Nivolumab plus chemotherapy has shown efficacy in clinical trials for advanced or recurrent gastric cancer (GC). However, real-world utilization data are limited. In this study, we aimed to assess the effectiveness, safety, and treatment status of first line nivolumab plus chemotherapy in Japanese patients with treatment-naïve advanced or recurrent GC. Untreated patients with advanced or recurrent GC who initiated nivolumab plus chemotherapy as first line treatment from November 2021 to June 2023 across 23 Japanese sites were enrolled in this observational study (G-KNIGHT). This report focused on the objective response rate (ORR), real-world progression-free survival (rwPFS), and the treatment-related adverse event (TRAE) incidence. Furthermore, subgroup analyses for ORR and rwPFS were conducted for patients stratified by various factors including age and the programmed cell death ligand 1 (PD-L1) combined positive score (CPS). Among 527 patients (median age, 70.3 years; 25.2
BACKGROUND:Aspiration pneumonia (AP) is one of the most important toxicities associated with chemoradiotherapy. Despite prior studies in definitive chemoradiotherapy, AP incidence and risk factors in postoperative chemoradiotherapy (POCRT) remain poorly defined. The present study investigated the clinical risk factors for AP after POCRT in patients with resected high-risk head and neck cancer. PATIENTS AND METHODS:Patients enrolled in a randomized phase II/III trial (Japan Clinical Oncology Group 1008) were analyzed to measure the incidence of AP, identify the clinical risk factors for AP post-POCRT, and assess the influence of AP on survival outcomes. AP was defined using the guidelines of the Japanese Respiratory Society. Analyses were performed via a logistic regression model. RESULTS:Of 251 patients who underwent POCRT, 100 patients who underwent laryngectomy were excluded. Among the 151 patients who received POCRT, 93 (61.6%), 85 (56.3%), and 113 (74.8%) developed AP during, after, and for an overall period of POCRT intervention, respectively. Multivariable analyses identified two independent risk factors for AP post-POCRT: dysphagia ≥ grade 3 during chemoradiotherapy (CRT) (Odds Ratio [OR] 4.691, p = 0.0009] and reconstruction surgery (OR 2.859, p = 0.0061). The occurrence of AP was not significantly associated with overall survival, relapse-free survival, or local relapse-free survival. CONCLUSIONS:Dysphagia ≥ grade 3 during POCRT and reconstruction surgery were associated with the onset of AP post-POCRT. Careful attention should be paid to these risk factors for AP in patients undergoing POCRT.
Recently, we reported the real-world effectiveness of palbociclib plus endocrine therapy (ET) in HR+/HER2– advanced breast cancer (ABC) in Japan (NCT05399329). However, median overall survival (OS) was not reached because of limited follow-up (36 months). Here, we present follow-up data from this study, including real-world clinical outcomes and treatment patterns. The P-BRIDGE study was a multi-center, observational study evaluating the real-world effectiveness and treatment patterns of patients diagnosed with HR+/HER2– ABC who received palbociclib plus ET in first (1L) or second line (2L) in Japan. The primary endpoint was real-world progression-free survival (rwPFS); secondary endpoints included OS and chemotherapy-free survival (CFS). Of the 693 eligible patients, 426 and 267 patients received palbociclib with ET as 1L and 2L treatment, respectively. After a median follow-up of 48.1 months, the median rwPFS (95
Lung cancer is the leading cause of cancer death worldwide. To aid the development of lung cancer control strategies, we analyzed trends in lung cancer survival using data from 16 population-based cancer registries in Japan that participated in the CONCORD-3 study. We included patients aged 15-99 years diagnosed with lung cancer between 2000 and 2014 and followed up until 31 December 2014. A total of 5-year net survival was estimated using the Pohar Perme estimator, stratified by calendar period, age group, sex, histological subtype, and stage. All-ages estimates were standardized with the International Cancer Survival Standard weights. Age-standardized 5-year net survival in 339 277 patients with lung cancer increased slightly over time, from 29.3% (95% confidence intervals 28.1%-30.5%) for patients diagnosed during 2000-2004 to 32.9% (32.3%-33.4%) in 2010-2014. Five-year net survival improved particularly for young patients (15-44 years), for women diagnosed with non-small cell lung cancer and with localized disease. We observed limited or no survival improvement for patients diagnosed with small-cell lung cancer or with distant disease. In Japan, 5-year net survival for patients with lung cancer improved slightly over the 15 years 2000-2014, but no improvement was observed for patients with small-cell lung cancer or with distant disease. Continued surveillance of cancer survival is essential to guide cancer control efforts and further improve treatment outcomes.
BACKGROUND/OBJECTIVES:The multicenter randomized trial JCOG0401 showed that initial salvage radiotherapy (SRT) before salvage hormonal therapy (SHT) significantly prolonged time to treatment failure (TTF) compared with SHT alone. This central pathology analysis aimed to explore pathological features potentially associated with reduced relative benefit from SRT, while distinguishing prognostic from predictive effects. METHODS:We re-analyzed 167 patients from JCOG0401 (SHT: 81, SRT ± SHT: 86). Prostatectomy specimens were re-evaluated, focusing on tertiary Gleason pattern (GP) 5 and intraductal carcinoma of the prostate (IDC-P). Cox proportional hazards models assessed exploratory interaction effects between pathological features and the treatment effect of bicalutamide on TTF. Pathological subgroups in which SRT failed to improve TTF over SHT alone were defined as having reduced benefit from SRT. RESULTS:Adverse pathological features associated with shorter TTF with limited SRT included Gleason score (≥8), GP5, tertiary GP5, IDC-P, positive surgical margins, lymphovascular invasion, and advanced pathological T stage. Exploratory Interaction analyses suggested that IDC-P and tertiary GP5 may be associated with reduced relative benefit from SRT. Among patients without IDC-P, SRT significantly improved TTF (HR 0.330, 95%CI 0.161-0.673), whereas no significant benefit was observed in those with IDC-P (HR: 0.771, 95% CI: 0.446-1.332). Similarly, the absence of tertiary GP5 was associated with a marked benefit from SRT (HR: 0.099, 95% CI: 0.021-0.466), whereas this effect was not observed with tertiary GP5 (HR: 0.760, 95% CI: 0.400-1.443). CONCLUSIONS:IDC-P and tertiary GP5 may represent pathological features associated with reduced relative benefit from SRT after radical prostatectomy. These findings are exploratory and hypothesis-generating and require prospective validation in independent cohorts. Careful pathological evaluation may help identify patients who could benefit from treatment intensification or alternative postoperative strategies.
