BACKGROUND:To evaluate the dissemination and real-world implementation of recommendations from the 5th Edition of the Japanese Esophageal Cancer Practice Guidelines and to inform development of the upcoming 6th Edition, the Guideline Committee of the Japanese Esophageal Society conducted a nationwide Quality Indicator (QI) survey in Japan. METHODS:A nationwide, cross-sectional, web-based questionnaire survey was distributed to 381 certified institutions participating in the 2023 National Registry of Esophageal Cancer in Japan. Conducted in November 2024, the survey covered six domains-epidemiology, surgery, endoscopy, chemotherapy, radiation therapy, and pathology-reflecting key recommendations of the 5th Edition. Responses were summarized descriptively at the institutional level. RESULTS:Valid responses were obtained from 190 institutions (49.9%). Smoking cessation guidance was implemented in more than 90% of institutions, and over 90% also provided guidance on alcohol abstinence or moderation, although complete alcohol abstinence was less uniformly recommended. Minimally invasive, including robot-assisted, esophagectomy was adopted by over 90% of institutions. The proportion of institutions performing prophylactic cervical lymph node dissection varied by tumor location and stage, reflecting contemporary staging concepts. The DCF regimen was the predominant neoadjuvant therapy for stage II/III disease (94.7%), and immune checkpoint inhibitor-based chemotherapy was widely used for unresectable or recurrent disease. Advanced endoscopic diagnostic modalities, including magnifying and image-enhanced endoscopy, were widely adopted. CONCLUSIONS:This nationwide QI survey demonstrates broad adherence to guideline-based multidisciplinary management of esophageal cancer in Japan and provides an evidence base for refining recommendations in the 6th Edition of the Japanese Esophageal Cancer Practice Guidelines.
Zolbetuximab is a monoclonal antibody targeting claudin 18 isoform 2 (CLDN18.2) approved for first-line treatment of CLDN18.2-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Here, we report efficacy and safety outcomes from the combined Japanese subgroup analysis of SPOTLIGHT and GLOW. Global, double-blind, phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials investigated zolbetuximab plus chemotherapy versus placebo plus chemotherapy in patients with CLDN18.2-positive, HER2-negative, LA unresectable or metastatic gastric or GEJ adenocarcinoma. The primary endpoint in both trials was progression-free survival (PFS); overall survival (OS) was a key secondary endpoint. Of 1072 patients enrolled, 116 Japanese patients (SPOTLIGHT, n = 65; GLOW, n = 51) comprised the combined Japanese subgroup. The baseline characteristics of Japanese patients were generally similar to those of the overall study populations. In the combined Japanese subgroup, PFS was improved with zolbetuximab plus chemotherapy versus placebo plus chemotherapy (20.53 months [95
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:Postoperative infections remain a critical concern in the management of osteosarcoma, particularly after limb salvage surgery. While infections are often perceived as detrimental, emerging evidence suggests that under certain circumstances, localized infections may improve survival outcomes. This study evaluated the relationship between postoperative infection and survival in Japanese patients with osteosarcoma. METHODS:We retrospectively reviewed the medical records of patients diagnosed with osteosarcoma who underwent surgery between April 1990 and October 2021 at nine institutions. Patients with trunk or pelvic lesions, distant metastases at initial diagnosis, age over 60, or infections occurring more than 1 year postoperatively were excluded. RESULTS:Among 466 eligible patients, 34 (7.3%) developed postoperative infections. The 5-year overall survival rate was 84.4% in infected patients and 82.9% in non-infected patients, with no significant difference (p = 0.778). The proximal tibia was more susceptible to infection than other sites, with an odds ratio of 2.621 (p = 0.008), and larger tumors were more likely to develop infection (odds ratio, 1.093; p = 0.009). CONCLUSIONS:Postoperative infection did not improve survival in patients with osteosarcoma. Tumors in the proximal tibia and those with larger maximum diameters were more susceptible to infection.
At present, no clinical guidelines have been established regarding the use of radiofrequency ablation (RFA) for early stage breast cancer. The Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (RAFAELO) study aimed to assess the efficacy and safety of RFA as an alternative to partial mastectomy in patients with early stage breast cancer. This study was a multicenter, single-arm, phase 3 study. Female patients with a single breast cancer classified as Tis–T1 (tumor size ≤ 1.5 cm), N0M0 Stage 0–I underwent treatment RFA. All patients then received radiation therapy totaling 45–60 Gy. The primary endpoint was the 5-year ipsilateral breast tumor recurrence-free survival (IBTRFS) rate. The threshold for a clinically unacceptable 5-year IBTRFS rate was set at 90
