1517P - Patient-related outcomes (PROs) after early palliative care (PC) (EPC) compared with standard oncologic care (SOC) for patients (pts) with metastatic upper gastrointestinal cancers (mUGIC): Results of the randomised EPIC trial

Background

Beyond the report of an improvement in quality of life with EPC in pts with lung cancers, Temel et al. (NEJM 2010) also claimed for a survival benefit observed as a secondary endpoint. This prompted us to address the overall survival (OS) benefit of EPC within the EPIC trial dedicated to mUGIC pts.

Methods

EPIC is a randomised (1:1), open-label, phase III trial aimed to estimate OS of EPC compared to SOC for ECOG-PS ≤ 2 pts with mUGIC. Other objectives were PROs (quality of life [QoL, EORTC QLQ-C30], time until definitive deterioration [TUDD] of QoL, depression and anxiety scores [HADS], number of pts receiving chemotherapy in their last 30 days of life, and the presence or absence of advanced directives in pt files. With the following hypotheses: 1- year OS (40% vs. 50.3%, HR=0.75), 2-sided alpha=5%, beta=20%, 381 deaths were required, leading to include 480 pts. Pts were stratified according to centre, ECOG-PS (0-1 vs. 2) and tumor location.

Results

Modified Intent To Treat population was 470 pts, from the 473 pts randomized from 10/2016 to 12/2021 in 19 French centers. Main pts characteristics were: median age= 67.5; 273/470 males; tumour site: oesophagus 39, HER2-negative esogastric 48, pancreas 297, biliary tree 86; ECOG-PS 0/1/2: 104/278/88. The mean number of PC visits was 4.7 and 0.6 in the EPC and SOC group, respectively. Median follow-up was 46m. OS data has already been reported at ASCO-2023. Overall, all dimensions of QoL remained stable along the study course, without any difference between arms. TUDD analysis did not show any difference between treatment arms for any of the QoL dimensions. Anxiety and depressions scores varied over time similarly in both arms. Respectively in EPC and SOC arms, 33% and 28% pts received chemotherapy in their last month of life; 17% and 11% had advanced directive written.

Conclusions

EPC did not improve QoL, anxiety and depression scores versus SOC in mUGIC pts. Whether these unexpected findings are related to our study population, to our study design (including content or number of EPC we provided), or to real facts remains to be determined.

Clinical trial identification

NCT02853474.

Editorial acknowledgement

Legal entity responsible for the study

Centre Oscar Lambret.

Funding

Ligue contre le cancer, France; Région Nord-Pas de Calais, France; National Cancer Institute, France.

Disclosure

All authors have declared no conflicts of interest.