Abstract

Simple SummaryImmune 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 patients participating in the GO2 Foundation’s Lung Cancer Registry who reported receiving atezolizumab, durvalumab, nivolumab, or pembrolizumab. Internationally, 226 patients (mean age 61, 75% female) participated. Patients reported worse quality of life 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.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.

Highlights

  • Immune checkpoint inhibitors (ICIs) have generated widespread excitement for their ability to significantly prolong survival in cancers with poor prognoses

  • The current study demonstrated the feasibility and acceptability of a registry-based approach, with 226 patients recruited in 24 months and 87% of patients who started the survey completing it

  • Participants were: (1) age 18 or older, (2) diagnosed with lung cancer or a caregiver to a person diagnosed with lung cancer, (3) treated with or a caregiver to a patient treated with an immune checkpoint inhibitor (i.e., PD-1 or PD-L1), (4) enrolled or eligible to be enrolled in the Lung Cancer Registry, and (5) able to speak and read English

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Summary

Introduction

Immune checkpoint inhibitors (ICIs) have generated widespread excitement for their ability to significantly prolong survival in cancers with poor prognoses. Non-small-cell lung cancer (NSCLC) has emerged as a target of immune-based therapies, with some patients with advanced NSCLC experiencing durable remissions and prolonged survival [1,2]. The success of ICIs in slowing disease progression comes with the cost of toxicity, . All checkpoint inhibitors can potentially induce immune-related toxicities in any organ system. Immune-related toxicities occur in up to 70% of patients treated with PD1/PD-L1 antibodies [3,4]. Up to 16% of patients experience grade 3 or higher toxicities [3,4]

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