1686P Selecting patient-reported outcomes to monitor symptomatic toxicities of immune-checkpoint inhibitors: A Delphi study

Immune checkpoint inhibitors (ICIs) are increasingly used for advanced lung cancer, but few studies have reported on patient-reported outcomes (PROs) outside the context of a clinical trial. The goal of the current study was to assess PROs in participants of a lung cancer registry who had been treated with an ICI. Patients participating in the GO2 Foundation’s Lung Cancer Registry who reported receiving atezolizumab, durvalumab, nivolumab, or pembrolizumab were invited to participate in a survey about their experiences during treatment. Quality of life was evaluated using the Functional Assessment of Cancer Therapy–General (FACT-G). Common symptomatic adverse events were evaluated using an item bank generated for ICIs. Internationally, 226 patients (mean age 61, 75% female) participated. Patients reported worse quality of life at the time of assessment than U.S. population and cancer normative samples. The most common moderate to severe adverse events during ICI treatment were fatigue (41%), aching joints (27%), and aching muscles (20%). Due to toxicity, 25% reported a treatment delay, 11% an emergency room visit, and 9% a hospitalization. This study is among the first to our knowledge to report on PROs of ICIs outside the context of a clinical trial. Results suggest higher rates of adverse events than previously reported in clinical trials.

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The impact of blinding on patient-reported outcomes (PROs) in randomized controlled trials of immune checkpoint inhibitors versus traditional chemotherapies.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e23160 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e23160-e23160

Author(s):

James Dickerson ◽

Evan Thomas Hall ◽

Surbhi Singhal ◽

Brooke Peterson Gabster ◽

Lidia Schapira

Keyword(s):

Immune Checkpoint ◽

Immune Checkpoint Inhibitors ◽

Checkpoint Inhibitors ◽

Controlled Trial ◽

Case Series ◽

Symptom Burden ◽

Open Label ◽

Patient Reported ◽

The Impact ◽

Blinded Trial

e23160 Background: Immune checkpoint inhibitors (ICIs) have been met with a wave of excitement due to their novel mechanism. We hypothesized that this may impact how patients (via PROs) report treatment tolerability in comparison to traditional therapies. We sought to examine if there was a notable difference in PROs in blinded vs unblinded trials of ICIs. Methods: We systematically searched PubMed, CINAHL, Embase, Web of Science, and Scopus in August 2018 for publications with quantitative PRO data comparing ICIs to cytotoxic chemotherapy. Case series, narrative reviews, and publications lacking original data were excluded. Eligible publications were reviewed to assess if patients were blinded to the agent received, and a comparison for common PRO metrics was performed. Results: Of the 1,450 unique references identified, eight met inclusion criteria: 1 double blinded placebo-controlled trial and 7 trials where patients were aware of the assigned arm. The blinded trial had quantitative PRO data in the form of the European Organisation for Research and Treatment of Cancer (EORTC) global health status (GHS) score and patient reported symptom burden at week 12. Most (6 of 7; 86%) unblinded trials reported the GHS at either week 12 or 15, and patient symptom burden at these time points as well (5 of 7; 71%). For the EORTC GHS, the blinded trial showed no inter-arm difference at week 12. 4 of 6 (67%) open label trials noted statistically significant differences in GHS favoring the ICI arm. For symptom burden at week 12 or 15, there was no difference found in the blinded study. In unblinded trials, there were domains where patients receiving ICIs reported a statistically significant lower symptom burden than those receiving chemotherapy: fatigue (4 of 5 trials favoring ICIs; 80%), dyspnea (2 of 5; 40%), insomnia (1 of 4; 25%), appetite loss (1 of 4; 25%), and diarrhea (1 of 5; 20%). There were no differences in pain (n = 5), nausea/vomit (n = 5), and constipation (n = 5). Conclusions: We found a trend towards more favorable reporting on common symptoms in unblinded studies of patients receiving ICIs. Our analysis is limited by the lack of available comparisons in the published literature.

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Meta-Analysis of Quality of Life in Cancer Patients Treated with Immune Checkpoint Inhibitors

JNCI Journal of the National Cancer Institute ◽

10.1093/jnci/djab171 ◽

2021 ◽

Author(s):

Brian D Gonzalez ◽

Sarah L Eisel ◽

Kristina E Bowles ◽

Aasha I Hoogland ◽

Brian W James ◽

...

Keyword(s):

Quality Of Life ◽

Cancer Patients ◽

Physical Functioning ◽

Immune Checkpoint ◽

Immune Checkpoint Inhibitors ◽

Checkpoint Inhibitors ◽

Statistical Tests ◽

Meta Analysis ◽

Patient Reported

Abstract Background Trials of immune checkpoint inhibitors (ICIs) have published patient-reported quality of life (QOL), but the size and heterogeneity of this literature can make patient education difficult. This meta-analysis aimed to describe change in QOL and symptomatology in patients receiving ICIs for cancer. Methods Following PRISMA guidelines, databases were searched through November 2019 for articles or abstracts of prospective, original studies reporting longitudinal QOL in adult cancer patients treated with ICIs. The prespecified primary outcomes were change in global QOL among patients treated with ICIs and difference in change since baseline in global QOL between patients treated with ICI vs. non-ICI active treatment. Secondary outcomes included physical functioning and symptomatology. All statistical tests were 2-sided. Results Twenty-six of 20,323 publications met inclusion criteria. Global QOL did not change over time in patients treated with ICIs (k = 26, n = 6,974, P = .19). Larger improvements in global QOL was observed in patients receiving ICI vs. non-ICI regimens (k = 16, ICI n = 3,588, non-ICI n = 2,948, P < .001). Physical functioning did not change in patients treated with ICIs (k = 14, n = 3,169, P=.47); there were no differences in mean change between ICI vs. non-ICI regimens (k = 11, n = 4,630, P=.94. Regarding symptoms, appetite loss, insomnia, and pain severity decreased but dyspnea severity increased in patients treated with ICIs (k = 14, n = 3,243–3,499) (Ps < 0.001). Insomnia severity was higher in patients treated with ICIs than non-ICI regimens (k = 11, n = 4,791) (P < .001). Conclusions This study is among the first to quantitatively summarize QOL in patients treated with ICIs. Findings suggest ICI recipients report no change in global QOL and higher QOL than patients treated with non-ICI regimens.

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