Carfilzomib monotherapy in Japanese patients with relapsed or refractory multiple myeloma: A phase 1/2 study

Autor: Masafumi Taniwaki, Koji Izutsu, Tadao Ishida, Takaaki Chou, Takashi Watanabe, Kenshi Suzuki, Naokuni Uike, Kiyohiko Hatake, Kensei Tobinai, Yoshihisa Shumiya, Takayuki Ishikawa, Kazutaka Sunami, Kiyoshi Ando, Morio Matsumoto, Shuji Ozaki, Hirohiko Shibayama, Shinsuke Iida
Rok vydání: 2019
Předmět:
Male
0301 basic medicine
Cancer Research
Gastroenterology
chemistry.chemical_compound
0302 clinical medicine
Japan
Clinical endpoint
Multiple myeloma
carfilzomib
Leukopenia
clinical trial
General Medicine
Middle Aged
Progression-Free Survival
multiple myeloma
Oncology
Tolerability
030220 oncology & carcinogenesis
Original Article
Female
medicine.symptom
Oligopeptides
medicine.medical_specialty
Neutropenia
Maximum Tolerated Dose
Antineoplastic Agents
Drug Administration Schedule
03 medical and health sciences
Clinical Research
Internal medicine
medicine
Humans
Adverse effect
Aged
Dose-Response Relationship
Drug
business.industry
Original Articles
medicine.disease
Survival Analysis
Carfilzomib
hematopoiesis
Confidence interval
030104 developmental biology
chemistry
Drug Resistance
Neoplasm
Japanese
Neoplasm Recurrence
Local
business
Follow-Up Studies
Zdroj: Cancer Science
ISSN: 1349-7006
1347-9032
Popis: This multicenter, open‐label phase 1/2 study evaluated single‐agent carfilzomib in 50 heavily pretreated Japanese patients with relapsed/refractory multiple myeloma (median of five prior treatments). In phase 1, patients were dosed at three levels: 15, 20, or 20/27 mg/m2. Maximum tolerated dosage was not reached at the tolerability evaluation. Patients in phase 2 were treated with 20/27 mg/m2 carfilzomib. Median duration of exposure to carfilzomib in the 20/27 mg/m2 group at this final analysis was 4.7 months (range: 0.3‐39.4). Overall response rate in the 20/27 mg/m2 group, primary endpoint of the study, was 22.5% (n = 9) (95% confidence interval, 12.3‐37.5) with 2.5% (n = 1) stringent complete response. Median progression‐free survival and overall survival in the 20/27 mg/m2 group were 5.1 months (95% CI, 2.8‐13.6) and 22.9 months (95% CI, 14.1‐not estimable), respectively. Frequently occurring grade ≥3 adverse events in the 20/27 mg/m2 group included lymphopenia (72.5%), neutropenia (40.0%), and leukopenia (32.5%). Giving long‐term carfilzomib monotherapy led to long‐term overall survival for heavily pretreated multiple myeloma patients with a favorable safety profile. Carfilzomib monotherapy can be a good option for heavily pretreated multiple myeloma patients.
Databáze: OpenAIRE
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