Josie Ford

Osteoporosis and related fractures pose a costly public health challenge. Primary prevention of bone loss is largely limited to non-pharmacologic options without consistent guidelines. Prior studies have demonstrated that modification of the gut microbiome can influence bone homeostasis. The Synbiotic To Attenuate Resorption of the Skeleton (STARS) trial aimed to evaluate the efficacy, safety, and mechanistic effects of daily intake of SBD111, a fruit and vegetable-derived synbiotic medical food on the skeleton, gut microbiome, and inflammation biomarkers in women aged ≥60 years. This 18-month, investigator-initiated, single-site, randomized, double-blind, placebo-controlled trial had an enrollment goal of 220 women, a primary endpoint of proportionate change in lumbar spine bone mineral density (BMD) relative to baseline, and secondary outcomes including Quantitative Computed Tomography derived volumetric BMD and vertebral compressive strength, gut microbiome function, and bone and inflammatory biomarkers. Recruitment approaches included simultaneous digital and traditional methods beginning August 2024. As of July 2025, there were 42 enrolled participants (32 via digital, 10 via traditional); baseline demographics, eligibility, and enrollment rates were similar across recruitment strategies. Digital recruitment achieved over three times faster enrollment (2.9 vs. 0.9 enrollments/month) and was nearly 10 times more staff-efficient (0.05 vs. 0.48 cumulative weekly full-time equivalent) despite greater cost per enrollment ($548 vs. $173). These findings demonstrate the feasibility and efficiency of digital recruitment of older adults, offering valuable insights for future nutrition and microbiome clinical trials. The STARS trial is positioned to provide high-quality evidence for skeletal health maintenance in older women using SBD111.

Approximately 10% of all cancers worldwide have been attributed to an underlying viral infection [1]. Regarding lymphoid malignancies, viral infections have been linked to several of these cancers ...

Patients with relapsed or refractory (R/R) peripheral T-cell lymphomas (PTCL) require lineage-specific therapies to bridge to hematopoietic stem cell transplantation (HSCT). A previous phase 1/2 study of duvelisib/romidepsin (duv/romi) reported an overall response rate (ORR) of 58% and a complete response rate (CRR) of 42% with reduced grade 3 to 4 transaminitis (14%). We report real-world duv/romi outcomes in a multicenter, 38-patient R/R PTCL cohort. The median age at diagnosis was 62 years. Histological subtypes included nodal T follicular helper cell (nTFH; n = 17), PTCL-not otherwise specified (n = 14), cutaneous T-cell lymphoma (TCL; n = 3), extranodal natural killer/TCL (n = 1), ALK-negative anaplastic large cell lymphoma (n = 1), adult T-cell leukemia/lymphoma (n = 1), and hepatosplenic TCL (n = 1). The median previous therapy count was 1 (interquartile range [IQR], 1-2); 15 patients relapsed and 23 were refractory to prior treatment, including 8 prior HSCT (5 autologous, 3 allogeneic). After a median of 3 cycles (IQR, 2-4), ORR and CRR were 61% and 47%, respectively, with higher ORR (82% vs 43%) and CRR (71% vs 29%) in nTFH versus non-nTFH. The median progression-free survival and overall survival (HSCT-censored) were 11 and 16 months for nTFH, versus 3.3 and 8.3 months for non-nTFH. The median time to response was 1.9 months (IQR, 1.7-2.6), duration of response was 21 months, and time to next therapy was 17 months. After duv/romi, 11 patients bridged to allo-HSCT. Treatment was well tolerated; the most common grade 3 to 4 toxicities were lymphopenia (n = 15), neutropenia (n = 15), thrombocytopenia (n = 10), and transaminitis (n = 6), seldom leading to discontinuation (n = 4) or death (n = 1). These findings reinforce duv/romi’s efficacy and bridging role to curative HSCT in high-risk R/R PTCL.

Variances in global access to drugs and treatment practices make it challenging to understand the benefit of contemporary therapies in patients with relapsed and refractory (R/R) mature T-cell and natural killer–cell lymphomas (MTCL and MNKCL). We conducted an international retrospective cohort study of 925 patients with R/R MTCL and MNKCL. In peripheral T-cell lymphoma–not otherwise specified and anaplastic lymphoma kinase–negative anaplastic large cell lymphoma (ALK– ALCL), patients with relapsed lymphoma demonstrated a superior median overall survival (OS) relative to refractory from the time of second-line treatment. We identified several independent predictors of OS for R/R lymphoma including age >60 years, primary refractory disease, histological subtype other than angioimmunoblastic T-cell lymphoma (AITL), extranodal sites >1, Ki67 ≥40%, and absolute lymphocyte count less than the lower limit of normal. A multivariable model incorporating these formed the basis for a prognostic index for R/R TCL, in which patients are stratified into low-risk (0-1 risk factor), intermediate-risk (2-3 risk factors), or high-risk (≥4 risk factors) groups, which were associated with 3-year OS of 57.14%, 23.3%, and 7%, respectively. Patients received either a "novel" single agent (SA; 35%) or cytotoxic chemotherapy (CC; 60%) for their second-line treatment. Higher progression-free survival was observed with SA over CC for the entire cohort with a higher 3-year OS in AITL and ALK– ALCL. Among the SA, small-molecule inhibitors demonstrated OS advantage relative to CC in AITL. Our results highlight continued efficacy of novel drugs globally and the potential of a new prediction model in informing heterogeneous prognosis within the R/R population of MTCL and MNKCL.

Supplementary Methods and Figures

Supplementary Methods and Figures

Venetoclax-obinutuzumab (Ven-O) is frequently administered off-label in relapsed/refractory (r/r) CLL/SLL where venetoclax-rituximab is the approved regimen. We conducted this retrospective, real-world study to evaluate Ven-O in r/r CLL/SLL. Between 7/2019 and 6/2022, 40 patients with r/r CLL/SLL on Ven-O were included. The median age was 72, 28.2% had TP53 mutation and/or 17p deletion, median number of prior therapies was 1 (range, 1-6), and 55% had prior BTK inhibitor exposure. The overall response rate was 90% (complete response [CR] or CR with incomplete marrow recovery in 27.5% and partial response in 62.5%) of patients, and the 2-year progression-free survival was 81.2% (95% CI, 69.5-94.8). Therapy was well tolerated. No laboratory or clinical TLS occurred with venetoclax (Howard criteria). One (3%) patient experienced laboratory TLS with obinutuzumab initiation. In summary, this retrospective cohort study demonstrated that Ven-O achieves frequent, durable responses and can be safely administered in r/r CLL/SLL.