Prostate biopsy remains the gold standard for the diagnosis of prostate cancer. Caudal block is one of the most common methods of anesthesia during prostate biopsy; however, lidocaine suppository can be a veritable option adapted for anesthesia in prostate biopsy.

Patients with gastrointestinal cancer (GIC) experience multiple psychological and physical complications during cancer treatment. A major psychological concern is the fear of cancer recurrence (FCR), which can negatively affect mental health and quality of life. Therefore, implementing effective interventions to manage FCR is essential.

Relapsed or refractory AML (R/R-AML) remains a particularly adverse population necessitating improved therapeutic strategies. In this phase 1 study, we evaluated the efficacy and safety of chidamide, azacitidine, cytarabine, aclarubicin and granulocyte colony-stimulating factor (CACAG) in combination with the B cell lymphoma-2 inhibitor venetoclax (VEN) in R/R-AML.

Clinical development of crizotinib in children with ALK-positive anaplastic large cell lymphoma (ALCL) was advanced in the US but not in Japan. The objectives of phase 1 part of a clinical study in Japan were to assess the safety and pharmacokinetics and determine the recommended phase 2 dose (RP2D) of crizotinib in children with relapsed/refractory (R/R) ALK-positive ALCL or neuroblastoma (NB). Two dose levels (165 and 280 mg/m2 twice daily (BID)) were planned to be evaluated. The aim of phase 2 part of the study was to assess the antitumor activity of crizotinib at the RP2D in children with R/R ALK-positive ALCL. Seven patients were eligible for phase 1 part, 5 with ALCL and 2 with NB. All 7 patients received crizotinib at a starting dose of 165 mg/m2 BID, with 1 dose-limiting toxicity observed (grade 3 gamma-glutamyltransferase increased). The most common grade 3 or 4 adverse event was neutropenia (71%). The steady-state Cmax and AUCtau of crizotinib at 165 mg/m2 BID were higher than expected. Considering the risk of a greater incidence of severe neutropenia, we decided that the 165 mg/m2 BID be the RP2D without evaluation at 280 mg/m2 BID. A total of 11 patients with ALK-positive ALCL were enrolled in the phase 2 part. The objective response rate was 72.7% (90% CI, 43.6%-92.1%). One patient permanently discontinued crizotinib due to disease progression. Crizotinib at 165 mg/m2 BID was well tolerated and showed favorable antitumor activity in children with R/R ALK-positive ALCL. Trial Registration: UMIN-CTR: UMIN000028075.

Relapsed or refractory acute lymphoblastic leukemia (R/R ALL) remains a major therapeutic challenge with poor long-term survival outcomes. Although checkpoint inhibitors targeting PD-1/PD-L1 have shown efficacy in other hematologic malignancies, their role in ALL has not been fully defined. Combination strategies integrating PD-1/PD-L1 blockade with chemotherapy or CAR-T cells may enhance anti-leukemic responses and overcome immune resistance.

Patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) face limited treatment options and poor outcomes. Preclinical evidence supports chemoimmunotherapy as a conversion therapy; therefore, this study aims to evaluate the efficacy and safety of preoperative camrelizumab with paclitaxel and nedaplatin.

In the Phase 2 IZALCO study, we evaluated efficacy, patient preference, safety and pharmacokinetics for isatuximab administered SC by an innovative on-body injector (OBI) or manual injection, plus carfilzomib-dexamethasone (Kd) in relapsed/refractory multiple myeloma (RRMM) patients. In Part 1, isatuximab SC was injected manually (cycles 1-6). In Part 2, patients were randomized to isatuximab SC by manual injection (cycles 1-3) followed by OBI administration (cycles 4-6) or to isatuximab OBI (cycles 1-3) followed by manual injection (cycles 4-6). From cycle 7, all patients could choose either treatment method. Overall, 74 RRMM patients received isatuximab SC plus Kd: 8 in Part 1 and 66 in Part 2. The patients had a median age of 65.0 years (44-85) with a median of 1 prior treatment line (1-5). The study met its primary efficacy endpoint with a 79.7% overall response rate (N = 74), at a median follow-up of 10.1 months. 74.5% of patients preferred the OBI rather than manual injection, 17% preferred manual injection, 8.5% had no preference. No impact of the SC delivery method was observed on efficacy, safety, pharmacokinetics, and immunogenicity of isatuximab given SC plus Kd, supporting the feasibility of using the OBI as a convenient method for isatuximab SC administration. Clinical trial information: ClinicalTrials.gov NCT05704049.

It has been hypothesized that sequencing antigen-directed immunotherapy with immune checkpoint inhibitors could prime a tumor for immune response to immune checkpoint inhibitors.

Although fractionated stereotactic radiation therapy (FSRT) remains understudied for the management of breast cancer brain metastases, this study aimed to investigate its therapeutic efficacy and safety in the context of contemporary systemic therapies. We enrolled patients with 1 to 10 brain lesions.

Chemotherapy-induced side effects can diminish physical and psychological well-being for women with breast cancer. Although nutrition and exercise improve quality of life (QoL) posttreatment, their ability to attenuate treatment-related declines in QoL during chemotherapy remains underexplored.

Darolutamide plus androgen-deprivation therapy (ADT) improved metastasis-free survival (MFS) by 2 years and reduced the risk of death by 31% in nonmetastatic castration-resistant prostate cancer (nmCRPC) in ARAMIS. Prior local therapy may influence the efficacy of subsequent systemic therapy. This post hoc analysis of ARAMIS evaluated the effect of prior local therapy on the efficacy and health-related quality of life (HRQoL) of darolutamide.

This study (TACTIC GC-01) aimed to evaluate the efficacy and safety of fruquintinib combined with albumin-bound paclitaxel as a second-line treatment for advanced gastric cancer (GC) following progression on programmed cell death protein 1 (PD-1) inhibitor-based therapy. In this single-center, single-arm, prospective trial, patients with metastatic gastric adenocarcinoma who failed first-line anti-PD-1 combined with chemotherapy treatment received six cycles of albumin-bound paclitaxel combined with fruquintinib, followed by fruquintinib maintenance monotherapy. The primary endpoint was progression-free survival (PFS), while secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse event (AE) incidence. Between February 24, 2022, and March 26, 2024, 41 patients were enrolled, with three receiving only one treatment cycle. The safety analysis included all 41 patients, while the full analysis set comprised 38 patients. Median PFS and OS were 5 months and 14 months, respectively, with corresponding 6- and 12-month PFS rates of 31.7% and 17.3%, and OS rates of 87.8% and 51.7%, respectively. Log-rank analysis identified frontline immunotherapy duration (≥3 cycles) as a key risk factor for PFS, while metastasis to ≥2 organs significantly impacted OS. The ORR and DCR were 44.7% and 94.7%, respectively. Treatment-related AEs occurred in 90.2% of patients, with grade 3-4 AEs (notably neutropenia and thrombocytopenia) observed in 41.5% of them. These findings suggest that fruquintinib plus albumin-bound paclitaxel exhibits promising efficacy and manageable toxicity in anti-PD-1-refractory GC, warranting further exploration in combination strategies targeting alternative pathways.

Neoadjuvant chemoradiotherapy (NCRT) followed by surgery is a standard treatment for locally advanced esophageal squamous cell carcinoma (ESCC). However, the survival outcomes remain suboptimal. Immune checkpoint inhibitors have shown promising efficacy in advanced ESCC, suggesting their potential to improve treatment outcomes when combined with NCRT and surgery.

Chemotherapy, with or without immunotherapy, is a standard of care for first-line treatment of locally advanced or metastatic oesophageal cancer. However, outcomes remain poor. We aimed to evaluate the activity and safety of tiragolumab, an anti-TIGIT monoclonal antibody, plus atezolizumab, an anti-PD-L1 monoclonal antibody, and chemotherapy in treatment-naive locally advanced unresectable or metastatic oesophageal cancer.

Androgen receptor pathway inhibitors (ARPIs) and docetaxel are established standards of care for chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC). We aimed to assess the efficacy and safety of adding nivolumab to docetaxel versus docetaxel alone in ARPI-pretreated, chemotherapy-naive mCRPC.

The CATNON trial investigated the benefit of the addition of concurrent or adjuvant temozolomide to radiotherapy in individuals with anaplastic astrocytoma. We report the long-term follow-up of the study focusing on the individuals with isocitrate dehydrogenase (IDH) mutated (IDHmt) tumours.

PORTEC-4a investigated molecular risk profile-based individualised adjuvant treatment for women with high-intermediate risk endometrial cancer, aiming to reduce both overtreatment and undertreatment while optimising locoregional control.

There is an unmet need for additional and more efficacious therapies for patients with unresectable metastatic oesophageal cancer. We aimed to evaluate the efficacy and safety of adding tiragolumab and atezolizumab to chemotherapy as first-line treatment for unresectable or metastatic oesophageal squamous cell carcinoma.

Pancreatic adenocarcinoma is marked by high mortality and limited treatment options. In mice, HSP90 inhibition limits cancer-associated fibroblasts activation and enhances T cell infiltration, sensitizing tumors to PD-1 blockade. We hypothesized that co-administration of pembrolizumab (anti-PD-1) with XL888 (an HSP90 inhibitor) would be safe and induce measurable immunological changes in the PDAC tumor microenvironment that could influence clinical outcome. We report results from an expansion cohort of patients with advanced PDAC (n = 16), who were enrolled in a single-center, open-label, nonrandomized, dose-escalation study. Patients received one cycle of either pembrolizumab (200 mg) alone or in combination with XL888 (90 mg, orally twice per week) over a 21-day cycle, followed by crossover to combination therapy. Peripheral blood and image guided liver biopsies were collected on Day 1 before treatment (C1D1) and Day 15 on-treatment (C1D15) for correlative studies. The combination regimen was well-tolerated with no unexpected adverse events. No objective responses were observed; two patients (13.3 %) achieved stable disease, while the remaining 13 (86.7 %) experienced disease progression. Median progression-free survival was 2.0 months, and median overall survival was 4.4 months. Treatment was associated with increased circulating Th1-associated cytokines and chemokines. Peripheral blood mononuclear cell (PBMC) analysis revealed elevated terminal effector CD8+ T cells and CD4+ regulatory T cells in the combination arm compared to pembrolizumab alone. Paired liver biopsies revealed no significant changes across treatment groups. While the combination of XL888 and pembrolizumab was safe and induced systemic immune modulation, limited clinical efficacy was observed and did not impact the PDAC TME.

Postoperative cisplatin and radiotherapy is the standard of care for high-risk resected locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). The NIVOPOST-OP trial aimed to assess the efficacy and safety of programmed death 1 blockade by nivolumab added to cisplatin and radiotherapy in this setting.