Prognostic Impact of Lymph Node Yield in a Phase III Clinical Trial (NRG/RTOG 9601) of Prostate Cancer Patients Treated With Salvage Radiation Following Prostatectomy.

Background: We aim to evaluate whether increased lymph node yield at prostatectomy (RP) is associated with improved outcomes in NRG/RTOG 9601, a randomized clinical trial of men who underwent either radiation (RT) alone or RT + bicalutamide for PSA elevation following RP for pT2/T3 prostate cancer.

Methods: We reviewed available pathology reports for patients in NRG/RTOG 9601 to determine the nodal count at RP. Cox proportional hazards models were used to assess effect of lymph nodes yield, arm (RT alone or RT + bicalutamide), Gleason score, positive margins, and seminal vesicle invasion on the following endpoints: times to local and distant failure and overall and disease-specific survival.

Time Without Transfusion Reliance (TWiTR): Integrating Survival Quality Into Myelofibrosis Treatment Strategies Based on the Phase 3 SIMPLIFY-1, SIMPLIFY-2, and MOMENTUM Trials.

Introduction: Myelofibrosis is characterized by debilitating constitutional symptoms and anemia, which negatively impact survival and quality of life. Red blood cell transfusions form the basis of anemia management in myelofibrosis but dependence on transfusions is further associated with poorer survival and quality of life.

Methods: Time without transfusion reliance (TWiTR), a method integrating transfusion dependence and survival quality, was applied to three Phase 3 trials of momelotinib in myelofibrosis.

Assessing Algorithmic Fairness With a Multimodal Artificial Intelligence Model in Men of African and Non-African Origin on NRG Oncology Prostate Cancer Phase III Trials.

Purpose: Artificial intelligence (AI) tools could improve clinical decision making or exacerbate inequities because of bias. African American (AA) men reportedly have a worse prognosis for prostate cancer (PCa) and are underrepresented in the development genomic biomarkers. We assess the generalizability of tools developed using a multimodal AI (MMAI) deep learning system using digital histopathology and clinical data from NRG/Radiation Therapy Oncology Group PCa trials across racial subgroups.

Practice Patterns of Reirradiation for Brain and Spinal Tumors-An International Survey From the Reirradiation Collaborative Group (ReCOG).

Purpose: An international workshop was convened by the Reirradiation Collaborative Group. We conducted a survey among the invited attendants to assess practice patterns of reirradiation for central nervous system tumors.

Methods And Materials: A web-based survey regarding central nervous system reirradiation was distributed to an international group of radiation oncologists and medical physicists via email.

Neoadjuvant Chemotherapy and Surgery versus Surgery for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma: ECOG-ACRIN EA3163.

Purpose: Neoadjuvant chemotherapy for structure preservation (SP) in nasal and paranasal sinus squamous cell carcinoma (NPNSCC) has been described in single-institution studies but not in randomized studies. EA3163 was a randomized study investigating whether cytoreductive neoadjuvant chemotherapy would improve SP or overall survival (OS).

Patients And Methods: Patients with T3/T4a and select T4b NPNSCC requiring orbital or base of skull (BOS) resection were randomized to surgery (arm A) versus surgery preceded by docetaxel/cisplatin for three cycles (arm B).

Comparing Durvalumab, Olaparib, and Cediranib Monotherapy, Combination Therapy, or Chemotherapy in Patients with Platinum-Resistant Ovarian Cancer with Prior Bevacizumab: The Phase II NRG-GY023 Trial.

Purpose: We assessed the efficacy of anti-PD-L1 durvalumab in combination with olaparib and cediranib (DOC), compared with the standard-of-care chemotherapy (SOC) in patients with platinum-resistant ovarian cancer (PROC), who had prior bevacizumab.

Patients And Methods: NRG-GY023 was the first randomized four-arm superiority phase II trial enrolling patients with high-grade serous/endometrioid or clear-cell PROC with prior bevacizumab exposure. Patients were randomized 1:2:2:2 to SOC (weekly paclitaxel, topotecan, or pegylated liposomal doxorubicin), DOC, durvalumab + cediranib (DC), or olaparib + cediranib (OC).

Effectiveness of out-of-pocket cost COMmunication and financial navigation (CostCOM) in cancer patients: Study protocol for ECOG-ACRIN EAQ222CD.

Background: High out-of-pocket costs (OOPC) of cancer treatment and lost income result in financial hardship. There is compelling evidence that OOPC communication complemented by financial navigation and counseling will decrease financial hardship by enabling cancer patients to anticipate and accommodate treatment costs and proactively seek financial assistance.

Methods: This is a two-arm randomized controlled trial enrolling 720 patients with newly diagnosed solid tumors (stratified by non-metastatic vs.

Pelabresib plus ruxolitinib for JAK inhibitor-naive myelofibrosis: a randomized phase 3 trial.

Janus kinase (JAK) inhibitors provide limited depth and durability of response in myelofibrosis. We evaluated pelabresib-a bromodomain and extraterminal domain (BET) inhibitor-plus ruxolitinib (a JAK inhibitor) compared with placebo plus ruxolitinib as first-line therapy. In this phase 3 study (MANIFEST-2), JAK inhibitor-naive patients with myelofibrosis were randomized 1:1 to pelabresib 125 mg once daily (QD; 50-175 mg QD permitted) for 14 days followed by a 7-day break (21-day cycle), or to placebo in combination with ruxolitinib 10 or 15 mg twice daily (BID; 5 mg QD-25 mg BID permitted).

Longitudinal Assessment of Transfusion Intensity in Patients With JAK Inhibitor-Naive or -Experienced Myelofibrosis Treated With Momelotinib.

Purpose: Anemia is a cardinal feature of myelofibrosis often managed with red blood cell (RBC) transfusions, which may contribute to negative prognostic, quality-of-life, and healthcare-related economic impacts. The Janus kinase (JAK) 1/JAK2/activin A receptor type 1 inhibitor momelotinib was approved for the treatment of patients with myelofibrosis and anemia based on clinical trial evidence of anemia, spleen, and symptom benefits illustrated using binomial response/nonresponse endpoints. In the present post hoc, descriptive analyses, the impact of momelotinib on RBC transfusion burden over time was further characterized across JAK inhibitor-naive and -experienced patients.

Prostate Cancer Risk Stratification in NRG Oncology Phase III Randomized Trials Using Multimodal Deep Learning With Digital Histopathology.

Purpose: Current clinical risk stratification methods for localized prostate cancer are suboptimal, leading to over- and undertreatment. Recently, machine learning approaches using digital histopathology have shown superior prognostic ability in phase III trials. This study aims to develop a clinically usable risk grouping system using multimodal artificial intelligence (MMAI) models that outperform current National Comprehensive Cancer Network (NCCN) risk groups.

Safety and efficacy of acalabrutinib plus bendamustine and rituximab in patients with treatment-naïve or relapsed/refractory mantle cell lymphoma: phase Ib trial.

This multicenter, open-label, phase Ib study (ACE-LY-106) assessed the safety and efficacy of acalabrutinib, bendamustine, and rituximab (ABR) in treatment-naïve (TN) and relapsed or refractory (R/R) mantle cell lymphoma (MCL). Patients received acalabrutinib from cycle 1 until disease progression or treatment discontinuation, bendamustine on days 1 and 2 of each cycle for up to 6 cycles, and rituximab on day 1 of each cycle for 6 cycles, continuing every other cycle from cycle 8 for 12 additional doses (TN cohort). Eighteen patients enrolled in the TN cohort and 20 in the R/R cohort.

Sacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer.

Purpose: Human trophoblast cell surface antigen 2 (Trop-2) is a protein highly expressed in urothelial cancer (UC). Sacituzumab govitecan (SG) is a Trop-2-directed antibody drug conjugate with a hydrolysable linker and a potent SN-38 payload. This study explored Trop-2 expression in tumors treated with SG in cohorts 1 to 3 (C1-3) from the TROPHY-U-01 study and evaluated whether efficacy was associated with Trop-2 expression.

Acalabrutinib plus venetoclax and rituximab in treatment-naive mantle cell lymphoma: 2-year safety and efficacy analysis.

This phase 1b study evaluated safety and efficacy of acalabrutinib, venetoclax, and rituximab (AVR) in treatment-naive mantle cell lymphoma (TN MCL). Patients received acalabrutinib from cycle 1 until progressive disease (PD) or undue toxicity, rituximab for 6 cycles with maintenance every other cycle through cycle 24 or until PD, and venetoclax, beginning at cycle 2, for 24 cycles. Twenty-one patients were enrolled; 95.

Polatuzumab vedotin, venetoclax, and an anti-CD20 monoclonal antibody in relapsed/refractory B-cell non-Hodgkin lymphoma.

The Phase 2 portion of this study evaluated safety and efficacy of polatuzumab vedotin 1.8 mg/kg and venetoclax 800 mg, plus fixed-dose obinutuzumab 1000 mg or rituximab 375 mg/m in patients with relapsed/refractory (R/R) follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), respectively. Patients with complete response (CR) or partial response (PR)/stable disease (FL) or CR/PR (DLBCL) at end of induction (EOI; six 21-day cycles) received post-induction therapy with venetoclax and obinutuzumab or rituximab, respectively.

A plain language summary of the TROPHY-U-01 study: sacituzumab govitecan use in people with locally advanced or metastatic urothelial cancer.

What Is This Summary About?: Sacituzumab govitecan (brand name: TRODELVY) is a new treatment being studied for people with a type of bladder cancer, called urothelial cancer, that has progressed to a locally advanced or metastatic stage. Locally advanced and metastatic urothelial cancer are usually treated with platinum-based chemotherapy. Metastatic urothelial cancer is also treated with immune checkpoint inhibitors.

Phase II Study of Erdafitinib in Patients With Tumors With Amplifications: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol K1.

Purpose: Despite fibroblast growth factor receptor () inhibitors being approved in tumor types with select rearrangements or gene mutations, amplifications of represent the most common alteration across malignancies. Subprotocol K1 (EAY131-K1) of the National Cancer Institute-MATCH platform trial was designed to evaluate the antitumor efficacy of the oral inhibitor, erdafitinib, in patients with tumors harboring amplification.

Methods: EAY131-K1 was an open-label, single-arm, phase II study with central confirmation of presence of amplification in tumors.

Phase II Study of Osimertinib in Patients With Epidermal Growth Factor Receptor Mutations: Results From the NCI-MATCH ECOG-ACRIN (EAY131) Trial Subprotocol E.

Purpose: The National Cancer Institute Molecular Analysis for Therapy Choice trial is a signal-finding genomically driven platform trial that assigns patients with any advanced refractory solid tumor, lymphoma, or myeloma to targeted therapies on the basis of next-generation sequencing results. Subprotocol E evaluated osimertinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with mutations.

Methods: Eligible patients had mutations (T790M or rare activating) and received osimertinib 80 mg once daily.

Patient-Reported Financial Burden of Treatment for Colon or Rectal Cancer.

Importance: The longitudinal experience of patients is critical to the development of interventions to identify and reduce financial hardship.

Objective: To evaluate financial hardship over 12 months in patients with newly diagnosed colorectal cancer (CRC) undergoing curative-intent therapy.

Design, Setting, And Participants: This prospective, longitudinal cohort study was conducted between May 2018 and July 2020, with time points over 12 months.

The Implications of Racialized Economic Segregation and Allostatic Load on Mortality in Patients with Breast Cancer.

Background: The objective of this study was to examine the association between racialized economic segregation, allostatic load (AL), and all-cause mortality in patients with breast cancer.

Patients And Methods: Women aged 18+ years with stage I-III breast cancer diagnosed between 01/01/2012 and 31/12/2020 were identified in the Ohio State University cancer registry. Racialized economic segregation was measured at the census tract level using the index of concentration at the extremes (ICE).