BACKGROUND: Japan Clinical Oncology Group (JCOG) defined gastric cancer (GC) with bulky lymph node (Bulky N) and/or para-aortic lymph node (PAN) as extensive lymph node metastasis (ELM), and has developed neoadjuvant chemotherapy followed by D2 gastrectomy with PAN dissection (PAND) through three phase II trials using different regimens (JCOG0001: irinotecan/cisplatin, JCOG0405: cisplatin/S-1, JCOG1002: docetaxel/cisplatin/S-1). However, whether PAND provides survival benefit remains uncertain. METHODS: The therapeutic value index was investigated using integrated data from JCOG0001, JCOG0405, and JCOG1002. Patients were classified into Bulky N group (only bulky N without PAN) and PAN group (PAN regardless of bulky N) based on the clinical diagnosis. The index was calculated by multiplication of incidence of metastasis and percentage 5-year relapse-free survival (5yRFS) of patients with metastasis for each lymph node area. RESULTS: A total of 122 patients were analyzed (Bulky N group: 68, PAN group: 54). In Bulky N group, the proportion of metastasis/5yRFS/index in the PAN area was 15.2%/30.0%/4.5 (JCOG0001: 27.8%/20.0%/5.6, JCOG0405: 13.6%/33.3%/4.5, JCOG1002: 7.7%/50.0%/3.8). The proportion of metastasis decreased across trials. In PAN group, the proportion of metastasis/5yRFS/index in the PAN area was 44.4%/4.2%/1.9 (JCOG0001: 81.3%/7.7%/6.3, JCOG0405: 30.0%/0.0%/0.0, JCOG1002: 27.8%/0.0%/0.0). Notably, the indices of the recent two trials were zero. CONCLUSIONS: PAND may retain a potential role in the Bulky N group, whereas its benefit appears limited in the PAN group. Decreasing trends in PAN metastasis and therapeutic value were observed in both groups. Given the distinct characteristics of these subgroups, the omission of PAND should be determined through separate future validation.
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
Transcriptomic classification methods have been proposed for ovarian clear cell carcinoma. However, their clinical significance and association with pathologically evaluated tumor-infiltrating lymphocytes (TILs) remain unclear. We established two large transcriptomic datasets and analyzed RNA-sequencing data from 189 (JGOG3025-TR1 cohort) and 38 (Kyoto cohort) ovarian clear cell carcinomas. Representative histopathological slides were also digitized (102 and 38, respectively). Cell types were classified by two state-of-the-art artificial-intelligence models, and TILs were quantified. The transcriptomically defined immune subtype was associated with significantly poor prognosis (hazard ratio, 2.54; 95
The JCOG1806 trial (jRCTs031190129) is underway to evaluate the omission of surgery in patients with human epidermal growth factor receptor (HER2)-positive early breast cancer who have a clinical complete response (cCR) after primary systemic therapy (PST). We aimed to assess the cCR rate in this trial and identify predictive factors. HER2-positivity was defined as an immunohistochemistry (IHC) score of 3 + or in situ hybridization-positivity. A cCR was defined as the absence of detectable lesions upon palpation, contrast-enhanced magnetic resonance imaging, and ultrasonography; biopsy-based confirmation was optional in hormone receptor (HR)-negative cases and mandatory in HR-positive cases. Multivariate logistic regression analyses were used to identify predictors of a cCR. The cCR rate was 57.6
Anthracyclines are widely used in breast cancer and hematologic malignancies but are associated with cancer therapy-related cardiac dysfunction (CTRCD). This study aimed to evaluate the clinical utility of the Heart Failure Association–International Cardio-Oncology Society (HFA–ICOS) risk tool for baseline risk stratification. We conducted a retrospective, single-center cohort study of consecutive patients aged 16 years or older with breast cancer or hematologic malignancies who received anthracycline-based chemotherapy for the first time between January 2016 and December 2024. Baseline cardiovascular risk was stratified according to the HFA–ICOS criteria, and CTRCD was defined based on the 2022 European Society of Cardiology guidelines. Among 591 patients included in the final analytic cohort, 40 (6.8
