This study examined changes in practice patterns and outcomes of allogeneic hematopoietic cell transplantation (HCT) over the past 20 years. Data were analyzed from a Japanese nationwide registry of consecutive adult patients with acute myeloid leukemia who underwent allogeneic HCT between 2001 and 2020. The study population included 17,553 patients, of whom 6653 underwent allogeneic HCT in 2001–2010 and 10,900 in 2011–2020. Patients in the later period were older, were more likely to be in first complete remission, and more frequently received umbilical cord blood transplantation. After adjusting for major covariates, the 2011–2020 cohort had lower risks of overall mortality (hazard ratio [HR], 0.84; 95
Treatment-free remission (TFR) is an emerging goal for patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKI). However, long-term TFR durability in real-world settings remains understudied. The J-SKI study, a large observational study, was conducted to evaluate long-term TFR outcomes in Japanese patients with CML. This interim analysis included 795 eligible patients from the prospective (n = 283) and retrospective (n = 512) cohorts. With a median follow-up of 32 months (range 0.8–168) after TKI discontinuation, the 5-year TFR rate was 65.2
Using data from a nationwide Japanese registry, we evaluated the impact of the total body irradiation (TBI) dose in reduced-intensity conditioning (RIC) for allogeneic hematopoietic cell transplantation (allo-HCT) in patients with acute myeloid leukemia (AML). Adults undergoing their first allo-HCT with RIC between 2010 and 2021 were classified into three groups: non-TBI, low-TBI (2 to < 4 Gy), or moderate-TBI (4-8 Gy). Outcomes were analyzed separately for patients in complete remission (CR, n = 1949) and those in the non-CR group (n = 1484). Non-TBI was associated with higher overall mortality than low-TBI (hazard ratio [HR], 1.27; 95% confidence interval [CI], 1.03-1.56 in CR; HR, 1.19; 95% CI, 1.00-1.42 in non-CR). Moderate-TBI showed no significant difference in overall mortality compared to low-TBI (HR, 0.96; 95% CI, 0.80-1.15 in CR; HR, 0.89; 95% CI, 0.77-1.05 in non-CR). Among patients in the CR group with matched sibling donors, moderate-TBI reduced overall mortality (HR, 0.33; 95% CI, 0.17-0.64) and relapse (HR, 0.29; 95% CI, 0.12-0.69). In cord blood transplantation, non-TBI increased relapse in CR (HR, 2.73; 95% CI, 1.48-5.06) and overall mortality in non-CR (HR, 1.62; 95% CI, 1.19-2.19). In haploidentical transplants, non-TBI increased relapse (HR, 5.52; 95% CI, 1.72-17.72 in CR; HR, 1.54; 95% CI, 1.04-2.30 in non-CR). The incidence of secondary primary malignancies did not differ according to the use or dose of TBI. In conclusion, adding low- or moderate-TBI to RIC may improve disease control and survival without increasing non-relapse mortality.
BACKGROUND:Docetaxel (DTX) is commonly employed in patients with castration-resistant prostate cancer (CRPC) following failure of androgen receptor signaling inhibitors (ARSIs). However, the impact of prior ARSI treatment on the efficacy of subsequent DTX therapy remains unclear. This study aimed to compare oncological outcomes between enzalutamide (ENZ)-DTX and abiraterone acetate plus prednisolone (ABI)-DTX sequential treatment strategies in patients with CRPC. METHODS:The ENABLE study for PCa was an investigator-initiated, multicenter, randomized controlled trial conducted in Japan to compare ENZ and ABI. This subanalysis evaluated the efficacy of subsequent DTX therapy in patients who had received either ENZ or ABI. RESULTS:Between February 2015 and July 2019, 203 patients were enrolled, of whom 184 were randomized to receive ENZ or ABI (92 per arm). Among them, 20 and 21 patients subsequently initiated DTX therapy following ENZ and ABI, respectively. Median prostate cancer-specific survival (PCSS) in the ENZ-DTX and ABI-DTX groups was 22.7 and 32.1 months, respectively (p = 0.1724). Median PCSS from the initiation of DTX was 16.1 months in the ENZ-DTX group and 25.3 months in the ABI-DTX group (p = 0.0966). In the overall cohort (n = 41), patients who received additional ARSIs after ARSI-DTX therapy had significantly longer PCSS from the initiation of DTX compared with those who did not (median 21.6 vs. 13.8 months, p = 0.0157). CONCLUSIONS:ENZ-DTX and ABI-DTX sequential therapies demonstrated comparable survival outcomes in patients with CRPC. Notably, the administration of additional ARSIs following ARSI-DTX therapy may confer a survival benefit, suggesting a potential role for continued ARSI use in this treatment sequence. TRIAL REGISTRATION:The trial was registered with the University Hospital Medical Information Network (UMIN) Center under the identifier UMIN000015529 on November 1, 2014.
INTRODUCTION:Antibiotics and proton pump inhibitors (PPIs) have been associated with the reduced efficacy of immune checkpoint inhibitor (ICI) in patients with advanced non-small cell lung cancer (NSCLC). This study assessed the clinical impact of these medications in the neoadjuvant setting. PATIENTS AND METHODS:This multicenter retrospective study was conducted in 29 Japanese institutions. Between March 2023 and July 2024, 131 patients with resectable clinical stage II-III NSCLC who received neoadjuvant chemoimmunotherapy with nivolumab were enrolled. In total, 113 patients who underwent definitive surgery were included in the surgical outcome analysis. We investigated the association between the use of antibiotics and PPIs within 30 days before treatment initiation and clinicopathological factors, including the pathological complete response (pCR) and major pathological response (MPR). RESULTS:Among 113 patients, 5 (4.4%) had received antibiotics and 23 (20.4%) PPIs. Antibiotic and PPI use showed no significant differences in any clinicopathological factors. Antibiotic and PPI use was not significantly associated with the objective response rate (ORR), pCR, or MPR; antibiotic (use/non-use): 80.0%/70.4% (p = 1.000), 40.0%/35.8% (p = 1.000), 60.0%/59.6% (p = 1.000) and PPI (use/non-use): 78.3%/68.9% (p = 0.532), 43.5%/33.3% (p = 0.507), 60.9%/58.9% (p = 1.000). CONCLUSION:Prior use of antibiotics and PPIs was not significantly associated with radiological or pathological response of neoadjuvant ICI in patients with resectable NSCLC. Further studies with larger sample size and longer survival follow-up are needed.
