Patient reported outcomes (PRO) during and after multimodal treatment for resectable esophageal adenocarcinoma in the prospective, randomized, controlled, multicenter phase III ESOPEC trial.

105 Background: The ESOPEC trial showed that perioperative chemotherapy improved survival compared with preoperative chemoradiotherapy in pts with esophageal adenocarcinoma (EAC). Here we report on PRO which was a key secondary endpoint. Methods: Pts with cT1 cN+ cM0 or cT2-4a cNany cM0 EAC were randomized between perioperative chemotherapy with FLOT (5-FU/leucovorin/oxaliplatin/docetaxel) or preoperative chemoradiotherapy with CROSS (41.4Gy/carboplatin/paclitaxel) both plus tumor resection. PRO was measured using the EORTC Quality of Life Questionnaire Core 30 (C30), Oesophageal Cancer Module (OES18) and Chemotherapy-Induced Peripheral Neuropathy Module (CIPN20) at baseline and during treatment and follow-up. The global health status / QOL (GH; C30), physical functioning (PF; C30), fatigue (FA; C30), dyspnoea (DY; C30), eating problems (EP; OES18), and sensory scale (SS; CIPN20) were chosen as primary outcomes. Predefined time points for comparison of PRO between treatment groups were directly before surgery, after discharge from surgery, and 6, 12, 24, and 36 months after start of treatment. Analyses were performed with mixed linear models for repeated measurements. Results: Of 438 randomized patients, 401 (197 FLOT, 204 CROSS) were included in the PRO analysis. Differences between The FLOT and CROSS groups are shown in the table. Before, surgery, GH and PF were higher in the FLOT group, while FA, DY, and EP were less pronounced in the FLOT as compared to CROSS group. At discharge from surgery and at follow-up, no significant differences in GH, PF, FA, DY, and EP were measured. Results in SS were worse in FLOT as compared to CROSS at all timepoints. Conclusions: Patients treated with FLOT as compared to CROSS reported better PRO results following neoadjuvant therapy and before surgery. In contrast, sensory problems were higher in FLOT versus CROSS over the whole treatment trajectory and follow-up. Clinical trial information: NCT02509286 . Adjusted mean difference in points (FLOT minus CROSS)with 95%-CI and two-sided p-value Preoperatively Discharge 6 months 36 months Global health status / QOL* 6.3 (1.1,11.5)p=0.019 0.6 (-4.9,6.1)p=0.83 -4.3 (-9.6,1.0)p=0.11 2.7 (-3.4,8.8)p=0.38 Physical functioning* 7.7 (3.1,12.4)p=0.001 5.3 (-0.6,11.1)p=0.076 -3.1 (-9.0,2.7)p=0.29 2.8 (-3.5,9.1)p=0.39 Fatigue** -8.6 (-14.2,-3.0)p=0.003 -2.7 (-9.1,3.7)p=0.41 5.2 (-1.5,11.8)p=0.13 -4.8 (-12.3,2.6)p=0.20 Dyspnoea** -10.9 (-17.1,-4.7)p<0.001 -1.8 (-10.5,6.8)p=0.68 1.5 (-7.5,10.4)p=0.75 0.7 (-8.9,10.2)p=0.89 Eating problems** -12.7 (-18.9,-6.4)p<0.001 -2.9 (-10.1,4.3)p=0.43 -0.0 (-7.3,7.3)p=1.00 -5.3 (-13.5,3.0)p=0.21 Sensory scale** 14.8 (11.6,18.0)p<0.001 4.8 (1.7,8.0)p=0.003 14.6 (10.7,18.5)p<0.001 7.1 (1.1,13.0)p=0.020 *Higher scores indicate better QOL/function. **Higher scores indicate more symptoms.