Quality of life after ablative 5-fraction radiation therapy from the phase II SMART pancreas trial

Document Type

Conference Proceeding

Publication Date


Publication Title

Radiother Oncol


Purpose or Objective Prospective trials have demonstrated that patient-reported quality of life (QoL) does not significantly change after non-ablative pancreas stereotactic body radiation therapy (SBRT). However, QoL outcomes after ablative SBRT are unknown. Acute grade 3+ toxicity from the phase II SMART pancreas trial (NCT03621644) for borderline resectable (BRPC) and locally advanced pancreas cancer (LAPC) was uncommon, as previously reported. We present QoL outcomes from the SMART pancreas trial, which were assessed as a secondary endpoint. Materials and Methods 136 patients completed study therapy. Eligibility criteria included adenocarcinoma or adenosquamous histology, absence of distant metastatic disease on re-staging after completing 3+ months of induction chemotherapy, CA19-9 <500 U/mL, and no prior pancreas surgery. The prescription dose was 50 Gy in 5 fractions (BED10=100 Gy). SMART was delivered on a 0.35T MR-guided device with intrafraction cine-MRI, soft tissue tracking, and automatic beam gating. On-table adaptive replanning using an isotoxicity approach was performed prior to each fraction as needed. Surgery was performed in 39 patients (28.7%) within 90 days of SMART. QoL assessments using the NCCN-FACT FHSI-18 survey instrument were acquired at 3 time points (TP): prior to SMART (TP1), 3 months after SMART (TP2), and 12 months after SMART (TP3). Median follow-up after SMART was 8.8 months and therefore evaluation of QoL in this analysis was limited to TP1 and TP2. Results QoL assessment was completed at TP1 and TP2 by 133 (97.8%) and 106 (77.9%) patients, respectively. There was no difference in mean total FACT FHSI-18 scores at TP1 vs. TP2 (25.1 vs. 25.2; p=0.629). No significant differences were observed in mean subscale scores: physical (13.6 vs. 14.1; p=0.535), emotional (2.5 vs. 2.5; p=0.449), treatment side effects (1.5 vs. 1.2; p=0.071), or function/well-being (7.5 vs. 7.4; p=0.408). Mean scores for the 18 individual survey questions were not significantly different over time except for an increase in pain (0.8 vs. 1.1; p=0.002) and discomfort in the stomach area (1.0 vs. 1.3; p=0.013). No significant increase in mean pain score was noted among unresected patients (1.0 vs. 1.1; p=0.076) in contrast to resected patients (0.4 vs. 1.0; p=0.003). Likewise, no significant increase in mean score related to discomfort in the stomach area was observed among unresected patients (1.2 vs. 1.4; p=0.297) in contrast to resected patients (0.4 vs. 1.2; p<0.001). Conclusion This is the first analysis of prospectively evaluated patient-reported QoL outcomes following 5-fraction SMART for BRPC/LAPC. Despite the ablative prescription dose, we observed no significant overall QoL change within the first 3 months after SMART for unresected patients. Additional follow-up is planned to evaluate long-term QoL within 12 months after SMART.



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