Home parenteral nutrition (HPN) using individually compounded PN administered via multi-chamber Eurotubes versus PN administered via 2/3-chamber bags in patients with metastatic or localized solid tumors requiring HPN: The randomized IKF-010 PEKANNUSS trial of AIO.
Authors: Al-Batran Salah-Eddin , Roetzer Ingeborg , Wohn Luisa , Blau Wolfgang , Zander Thomas , Luley Kim Barbara , Ivanyi Philipp , Hofheinz Ralf-Dieter , Groschek Matthias , Kreiss-Sender Janine , Baur Christina , Wolff Thomas , Wenning Barbara , Decker-Baumann Christiane , Bouymayan Selma , Sookthai Disorn , Schaaf Marina , Riedel Johanna , Goetze Thorsten Oliver , Haag Georg Martin 
Published: June 2023

e24123

Background: Cancer patients (pts) often experience malnutrition and some of them require HPN. However, HPN is associated with challenges, including the need for nursing service to prepare PN bags and add supplements, severely limiting patient autonomy and flexibility. Moreover, HPN is a major risk factor for catheter-related infections (CRI). Eurotubes is a 7/8/9-multi-chamber system that offers fully individualized PN compounding without need for further line or bag manipulation outside GMP environment. This study evaluates whether HPN via Eurotubes improves patient autonomy compared with HPN via traditional 2/3-chamber bags. Methods: This is a randomized, multicenter, investigator-initiated, phase IV trial. Pts with metastatic/locally advanced tumors and need for HPN were stratified according to ECOG PS, the modified Glasgow Prognostic Score (mGPS) and concurrent systemic treatment and randomized 2:1 to receive HPN via Eurotubes (Arm A) or HPN via 2/3-chamber bags (Arm B). Primary endpoint was patient autonomy defined as the proportion of pts with ≥70% of HPN administrations done without nursing service assistance (self-administration or with help of relatives) as provided in pts diaries in the intent to treat population (ITT). A total of 192 pts were required to show a significant improvement in proportions of pt autonomy from 5 to 20% (80% power; 2-sided α < .05 [Fisher’s exact]). Secondary endpoints included CRI, safety, body weight and serum albumin. Results: Study was terminated for slow recruitment after enrollment of 142 pts of which 131 pts qualified for ITT. Baseline criteria were well balanced regarding ECOG PS, body weight, albumin, mGPS, and nutritional risk score, but more pts in Arm A had metastatic disease (78% vs 61%). In median, pts received HPN for 48 days (1 - 320 days) and median cumulative macronutrients of glucose, 3805g; amino acids, 2100g; and lipids, 2250g. Injections of additional supplements into PN bag at home were required in 11% v 96% of pts for Arm A vs B (p < .01). The primary endpoint was met, with patient autonomy being 52% vs 33% in Arm A vs B (p = .04) and the difference was more pronounced in pts with ECOG PS ≤1 (68% vs 42%). Relative changes in body weight and serum albumin favored the Arm A until visit 5. All grade adverse events related to HPN were lower in Arm A (27% vs 55%; p < .01) as were CRI rates (13% vs 22%; p = .22). Device deficiency (8% vs 7%) and PN related death (1% vs 2%), and median overall survival (6.6 vs 6.8 months) were similar. Conclusions: Eurotubes significantly improved patient autonomy, compared with 2/3-chamber bags and were associated with significantly less HPN-related adverse events. HPN via Eurotubes represents a treatment option that is safe and renders pts more able to self-manage their treatment. Clinical trial information: NCT04105777 .