Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301).

The relationship between nanoliposomal irinotecan/fluorouracil/leucovorin (NFF) treatment outcomes and neutropenia in patients with pancreatic cancer has not been thoroughly examined. Thus, we conducted a retrospective analysis of data from patients with pancreatic cancer who were treated with NFF to investigate this relationship. Neutropenia was assessed according to the Common Terminology Criteria for Adverse Events across three cutoffs: A (grade 0 versus grade 1-4), B (grades 0-1 versus 2-4), and C (grades 0-2 versus 3-4).

Nationwide multi-centric prospective study for the identification of biomarkers to predict the treatment responses of nivolumab through comprehensive analyses of pretreatment plasma exosome mRNAs from head and neck cancer patients (BIONEXT study).

Background: Nivolumab paved a new way in the treatment of patients with recurrent or metastatic (RM) head and neck squamous cell carcinoma (RM-HNSCC). However, the limited rates of long-term survivors (< 20%) demand a robust prognostic biomarker. This nationwide multi-centric prospective study aimed to identify a plasma exosome (PEX) mRNA signature, which serves as a companion diagnostic of nivolumab and provides a biological clue to develop effective therapies for a majority of non-survivors.

Pharmacokinetic and Exposure-Response Modeling Support Body Surface Area-Based Dosing of Farletuzumab Ecteribulin in Japanese Patients with Solid Tumors.

The first-in-human, Phase 1 Study 101 showed antitumor activity and a tolerable safety profile of farletuzumab ecteribulin in Japanese patients with platinum-resistant ovarian and non-small cell lung cancer. A pharmacometric assessment evaluated farletuzumab ecteribulin pharmacokinetics and exposure-response (E-R) relationships for efficacy and safety to support dose optimization. Patients received 0.

Lipidomic profiling of plasma from patients with multiple myeloma receiving bortezomib: an exploratory biomarker study of JCOG1105 (JCOG1105A1).

Purpose: A comprehensive analysis of metabolites (metabolomics) has been proposed as a new strategy for analyzing liquid biopsies and has been applied to identify biomarkers predicting clinical responses or adverse events associated with specific treatments. Here, we aimed to identify metabolites associated with bortezomib (Btz)-related toxicities and response to treatment in newly diagnosed multiple myeloma (MM).

Methods: Fifty-four plasma samples from transplant-ineligible MM patients enrolled in a randomized phase II study comparing two less-intensive regimens of melphalan, prednisolone and Btz (MPB) were subjected to the lipidomic profiling analysis.

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.

Prognostic significance of right subdiaphragmatic washing cytology in patients with endometrial cancer.

Cancer cells in the right subdiaphragmatic lavage may reflect peritoneal dissemination, but its prognostic significance is unknown. This study investigated recurrence-free survival (RFS), overall survival (OS), and recurrence patterns in patients with curatively resected endometrial cancer by cytology collection site. Peritoneal cytology was collected at the beginning of surgery by washing the pelvic and right subdiaphragmatic cavity separately.

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.

Impact of C-Reactive Protein-to-Albumin Ratio on Lung Cancer With Interstitial Pneumonia.

Background: Lung cancer with interstitial pneumonia is known to be a refractory disease. We explored whether systemic inflammatory response markers are associated with outcomes in these patients.

Methods: The participants of this multicenter retrospective study, consisting of 17 medical institutions, were treatment-naïve patients with lung cancer combined with interstitial pneumonia who underwent surgical resection between 2012 and 2017.

Quantitative Structural Analysis of Hyperchromatic Crowded Cell Groups in Cervical Cytology: Overcoming Diagnostic Pitfalls.

Background: The diagnostic challenges presented by hyperchromatic crowded cell groups (HCGs) in cervical cytology often result in either overdiagnosis or underdiagnosis due to their densely packed, three-dimensional structures. The objective of this study is to characterize the structural differences among HSIL-HCGs, AGC-HCGs, and NILM-HCGs using quantitative texture analysis metrics, with the aim of facilitating the differentiation of benign from malignant cases.

Methods: A total of 585 HCGs images were analyzed, with assessments conducted on 8-bit gray-scale value, thickness, skewness, and kurtosis across various groups.

High Fracture Risk of Femoral Bone Metastasis Treated with Palliative Radiotherapy in Recent Years.

Bone-modifying agents (BMAs) have been widely used to reduce skeletal-related events, including pathological fractures. Herein, we aimed to clarify the incidence of pathological fractures caused by high-risk femoral bone metastases after palliative radiotherapy (RT) in the BMA era and evaluate the necessity of prophylactic surgical stabilization. We assessed 90 patients with high-risk femoral bone metastases, indicated by Mirels' scores ≥ 8, without pathological fractures and surgical fixations, who received palliative RT at our institution between January 2009 and December 2018.

Real-world status of multimodal treatment of Stage IIIA-N2 non-small cell lung cancer in Japan: Results from the SOLUTION study, a non-interventional, multicenter cohort study.

Objectives: There is limited consensus on resectability criteria for Stage IIIA-N2 non-small cell lung cancer (NSCLC). We examined the patient characteristics, N2 status, treatment decisions, and clinical outcomes according to the treatment modality for Stage IIIA-N2 NSCLC in Japan.

Materials And Methods: Patients with Stage IIIA-N2 NSCLC in Japan were consecutively registered in the SOLUTION study between 2013 and 2014.

Improved prognosis of de novo metastatic prostate cancer after an introduction of life-prolonging agents for castration-resistant prostate cancer.

Background: In Japan, since 2014, new treatments such as androgen receptor signaling inhibitors and cabazitaxel have become applicable for metastatic castration-resistant prostate cancer (mCRPC), leading to dramatic changes in treatment options.

Objective: This study aims to evaluate the impact of recent advancements in treatment options on the overall survival (OS) of patients diagnosed with de novo metastatic castration-sensitive prostate cancer (mCSPC) in Japan.

Methods: A retrospective analysis was conducted on 2450 Japanese men diagnosed with de novo mCSPC between 2008 and 2018.

Efficacy of liposomal irinotecan + 5-FU/LV vs. S-1 in gemcitabine-refractory metastatic pancreatic cancer: a real-world study using inverse probability of treatment weighting.

Background: S-1 monotherapy had previously been widely used as a second-line treatment for pancreatic cancer (PC) after gemcitabine-based chemotherapy mainly in Japan. Based on the results of the NAPOLI-1 trial, the recommended second-line therapy is now liposomal irinotecan plus fluorouracil/folinic acid (nal-IRI + 5-FU/LV). However, there have been no studies comparing nal-IRI + 5-FU/LV therapy with S-1 monotherapy.

Long-term follow-up of the conventional versus no-touch isolation technique for resection of primary colon cancer (JCOG1006): randomized clinical trial.

Background: The Japan Clinical Oncology Group (JCOG) 1006 was a phase III trial of patients with clinical T3/T4 colon cancer comparing the no-touch isolation technique ('No Touch') with the conventional technique ('Conventional'). The planned primary analysis at 3 years failed to confirm the superiority of the No Touch over the 'Conventional'. The present study aimed to compare the 'No Touch' and 'Conventional' using long-term (6-year) follow-up data.

Features of late local failure of early‑stage non‑small cell lung cancer treated with stereotactic body radiotherapy.

Local failure of non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) often occurs within 2 years and delayed local failure is uncommon. In the present study, features of late local failure (LLF; >2 years after SBRT) after SBRT were investigated and compared with those of early local failure (ELF; ≤2 years after SBRT) to explore whether these two local recurrence features have different prognostic implications. Patients who underwent SBRT for stage I-IIA NSCLC between July 2006 and March 2014 were retrospectively reviewed.

Standardization of radiation therapy quality control system through mutual quality control based on failure mode and effects analysis.

The advancement of irradiation technology has increased the demand for quality control of radiation therapy equipment. Consequently, the number of quality control items and required personnel have also increased. However, differences in the proportion of qualified personnel to irradiation techniques have caused bias in quality control systems among institutions.

Trends of prostate cancer treatment in Ehime Prefecture, Japan: analysis of a hospital-based cancer registry.

Background: We previously conducted a retrospective Japanese cohort study of patients who underwent radical prostatectomy (RP) between January 2010 and December 2020 in Ehime Prefecture. This study revealed an increase in the number of RP, but other treatment trends remained unclear. In the current study, we examined prostate cancer treatment in Ehime Prefecture using the hospital-based cancer registry of all designated cancer care hospitals and community cancer care hospitals belonging to the Council of Ehime Cancer Care Hospitals.