Radiation dose esclation with contact X-ray brachytherapy (Papillon) and quality of life in patients with rectal cancer: Results from the phase 3 randomised trial OPERA.

Abstract

e23180 Background: Organ preservation has been increasingly offered to patients with rectal cancer as most patients wish to avoid extirpative surgery and a stoma if they have a choice. The standard of care is to offer external beam chemo radiotherapy (EBCRT) to those who are fit. OPERA (Organ Preservation in Early Rectal Adenocarcinoma) has shown improved organ preservation rate with addition of contact X-ray brachytherapy(CXB-Arm B) compared to EBCRT with EBRT boost. We evaluate whether addition od CXB boost compromise the patients Quality of Life (QOL) compared to EBRT boost and if so by how much. We report our results at 38.2 months follow up. Methods: From June 2015 to June 2020, there were 148 patients randomised of which 141 were evaluable. We used EORCT QLQ -C30, QLQ -CR29 and modified LARS score at FU visits every 3 months during FU visit 1(8 weeks)-9 (32 weeks). Results: At screening (baseline) we enrolled 126 patients (Arm A: 59, Arm B: 66). At FU -1 we received questionnaire back from 78 patients (Arm A: 35, Arm B: 43). At FU-5 there were 55 patients (Arm A:18, Arm B: 37). Finally, at FU 8 there were 43 patients (Arm A: Arm B xx). Using EORTC QOL-C30 and QOL CR-29, global QOL score for Arm A was 77.6 vs Arm B 72.22 (p = 0.14). Mean functional scale (1-5) for Arm A was 95.2 vs Arm B 92.1 (p = 0.09). Role functioning scale (6-7) for Arm A was 91.2 vs Arm B 93.18 (p = 0.57). Emotional functioning (21-24) for Arm A was 77.5 vs Arm B 73.99 (p = 0.33). Cognitive functioning (20-25) for Arm A 87.85 vs Arm B 91.92(p = 0.17). Social functioning (26-27) for Arm A 95.2 vs Arm B 92.93 (p = 0.31). Conclusions: In our analysis so far, we do not detect significant difference in QOL between Arm A and Arm B. Consider Contact x-ray brachytherapy first in patients with rectal cancer < 3cm (Arm B1) which has shown higher organ preservation rate without effecting their QOL compare to EBCRT (Arm A1). Clinical trial information: NCT02505750 .