medwireNews: A meta-analysis has revealed a favorable association between immune checkpoint inhibitors (ICIs) as monotherapy and patient-reported outcomes (PROs) and quality of life (QoL).
Moreover, there is no worsening of QoL when ICIs are combined with chemotherapy or other agents, report Laura Pala, from the European Institute of Oncology in Milan, Italy, and collaborators in JAMA Network Open.
They believe that this “is a noteworthy finding considering that such combinations will be increasingly used in many solid tumors.”
The meta-analysis included 34 randomized controlled trials (RCTs) – with 18,709 patients – that pitted ICIs as monotherapy (n=19 trials) or together with chemotherapy (n=8) or other agents (n=7) against control regimens not containing immunotherapy for the treatment of advanced solid tumors.
Most (n=12) of the trials were conducted in the non-small-cell lung cancer setting, followed by four in melanoma and three each in small-cell lung cancer, renal cell carcinoma, and urothelial cancer, while other tumor types such as gastroesophageal and breast cancer were represented in one or two trials.
PROs in the trials were assessed via the Global Health Status scale of the EORTC Core Quality of Life Questionnaire (QLQ-C30 GHS) or the EuroQol Health-Related Quality of Life 5-Dimension, 3-Level visual analog scale (EQ-5D-3L VAS).
Pooled analysis of the ICI monotherapy trials showed a difference between the experimental and control groups in the mean change in PRO score from baseline to 12 weeks of 4.6 points and to 24 weeks of 6.1 points, significantly favoring ICI monotherapy at both timepoints.
The between-group differences favored ICI combinations, albeit without reaching statistical significance, when used with chemotherapy (1.4 and 2.5 points at week 12 and 24, respectively) or other agents, such as other ICIs or targeted therapy (2.1 points at both timepoints).
“Although this result does not allow for the conclusion of better [health-related] QoL in patients treated with an ICI combination, it supports the conclusion that none of the multidrug combinations worsened patient [QoL] compared with control groups,” write Pala and co-authors.
They continue: “A significantly longer preservation of [QoL] for patients treated with immunotherapy-containing treatments, including multidrug combinations, is further supported by the results of TTD [time to deterioration] analysis.”
Specifically, the TTD of PRO scores was significantly longer for ICI monotherapy and ICI combinations with other agents than for control regimens, at pooled hazard ratios (HRs) of 0.80 and 0.78, respectively. The TTD also favored ICI combinations with chemotherapy over control treatments, but the HR of 0.89 was only borderline significant.
The favorable associations with QoL “could be partially explained by the longer disease control achieved in many trials by patients receiving ICIs compared with the control group as well as by the characteristic toxicity profile of this new class of drugs,” say the researchers.
They conclude: “Future research should incorporate PROs as a primary end point of RCTs testing immunotherapy to concretely develop a patient-centered model of care.”
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