An Evidence-Based Determination of Issues Affecting Quality of Life and Patient-Reported Outcomes in Lung Cancer: Results of a Survey of 660 Patients

PURPOSE Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) demonstrated survival benefit versus bevacizumab, carboplatin, and paclitaxel (BCP) in chemotherapy-naïve nonsquamous non–small-cell lung cancer (NSCLC). We present safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in nonsquamous NSCLC. METHODS Patients were randomly assigned to receive atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP. Coprimary end points were overall survival and investigator-assessed progression-free survival. The incidence, nature, and severity of adverse events (AEs) were assessed. PROs, a secondary end point, were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13. RESULTS Overall, 400 (ACP), 393 (ABCP), and 394 (BCP) patients were safety evaluable (ie, intention-to-treat population that received one or more doses of any study treatment). More patients had grade 3/4 treatment-related AEs during the induction versus maintenance phase (ACP, 40.5% v 8.2%; ABCP, 48.6% v 21.2%; BCP, 44.7% v 11.1%). During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively. During maintenance, SAE incidences were 20.0%, 26.3%, and 13.0%, respectively. Completion rates of the PRO questionnaires were > 88% at baseline and remained ≥ 70% throughout most study visits. Across arms, patients on average reported no clinically meaningful worsening of global health status or physical functioning scores through cycle 13. Patients across arms rated common symptoms with chemotherapy and immunotherapy similarly. CONCLUSION ABCP seems tolerable and manageable versus ACP and BCP in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. PROs reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen.

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Cancer anorexia-cachexia syndrome in advanced lung cancer: An exploratory analysis of patient-reported outcomes data.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e17521 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e17521-e17521

Author(s):

Ryan David Nipp ◽

Susan C. Locke ◽

Gregory Samsa ◽

Arif Kamal ◽

Amy Pickar Abernethy ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Weight Loss ◽

Patient Reported Outcomes ◽

Advanced Lung Cancer ◽

Small Cell Lung ◽

Patient Reported ◽

Cancer Anorexia ◽

Cachexia Syndrome

e17521 Background: The cancer anorexia-cachexia syndrome (CACS) is a debilitating syndrome of involuntary weight loss, anorexia, declining function, muscle catabolism, and inflammation. It affects many patients with cancer, especially those with advanced disease. We aimed to describe the experience of a group of patients with advanced lung cancer who meet published weight-based criteria for CACS. Methods: Tablet computers were used to collect patient-reported outcomes data from 97 patients with advanced non-small cell lung cancer, using the Patient Care Monitor v2.0 and the FACIT family of questionnaires. 25 patients met published weight criteria for CACS (>=5% weight loss in the past 6 months). 51 patients with stable weights were used as a comparison group; those lacking weight data were excluded. Statistical comparisons were made between these groups to explore differences in symptoms, quality of life, and survival. Results: Patients meeting weight criteria for CACS had lower serum albumins (median 3.7 vs. 3.9, p=0.006) and worse performance status by Karnofsky and ECOG (70 vs. 80, p=0.004, and 2 vs. 1, p=0.027). CACS patients had worse FAACT anorexia-cachexia subscale scores (34.5 vs. 38.5, p=0.018) but were not statistically more likely to be prescribed CACS therapies; only 17% of patients in the CACS group were on medication for this (N=4). FACIT fatigue subscale scores were not statistically different between groups, nor was quality of life by FACT-G. Grip strength and 6-minute walk distance were also not statistically different. Patients in the CACS group had a significantly shorter survival (HR 2.066 [95% CI=1.229,3.474], p=0.005). Conclusions: Patients with advanced non-small cell lung cancer who meet standard weight-based criteria for CACS have inferior survival compared to a similar population without weight loss. Though traditional descriptions of CACS presume a general impairment in quality of life, we did not find statistical differences here aside from the anorexia-cachexia subscale score of FAACT. Few patients were prescribed medication to address symptomatic anorexia/cachexia, suggesting it may be an unmet need in patients with advanced lung cancer.

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Use of a Cancer Registry to Evaluate Patient-Reported Outcomes of Immune Checkpoint Inhibitors

Cancers ◽

10.3390/cancers13010103 ◽

2020 ◽

Vol 13 (1) ◽

pp. 103

Author(s):

Heather S. L. Jim ◽

Sarah L. Eisel ◽

Aasha I. Hoogland ◽

Sandra Shaw ◽

Jennifer C. King ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Clinical Trial ◽

Adverse Events ◽

Cancer Registry ◽

Patient Reported Outcomes ◽

Immune Checkpoint Inhibitors ◽

Checkpoint Inhibitors ◽

Patient Reported

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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