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Safety and effectiveness of mogamulizumab in relapsed or refractory adult T‐cell leukemia‐lymphoma
- Source :
- European Journal of Haematology
- Publication Year :
- 2019
- Publisher :
- Wiley, 2019.
-
Abstract
- Objective This prospective, observational, postmarketing surveillance was conducted to evaluate the safety and effectiveness of mogamulizumab, an anti‐CC chemokine receptor 4 (CCR4) monoclonal antibody, in patients with CCR4‐positive, relapsed or refractory (r/r) adult T‐cell leukemia‐lymphoma (ATL) in Japan. Method All patients were scheduled to receive intravenous infusions of mogamulizumab 1.0 mg/kg once weekly for 8 weeks, alone or in combination with other modalities. Results In the safety analysis population comprising 572 patients, mogamulizumab therapy was started between May 29, 2012, and April 30, 2013, and adverse drug reactions (ADRs) were reported in 73.4% (38.6% serious cases) of patients. The most common ADRs were skin disorders (33.2% [10.8% serious cases]), infusion‐related reactions (30.1% [4.7% serious cases]), and infections (22.0% [14.7% serious cases]). In the effectiveness analysis population comprising 523 patients, the best overall response rate and the response rate at the end of therapy were 57.9% and 42.0%, respectively. The median overall survival was 5.5 months. Safety and effectiveness results were similar between patients aged ≥70 and
- Subjects :
- Male
Oncology
medicine.medical_specialty
medicine.drug_class
CCR4
Postmarketing surveillance
Kaplan-Meier Estimate
elderly patients
Antibodies, Monoclonal, Humanized
Monoclonal antibody
03 medical and health sciences
Chemokine receptor
Antineoplastic Agents, Immunological
0302 clinical medicine
Refractory
Recurrence
hemic and lymphatic diseases
Internal medicine
Mogamulizumab
medicine
Humans
Leukemia-Lymphoma, Adult T-Cell
postmarketing surveillance
In patient
Prospective Studies
Aged
Aged, 80 and over
relapsed or refractory
business.industry
mogamulizumab
Original Articles
Hematology
General Medicine
Middle Aged
Refractory Adult T-Cell Leukemia/Lymphoma
Treatment Outcome
ATL
Drug Resistance, Neoplasm
030220 oncology & carcinogenesis
Original Article
Female
business
030215 immunology
medicine.drug
Subjects
Details
- ISSN :
- 16000609 and 09024441
- Volume :
- 102
- Database :
- OpenAIRE
- Journal :
- European Journal of Haematology
- Accession number :
- edsair.doi.dedup.....52eff07a94634105e4f00f7631665e50