International Journal of Clinical Oncology最新文献

Background: Major hepatectomy (MH) can increase the risk of adverse events (AEs) owing to impaired drug metabolism due to decreased liver volume and surgical injury. Thus, we performed this subgroup analysis using data from JCOG1113, a phase III trial comparing gemcitabine plus S-1 (GS) and gemcitabine plus cisplatin (GC) in patients with advanced and recurrent biliary tract cancer (BTC), to evaluate the effect of MH on the safety and efficacy of GC and GS regimens in patients with recurrent BTC.

Methods: Of the 354 patients with advanced BTC enrolled in JCOG1113, 76 patients with postoperative recurrence (30 in the MH group and 46 in the non-MH group) were analyzed.

Results: Grade ≥ 3 platelet count decreased in both arms was more frequent in the MH group than in non-MH group (GC, 0.0 vs. 17.6%; GS, 3.9 vs. 15.4%). However, in the MH group, the white blood cell decreased (GC, 55.0 vs. 38.5%; GS, 23.1 vs. 7.7%) and anemia (GC, 15.0 vs. 11.8%; GS, 23.1 vs. 7.7%) were less common than in the non-MH group. The MH and non-MH groups showed no significant difference in overall survival (OS) in both GC [median OS, 23.0 in MH vs. 16.9 months in non-MH (hazard ratio, 0.857; 95% CI 0.387-1.899)], and GS [median OS, 21.5 vs. 14.9 months (hazard ratio, 0.670; 95% CI 0.310-1.447)] arms.

Conclusions: The safety and efficacy of gemcitabine-based chemotherapy were comparable between patients who underwent MH and those who underwent other surgeries.

Background: Cluster of differentiation 155 (CD155) is expressed in many tumor types. CD155 is involved in the immune avoidance of tumor cells and contributes to tumor development and progression. Therefore, CD155 is a novel target for cancer immunotherapy. The clinical significance of CD155 expression in lung squamous cell carcinoma (LUSC) has not been fully elucidated.

Materials and methods: We performed a retrospective analysis of 264 patients with surgically resected LUSC. Immunohistochemistry was used to evaluate CD155 expression. The association of CD155 expression with clinicopathological features and clinical outcomes was assessed. We also analyzed the relationship between CD155 expression and programmed cell death-ligand 1 (PD-L1) expression and tumor-infiltrating lymphocytes.

Results: Among the 264 patients, 137 patients (51.9%) were classified in the high CD155 expression group. High CD155 expression was significantly associated with pleural invasion, vascular invasion, PD-L1 positivity, and high CD3, CD4, and CD8 expressions. In multivariate analysis, the presence of pleural invasion and PD-L1 positivity were independent predictors of high CD155 expression. Kaplan-Meier curve analysis showed that high CD155 expression was significantly associated with shorter disease-free survival and overall survival. In multivariate analysis, high CD155 expression was an independent poor prognostic factor for overall survival, but not for disease-free survival. Subgroup analyses revealed that the prognostic effect of CD155 expression was observed in the PD-L1 positive group but not the PD-L1 negative group.

Conclusion: Our analysis revealed that high CD155 expression significantly predicted poor prognosis in patients with surgically resected LUSC, especially in patients with PD-L1-positive tumors.

Background: In early-stage endometrial cancer (EC), the treatment of aggressive histological subtypes (endometrioid carcinoma grade 3, serous carcinoma, clear-cell carcinoma, undifferentiated carcinoma, mixed carcinoma, and carcinosarcoma) is controversial. We aimed to investigate the treatment of patients with International Federation of Gynecology and Obstetrics (FIGO) stage IC and stage IIC EC according to the 2023 classification.

Methods: We retrospectively identified patients with FIGO 2023 stage IC, IIC-intermediate risk (IIC-I), and IIC-high risk (IIC-H) EC who underwent adjuvant therapy or observation after surgery at eight medical institutions from 2004 to 2023. Progression-free survival (PFS) and overall survival (OS) were evaluated using Kaplan-Meier estimates and univariate and multivariate analyses.

Results: The PFS and OS were significantly worse in patients with FIGO 2023 stage IIC-H EC than in those with FIGO 2023 stage IIC-I EC (PFS: p = 0.008 and OS: p = 0.006). According to the FIGO 2023 stage IIC-H classification, lymphadenectomy and chemotherapy resulted in better prognoses regarding both PFS and OS (p < 0.001 for both) than other treatments. Our findings suggest that lymphadenectomy and chemotherapy effectively reduced vaginal stump and lymph node metastases in FIGO 2023 stage IIC-H EC (p < 0.001 and p = 0.008, respectively). Furthermore, in the multivariate analysis, not undergoing lymphadenectomy or chemotherapy were independent predictors of recurrence and poor prognoses in patients with FIGO 2023 stage IIC-H EC (p < 0.001 and p = 0.031, respectively).

Conclusion: Lymphadenectomy and chemotherapy resulted in better prognoses regarding both recurrence and survival in patients with FIGO 2023 stage IIC high-risk EC.

Background: Vepdegestrant (ARV-471) is an oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader.

Methods: This phase 1 study (NCT05463952) investigated safety, pharmacokinetics, and antitumor activity of vepdegestrant in Japanese patients with ER-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer at the 200-mg once daily (QD) recommended phase 3 dose. Eligible patients had ER+/HER2- advanced breast cancer resistant to standard therapy, with no standard therapy available, or had received two or more prior endocrine therapies in any setting. The primary endpoint was dose-limiting toxicities (DLTs) in cycle 1; secondary endpoints included safety, pharmacokinetics, and antitumor activity.

Results: Six female patients (median age, 58 [range: 47-62] years) were treated. For advanced disease, three (50.0%) patients received three or more prior regimens and five (83.3%) patients received prior cyclin-dependent kinase 4/6 inhibitors. At data cutoff, median treatment duration was 9.8 (range: 6-28) weeks; two patients remained on treatment. No DLTs were observed. Four (66.7%) patients experienced adverse events; none led to dose reduction or discontinuation. Four (66.7%) patients had treatment-related adverse events; all were grade 1 except anemia (grade 2). Geometric mean maximum plasma concentration and 24-h area under the plasma concentration-time curve of vepdegestrant were 630.9 ng/mL and 10,400 ng∙hr/mL after a single dose and 1056 ng/mL and 18,310 ng∙hr/mL after multiple doses. Two (33.3%) patients demonstrated stable disease at week 24.

Conclusion: Vepdegestrant 200 mg QD was well tolerated in Japanese patients with ER+/HER2- advanced breast cancer with no notable differences in pharmacokinetics from Western patients.

Clinical trial registration: ClinicalTrials.gov: NCT05463952 (date of registration: July 19, 2022).

Background: Chronic lymphocytic leukemia (CLL) is a rare form of lymphoma in Japan. This study aimed to explore hematologists' motivations and considerations in making treatment decisions for CLL.

Methods: Responses from hematologists treating CLL, obtained through an online survey, were descriptively analyzed. Subgroup analyses by preferred first-line (1L) treatment, years of clinical experience, and level of interest in CLL were conducted.

Results: Out of 107 hematologists surveyed, 82.2% identified Bruton tyrosine kinase inhibitors (BTKi) as their primary choice for 1L treatment; the reasons included established clinical evidence (61.4%) and oral administration convenience (56.8%). Key factors influencing 1L treatment selection among those favoring BTKi included the presence of 17p deletion, TP53 mutation, and patient's fitness status. BTKi was favored by 92.6% of hematologists with < 10 years of clinical experience and by 78.8% with more experience. The main reasons for choosing BTKi included safety (50.0%) and tolerance (46.7%) among hematologists who stated they had a specific interest in CLL and the oral administration route (62.1%) among hematologists with lower interest. When BTKi was used as 1L therapy, venetoclax-based regimens were preferred for second-line treatment. The most common concern about BTKi was substantial out-of-pocket costs.

Conclusion: Although many Japanese hematologists select their treatment based on clinical evidence, variations exist in treatment strategies, possibly associated with hematologists' experience and interest in CLL. These findings underscore the importance of further promoting evidence-based treatments to ensure that all physicians can make informed decisions. Future research should explore additional factors that influence CLL treatment decisions.

Objectives: To ascertain the effects of prolonging flushing intervals (FIs) for Totally Implantable Venous Access Devices (TIVADs) on catheter-related complications in the off-treatment period.

Methods: A preliminary search of PubMed, EMBASE, Cochrane, Web of Science, Web of Science, Scopus, CNKI, and SinoMed was conducted from inception to 6th June 2023, using the keywords "vascular access devices", "interval", "occlusion", and "complication". Two independent reviewers performed studies screening, quality assessment, and data extraction. The methodological quality of included articles was assessed using the Newcastle-Ottawa Scale (NOS) and Risk of Bias (ROB) tools. Meta-analysis and trial sequential analysis (TSA) was performed to calculate the risk ratios and 95% confidence interval (CI).

Results: Eleven studies with 4,924 participants were included. Extending FIs to two or three months increased the risk of catheter occlusion compared to one-month intervals [RR = 1.50 (1.18-1.92), P = 0.001], but this finding was not confirmed by sensitivity analysis and TSA. Extending FIs to three months showed no significant effect on overall complications rates [RR = 1.21 (0.99-1.48), P = 0.49], consistent with sensitivity analysis and TSA results. For other catheter-related complications, the results showed extending the FIs to three months was feasible, but with weak measurements due to insufficient data.

Conclusion: Data from the current included studies tended to support the feasibility of extending the flushing interval to every three months, with no expected increase in catheter occlusion or overall catheter complications. However, due to the inherent limitations of the included study, the findings of the current study should be interpreted with caution.

Improved cancer treatment outcomes have increased the demand for medical care that considers the quality of life of patients with cancer. Patient-reported outcomes (PROs) help assess the quality of life because they involve direct evaluation of the patients. Recently, electronic PROs (ePROs) have been used in clinical cancer care settings in Europe and the United States. Electronic PROs positively affected communication between patients with cancer and healthcare providers, enhanced education, optimized self-management, contributed to healthcare economics, assisted in monitoring adverse events, and improved prognosis. However, challenges such as adherence, burden on healthcare providers, lack of personalized formats, low digital literacy, and implementation costs remain. Therefore, carefully selecting the items to be recorded by ePROs in alignment with specific objectives is essential. Additionally, developing systems using lifelogs-digital records of daily activities-and creating mechanisms that automatically encourage patient behavioral changes based on the reported data are crucial. This review delineates the advantages and challenges of ePROs according to their history and proposes the prospects of ePRO.

Background: The association between aspirin and hepatocellular carcinoma (HCC) has been reported to prevent carcinogenesis caused by hepatitis B or C virus infection. The objective of this study was to investigate the prognostic impact of aspirin in patients who underwent liver resection for HCC.

Methods: Data for 1032 patients who underwent primary resection for HCC between 2000 and 2019 were reviewed. There were 87 patients (8.4%) who took aspirin (aspirin group) and 945 (91.6%) who did not (non-aspirin group). Short-term outcomes, recurrence-free survival (RFS), and overall survival (OS) were compared between two groups in the matched cohort using propensity-score matching.

Results: The median patient follow-up was 42.6 months (95% confidence interval 3.12-136.8 months). There was no significant difference in short-term outcomes, including bleeding events. RFS and OS after liver resection in the aspirin group were significantly better than those in the non-aspirin group in the unmatched cohort [5-year RFS rate: 50.3% vs 31.4%, hazard ratio (HR) 0.55, P = 0.0002; 5-year OS rate: 82.9% vs 70.2%, HR 0.46, P = 0.002]. In the matched cohort, RFS and OS after liver resection in the aspirin group were also significantly better than those in the non-aspirin group (5-year RFS rate: 50.3% vs 32.0%, HR 0.60, P = 0.003; 5-year OS rate: 82.9% vs 74.6%, HR 0.56, P = 0.03).

Conclusion: Use of aspirin was associated with better prognosis for patients who underwent primary resection for HCC.

Background: To assess the predictive factors of immediate urinary continence after robot-assisted radical prostatectomy.

Methods: This study included 282 patients who underwent conventional robot-assisted radical prostatectomy at our institution from April 2019 to March 2024. The primary outcome was immediate urinary continence, defined as the absence of urine leakage immediately after urinary catheter removal on postoperative day 6 or 7. In addition, the immediate urine loss rate, defined as the 24-h urine loss volume divided by the total urine volume after catheter removal, was calculated. The multivariable logistic model was used to assess the possible predictive factors of immediate continence (urine loss rate of 0%). The factors included age, body mass index, Charlson Comorbidity Index, pre-existing lower urinary tract symptoms, presence of an inguinal hernia, prostate volume, membranous urethral length, stratified cancer risk, surgeon's experience, and nerve-sparing procedure. In addition, a multiple linear regression model was established to investigate the associations of the same predictors with immediate urine loss rate (%). We also presented our techniques to achieve immediate continence.

Results: The patients' median age was 70 (interquartile range: 63.0-73.0) years. Approximately 39% (n = 111) of patients presented with immediate continence. Age, inguinal hernia, membranous urethral length, and low risk for prostate cancer were associated with immediate continence. These were also statistically significant predictors of immediate urine loss rate.

Conclusion: Our study identified factors predicting immediate urinary continence after conventional robot-assisted radical prostatectomy. This information is potentially valuable for preoperative counseling in patients undergoing robot-assisted radical prostatectomy.