A single-arm, phase II study of sotorasib plus carboplatin/pemetrexed in advanced non-squamous non-small cell lung cancer patients with KRAS G12C mutation (WJOG14821L, SCARLET).

Background: The efficacy and safety of sotorasib plus platinum-doublet chemotherapy in KRAS G12C-mutated non-squamous non-small cell lung cancer (non-Sq NSCLC) were previously reported with limited follow-up period.

Method: SCARLET was a single-arm phase II study of chemotherapy-naïve patients with KRAS G12C-mutated non-Sq NSCLC. Participants received sotorasib 960 mg daily plus four cycles of carboplatin (area under the curve, 5)/pemetrexed 500 mg/m, followed by sotorasib/pemetrexed until disease progression.

Low survival due to higher risk of relapse and non-relapse mortality after allogeneic HSCT in ATL compared with AML and ALL.

Background: Patients with adult T-cell leukemia/lymphoma (ATL) are considered to have worse outcomes after allogeneic hematopoietic stem cell transplantation (allo-HSCT) than patients with other hematological malignancies, owing to high risk of relapse and immunocompromised status. However, no studies have compared transplant outcomes between patients with ATL and those with other hematological malignancies using a large-scale database.

Objectives: To compare transplant outcomes between patients with ATL and those with other leukemias and to identify factors contributing to worse transplant outcomes in ATL patients.

Prognostic Analysis of Pathological Stage I Lung Adenocarcinoma Harboring Major EGFR Mutations.

Background: While Epidermal growth factor receptor (EGFR) mutation-positive lung adenocarcinoma (LUAD) has favorable outcomes with targeted therapy, early-stage prognosis remains influenced by pathological factors and central nervous system (CNS) recurrence. The study aimed to clarify prognostic factors in pathological stage (pStage) I EGFR mutation-positive LUAD.

Methods: Between 2015 and 2018, 2,191 pStage I LUAD cases with known EGFR status (excluding EGFR testing after recurrence) who received anatomical resection were included from multiple institutions in Japan.

Artificial Intelligence-Powered Human Epidermal Growth Factor Receptor 2 and Tumor Microenvironment Analysis in Human Epidermal Growth Factor Receptor 2-Amplified Metastatic Colorectal Cancer: Exploratory Analysis of Phase II TRIUMPH Trial.

Purpose: Human epidermal growth factor receptor 2 (HER2)-targeted therapies have shown promise in treating -amplified metastatic colorectal cancer (mCRC). Identifying optimal biomarkers for treatment decisions remains challenging. This study explores the potential of artificial intelligence (AI) in predicting treatment responses to trastuzumab plus pertuzumab (TP) in patients with -amplified mCRC from the phase II TRIUMPH trial.

A first-in-human phase 1/2 dose-escalation study of MAK683 (EED inhibitor) in patients with advanced malignancies.

Purpose: MAK683, a first-in-class and highly selective allosteric inhibitor of the embryonic ectoderm development subunit of polycomb repressive complex 2, has shown sustained antitumor activity in tumor xenograft models. This first-in-human phase 1/2 study evaluated the safety, pharmacokinetics (PK), and clinical activity of single-agent MAK683 in advanced malignancies.

Methods: MAK683 was administered fasted once daily or twice daily continuously in 28-day treatment cycles.

Assessment of heterogeneity according to hospital or medical experience factors in outcomes of chemotherapy for advanced biliary tract cancer: a post-hoc analysis of JCOG1113.

Background: JCOG1113 is a randomized phase III trial that showed non-inferiority of gemcitabine plus S-1 to gemcitabine plus cisplatin in patients with advanced biliary tract cancer. Assessment of inter-institutional heterogeneity in chemotherapy contributes to confirm generalizability and reliability of the study itself. However, there have been no studies conducted to assess the heterogeneity among participating centers in randomized phase III trials for biliary tract cancer.

Access Program for Unapproved and Off-Label Drug Use in Pediatric BRAF V600E-Mutated Brain Tumors in Japan.

Programs allowing access to investigational drugs and off-label drug use for serious diseases have often been applied to pediatric cancers. A clinical study conducted under the Japanese "Patient-Proposed Healthcare Services" evaluated the efficacy and safety of dabrafenib plus trametinib in children with BRAF V600 mutant glioma (jRCTs071210071). This study successfully provided unapproved and off-label medications to four enrolled patients, two with low-grade glioma and two with high-grade glioma (median age: 10.

Treatment for low-grade and high-grade endometrial carcinoma after recurrence/relapse before the molecular targeted therapy era: A retrospective, propensity score-matched cohort study.

Aim: To compare the prognosis of low-grade endometrial carcinoma (LG-EC) with that of high-grade endometrial carcinoma (HG-EC) after first recurrence/relapse before the molecular targeted therapy era.

Methods: Recurrent/relapsed endometrial cancer was diagnosed in 155 women at our hospital between January 26, 1999 and February 26, 2019. Fifty of these women received paclitaxel-carboplatin, two received doxorubicin-cisplatin, and one received docetaxel-carboplatin as postoperative chemotherapy.

Impact of Relative Dose Intensity of Enfortumab Vedotin for Advanced Urothelial Carcinoma.

Background/aim: The impact of enfortumab vedotin (EV) dose reduction and/or interruption on its efficacy for advanced urothelial carcinoma (UC) is unclear.

Patients And Methods: We retrospectively analyzed consecutive patients with advanced UC who received EV after the failure of platinum-based chemotherapy and immune checkpoint inhibitors from December 2021 to June 2024. Patients were categorized into three groups based on the calculated relative dose intensity (RDI): RDI<50%, RDI ≥50 to <80%, and RDI ≥80%.

Phase 3 Study of Talazoparib Plus Enzalutamide Versus Placebo Plus Enzalutamide as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer: TALAPRO-2 Japanese Subgroup Analysis.

Background: In TALAPRO-2, the poly(ADP-ribose) polymerase inhibitor talazoparib plus the androgen receptor-signaling inhibitor enzalutamide improved radiographic progression-free survival (rPFS) versus placebo plus enzalutamide (hazard ratio [HR] = 0.63; 95% CI, 0.51-0.

Is Sublobar Resection Feasible for High-Risk Pathologic Stage I Non-small Cell Lung Cancer?

Background: Sublobar resection is the standard procedure for cT1N0 stage I non-small cell lung cancer (NSCLC) size ≤2 cm. However, its efficacy for high-risk pathologic stage I cases with a preoperative diagnosis of cT1N0 stage I NSCLC size ≤2 cm remains unclear. This study compared the outcomes of sublobar resection with those of lobectomy from a pathologic perspective.

An open-label, randomized, controlled trial on the benefit of β-hydroxy-β-methyl butyrate, l-arginine, l-glutamine combination beverages and locomotion training as supportive care for the treatment of unresectable hepatocellular carcinoma using lenvatinib: A pilot study (HELLO study).

Introduction: Hand-foot-skin reaction (HFSR) is the most common side effect of multi-tyrosine kinase inhibitor therapy for unresectable hepatocellular carcinoma (uHCC). Sarcopenia has been reported to be a poor prognostic factor for HCC. Here, we performed a randomized controlled trial (RCT) of the efficacy of a β-hydroxy-β-methyl butyrate/l-arginine/l-glutamine (HMB/Arg/Gln) beverage and locomotion training as supportive care in the treatment of uHCC with lenvatinib.

Imlunestrant with or without Abemaciclib in Advanced Breast Cancer.

Background: Imlunestrant is a next-generation, brain-penetrant, oral selective estrogen-receptor (ER) degrader that delivers continuous ER inhibition, even in cancers with mutations in the gene encoding ERα ().

Methods: In a phase 3, open-label trial, we enrolled patients with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer that recurred or progressed during or after aromatase inhibitor therapy, administered alone or with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor. Patients were assigned in a 1:1:1 ratio to receive imlunestrant, standard endocrine monotherapy, or imlunestrant-abemaciclib.

RELAY: Final Overall Survival for Erlotinib Plus Ramucirumab or Placebo in Untreated, EGFR-Mutated Metastatic NSCLC.

Introduction: RELAY, a global double-blind, placebo-controlled phase 3 study (NCT02411448) found statistically significant improvement in progression-free survival (primary end point) for ramucirumab (RAM) plus erlotinib (ERL) (RAM + ERL) in patients with untreated EGFR-mutated metastatic NSCLC (hazard ratio [HR] = 0.59, 95% confidence interval [CI]: 0.46-0.

Clinical significance of NOTCH1 and FBXW7 alterations in adult T-cell leukemia/lymphoma.

Here, we investigated the clinical significance of NOTCH1 and FBXW7 alterations for adult T-cell leukemia/lymphoma (ATLL) treatment outcomes. NOTCH1 alterations were identified in 37 (14.4%) of 257 patients, of which 33 were single nucleotide variants/insertion-deletions in the PEST domain, and 7 were in the heterodimerization or LIN-12/Notch repeats domains.

Photon and Neutron Dose Estimation Using Monte Carlo Simulation in TrueBeam's Room.

Purpose: The distribution of neutron ambient dose equivalent within the TrueBeam 10 MV photon chamber was investigated.

Materials And Methods: The research used particle and heavy ion transport code system (PHITS) code and JENDL-5.0 to simulate the neutron ambient dose equivalent on and around TrueBeam's head.