Infection rates, feeding outcomes, and incidence of acute graft-versus-host disease (aGVHD) were not significantly different in patients with neutropenia after hematopoietic stem cell transplantation (HSCT) who followed a nonrestrictive diet (NRD) compared with those who followed a low microbial protective diet (PD), according to study results presented at the 2022 ASH Annual Meeting.
The multicenter, randomized, noninferiority, phase 3 Neutrodiet trial included consecutive adult patients who underwent HSCT or high-dose induction chemotherapy. Participants were randomly assigned 1:1 to follow a PD or a NRD from chemotherapy initiation through the duration of neutropenia. The scheduled follow-up was 100 days for allogeneic patients and 30 days for other patients.
The primary endpoint was the absence of significant differences in infections (grade 2 or higher based on the Common Terminology Criteria for Adverse Events 4.0) and deaths during neutropenia in the 2 groups.
A total of 247 patients were enrolled from July 2016 to March 2022, of whom 222 were randomly assigned 1:1 and included in the analysis: 111in the PD group (median age, 57 years; 41% female) and 111 in the NRD group (median age, 57 years; 45% female). The 2 treatment groups had similar clinical and demographic characteristics. Of the full cohort, 79% of patients underwent autologous HSCT and 18% underwent allogeneic HSCT.
Grade 2 or higher infections occurred in 72 patients (65%) in the PD group and in 69 patients (62%) in the NRD group (relative risk [RR], 1.0; 95% CI, 0.8-1.3; P =.8). Rates of severe infection (grade 3 or higher), fever of unknown origin, sepsis, and pneumonia were similar in the 2 groups.
At 30 days, 1 death occurred in the NRD group owing to cytokine release syndrome after ruxolitinib suspension. The patient was undergoing allogeneic HSCT for myeloproliferative neoplasm.
The rates of gastrointestinal infection also were comparable in the PD and NRD groups, with no differences in infection with abdominal recall and mucositis. The PD group trended toward increased GI infection with microbiologic isolation (9% vs 2.7% in the NRD group; RR, 3.3; 95% CI, 0.1-11; P =.08). No differences were observed in hospital length of stay.
Bacteria isolated from blood cultures were primarily from the Enterobacteriaceae family in both treatment arms. Clostridium difficile was the most common bacteria isolated in stool tests in both groups.
The NRD group had a lower body weight loss at 1 month (mean −2.7 kg vs −3.7 kg in the PD group; P =.04). No differences were observed in use and number of days of parenteral nutrition, serum albumin level, and body mass index variation between the 2 groups.
According to analysis of patients’ daily diaries, 35% of participants in the NRD group reported that “diet prescriptions don’t negatively impact my alimentation” compared with 16% of those in the PD group (RR, 0.5; 95% CI, 0.3-0.8; P =.006).
The incidence of grade 3 or higher aGVHD was 20% in the PD group and 9.5% in the NRD group (RR, 2.1; 95% CI, 0.5-9.1; P =.4).
“These results, together with data published in settings other than posttransplantation, demonstrate that the use of a restrictive diet is an unnecessary burden for patients’ quality of life,” stated the researchers.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Stella F, Marasco V, Levati GV, et al. Non-restrictive diet does not increase infections in patients with neutropenia after stem cell transplantation: final analysis of the Neutrodiet multicenter, randomized trial. Presented at ASH 2022. December 10-13, 2022. Abstract 169.