Italian researchers report a significant improvement in patient-reported outcomes (PROs) with immune checkpoint inhibitors (ICI) in patients with solid tumours. These findings were recently published in the journal JAMA Network Open.
Laura Pala, MD, of the division of melanoma, sarcomas, and rare tumours at the European Institute of Oncology in Milan, Italy, and colleagues have performed a meta-analysis of clinical trials involving immunotherapy for treating patients with solid tumours.
The researchers performed a systemic review and meta-analysis of 34 randomized controlled trials (RCTs). Data were collected from studies using programmed cell death receptor 1, programmed cell death ligand 1 (PD-L1), and cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) inhibitors for treating solid tumours. The analysis evaluated the efficacy of ICI alone (19 RCTs), in combination with chemotherapy (8 RCTs), and combination with other ICs or focussed therapies ( 8 RCTs). Treatments that did not use immunotherapy were considered the control group. Only those study were included that 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 analogue scale (VAS) for assessing the quality of life (QoL) during and after treatment.
The patients in the ICI monotherapy RCTs showed a between-group difference of mean change in PRO score of 4.6 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 versus the control group. Additionally, the 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 was seen for ICI+ chemotherapy. Patients receiving ICI RCTs with other combinations showed a pooled difference of 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 saw a clear difference in PRO over time in studies using ICI as monotherapy. However, other studies that used ICI in combination had a reduced PRO improvement at 12 and 24 weeks.
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