Large type 3 (≥ 8 cm) and type 4 gastric cancers are associated with extremely poor prognoses. The phase III JCOG0501 trial, which evaluated neoadjuvant S-1 plus cisplatin, failed to demonstrate any survival benefits. Docetaxel, oxaliplatin, and S-1 (DOS) have been explored as more effective perioperative regimens for these tumors. Eligible patients had large type 3 or type 4 gastric cancer without distant metastases, except for positive peritoneal cytology (CY). Patients received three cycles of neoadjuvant DOS (docetaxel 40 mg/m2, oxaliplatin 100 mg/m2, and oral S-1 at 80 mg/m2/day for 14 days), followed by gastrectomy with ≥ D2 lymphadenectomy and one year of adjuvant docetaxel plus S-1. The primary endpoint was the 3 year progression-free survival (PFS) rate, with an expected value of 60
BACKGROUND:Idiopathic pulmonary fibrosis (IPF) is a progressive fibrosing interstitial lung disease with a poor prognosis. Honeycombing on high-resolution computed tomography (HRCT) is a defining feature of the usual interstitial pneumonia (UIP) pattern and has traditionally been considered a marker of advanced disease. However, in the era of antifibrotic treatment (AFT), the prognostic significance of the UIP pattern in IPF remains uncertain. This study aimed to evaluate the association between HRCT UIP pattern and long-term prognosis in patients with IPF receiving AFT. METHODS:This retrospective multicenter study investigated consecutive patients with IPF who initiated AFT between 2009 and 2019 at seven institutions in Japan. HRCT patterns were classified as UIP or non-UIP by multidisciplinary assessment. The primary outcome was IPF-related events, defined as IPF-related death or first acute exacerbation (AE) after initiating AFT. Event-free survival was analyzed using Kaplan-Meier methods with stratification by gender-age-physiology (GAP) stage. Propensity score matching (PSM) was performed to adjust for age, sex, GAP score, and antifibrotic agent. RESULTS:Of the 139 patients included, 99 had a UIP pattern, and 40 had a non-UIP pattern. In the overall cohort, event-free survival did not differ significantly. Stratified analyses showed no significant survival difference between UIP and non-UIP patterns among GAP Stage I patients (median survival time [MST]: 2050 vs. 1104 days; p = 0.90). Similarly, among patients with GAP Stages II-III, MST did not differ significantly. After PSM, 34 matched pairs were analyzed, and no significant differences in event-free survival were observed between UIP and non-UIP patterns. CONCLUSIONS:In patients with IPF treated with AFT, the radiological UIP pattern on HRCT was not independently associated with long-term prognosis. Multidimensional risk assessment incorporating physiological impairment and disease behavior may provide more accurate prognostic stratification in treated UIP populations.
Background Sodium glucose transporter 2 inhibitors (SGLT2i) reduce proteinuria in patients with diabetes and chronic kidney disease. This study aimed to evaluate the prophylactic effect of SGLT2i on bevacizumab-induced proteinuria. Methods This was a multi-institutional retrospective study including patients with hepatocellular carcinoma (HCC) who initiated atezolizumab plus bevacizumab between September 2020 and December 2023. The primary outcome was the time to exacerbation of proteinuria grade from baseline during the first 6 months of bevacizumab treatment according to the administration of SGLT2i. Results No significant difference in the time to exacerbation of proteinuria grade was observed between the SGLT2i ( n = 29) and non-SGLT2i ( n = 159) groups (the median time of SGLT2i group: 157 days vs. non-SGLT2i group: 116 days, p = 0.95). Multivariate analysis revealed that diabetes and systolic blood pressure (sBP) ≥ 130 mmHg (hazard ratio, 2.12; 95% confidence interval, 1.14–3.95; p = 0.018) were significantly associated with an exacerbation of proteinuria grade, whereas SGLT2i were not significantly associated with an exacerbation of proteinuria grade. Among patients with comorbidities of diabetes and sBP ≥ 130 mmHg at the initiation of bevacizumab ( n = 27), the SGLT2i had a significantly longer time to exacerbation of proteinuria grade (the median time of SGLT2i group: 90 days vs. non-SGLT2i group: 42 days, p = 0.016). Conclusion SGLT2i did not exert a prophylactic effect on proteinuria in the overall patient population. However, it significantly suppressed the exacerbation of proteinuria grade in patients with HCC receiving bevacizumab who had diabetes and sBP ≥ 130 mmHg.
Low-voltage areas (LVAs) in the left atrium may promote atrial fibrillation (AF), but the efficacy of LVA ablation for preventing arrhythmia has not been determined. In the present study, we carried out a multicenter, randomized controlled trial (SUPPRESS-AF) to investigate the efficacy of LVA ablation in patients with persistent AF who had left atrial LVAs. Patients with persistent AF and left atrial LVAs that covered ≥5 cm2 of the left atrial surface on a voltage map after pulmonary vein isolation (PVI) were randomized to undergo LVA ablation (PVI + LVA-ABL group) or not (PVI-alone group) in a 1:1 fashion. Recurrence of AF or atrial tachycardia (AT) was monitored using 24-h Holter electrocardiography (ECG) and twice-daily portable ECG recordings. The primary endpoint was freedom from AF or AT recurrence without antiarrhythmic drug use during 1 year of follow-up. Of 1,347 patients (1,003 males and 344 females) who underwent initial ablation for AF, patients with left atrial LVAs were assigned to the PVI + LVA-ABL (n = 170) or the PVI-alone group (n = 171). Although the PVI + LVA-ABL group demonstrated a numerically higher rate of freedom from AF or AT recurrence compared with the PVI-alone group (61% (95% confidence interval (CI) = 53-68%) versus 50% (95% CI = 42-57%)), this difference did not reach statistical significance (P for log(rank) test = 0.127). There was no difference in the procedure-related serious adverse events between the two groups (1.7% versus 1.8%, P < 0.0001). In conclusion, LVA ablation in addition to PVI did not significantly reduce 1-year AF or AT recurrence in patients with persistent AF with left atrial LVAs. Future studies are needed to identify patients who may receive greater benefit from LVA ablation.
Objective:To clarify the long-term oncological outcomes and postoperative anal, urinary, and sexual functions after laparoscopic surgery for clinical stage I very low rectal carcinoma located near the anal canal.Background:Laparoscopic surgery is widely applied for rectal cancer; however, concerns remain, with some studies showing poorer outcomes compared with open surgery.Methods:This single-arm, phase II trial included patients registered preoperatively from 47 institutions in Japan. The planned sample size was 300. The primary end point was the 3-year local recurrence rate. Anal, urinary, and sexual functions were evaluated using a prospective questionnaire.Results:Three hundred patients were registered between January 2014 and March 2017. Anus-preserving surgery was performed in 278 (93%), including 172 who underwent intersphincteric resection (58%) and 106 (36%) who underwent low anterior resection. The 3-year cumulative local recurrence rate was 6.3%. At 3 years postoperatively, 87% of patients used their own anus, and the median incontinence score improved from 12 at 3 months to 8 at 3 years. Only 5% of patients had severe incontinence (incontinence score of 16 points). Postoperative urinary function evaluation showed that the International Prostate Symptom Score and Overactive Bladder Symptom Score decreased 1 week after surgery but recovered to preoperative level 1 month after surgery. International Consultation on Incontinence Questionnaire-Sort Form remained almost stable after surgery. Sexual function evaluation using the International Index of Erectile Function-5 and International Index of Erectile Function-15 revealed that the patients had deteriorated 3 months after surgery but had recovered only slightly by 6 months.Conclusions:Laparoscopic surgery achieves feasible long-term oncological outcomes and a high rate of anus preservation with moderate anal function and an acceptable incontinence score. While urinary function recovered rapidly, sexual function showed poor recovery.
