Quality of life and pain-response after stereotactic ablative radiotherapy of oligometastatic bone metastases in the phase 2 BONY-M trial.

PURPOSE: The Bony-M phase 2 multicentre trial included patients with oligometastatic disease (OMD) for stereotactic ablative radiotherapy (SABR) of bone metastases (clinicaltrials.gov ID-no.NTC05101824). We report the secondary endpoint analyses of longitudinal health-related quality of life (HRQoL) outcomes and pain response.

METHODS

Patients with ≥ 1 bone metastasis were eligible for inclusion. Prescription doses were 37.5 or 30 Gy in three fractions. EuroQol EQ-5D-5L and numeric pain rating scale (NPRS) responses were collected at baseline and weeks 12, 24, 36, and 52 (pain also at week 2). For this analysis, patients were grouped by baseline NPRS as being either asymptomatic (NPRS 0-1) or symptomatic (NPRS ≥ 2).

RESULTS

Sixty-seven patients were analysed, including one patient without baseline NPRS. Most had prostate (33 %), breast (28 %), kidney (15 %), or lung cancer (10 %). Mean EQ-5D-5L index and visual analogue scale scores remained stable through 52 weeks of follow-up. Symptomatic patients (n = 22) reported more pain/discomfort and had a lower EQ-5D-5L index value at baseline and follow-up than asymptomatic patients (n = 44). Among symptomatic patients, overall pain response was 59 % (13/22) at 24 weeks and 41 % (9/22) at 52 weeks. Mean pain score decreased by 2.3 points (95 % CI: 1.4-3.2) at 24 weeks. Pain flare at week 2 occurred in 11 % (7/66) of patients.

CONCLUSIONS

Mean HRQoL remained stable throughout one year of follow-up, and expected pain relief was achieved for symptomatic metastases. Our findings suggest that SABR for local disease control in carefully selected patients with asymptomatic and symptomatic OMD can be used without compromising HRQoL.