Outcomes
PD, tumor
TUMOR, RECURRENCE, RESIDUAL TUMOR, DISEASE, RECURRENT DISEASE, SECONDARY
A secondary endpoint in the RAPIDO trial and the primary endpoint in this study was LRF, including eLRF and LRR. eLRF was defined as patients having no surgery/nonresectional surgery unless this was in an organ preservation setting or R2 resection. Patients who were lost to follow-up, withdrew informed consent, or died before surgery were excluded from analyses.An LRR was defined as a locoregionally recurrent disease after a previous R0 or R1 resection. When watch-and-wait (W&W) patients with tumor regrowth underwent a curative resection, this was not scored as LRR. However, any subsequent local recurrence after a radical resection in W&W patients was considered as an LRR. Patients refusing surgery were grouped with those entering the W&W strategy, as the predominant reason for refusal was no residual tumor. The 2 patients who were not operated up-front and much later had locally progressive disease were scored as LRR (Fig. Consort diagram. Patients entering a W&W program or who “refused surgery” according to the case record forms were grouped together since the predominant reason for the refusers was no remaining tumor/no need for surgery. These patients were included in the LRR analysis. The 2 patients who initially entered a W&W strategy/refused surgery but later developed regrowth without having surgery were scored as LRR. When W&W patients with tumor regrowth underwent a curative resection, this was not scored as LRR. However, when regrowth was subsequent to a radical resection in W&W patients, this was scored as LRR. F-UP indicates follow-up; IC, informed consent; PD progressive disease.