Background: This study aimed to determine the status of in-hospital cardiac rehabilitation (CR) and hospital-associated disability (HAD) for patients with acute myocardial infarction (AMI) aged >80 years. Methods and Results: This study involved the Japanese Registry of All Cardiac and Vascular Diseases and the Diagnosis Procedure Combination databases, and included patients who were hospitalized with AMI from April 2014 to March 2021. Patients were categorized by the daily amount of CR: NA, not applicable; Low, 20-30 min; Moderate, 30-40 min; and High, >40 min. Activities of daily living were assessed using the Barthel index (BI) score, and evaluated at both admission and discharge. This study defined HAD as a >= 5-point decrease in BI score at discharge compared with admission. A total of 12,061 eligible patients were selected (age 83.0 years; 36.4% female), of which 2.7% had HAD (NA, 2.0%; Low, 4.7%; Moderate, 2.6%; High, 2.6%). The Low group was more likely to develop HAD. Chronological trends in hospital stay and incidence rate of HAD gradually decreased with the increased in-hospital CR participation rate. The multivariable logistic regression analysis revealed that the daily amount of CR was selected as an independent associated factor for preventing HAD (odds ratio 0.737; 95% confidence interval 0.567-0.960; P=0.023). Conclusions: Our results revealed that higher amounts of in-hospital CR for patients with AMI should be performed, especially in octogenarians.
124 Background: Phase III trials (ML18147, VELOUR, and RAISE trials) of second-line combination therapy with molecular-targeted agents after first-line treatment with bevacizumab (BEV) for metastatic colorectal cancer (mCRC) demonstrated significant improvements in overall survival (OS). In the RAISE trial (irinotecan (IRI) dose: 180 mg/m²), the relative dose intensity (RDI) of IRI was lower (63.8%) and the incidence rates of adverse events leading to discontinuation of cytotoxic agents was higher (48.6%) in the Japanese population compared to all patients. Based on these results, we conducted a prospective trial to evaluate the efficacy and safety of fluorouracil, levofolinate, and IRI (150 mg/m², standard dose in Japan) (FOLFIRI) plus ramucirumab (RAM) as second-line treatment for mCRC in Japanese patients. Methods: On day 1 of each 2-week cycle, patients with unresectable mCRC who were refractory to oxaliplatin and fluoropyrimidine in combination with BEV or anti-epidermal growth factor receptor (EGFR) antibodies as first-line treatment received 8 mg/kg RAM, followed by the FOLFIRI regimen with low-dose IRI (150 mg/m²). The primary endpoint was progression-free survival (PFS), and secondary endpoints were OS, treatment compliance, and safety. We hypothesized an RFS threshold of 4.3 months and expected RFS of 5.7 months based on data from a Japanese subgroup of the RAISE trial. The protocol treatment was considered to be effective if the lower limit of the 95% confidence interval (CI) exceeded the 4.3-month threshold. Results: A total of 62 patients were enrolled from 15 institutions between January 2018 and August 2021. The intent-to-treat and safety populations included 61 and 58 patients, respectively. The cutoff date for the primary analysis was December 2023. Median PFS and OS were 5.9 months (95% CI, 4.8-6.9 months) and 17.0 months (95%CI, 12.0-21.0 months), respectively. Median PFS was 5.7 months (95% CI, 4.4-6.8 months) in patients treated with first-line chemotherapy with BEV and 7.4 months (95% CI, 4.6-11.0 months) in those treated with first-line chemotherapy with anti-EGFR antibodies (hazard ratio [HR], 1.17; 95% CI, 0.64-2.12; p = 0.60), and median OS was 19.8 months (95% CI, 10.4-22.4 months) and 17.5 months (95% CI, 11.5-26.1 months), respectively (HR, 0.96; 95% CI, 0.52-1.78; p = 0.91). The objective response rate and disease control rate were 8.2% and 74%, respectively. Median RDI of IRI, 5-fluorouracil, and RAM were 73.8% (range, 40.3-102.4%), 58.5% (range, 22.8-102.4%), and 80.8% (range, 36.1-102.4%), respectively. The observed Grade ≥3 adverse events included neutropenia (40%), anemia (1.7%), diarrhea (8.6%), fatigue (6.9%), decreased appetite (10%), hypertension (6.9%), and proteinuria (3.4%). Conclusions: FOLFIRI with low-dose IRI plus RAM is a feasible second-line treatment in Japanese patients with mCRC. Clinical trial information: jRCTs041180074 .
BackgroundAlthough the Omicron variant has been reported to reduce COVID-19 severity in the general population, its impact on patients with hematologic malignancies remains uncertain, and epidemiological investigation is warranted.MethodsWe conducted a multicenter retrospective cohort study of 1, 023 patients with hematologic diseases diagnosed with COVID-19 at 22 centers in Japan between January 2020 and January 2023. Outcomes within 60 days after diagnosis including severe and/or prolonged disease, COVID-19–related mortality, and overall survival (OS) were compared between the pre-Omicron and Omicron periods. Multivariable analysis was performed to identify independent adverse prognostic factors.ResultsSevere and/or prolonged disease occurred in 27.5% of patients, COVID-19–related mortality was 6.3%, and OS was 91.4%. Compared with the pre-Omicron period, the Omicron period was associated with significantly lower rates of severe/prolonged disease (26.0% vs. 48.0%, P<0.01) and COVID-19–related mortality (5.0% vs. 15.0%, P<0.01), but no significant difference in OS (92.0% vs. 84.0%, P = 0.62). Age ≥60 years was the strongest predictor of severe/prolonged disease (sHR 3.08, P<0.01) and mortality (HR 8.94, P<0.01). Male sex (sHR 1.38; HR 1.82, both P<0.01) and prior bendamustine exposure (sHR 1.83; HR 1.87, both P<0.01) were also associated with both outcomes, whereas anti-CD38 antibody therapy was linked only to mortality (HR 3.65, P<0.01).ConclusionIn patients with hematologic diseases, the Omicron period was associated with reduced severity and COVID-19–related mortality but no improvement in OS. Older age and prior bendamustine exposure were strongly associated with adverse outcomes, highlighting the need for strict infection prevention and prompt, aggressive COVID-19 management in these high-risk populations.
