Randomised phase II study to optimise melphalan, prednisolone, and bortezomib in untreated multiple myeloma (JCOG1105)
Autor: | Hirokazu Nagai, Gakuto Ogawa, Shinsuke Iida, Ishikazu Mizuno, Eiichi Ohtsuka, Takahiro Yamauchi, Dai Maruyama, Noriko Fukuhara, Koichiro Minauchi, Junya Kuroda, Shinichiro Yoshida, Youko Suehiro, Hideki Tsujimura, Yasuyuki Nagata, Kunihiro Tsukasaki, Satoshi Yamasaki, Sachiko Seo, Kana Miyazaki, Makoto Yoshimitsu, Akira Hangaishi, Norifumi Tsukamoto, Takahiko Utsumi, Yutaro Kamiyama, Ichiro Hanamura, Yasushi Takamatsu |
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Rok vydání: | 2020 |
Předmět: |
Male
Melphalan medicine.medical_specialty Prednisolone Phases of clinical research Neutropenia Gastroenterology Bortezomib 03 medical and health sciences 0302 clinical medicine immune system diseases Prednisone hemic and lymphatic diseases Internal medicine Antineoplastic Combined Chemotherapy Protocols Humans Medicine clinical studies Multiple myeloma Aged Aged 80 and over business.industry Cumulative dose Haematological Malignancy ‐ Clinical eldery Hematology medicine.disease Survival Analysis multiple myeloma Treatment Outcome 030220 oncology & carcinogenesis Female business Research Paper 030215 immunology medicine.drug |
Zdroj: | British Journal of Haematology |
ISSN: | 1365-2141 0007-1048 |
Popis: | Summary We conducted a randomised phase II study to determine the optimal dose and schedule of melphalan, prednisone, and bortezomib (MPB) (jRCTs031180097). Transplant‐ineligible untreated multiple myeloma patients were randomised to Arm A (twice weekly bortezomib in one six‐week cycle followed by eight five‐week cycles of four times once weekly bortezomib with melphalan and prednisolone on days 1–4) or Arm B (nine four‐week cycles of three times once weekly bortezomib with melphalan and prednisolone on days 1–4). The primary end‐point was complete response (CR) rate. Of 91 patients randomised to two arms, 88 were eligible. The median cumulative bortezomib doses were 45·8 and 35·1 mg/m2, CR rate was 18·6% [95% confidence interval (CI) 8·4–33·4] and 6·7% (95% CI 1·4–18·3), and the median progression‐free survival (PFS) was 2·5 and 1·4 years in Arms A and B [hazard ratio (HR) 1·93 (95% CI 1·09–3·42)], respectively. Frequent grade ≥3 haematologic toxicities in Arms A and B were neutropenia (64·4% vs. 28·3%) and thrombocytopenia (35·6% vs. 10·9%). Grade 2/3 peripheral neuropathy was observed in 24·4/2·2% in Arm A and 8·7/0% in Arm B. In conclusion, Arm A was the more promising regimen, suggesting that the twice weekly schedule of bortezomib in the first cycle and higher cumulative dose of both bortezomib and melphalan influences the efficacy of modified MPB. |
Databáze: | OpenAIRE |
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