ASCO 2021: Impact of Recurrence On Health-Related Quality of Life In Patients at High Risk of Recurrence After Radical Surgery For Muscle-Invasive Urothelial Carcinoma: Results From the Phase 3 CheckMate 274 Trial

(UroToday.com) Patients undergoing radical surgery for muscle-invasive urothelial carcinoma face a high risk of disease recurrence. Recurrence is associated with worse survival, but its effect on health-related quality of life (HRQoL) is unclear. In the ongoing phase 3 CheckMate 274 trial, adjuvant nivolumab monotherapy significantly improved disease-free survival in patients with muscle-invasive urothelial carcinoma who had undergone radical resection surgery. At the 2021 America Society of Clinical Oncology (ASCO) virtual annual meeting, Dr. Matt Galsky and colleagues presented results of a post hoc analysis assessing the impact of recurrence on HRQoL using data from the phase 3 CheckMate 274 trial.

In CheckMate 274, patients who had undergone radical surgery for high-risk muscle-invasive urothelial carcinoma (≤ 120 days previously) were randomized 1:1 to nivolumab 240 mg Q2W or placebo for ≤ 1 year. HRQoL was assessed using the EORTC QLQ-C30 and EQ-5D-3L every 4–6 weeks during treatment, at 35 and 115 days after the last dose of treatment, and every 3 months thereafter until the end of the study (EQ-5D-3L only). The analysis included patients with a valid HRQoL assessment at baseline and at ≥1 post-baseline visits. Confirmed deterioration in HRQoL was defined as worsening exceeding an a priori points threshold (± 10 for the EORTC QLQ-C30 domains, –7 for the EQ-5D visual analog scale [VAS]) at ≥ 2 consecutive visits. Recurrence was classified as local only or distant (with or without local recurrence). The effect of recurrence on HRQoL deterioration was assessed by Cox proportional hazards regression with recurrence as a time-dependent covariate. The models controlled for treatment arm and baseline HRQoL score, and were stratified by PD-L1 expression, pathologic nodal status, and use of neoadjuvant cisplatin-based chemotherapy.

The analysis included 645 patients for EORTC QLQ-C30, of whom 74 (11%) had local recurrence only and 136 (21%) had distant recurrence during the HRQoL assessment period. Mean EQ-VAS score at baseline (73.9) was worse than the score in the general population by 6.8 points (less than the prespecified 7-point difference that defined inferiority):

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For all HRQoL outcomes, patients with recurrence had a significantly higher risk of confirmed deterioration than patients without recurrence. Overall, hazard ratios were consistently greater for distance recurrence than for local recurrence only:

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For local recurrence only, a higher risk of confirmed deterioration of HRQoL compared to no recurrence was only observed for EORTC QLQ-C30 global health status/QoL:

Dr. Galsky concluded this presentation of HRQoL based on the CheckMate 274 trial data with the following concluding remarks:

  • Recurrence, particularly distant recurrence, had a significant, negative impact on HRQoL
  • This suggests that treatment delaying recurrence after radical surgery for high-risk muscle-invasive urothelial carcinoma may prevent or delay HRQoL deterioration in these patients

Clinical trial information: NCT02632409

Presented by: Matt D. Galsky, Division of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY

Co-Authors: Johannes Alfred Witjes, Jürgen Gschwend, Julia Braverman, Edward Broughton, Federico Nasroulah, Hasan Alhasani, Mario Maira-Arce, Xiaomei Ye, Ling Shi, Melissa Hamilton, Dean F. Bajorin; Department of Urology, Radboud University, Nijmegen, Netherlands; Department of Urology, Technical University of Munich, Munich, Germany; Bristol Myers Squibb, Princeton, NJ; Bristol-Myers Squibb, Princeton, NJ; Evidera, Waltham, MA; Genitourinary Medical Oncology Service, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, New York, NY

Written by: Zachary Klaassen, MD, MSc, Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia Twitter: @zklaassen_md at the 2021 America Society of Clinical Oncology (ASCO) Annual Meeting, Virtual Annual Meeting #ASCO21, June, 4-8, 2021 

 

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