Prospective Longitudinal Assessment of Quality of Life after Stereotactic Ablative Radiotherapy for Oligometastases: Analysis of the Population-Based SABR-5 Phase II Trial

Abstract

To evaluate longitudinal patient-reported quality of life (QoL) in patients treated with stereotactic ablative radiotherapy (SABR) for oligometastases. The SABR-5 trial was a population-based single-arm phase II study of SABR to up to 5 sites of oligometastases, conducted in 6 regional cancer centers in British Columbia from 2016 to 2020. Prospective QoL was measured using treatment site-specific QoL questionnaires at pre-treatment baseline and 3, 6, 9, 12, 15, 18, 21, 24, 30, and 36 months after treatment. Patients with bone metastases were assessed with the Brief Pain Inventory (BPI). Patients with liver, adrenal, and abdominopelvic lymph node metastases were assessed with the Functional Assessment of Chronic Illness Therapy-Abdominal Discomfort (FACIT-AD). Patients with lung and intrathoracic lymph node metastases were assessed with the Prospective Outcomes and Support Initiative (POSI) lung questionnaire. The two one-sided test procedure was used to assess equivalence between the worst QoL score and baseline score of individual patients. Mean QoL at all time points was used to determine the trajectory of QoL response after SABR. The proportion of patients with "stable," "improved," or "worsened" QoL was determined for all time points based on standard minimal clinically important differences (MCID; BPI worst pain = 2, BPI Functional Interference Score [FIS] = 0.5, FACIT-AD Trial Outcome Index [TOI] = 8, POSI = 3). All enrolled patients with baseline QoL assessment and at least 1 follow-up assessment were analyzed (n = 135). On equivalence testing, patients' worst QoL scores were clinically different from baseline scores and met MCID (BPI worst pain mean difference: 1.8, 90% CI [1.19 to 2.42]; BPI FIS mean difference: 1.68, 90% CI [1.15 to 2.21]; FACIT-AD TOI mean difference: -8.76, 90% CI [-11.29 to -6.24]; POSI mean difference: -4.61, 90% CI [-6.09 to -3.14]). However, the mean FIS transiently worsened at 9, 18 and 21 months but eventually returned to stable levels. The mean FACIT and POSI scores also worsened at 36 months, albeit with a limited number of responses (n = 4 and 8, respectively). The majority of patients reported stable QoL at all time points (range: BPI worst pain 71-82%, BPI FIS 45-78%, FACIT-AD TOI 50-100%, POSI 25-73%). Clinically significant stability, worsening, and improvement were seen in 70%/13%/18% of patients at 3 months, 53%/28%/19% at 18 months and 63%/25%/13% at 36 months. SABR in the oligometastatic setting can lead to transient decreases in QoL. However, most patients experienced stable QoL relative to pre-treatment levels on long-term follow-up. Further studies are needed to characterize patients at greatest risk for decreased QoL.