Long‐term efficacy and safety of bexarotene for Japanese patients with cutaneous T‐cell lymphoma: The results of a phase 2 study (B‐1201)

Autor: Toshihisa Hamada, Kentaro Yonekura, Mitsuru Setoyama, Toshiaki Saida, Keiji Iwatsuki, Yoshiki Tokura, Ryoji Tsuboi, Eiji Kiyohara, Mikio Ohtsuka, Makoto Sugaya, Shigeto Matsushita, Kazuhiro Kawai, Tetsuo Nagatani, Mamori Tani
Rok vydání: 2019
Předmět:
Male
Skin Neoplasms
Time Factors
adverse event
Phases of clinical research
Gastroenterology
030207 dermatology & venereal diseases
Lymphoma
Primary Cutaneous Anaplastic Large Cell
0302 clinical medicine
Japan
Hypertriglyceridemia
Bexarotene
education.field_of_study
Leukopenia
General Medicine
Tolerability
030220 oncology & carcinogenesis
Female
Original Article
medicine.symptom
objective response rate
medicine.drug
Adult
medicine.medical_specialty
Neutropenia
cutaneous T‐cell lymphoma
Hypercholesterolemia
Population
Antineoplastic Agents
Dermatology
Young Adult
03 medical and health sciences
Mycosis Fungoides
Hypothyroidism
Internal medicine
medicine
Humans
education
Neoplasm Staging
Dose-Response Relationship
Drug
business.industry
Cutaneous T-cell lymphoma
bexarotene
Original Articles
medicine.disease
Clinical trial
business
Follow-Up Studies
Zdroj: The Journal of Dermatology
ISSN: 1346-8138
0385-2407
DOI: 10.1111/1346-8138.14923
Popis: The present study (B‐1201 clinical trial) was conducted as a multicenter, open‐label, single‐arm phase II study to evaluate the long‐term safety, tolerability and efficacy of bexarotene. This study enrolled 10 Japanese adults aged more than 20 years with cutaneous T‐cell lymphoma (CTCL) who completed the 24‐week study period of the B‐1101 trial. The objective response rate (ORR) was 53.8% (95% confidence interval, 25.1–80.8). In the early stage (IB), the ORR was 60% (3/5 cases). In the advanced stage (IIB and IIIA), the ORR was 57.1% (4/7 cases). The median time to response was 58 days (range, 27–168). The median treatment duration was 380 days (range, 33–1674). The median duration of response (DOR) could not be reached during the study period. The longest DOR reached 1618 days at the end of the B‐1201 trial. Nine patients (56.3%) in the full analysis set (FAS) population experienced dose reduction of bexarotene. Common drug‐related adverse events in the FAS population included hypothyroidism (93.8%), hypertriglyceridemia (81.3%), hypercholesterolemia (81.3%), leukopenia (68.8%) and neutropenia (56.3%). Dose‐limiting toxicity (DLT) was present in five (38.5%) of the 13 patients in the 300 mg/m2 cohort. Of the five patients, four developed grade 3 neutropenia and one developed grade 4 hypertriglyceridemia. All DLT cases recovered after the discontinuation of bexarotene. None of the five patients discontinued this trial because of DLT. The B‐1201 trial shows the long‐term safety of oral bexarotene for Japanese patients with CTCL, despite frequent dose reduction.
Databáze: OpenAIRE
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