Purpose/Objective(s) Biopsy Gleason 8–10 disease and MRI-suspected extracapsular extension identify men at high risk for adverse pathologic features at prostatectomy, observed in ∼55–75% of cases. For a substantial subset, surgery alone is not curative, and PSA recurrence leads to radiotherapy (RT) to preserve curative intent. Conventionally fractionated postprostatectomy RT (COPORT) requires 37 fractions, 48% more than hypofractionated RT (HYPORT). In the primary 2-year analysis of this trial, HYPORT was noninferior to COPORT for patient-reported genitourinary and gastrointestinal toxicity. We now report longer-term 5-year results. Materials/Methods A total of 296 men were randomized (152 to COPORT and 144 to HYPORT). Men with a detectable post-op PSA (≥0.1 ng/mL) with pT2/3pNX/0 disease or an undetectable PSA (<0.1 ng/mL) with either pT3 or pT2 disease with a positive surgical margin were eligible. HYPORT was 62.5 Gy to the prostate bed in 25 fractions of 2.5 Gy. COPORT was 66.6 Gy in 37 fractions of 1.8 Gy. Patient-reported GU and GI toxicity was measured using the Expanded Prostate Index Composite (EPIC). Other secondary endpoints include quality of life as measured by EQ-5D, adverse events (AEs), overall survival, prostate-cancer specific survival, and biochemical failure (BF; PSA ≥ 0.4 ng/mL and rising). Results No grade 4–5 AEs related to RT were reported. Grade 3 AEs occurred in 7% (11 men) with COPORT and 16% (23 men) with HYPORT (p=0.02). Grade 3 renal and urinary disorders occurred in 3% (5 men) with COPORT and 13% (18 men) with HYPORT (p=0.003). This difference reflected higher rates of noninfective cystitis (0% vs 7%) and hematuria (0.7% vs 6%) with HYPORT vs COPORT. There was only one grade 3 urinary tract obstruction (stricture) on the COPORT arm. Time to grade 3 AEs did not differ between arms (p=0.4).At 5 years, EPIC compliance was 56% (58% in the COPORT arm and 55% in the HYPORT arm), while EQ-5D compliance was 51% in both arms. No significant differences were observed in 5-year EPIC bowel (0.6 vs -2.0; p=0.1) or urinary change scores (−5.7 vs −8.0; p=0.4) between COPORT and HYPORT. No significant difference was observed in EQ-5D score change from baseline to 5 years between COPORT and HYPORT (−0.01 vs 0.0; p=0.5).Median follow-up is 7 years (range: 0 to 8). A total of 31 deaths have been reported (14 on COPORT and 17 on HYPORT), 4 (13%) due to prostate cancer. There was no difference in BF (5-year rate: 18% for COPORT vs. 21% for HYPORT; p=0.3). Conclusion The rates of grade 3 GU AEs (3% with COPORT and 13% with HYPORT), including the higher incidence with HYPORT and the predominance of cystitis and hematuria, were consistent with contemporary series. Despite a small absolute increase in physician-reported cystitis (7%) and hematuria (5%), HYPORT showed no differences in patient-reported outcomes compared with COPORT and comparable biochemical control, supporting HYPORT as an effective, patient-centered, and acceptable treatment approach.
INTRODUCTION:The landscape of drug-delivery methods in oncology is evolving, with increased availability of subcutaneous (SC) drug administration options. SC injections reduce treatment duration and enhance patient comfort and satisfaction. However, opportunities exist to improve administration modalities, including enhancing practice efficiency and patient experience, addressing needle-phobia, and reducing physical strain for HCPs related to manual injection. Isatuximab (Isa), an anti-CD38 monoclonal antibody approved for intravenous administration in multiple myeloma (MM), is being investigated across the MM treatment continuum for SC delivery via an innovative on-body injector (OBI; Isa SC OBI). With a small, retractable needle enabling hands-free delivery, the Isa SC OBI has the potential to address gaps in the MM treatment experience. AREAS COVERED:We conducted a literature search of MEDLINE/PubMed through 2025 for data on the use of an OBI in oncology (through Isa SC OBI), examining its advantages over SC manual or intravenous administration, considerations for clinical practice, ongoing and upcoming clinical trials, and future MM treatment opportunities. EXPERT OPINION:The use of an OBI for the delivery of SC isatuximab could potentially improve clinical workflow, reduce duration of clinical visits and physical burden for HCPs through hands-free administration, and enhance patient experience through the small, hidden needle.
Objective To evaluate whether a structured, physiology-first surveillance protocol improves arteriovenous fistula (AVF) clinical maturation rates and reduces time to cannulation readiness compared with standard postoperative observation. Methods Two consecutive cohorts of surgically created AVFs by a single surgeon at a community-based center were compared: a standard observation cohort (January–May 2025; 64 created, 58 analyzable), and a physiology-first cohort (June 2025–March 2026; 52 created, all analyzable) managed with a structured protocol featuring standardized 2.7-mm anastomosis, day-of-creation (DOC) baseline flow documentation, structured ultrasound surveillance at weeks 2 and 4, and defined failure-to-progress intervention triggers and procedure. Salvage intervention for both cohorts included kinetic endovascular microincision creation followed by angioplasty with a drug-coated balloon. Results Overall maturation increased from 75.9%(44/58) to 92.3% (48/52; P=0.022). Unassisted maturation rose from 53.4%(31/58) to 69.2% (36/52). The overall median time to clinical maturation decreased from 49 days (IQR 42–68) to 30 days (IQR 26–43; P <0.001). Salvage intervention success was comparable between cohorts. DOC flow documentation increased from 0% to 100% and no steal syndrome was observed (0/52) with the new physiology-first protocol. Conclusions As a quality-improvement evaluation, the physiology-first protocol generated a clear and consistent signal of improved maturation outcomes: access failure decreased, unassisted maturation increased, overall maturation increased and median time to cannulation readiness decreased. These findings support adopting the protocol as a meaningful adjunct to care and warrant multi-center evaluation.
Granulomatosis with polyangiitis (GPA) is a systemic necrotizing small-vessel vasculitis that commonly involves the upper and lower respiratory tracts and kidneys and is potentially life-threatening. Early manifestations may be subtle and misleading, resulting in delayed diagnosis and treatment. Laryngeal involvement, particularly presenting as isolated dysphonia, remains an underrecognized and easily overlooked feature. We report a 77-year-old man with a history of lymphoma and previous lung cancer in remission who presented with six weeks of progressive hoarseness, shortness of breath, profound weight loss, and constitutional symptoms. On presentation, he was found to have multifocal pulmonary opacities, acute kidney injury with active urinary sediment, and systemic inflammation. The constellation of symptoms and his complex medical history created a diagnostic challenge. A unifying diagnosis emerged only after serologic testing revealed positive cytoplasmic anti-neutrophil cytoplasmic antibodies (C-ANCA) and anti-elevated proteinase-3 (PR3) antibodies. Renal biopsy confirmed pauci-immune crescentic glomerulonephritis consistent with GPA. Prompt initiation of pulse-dose corticosteroids and rituximab resulted in rapid clinical improvement. This case underscores dysphonia, which may represent an early and critical clue to airway involvement, preceding fulminant multisystem disease. Recognition of this presentation is essential, as diagnostic delay may lead to irreversible organ damage, whereas timely immunosuppressive therapy can be rapidly life-saving and organ-preserving.
