs or as targeted therapy (8 RCTs). All cancer interventions were compared with a control group that did not receive immunotherapy.
Each study included in the analysis also used the Global Health Status (GHS) scale from the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) or the EuroQol Health-Related Quality of Life 5-Dimension, 3-Level (EQ-5D-3L) visual analog scale (VAS) to assess patient-reported outcome measures. Pala and colleagues analyzed the mean change in PRO score in ICI and control groups up to 24 weeks.
The pooled estimate showed a between-group difference of mean change in PRO score in the ICI monotherapy RCTs of 4.6 (95% CI, 2.8–6.4) at 12 weeks and 6.1 (95% CI, 4.2-8.1) at 24 weeks of follow-up favoring patients receiving an ICI as monotherapy compared with a control group. For patients receiving ICIs in combination with chemotherapy, there was a mean pooled difference of 1.4 (95% CI, −0.4 to 3.2) at 12 weeks and 2.5 (95% CI, −0.8 to 5.9) at 24 weeks. Among patients in RCTs who received ICIs in other combinations, the pooled difference was 2.1 (95% CI, −0.8 to 5.0) at 12 weeks and 2.1 (95% CI, −0.4 to 4.5) at 24 weeks.
The researchers also found a significantly longer deterioration time in patient groups that received ICIs compared with a control group, including ICI monotherapy (hazard ratio, 0.80; 95% CI, 0.70–0.91), ICIs together with chemotherapy (HR, 0.89; 95% CI, 0.78–1.00), and ICIs in other combinations (HR, 0.78; 95% CI, 0.63–0.96).
Pala and colleagues said the findings “clearly show that differences in PROs over time favor immunotherapy in trials testing ICI monotherapy,” but noted some trials evaluating ICIs in other combinations had a lower degree of PRO improvement at 12 weeks and 24 weeks.
“Although this result does not allow for the conclusion of better [health-related quality of life] in patients treated with an ICI combination, it supports the conclusion that none of the multidrug combinations worsened patient quality of life compared with control groups,” the researchers said. “This finding is noteworthy considering that in some RCTs, patients received up to 3 different classes of drugs.”
The finding that ICIs can be combined with other anticancer drugs and it doesn’t result in lowered quality of life for patients is noteworthy, the researchers said, as this treatment combination will be used with an increased number of patients with solid tumors in the future.
“Future research should incorporate PROs as a primary end point of RCTs testing immunotherapy to concretely develop a patient-centered model of care,” they wrote.
JAMA Netw Open Pala et al.


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