A5022033250- Biosimilars and Bioanalytical Methods
- Colorectal Cancer Treatments and Studies
- HER2/EGFR in Cancer Research
- Cancer Risks and Factors
- Monoclonal and Polyclonal Antibodies Research
- Assisted Reproductive Technology and Twin Pregnancy
- CAR-T cell therapy research
- Ovarian cancer diagnosis and treatment
- Chronic Lymphocytic Leukemia Research
- Prenatal Screening and Diagnostics
- Pregnancy and preeclampsia studies
- Advanced Breast Cancer Therapies
- Childhood Cancer Survivors' Quality of Life
- Reproductive Biology and Fertility
- Maternal and Perinatal Health Interventions
- Cancer-related Molecular Pathways
- Acute Myeloid Leukemia Research
- Pharmaceutical studies and practices
- Acute Lymphoblastic Leukemia research
- Preterm Birth and Chorioamnionitis
- Cancer Treatment and Pharmacology
- Multiple and Secondary Primary Cancers
Pfizer (Japan)
2019-2024
Tohoku University
2021-2023
Pfizer (United States)
2023
Abstract Background A recent large real-world study conducted in the United States reported effectiveness of palbociclib plus aromatase inhibitor HR+/HER2− advanced breast cancer (ABC). However, local clinical practice and available medical treatment can vary between Japan Western countries. Thus, it is important to investigate Japanese data. This observational, multicenter (NCT05399329) reports interim analysis ET as first-line or second-line for ABC by estimating progression-free survival...
PF-05280014 was compared with trastuzumab sourced from the European Union (trastuzumab-EU), each plus paclitaxel, as first-line treatment for human epidermal growth factor receptor 2-positive metastatic breast cancer in a phase III study. Equivalence between groups demonstrated. The aim of this study to report long-term safety and overall survival (OS) over 6 years after first patient screened. Randomized patients received intravenous or trastuzumab-EU, until objective disease progression....
Biologics have dramatically changed breast cancer treatment, and trastuzumab has been an essential treatment drug for HER2-positive cancer. The introduction of biosimilar offers the potential to deliver long-term cost savings plus efficiencies healthcare systems in Japan. goal development is demonstrate comparability original biologic with a different concept from that biologic. Hence, better understanding itself urgently needed appropriate adoption integration biosimilars into oncology...
This study aimed to develop and validate claims-based algorithms for identifying live birth, fetal death, cesarean section by utilizing administrative data from a university hospital in Japan. We included women who visited the Department of Obstetrics at 2018. The diagnosis, medical procedures, medication were used identify potential cases section. By reviewing electronic records, we evaluated positive predictive values (PPVs) accuracy end date pregnancy each claims datum. “Selected...
To describe patient and treatment characteristics associated with bevacizumab BS-Pfizer, rituximab BS-Pfizer trastuzumab their reference products in Japan.
Aim: To evaluate treatment patterns of novel therapies (inotuzumab ozogamicin (inotuzumab), blinatumomab, and tisagenlecleucel) in patients with acute lymphoblastic leukemia (ALL) a Japanese real-world setting. Patients & Methods: ALL diagnoses from claims database were examined. Results: We included 194 (97 prescribed inotuzumab; 97 blinatumomab; no patient was tisagenlecleucel); 81.4% the inotuzumab group 78.4% blinatumomab chemotherapy prior to initiation those drugs. Most subsequent...
Aim: To describe real-world breast cancer medications among reproductive-age women. Patients & methods: Using data from a Japanese claims database, anticancer prescriptions were classified into seven categories of amenorrhea risk based on fertility preservation guidelines. Results: We identified 2999 women with records and prescription 2005 to 2018. The proportions as follows: high, 4.1–12.9%; intermediate: 6.0–16.3%; low: 0.4–2.3%; very low/no: 0.3–12.2%; unknown: 33.9–45.5%; unlisted...
When using administrative data, validation is essential since these data are not collected for research purposes and misclassification can occur. Thus, this study aimed to develop algorithms identifying pregnancy evaluate the validity of claims in Japan.All females who visited Tohoku University Hospital Department Obstetrics 2018 were included. The diagnosis, medical procedure, medication, service addition fee utilized identify pregnancy, with electronic records set as gold standard....
We aimed to evaluate the adverse birth outcomes of anticancer drug prescription during pregnancy using a Japanese claims database from 2005 2019. applied validated claims-based algorithms identify pregnant women with outcomes, and evaluated pregnancy. The causal relationship between drugs was Council for International Organizations Medical Sciences Working Group VI criteria. Thirteen were identified (mean age: 34.6 years). Atrial/ventricular septal defect observed in one infant after...