Achieving demographically representative samples remains a challenge in oncology trials but is essential for generalizable findings. We describe recruitment and enrollment to a decentralized trial for an online sexual health intervention for breast cancer survivors, evaluating differences by race, ethnicity, and age. Partnered breast cancer survivors with sexual concerns were recruited to the Sexual Health and Intimacy Enhancement (SHINE) trial (WF-2202, NCT06216574) via the Wake Forest NCI Community Oncology Research Program (NCORP) Research Base. Sites identified potentially eligible survivors; recorded their race, ethnicity, and age; and sent them online eligibility screeners. Eligible, consenting survivors were enrolled. Screener completion (78.3
Background:With negligible risk of distant metastasis, the primary treatment focus in patients with primary retroperitoneal well-differentiated liposarcoma (pRP-WDLPS) is local control. The recently completed phase 3 STRASS trial suggested a potential benefit to neoadjuvant radiotherapy (RT) in optimizing local control in these patients. This study investigates outcomes associated with neoadjuvant RT in a larger cohort of patients undergoing surgery for pRP-WDLPS. Methods:In this study from 24 participating sites, we retrospectively identified all patients with pRP-WDLPS who underwent curative-intent resection between January 1, 2002 and December 31, 2017. The primary endpoint was the cumulative incidence function (CIF) of local recurrence (LR), and the secondary endpoint was overall survival (OS). The impact of neoadjuvant RT on the CIF of LR was analyzed using a 1:2 propensity score matching (PSM). Findings:Of 582 patients included in the entire cohort, 72 patients (12%) received neoadjuvant RT. The 1:2 PSM group included 208 patients of which 138 patients (66%) underwent surgery alone and 70 patients (34%) underwent neoadjuvant RT and surgery. With a median follow up of 73 months, the 5- and 8-year CIF of LR for neoadjuvant RT and surgery group was 6% and 10%, respectively, and 26% and 33%, respectively, for the surgery alone group (odds ratio (OR) 0·85, 95% confidence interval (CI) 0·76-0·97, P < 0·001). The 5- and 10-year OS for the neoadjuvant RT and surgery group was 92% and 80%, respectively, and 84% and 71%, respectively, for the surgery alone group (HR 0·50, 95% CI 0·27-1·21, P = 0·07). Interpretation:To the best of our knowledge, this is the largest study to report outcomes of neoadjuvant RT for pRP-WDLPS. Neoadjuvant RT was associated with a significant decrease in LR compared to surgery alone. These data further validate the use of neoadjuvant RT for pRP-WDLPS. Funding:Funding was received from the Susan and Habib Gorgi Family Fund for Sarcoma Research.
Abstract Patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), especially those progressing after Bruton tyrosine kinase (BTK) inhibitor and/or chimeric antigen receptor (CAR) T-cell therapy and those with high-risk features, have poor outcomes. The bispecific antibody, mosunetuzumab, combined with the antibody-drug conjugate (ADC), polatuzumab vedotin (Mosun-Pola), targets CD20 and CD79b via independent cell-killing mechanisms. In this multicenter phase 2 study, patients with MCL who had received ≥2 previous lines of therapy, including a BTK inhibitor, were enrolled. Patients received outpatient fixed-duration mosunetuzumab subcutaneously (17 cycles), with cycle 1 step-up dosing to mitigate cytokine release syndrome (CRS), and polatuzumab vedotin (1.8 mg/kg IV) for 6 cycles. The primary end point was centrally assessed best objective response rate. A total of 42 patients with a median of 3 previous therapies were enrolled; 26% had previous CAR T-cell therapy. A number of patients had MCL with high-risk features (Ki-67 of ≥50%, 67%; blastoid/pleomorphic morphology, 38%; TP53 aberration, 48%). Objective response occurred in 88.1% of evaluable patients (95% confidence interval [CI], 74.4-96.0) and complete response in 78.6% (95% CI, 63.2-89.7). With a median follow-up of 15.9 months, median progression-free survival was 18.6 months (95% CI, 13.9 to not estimable). Consistent efficacy was observed in high-risk subgroups. CRS occurred in 42.9% of patients and was limited to grade 1/2 events. Mosun-Pola achieved high complete remission rates while maintaining a manageable safety profile in patients with R/R MCL exhibiting high-risk features. This is, to our knowledge, the first bispecific-ADC combination therapy study in MCL. This trial was registered at www.clinicaltrials.gov as #NCT03671018.
To examine how omission of axillary surgery in early-stage breast cancer influences systemic therapy and radiation decision-making as treatment paradigms shift toward biologic rather than anatomic risk. The SOUND and INSEMA trials demonstrated that sentinel lymph node biopsy can be safely omitted in selected patients with early-stage, hormone receptor–positive, HER2-negative, clinically node-negative disease and negative axillary ultrasound findings. These findings have redefined multidisciplinary treatment planning, prompting new challenges in systemic therapy selection, radiation field design, and trial eligibility in the absence of nodal data. Omission of axillary surgery requires thoughtful multidisciplinary coordination and integration of patient preferences to ensure oncologic safety. Future studies should evaluate concurrent surgical, systemic, and radiation de-escalation to establish evidence-based pathways that right-size care across diverse practice settings.
