A post hoc analysis of data from the CheckMate 274 trial has shown how health-related quality of life (HRQoL) is adversely affected by disease recurrence after radical surgery in patients with high-risk muscle-invasive urothelial carcinoma (MIUC). They also show how this effect can be ameliorated by treatments that delay recurrence. The new data were presented as a poster by trial investigators led by Matthew D. Galsky, MD (Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York).
Patients who have undergone radical surgery for MIUC are at high risk of recurrence and often have impaired HRQoL, the investigators observed. In CheckMate 247, an international phase 3 trial, adjuvant nivolumab monotherapy was found to significantly improve disease-free survival vs placebo in adult MIUC patients who had had radical surgery of the bladder or upper urinary tract ≥120 days previously. No deterioration in HRQoL was seen in patients who received nivolumab compared with those who received a placebo.
As an exploratory endpoint in Checkmate 274, HRQoL was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol Group 5-Dimension 3-Level questionnaire (EQ-5D-3L). Patients completed these questionnaires at baseline and every 4-6 weeks during the first 6 months of study treatment, then every 6 weeks until discontinuation of study treatment, and again 35 and 115 days after the last dose. Confirmed deterioration in HRQoL was defined as “worsening above an a priori points threshold of 10 points for the EORTC QLQ-C30 domains and 7 points for the EQ-5D Visual Analog scale [EQ-VAS] on ≥2 consecutive visits.”
Among the 645 evaluable patients (mean age 66 years, 76% male, 75% white) who completed the EORTC QLQ- C30, 210 had recurrence, 74 (11%) with local recurrence only and 136 (21%) with distant recurrence with or without local recurrence. Among these patients, as well as 648 patients who completed the EQ-5D-3L, there was a significantly higher risk of confirmed deterioration in HRQoL associated with recurrence compared with patients with no recurrence, although for EORTC QLQ- C30 patients with local recurrence only, this difference was significant only for global health status/QoL. Patients with distant recurrence were consistently at significantly higher risk than those with local recurrence.
Dr. Galsky and his colleagues concluded that treatments that delay recurrence, such as nivolumab monotherapy as administered in CheckMate 274, may also prevent or delay deterioration in HRQoL.
This study was supported by Bristol Myers Squibb. See original ASCO abstract for disclosures.
Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384(22):2102-2114. DOI: 10.1056/NEJMoa2034442.
Galsky MD, Witjes JA, Gschwend J, et al. Impact of recurrence on health-related quality of life in patients at high risk of recurrence after radical surgery for muscle-invasive urothelial carcinoma (MIUC): Results from the phase 3 CheckMate 274 trial. J Clin Oncol. 2021;39(15 Suppl):Abstract 4540. DOI:10.1200/jco.2021.39.15_suppl.4540