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 |
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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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