S241: NON-RESTRICTIVE DIET DOES NOT INCREASE GASTROINTESTINAL INFECTIONS AND FEBRILE NEUTROPENIA IN PATIENTS WITH NEUTROPENIA AFTER STEM CELL TRANSPLANTATION: DATA FROM A MULTICENTRE, RANDOMIZED TRIAL

Abstract

Background: Infections represent a major cause of morbidity and mortality during neutropenia, especially after hematopoietic stem cell transplantation (HSCT). Multiple preventive measures, including low microbial diet, have been adopted to reduce these complications. However, the effect of a protective diet (PD) in this setting has never been explored prospectively and evidence-based results lack. Conversely, there is evidence that PD could negatively affect the quality of life and that a prolonged fasting duration can increase the incidence of acute gastrointestinal graft-versus-host disease (aGVHD) in allo-HSCT recipients. Aims: To prospectively compare infection and aGVHD rates in patients receiving a non-restrictive diet (NRD) compared to PD after HSCT. Methods: Since July 2016 we conducted a multicentre randomized interventional study comparing the use of a PD (Arm A) vs NRD (Arm B) in hematological patients aged≥18 years hospitalized to receive autologous or allogenic HSCT. Stratification for allo-HSCT patients was planned. Patients received the assigned diet during the entire period of neutropenia. For PD, foods cooked >80°C and/or thick peel fruit were considered diet-specific. For the NRD, raw fruit and vegetables (adherent to hospital hygiene standards) were considered diet-specific. The primary objective was to demonstrate the lack of significant differences in incidence of infections grade >2 (according to CTCAE 4.0) and deaths during neutropenia between the two arms. Secondary endpoints included assessment of gastrointestinal infections and fever of undetermined origin (FUO), change in body weight, length of hospitalization, overall survival estimated at 30 days and cumulative incidence of aGVHD within 100 days after allo-HSCT. Results: Overall, 162 patients were analyzed at interim analysis, 80 patients in PD group and 82 in NRD group. The two arms were well balanced in terms of: sex, age, disease type, number of previous therapeutic lines, disease status at enrollment, antimicrobial prophylaxis, and reason for hospital admission. Moreover, 32 patients received an allo-HSCT, 17 in the PD and 15 in the NRD group respectively. Detailed patients’ characteristics are summarized in Table 1. We did not observe a significant difference in terms of infections in the two randomized arms; infections grade >2 or death were reported in 35 (43.7%) patients in arm A and in 34 (41.5%) patients in arm B [relative risk RR=1.05, confidence interval (CI)95%=0.76-1.4]. The number of patients developing gastrointestinal infections and FUO during hospitalization was 8 (10%) vs 8 (9.8%) [RR=1.01, CI95%=0.57-1.53] and 32 (40%) vs 28 (34.1%) [RR=1.13, CI95%=0.82-1.54] in arm A and arm B, respectively. No differences in weight variations from admission to discharge were observed comparing arm A and arm B (mean 4.15kg vs 3.66kg, p=0.3). Average hospitalization length in the two arms was respectively 20.6 vs 21.5 days (p=0.4). No deaths were reported at day+30. For 32 allo-HSCT recipients, aGVHD grade ≥2 incidence at day +100 was 5% vs 1.2% in arm A and arm B, respectively (RR 1.65, CI95%=0.77-2.19). Image:Summary/Conclusion: Results of this multicentre prospective trial show similar rate of infections and deaths between patients receiving a PD versus a NRD during neutropenia after HSCT. These data suggest that the use of NRD could be considered for transplanted patients without risks of more infective events.