Ramucirumab has shown efficacy in combination with paclitaxel in the second-line treatment of advanced gastric cancer (AGC). The efficacy and safety regarding the combination therapy of ramucirumab and docetaxel have not been reported. This treatment could reduce the incidence of neuropathy and patients’ hospital visits. This was a multicenter, single-arm phase II trial. Patients with AGC who were refractory or intolerant to primary treatment were eligible. Patients received ramucirumab at a dose of 8 mg/kg on day1 and 15, and docetaxel at a dose of 60 mg/m2 on day1 of a 28-day cycle. The primary endpoint was overall response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), relative dose intensity, and safety. A final analysis of efficacy and safety was performed in 35 patients. ORR was 25.7
Anamorelin hydrochloride (ANAM), used to treat cancer cachexia, is often discontinued early in clinical practice. Herein, we explored the clinical factors associated with the early discontinuation (Ed) of ANAM and examined its effect on treatment outcomes. Clinical data of patients with gastrointestinal cancers who were administered ANAM between April and November 2021 from 16 institutions were retrospectively collected. Ed was defined as ANAM discontinuation within 4 weeks of initiation. ANAM efficacy was compared between the continuation (Co) and Ed groups. Of the 123 patients, 50 had an Ed of ANAM. The most common reasons were cancer progression (36
BACKGROUND:Secondary acute myeloid leukemia (sAML) and AML with myelodysplasia-related changes (AML-MRC) are associated with poor prognosis, but the impact relative to de novo AML remains controversial. We investigated clinical and genetic features in a multicenter Japanese cohort before CPX-351 approval. METHODS:We retrospectively analyzed 294 patients with newly diagnosed AML registered in the Hokkaido Leukemia Net between 2022 and 2023. Propensity score matching was used to adjust baseline variables. Genetic profiles were assessed in 160 matched patients. RESULTS:In the matched cohort, sAML/AML-MRC did not show inferior overall survival compared with non-sAML/non-AML-MRC (P = 0.90). Adverse karyotypes were the predominant determinant among sAML/AML-MRC. Among sAML/AML-MRC patients, adverse karyotypes were associated with poorer survival than those without adverse karyotypes (P = 0.0075). In contrast, non-sAML/non-AML-MRC groups did not affect survival regardless of adverse karyotypes (P = 0.51). Among 65 patients with ELN 2017 adverse-risk, those with TP53 mutations had markedly shorter survival than those with TP53 wild-type (P = 0.018). CONCLUSIONS:sAML/AML-MRC with an adverse karyotype had a dismal outcome. These findings provide a benchmark for risk stratification in the pre- CPX-351 era.
OBJECTIVE:Our prior interim report remains the only prospective study evaluating tenofovir alafenamide (TAF) for HBV reactivation prevention, with prophylaxis assessed up to 12 months. Herein, we report the final 24-month follow-up results. METHODS:This multicentre prospective-study enrolled HBV carriers who received prophylactic TAF before antineoplastic or immunosuppressive therapy and patients with resolved HBV infection who developed reactivation and received TAF as reactivation-related hepatitis prophylaxis. We examined TAF effectiveness at 12 and 24 months. The primary endpoints were HBV reactivation and reactivation-related hepatitis. RESULTS:Of 191 enrolled patients, 150 and 127 were evaluable at 12 and 24 months, respectively. At 12 months, no HBV reactivation, HBV reactivation-related hepatitis, or therapy interruption occurred. Between months 12-24, four patients discontinued TAF. None of the remaining patients experienced HBV reactivation, HBV reactivation-related-hepatitis, or treatment interruption. Virologic relapse occurred in one of two patients with TAF discontinuation after anticancer/immunosuppressive therapy completion; TAF re-initiation enabled biochemical hepatitis prevention and viral suppression. Neither patient who switched to entecavir experienced reactivation. No patients on high-risk regimens developed reactivation, reactivation-related hepatitis, or treatment interruption. No patient discontinued therapy for TAF-related adverse events. CONCLUSIONS:Over 24 months, TAF demonstrated effectiveness in preventing HBV reactivation and reactivation-related hepatitis.
The Sequential Organ Failure Assessment (SOFA)-2 score was developed to better reflect contemporary critical care practice by incorporating modern organ support modalities and updated thresholds based on recent data. However, the generalizability of this framework to intensive care unit (ICU) populations beyond the development cohort, particularly across organ support subgroups and major disease categories, remains uncertain. We aimed to evaluate the external validity of SOFA-2 using the OneICU database, a large Japanese critical care database with comprehensive domain-level data. Adult ICU stays between February 2013 and August 2025 were included and classified into two cohorts: those with complete SOFA-1 and SOFA-2 component data on the day of ICU admission, and those with complete SOFA-2 data on that day. Discriminatory performance for ICU mortality was evaluated using the area under the receiver operating characteristic curve (AUROC) and compared between SOFA-1 and SOFA-2 using the DeLong test. Subgroup analyses were performed by major organ support device use and across disease categories. Among 152,883 eligible ICU stays, 67,116 had complete SOFA-1 and SOFA-2 data, and 121,443 had complete SOFA-2 data. SOFA-2 showed a slightly higher AUROC for ICU mortality than SOFA-1 (0.859 vs. 0.853; p < 0.001), although the absolute difference was small. Across subgroups defined by mechanical circulatory support use, SOFA-2 showed higher discrimination than SOFA-1. Discrimination was similar in other device-defined subgroups and in patients readmitted to the ICU. SOFA-2 also demonstrated good discrimination across major diagnostic groups. SOFA-2 showed similar discrimination for ICU mortality compared with SOFA-1 and maintained broadly comparable performance across clinically relevant subgroups, supporting its applicability for early severity assessment in heterogeneous ICU populations.
