Publications by authors named "Nobuaki Matsubara"
Introduction: KEYNOTE-361 evaluated first-line pembrolizumab with and without platinum-based chemotherapy versus chemotherapy alone in advanced or metastatic urothelial carcinoma. The primary end points of progression-free survival (PFS) or overall survival (OS) were not met. Exploratory analysis of efficacy by platinum agent (cisplatin or carboplatin) is reported.
View Article and Find Full Text PDFBackground: First-line pembrolizumab monotherapy is a standard of care for platinum-ineligible patients with advanced urothelial carcinoma (UC). No global standardized definition of platinum ineligibility exists. This study aimed to evaluate the efficacy and safety of pembrolizumab monotherapy in patients with UC who met various criteria for platinum ineligibility.
View Article and Find Full Text PDFWhat Is This Summary About?: This summary is about the ongoing research study called TALAPRO-3. This study is testing the use of two medicines called talazoparib and enzalutamide. The two medicines are being used together as a treatment for patients with a type of cancer called metastatic castration-sensitive prostate cancer and changes in specific DNA repair genes within their tumors.
View Article and Find Full Text PDFBackground: Undetectable circulating tumor DNA (ctDNA) is an obstacle to performing comprehensive genomic profiling in daily practice to identify genomic alterations. We investigated the associations between clinicopathological factors and undetectable ctDNA using a commercially available comprehensive genomic profiling assay in metastatic prostate cancer.
Patients And Methods: Patients treated with systemic treatment for metastatic prostate cancer were included.
Article Synopsis
- - This fourth edition of the Japanese Clinical Practice Guidelines for Prostate Cancer 2023 was developed by the Japanese Urological Association and involved experts from various related organizations, ensuring a comprehensive approach to prostate cancer management.
- - The guidelines emphasize the use of systematic reviews to inform recommendations for 14 specific clinical questions, with decisions made based on the collective input of 24 guideline development members.
- - A general statement outlines findings from literature searches on areas not covered by systematic reviews, with a focus on updates and changes since the last guidelines published in 2016.
Background: In the THOR trial (NCT03390504) Cohort 1, erdafitinib demonstrated significantly prolonged overall survival (OS) (median 12.1 versus 7.8 months) and reduced risk of death by 36% (hazard ratio 0.
View Article and Find Full Text PDFWhat Is This Summary About?: This summary describes the results from the TALAPRO-2 research study (also known as a clinical trial). The TALAPRO-2 study tested the combination of two medicines called talazoparib plus enzalutamide. This combination of medicines was used as the first treatment for adult patients with metastatic castration-resistant prostate cancer.
View Article and Find Full Text PDFChest computed tomography (CT) revealed a focal ground glass opacity (GGO) with a minimal solid area in a 75-year-old man. The shadow was located in the periphery of the right upper lobe and measured 11 mm in diameter. The patient had a medical history of metachronous prostate and gastric cancers.
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- Recent clinical trials indicate that combining PARP inhibitors with novel hormonal therapy can improve progression-free survival in men with metastatic prostate cancer, leading to new approvals for this treatment by regulatory bodies in several countries.
- * The study utilized the RAND/UCLA Delphi method, involving a panel of 12 experts who reviewed literature and rated management options for adverse events (AEs) arising from treatment across 419 patient scenarios.
- * Key findings showed a significant reduction in disagreement among experts on AE management strategies, with consensus on approaches for managing mild, moderate, and severe AEs, enhancing guidance for clinical decision-making.
Article Synopsis
- The study evaluated the safety and efficacy of retifanlimab (a monoclonal antibody) and INCB001158 (an oral arginase inhibitor) in Japanese patients with advanced solid tumors through a phase Ib trial.
- Eighteen patients participated, with no dose-limiting toxicities or severe adverse events; common treatment-related issues included mild rash and one immune-related thyroid disorder.
- Results showed some antitumor activity with retifanlimab monotherapy (33.3% overall response rate), but the combination therapy did not yield any positive responses, indicating further research is needed.
Background And Objective: In comparison to chemotherapy, enfortumab vedotin (EV) prolonged overall survival in patients with previously treated advanced urothelial carcinoma in EV-301. The objective of the present study was to assess patient experiences of EV versus chemotherapy using patient-reported outcome (PRO) analysis of health-related quality of life (HRQoL).
Methods: For patients in the phase 3 EV-301 trial randomized to EV or chemotherapy we assessed responses to the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, weekly for the first 12 wk, and then every 12 wk until discontinuation.
Article Synopsis
- A first-in-human study was conducted to evaluate the safety and efficacy of acapatamab, a bispecific T-cell engager targeting metastatic castration-resistant prostate cancer (mCRPC).
- 133 patients participated, receiving varying doses of acapatamab; the most common side effect was cytokine release syndrome (CRS), noted in a large majority, particularly during the first treatment cycle.
- Preliminary results showed some antitumor activity, with 30.4% of patients experiencing confirmed PSA responses, though the overall durable activity was limited and further evaluation is needed.
Purpose: Imaradenant is a novel potent and selective adenosine A2A receptor antagonist that is hypothesized to reduce immune suppression in the tumor microenvironment. This phase I, open-label, dose-escalation study evaluated the safety, pharmacokinetics, and anti-tumor activity of imaradenant.
Methods: Japanese patients with advanced solid malignancies received imaradenant 50 mg (n = 3) or 75 mg (n = 7) once daily (QD).
We evaluated the efficacy and safety of TAS0313, a multi-epitope long peptide vaccine, plus pembrolizumab in post-chemotherapy immune checkpoint inhibitor-naïve patients with locally advanced/metastatic urothelial carcinoma (la/mUC). TAS0313 9 mg was administered subcutaneously followed by pembrolizumab 200 mg on Day 1, and as monotherapy on Day 8 and 15 of Cycles 1 and 2, and Day 1 of subsequent cycles in 21-day cycles. The primary endpoint was the objective response rate (ORR).
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- Preclinical studies indicate a link between the androgen receptor and poly(ADP-ribose) polymerase in prostate cancer, suggesting that inhibiting both may effectively treat metastatic castration-resistant prostate cancer (mCRPC).
- The TALAPRO-2 phase 3 study compared the effects of combining talazoparib (a poly(ADP-ribose) polymerase inhibitor) with enzalutamide against enzalutamide alone, specifically focusing on patients with DNA damage response gene alterations.
- Results showed that the combination therapy significantly extended radiographic progression-free survival for patients with homologous recombination repair (HRR) deficiencies, with the talazoparib group not reaching median survival at the time of
Olaparib improved PFS and OS across subgroups of BRCA1/2mut #prostatecancer patients in the PROFOUND phase III trial.
View Article and Find Full Text PDFBackground: In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available.
Methods: Treatment-emergent adverse events (TEAEs) for patients receiving darolutamide for a median of 38 months (n = 13) are described in this pooled analysis of individual patient data from phase 1/2 studies.
Results: All patients reported TEAEs (mostly grade 1/2).
Poly(ADP-ribose) polymerase inhibitors in combination with androgen-receptor signaling inhibitors are a promising therapeutic option for patients with metastatic castration-sensitive prostate cancer (mCSPC) and homologous recombination repair (HRR) gene alterations. Here, we describe the design and rationale of the multinational, phase III, TALAPRO-3 study comparing talazoparib plus enzalutamide versus placebo plus enzalutamide in patients with mCSPC and HRR gene alterations. The primary end point is investigator-assessed radiographic progression-free survival (rPFS) per RECIST 1.
View Article and Find Full Text PDFBackground: Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with -altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti-programmed cell death protein 1 [PD-1] or anti-programmed death ligand 1 [PD-L1] agents) are unclear.
Methods: We conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible alterations who had progression after one or two previous treatments that included an anti-PD-1 or anti-PD-L1.
Unlabelled: Xaluritamig (AMG 509) is a six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted T-cell engager designed to facilitate lysis of STEAP1-expressing cancer cells, such as those in advanced prostate cancer. This first-in-human study reports monotherapy dose exploration for patients with metastatic castration-resistant prostate cancer (mCRPC), primarily taxane pretreated. Ninety-seven patients received ≥1 intravenous dose ranging from 0.
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