Publications by authors named "Niikura N"

Novel selective estrogen receptor degraders (SERDs) are a promising therapeutic option under investigation for patients with estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The efficacy of novel SERDs in the treatment of advanced disease has prompted investigation into their use in the early disease setting, to reduce breast cancer recurrence. Here, we describe the design and rationale of the phase III, randomized, open-label CAMBRIA-1 and CAMBRIA-2 studies.

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Background: Despite treatment advances for patients with early-stage triple-negative breast cancer (TNBC) and hormone receptor (HR)-low/human epidermal growth factor receptor 2-negative (HER2-) breast cancer, treatments that improve clinical outcomes while mitigating toxicity are needed. Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate consisting of a humanized IgG1 monoclonal antibody attached via a plasma-stable cleavable linker to a topoisomerase-I inhibitor payload, has shown efficacy alone or in combination with durvalumab, a selective, high-affinity anti-programmed cell death ligand 1 antibody, in early-phase clinical studies.

Objectives: The primary objective of TROPION-Breast04 is to evaluate the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy versus standard of care in patients with previously untreated early-stage TNBC or HR-low/HER2- breast cancer.

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This is an annual report by the Japanese Breast Cancer Society, which provides statistics on the clinical data on breast cancer in Japan, extracted from the National Clinical Database-Breast Cancer Registry (NCD-BCR). This report includes an update of 102,453 breast cancer cases at 1339 institutions registered in the NCD-BCR in 2022. Among the 101,793 female patients, the median age at cancer diagnosis was 62 years (interquartile range, 50-73 years), and 29.

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In the primary analysis of the open-label phase III PRECIOUS study, pertuzumab retreatment combined with trastuzumab plus chemotherapy of physician's choice (PTC) significantly improved investigator-assessed progression-free survival (PFS) compared with trastuzumab plus physician's choice chemotherapy (TC) in patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced/metastatic breast cancer (LA/mBC). Here, we report final overall survival (OS) at the median follow-up of 25.8 months.

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Article Synopsis
  • The DESTINY-Breast12 study is the largest prospective trial examining the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive metastatic breast cancer, including those with brain metastases (BMs).
  • In this study, T-DXd showed promising results, with a 12-month progression-free survival (PFS) of 61.6% for patients with BMs and an objective response rate (ORR) of 62.7% for those without BMs.
  • Adverse events were observed in both cohorts, with 51% of patients with BMs and 49% of those without experiencing grade 3 or higher side effects, indicating the need for careful monitoring
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We provide updated results (median follow-up duration: 20.4 months) of a retrospective study on the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer with brain metastases (BM) and/or leptomeningeal disease (ROSET-BM). Median progression-free survival (PFS) was 14.

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Article Synopsis
  • The study focused on improving breast cancer diagnosis using diffusion-weighted imaging with background suppression (DWIBS), which typically has lower signal-to-noise ratio (SNR) but high specificity.
  • It compared the image quality and reliability of apparent diffusion coefficients (ADC) derived from two imaging techniques: conventional SENSE and a newer method called echo-planar imaging with C-SENSE (EPICS).
  • Results indicated that EPICS provided better lesion conspicuity, lower noise ratings, and higher SNR and contrast-to-noise ratios compared to SENSE, with excellent agreement in ADC measurements between the two methods.
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Purpose: This study aimed to determine whether the 21-Gene Breast Recurrence Score® assay from primary breast tissue predicts the prognosis of patients with hormone receptor-positive and human epidermal growth factor 2-negative advanced breast cancers (ABCs) treated with fulvestrant monotherapy (Group A) and the addition of palbociclib combined with fulvestrant (Group B), which included those who had progression in Group A from the Japan Breast Cancer Research Group-M07 (FUTURE trial).

Methods: Progression-free survival (PFS) and overall survival (OS) were compared using the log-rank test and Cox regression analysis based on original recurrence score (RS) categories (Low: 0-17, Intermediate: 18-30, High: 31-100) by treatment groups (A and B) and types of ABCs (recurrence and de novo stage IV).

Results: In total, 102 patients [Low: n = 44 (43.

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Background: The prognosis in patients with breast cancer with isolated locoregional recurrence (ILRR) without simultaneous distant metastases after immediate breast reconstruction (IBR) remains unknown. We aimed to investigate the prognosis in this patient population.

Methods: This multi-institutional retrospective observational study evaluated 3295 patients with primary breast cancer who underwent IBR at 12 Japanese medical facilities between January 1, 2008 and December 31, 2016.

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Article Synopsis
  • The DESTINY-Breast04 study found that trastuzumab deruxtecan (T-DXd) significantly improved progression-free survival (PFS) and overall survival (OS) compared to the treatment of physician's choice (TPC) in patients with HER2-low metastatic breast cancer who had undergone prior chemotherapy.
  • In a subgroup analysis involving 213 Asian patients, T-DXd showed a median PFS of 10.9 months compared to 5.3 months for TPC, with higher objective response rates and longer treatment durations.
  • The safety profile of T-DXd was manageable, with common side effects being neutropenia, anemia, and leukopenia, while serious lung issues were relatively
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The burden of cancer exerts a disproportionate impact across different regions and population subsets. Disease-specific attributes, coupled with genetic and socioeconomic factors, significantly influence cancer treatment outcomes. Precision oncology promises the development of safe and effective options for specific ethnic phenotypes and clinicodemographic profiles.

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Objective: Obesity adversely impacts breast cancer treatment and outcomes. This study assessed the efficacy of nurses' motivational interviews (MI) in promoting weight loss among breast cancer patients.

Methods: Motivational Interviewing was performed at 4, 8, and 12 weeks from baseline in 27 overweight/ obese breast cancer patients receiving adjuvant endocrine therapy.

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Purpose: Oncotype DX® is a frequently used multigene assay for hormone receptor-positive breast cancers. However, limited evidence is available regarding its application in Japan owing to the lack of insurance coverage. Therefore, we conducted this large-scale, retrospective study by collecting data from nine Japanese institutes and assessed postoperative treatment choice and prognosis by using Oncotype DX®.

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Background: The FUTURE trial (UMIN000029294) demonstrated the safety and efficacy of adding palbociclib after fulvestrant resistance in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced and metastatic breast cancer (ABC/MBC). In this planned sub-study, cancer panel sequencing of cell-free DNA (cfDNA) was utilized to explore prognostic and predictive biomarkers for further palbociclib treatment following fulvestrant resistance.

Materials And Methods: Herein, 149 cfDNA samples from 65 patients with fulvestrant-resistant disease were analysed at the time of palbociclib addition after fulvestrant resistance (baseline), on day 15 of cycle 1, and at the end of treatment using the assay for identifying diverse mutations in 34 cancer-related genes.

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Background: Alpha-2-glycoprotein 1, zinc-binding (ZAG), a secreted protein encoded by the AZGP1 gene, is structurally similar to HLA class I. Despite its presumed immunological function, little is known about its role in tumor immunity. In this study, we thus aimed to determine the relationship between the expression of AZGP1/ZAG and the immunological profiles of breast cancer tissues at both the gene and protein level.

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This is a prognostic report by the Japanese Breast Cancer Society on breast cancer extracted from the National Clinical Database-Breast Cancer Registry of Japan. Here, we present a summary of 457,878 breast cancer cases registered between 2004 and 2016. The median follow-up duration was 5.

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The Japanese Breast Cancer Society initiated the breast cancer registry in 1975, which transitioned to the National Clinical Database-Breast Cancer Registry in 2012. This annual report presents data from 2020 and analyzes the ten-year mortality rates for those aged 65 and older. We analyzed data from 93,784 breast cancer (BC) cases registered in 2020 and assessed 10-year mortality rates for 36,279 elderly patients diagnosed between 2008 and 2012.

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This is an annual report by the Japanese Breast Cancer Society regarding the clinical data on breast cancer extracted from the National Clinical Database-Breast Cancer Registry (NCD-BCR) of Japan. Here, we present an updated summary of 98,300 breast cancer cases registered in 2019. The median age at cancer diagnosis was 61 years (interquartile range 49-72 years), and 30.

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Tumor sensitivity to platinum (Pt)-based chemotherapy and poly(adenosine diphosphate ribose) polymerase (PARP) inhibitors is increased by homologous recombination deficiency-causing mutations; in particular, reversion mutations cause drug resistance by restoring protein function. Treatment response is predicted by breast cancer susceptibility gene 1/2 (BRCA1/2) mutations; however, BRCA1/2 reversion mutations have not been comprehensively studied in pan-cancer cohorts. We aimed to characterize BRCA1/2 reversion mutations in a large pan-cancer cohort of Japanese patients by retrospectively analyzing sequencing data for BRCA1/2 pathogenic/likely pathogenic mutations in 3738 patients with 32 cancer types.

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Article Synopsis
  • The study aimed to examine how changes in cell-free DNA (cfDNA) after treatment with palbociclib and fulvestrant might predict clinical outcomes for patients with advanced breast cancer.
  • This analysis involved 56 patients from a prior clinical trial, comparing cfDNA samples taken before treatment and on day 15 of the first treatment cycle.
  • Although there was a significant decrease in the number of mutated genes by day 15, no significant impact on progression-free survival (PFS) was found, suggesting that further research is needed to understand the clinical relevance of cfDNA changes.
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  • Pegfilgrastim, a granulocyte-colony stimulating factor, is used to reduce the risk of febrile neutropenia during chemotherapy, and its biosimilar, MD-110, was tested for safety and efficacy in early-stage breast cancer patients undergoing chemotherapy.
  • In a study with 101 participants receiving docetaxel and cyclophosphamide, the mean duration of severe neutropenia was only 0.2 days, significantly lower than the safety threshold.
  • Common side effects included alopecia, constipation, and malaise, but MD-110 showed no additional safety issues compared to the original pegfilgrastim.
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Article Synopsis
  • Therapeutic options are limited for breast cancer patients with brain metastases (BM) and leptomeningeal carcinomatosis (LMC), but trastuzumab deruxtecan (T-DXd) shows promise.
  • In a study of 104 HER2-positive breast cancer patients treated with T-DXd, the overall response rate (ORR) was 55.7%, with median progression-free survival (PFS) of 16.1 months.
  • For patients with BM, intracranial ORR was 62.7%, while in those with LMC, 12-month PFS and overall survival (OS) rates were 60.7% and 87.1%, indicating effective disease control.
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Ataxia telangiectasia (AT) is a rare autosomal recessive disorder caused by the pathological variants of the gene. Owing to i ts r arity a nd n ature, complications of AT, such a s malignant tumors, a re often difficult to manage with standard imaging studies and treatments, and there are no established management strategies. We report the case of a woman who had AT in childhood and developed breast cancer in her 20s; the disease was successfully managed by the decision-making of multidisciplinary physicians professionals with ethics support.

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