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- Title
Patient-Reported Adverse Events and Early Treatment Discontinuation Among Patients With Multiple Myeloma.
- Authors
Peipert, John Devin; Zhao, Fengmin; Lee, Ju-Whei; Shen, Shu-en; Ip, Edward; O'Connell, Nathaniel; Carlos, Ruth C.; Graham, Noah; Smith, Mary Lou; Gareen, Ilana F.; Raper, Pamela J.; Weiss, Matthias; Kumar, Shaji K.; Rajkumar, S. Vincent; Cella, David; Gray, Robert; Wagner, Lynne I.
- Abstract
This secondary analysis of the ECOG-ACRIN E1A11 trial analyzes the association of patient-reported adverse effects with early treatment discontinuation in patients with multiple myeloma. Key Points: Question: Are direct reports from patients about their treatment's adverse effects associated with early treatment discontinuation? Findings: In this survey study with 1058 participants in the ECOG-ACRIN E1A11 trial, with newly diagnosed multiple myeloma, when captured during treatment, a single question from the Functional Assessment of Cancer Therapy ("I am bothered by side effects of treatment") was significantly associated with subsequent discontinuation of treatment due to adverse events. Meaning: These findings suggest that brief, single-question assessments accurately reflect patients' ability to tolerate treatment and may be an efficient way to assess risk for treatment discontinuation due to adverse events or compare tolerability of different treatments. Importance: There is substantial interest in capturing cancer treatment tolerability from the patient's perspective using patient-reported outcomes (PROs). Objective: To examine whether a PRO question, item 5 from the Functional Assessment of Cancer Therapy-General General Physical Wellbeing Scale (GP5), was associated with early treatment discontinuation (ETD) due to adverse events. Design, Setting, and Participants: This prospective survey study was conducted from February to April 2023. Among participants in the ECOG-ACRIN E1A11 trial (a phase 3, parallel design trial conducted between 2013 and 2019), patients with newly diagnosed multiple myeloma were randomized to receive bortezomib (VRd) or carfilzomib (KRd) plus lenalidomide and dexamethasone as induction therapy. The GP5 item was administered at baseline (pretreatment) and at 1 month, 2.8 months, and 5.5 months postbaseline. Eligible participants included patients with newly diagnosed multiple myeloma treated at community oncology practices or academic medical centers in the US. Exposures: GP5 response options were "very much," "quite a bit," "somewhat," "a little bit," and "not at all." Responses at each assessment while undergoing treatment (1 month, 2.8 months, and 5.5 months) were categorized as high adverse event bother (ie, "very much," and "quite a bit") and low adverse event bother (ie, "somewhat," "a little bit," or "not at all"). In addition, change from baseline to each assessment while undergoing treatment was calculated and categorized as worsening by 1 response category and 2 or more response categories. Main Outcome and Measure: ETD due to adverse events (yes vs no) was analyzed using logistic regression adjusting for treatment group, performance status, gender, race, and disease stage. Results: Of the 1087 participants in the original trial, 1058 (mean [SD] age 64 [9] years; 531 receiving VrD [50.2%]; 527 receiving KRd [49.8%]) responded to item GP5 and were included in the secondary analysis. A small proportion (142 patients [13.4%]) discontinued treatment early due to AEs. For those with high adverse-effect bother, GP5 while undergoing treatment was associated with ETD at 1 month (adjusted odds ratio [aOR], 2.20; 95% CI, 1.25-3.89), 2.8 months (aOR, 3.41; 95% CI, 2.01-5.80), and 5.5 months (aOR, 4.66; 95% CI, 1.69-12.83). Worsening by 2 or more response categories on the GP5 was associated with ETD at 2.8 months (aOR, 3.02; 95% CI, 1.64-5.54) and 5.5 months (aOR, 5.49; 95% CI, 1.45-20.76). Conclusions and Relevance: In this survey study of the E1A11 trial, worse GP5 response was associated with ETD. These findings suggest that simple assessment of adverse-effect bother while receiving treatment is an efficient way to indicate treatment tolerability and ETD risk.
- Subjects
MULTIPLE myeloma; RESEARCH funding; TERMINATION of treatment; DESCRIPTIVE statistics; HEALTH outcome assessment; ADVERSE health care events; DATA analysis software
- Publication
JAMA Network Open, 2024, Vol 7, Issue 3, pe243854
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.3854