Purpose Neutropenic diet (ND) has historically been recommended to reduce infectious complications in patients with cancer. Although its use has declined over the past decade, recent studies, particularly in patients undergoing hematopoietic stem-cell transplantation (HSCT), have renewed concern regarding the safety of a liberalized diet (LD). We performed a meta-analysis of studies comparing ND with LD in patients with cancer. Methods We searched MEDLINE, Embase, and Cochrane databases from inception through January 2026. Comparative studies evaluating ND versus LD in adults or children with cancer were included. Primary outcomes were major infections and bacteremia/fungemia; secondary outcomes were pneumonia, diarrhea, and mortality. Random-effects meta-analyses were performed to calculate pooled relative risks (RRs) with 95% CIs. Results Fifteen studies including 4,320 patients met criteria for analysis. ND was not associated with significant differences in major infections (RR, 1.02 [95% CI, 0.88 to 1.18]; P = .795), bacteremia/fungemia (RR, 0.97 [95% CI, 0.78 to 1.22]; P = .805), pneumonia (RR, 0.98 [95% CI, 0.59 to 1.63]; P = .933), diarrhea (RR, 1.12 [95% CI, 0.96 to 1.31]; P = .159), or mortality (RR, 0.94 [95% CI, 0.77 to 1.15]; P = .632). Sensitivity analyses restricted to randomized controlled trials (RCTs) were consistent. In hematologic malignancy/HSCT studies (9 studies; 1,769 patients), no differences were observed across outcomes. In RCTs limited to these patients (6 studies; 855 patients), ND was associated with lower bacteremia/fungemia risk (RR, 0.67 [95% CI, 0.47 to 0.95]; P = .023), with no differences in other outcomes. Conclusion ND was not associated with reductions in major infections, pneumonia, diarrhea, or mortality compared with LD. These findings do not support routine implementation of ND for patients with short-term neutropenia or lower-risk cancer populations although selected high-risk patients, particularly those undergoing HSCT or experiencing prolonged neutropenia related to hematologic malignancies, may still warrant cautious dietary practices.
PURPOSE Participation in clinical trials imposes additional time commitments beyond routine care; however, trial-associated time toxicity (TT) remains underinvestigated and poorly characterized. The purpose of this study was to develop a scalable, procedure-based metric to quantify total time required for trial participation using the protocol schedule of events. We applied this framework to lung cancer clinical trials to estimate trial-associated burden and explore changes in TT over time. MATERIALS AND METHODS Protocols for clinical trials associated with United States (US) Food and Drug Administration (FDA) approvals of oral lung cancer therapies were obtained from public sources. Using each protocol's schedule of events, study-mandated procedures were assigned time toxicity units (TTUs) based on standardized time estimates. TTUs for each procedure were multiplied by their frequency and summed for screening through cycle 5 to determine a trial's total time toxicity (TTT). Days with health care contact (DHC) were summed over the same period to determine total DHC (TDHC). Median (m) TTT and TDHC were compared between studies published in 2005-2014 and 2015-2024 to assess temporal trends. Two-sample Mann-Whitney U tests were used for nonparametric comparisons. RESULTS Thirty-two phase-specific protocols from trials published between 2005 and 2024 were included. Among studies published in 2005-2014 (n = 7), the median TTT (mTTT) was 63.8 (41.8-109.3) versus 82 (50.3-139.5) in 2015-2024 (n = 25) ( P = .042). Corresponding median TDHC values were 14 (10-21) versus 15 (11-44), respectively ( P = .16). CONCLUSION More contemporary studies demonstrated higher TTT, with significantly greater mTTT observed in studies published in 2015-2024 versus 2005-2014. TDHC demonstrated less sensitivity in capturing differences in time burden. These findings demonstrate the feasibility and practical applicability of the proposed TT framework for characterizing protocol-associated time burden. Prospective validation and broader implementation may help inform patients and encourage streamlined protocol development.
PURPOSE:Oncologists struggle to know which patients are near end of life to enable timely transitions to supportive care. We developed an electronic health record-based prognostic model to identify patients with metastatic breast cancer (MBC) at high risk of near-term death. METHODS:For model development, we identified patients with MBC in CancerLinQ Discovery, 2000-2020. We randomly selected one encounter per patient, allocating encounters to training (70%) and test (30%) data sets. We evaluated candidate predictors of death within 30 and 90 days using logistic regression, including age, vital signs, laboratory values, performance status, time since last chemotherapy, and tumor phenotype. We varied the alert rate (ie, high-risk proportion) from 5% to 40% and evaluated performance for 30- and 90-day outcomes at each rate. We conducted external validation using an integrated health system database. RESULTS:We identified 9,270 patients with MBC. Significant predictors of mortality were lower sodium, albumin, or pulse oximetry; higher alkaline phosphatase, aspartate transaminase, white blood cell count, creatinine, or pulse rate; decrease in body mass; poor performance status; opioid use; and recent chemotherapy discontinuation. For 90-day mortality, in the internal test set, models had a prediction accuracy of 72%-83% and a positive predictive value of 41%-76% with an AUC of 0.81. External validation revealed an AUC of 0.68 and a Brier score of 0.321 ± 0.027. CONCLUSION:Clinical variables can predict risk of death within 30 and 90 days for patients with MBC. Further validation and optimization studies are required to maximize clinical utility and acceptability before implementation.
