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Cancer Sci. 2018 May;109(5):1552-1561. doi: 10.1111/cas.13550. Epub 2018 Apr 17.

Bortezomib plus dexamethasone vs thalidomide plus dexamethasone for relapsed or refractory multiple myeloma.

Author information

1
Department of Hematology and Oncology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Nagoya City University Hospital, Nagoya, Japan.
2
JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan.
3
Department of Hematology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), National Cancer Center Hospital East, Kashiwa, Japan.
4
Department of Hematology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), National Cancer Center Hospital, Tokyo, Japan.
5
Department of Hematology and Cell Therapy, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Aichi Cancer Center Hospital, Nagoya, Japan.
6
Department of Hematology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Imamura General Hospital, Kagoshima, Japan.
7
Division of Hematology and Oncology, Department of Medicine, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Kyoto Prefectural University, Kyoto, Japan.
8
Department of Hematology and Oncology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Tokai University of School of Medicine, Isehara, Japan.
9
Department of Hematology, Rheumatology and Infectious Diseases, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Kumamoto University Hospital, Kumamoto, Japan.
10
Department of Hematology and Immunology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Kanazawa Medical University, Kahoku, Japan.
11
Department of Hematology and Oncology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
12
Division of Hematology, Department of Internal Medicine, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Aichi Medical University, Nagakute, Japan.
13
First Department of Internal Medicine, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Ehime University Hospital, Toon, Japan.
14
Department of Hematology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
15
Department of Hematology and Oncology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Nagoya University Graduate School of Medicine, Nagoya, Japan.
16
Oncology Center, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), Gunma University Hospital, Maebashi, Japan.
17
Department of Hematology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG), National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.

Abstract

A randomized phase II selection design study (JCOG0904) was carried out to evaluate the more promising regimen between bortezomib (Bor) plus dexamethasone (Dex; BD) and thalidomide (Thal) plus Dex (TD) in Bor and Thal-naïve patients with relapsed or refractory multiple myeloma (RRMM). Patients ≥20 and <80 years old with a documented diagnosis of symptomatic multiple myeloma (MM) who received one or more prior therapies were randomized to receive BD (Bor 1.3 mg/m2 ) or TD (Thal 200 mg/d). In both arms, 8 cycles of induction (3-week cycle) were followed by maintenance phase (5-week cycle) until disease progression, unacceptable toxicity, or patient refusal. The primary end-point was 1-year progression-free survival (PFS). Forty-four patients were randomized and assigned to receive BD and TD (n = 22, each group). At a median follow-up of 34.3 months, the 1-year PFS in the BD and TD arms were 45.5% (95% confidence interval (CI), 24.4%-64.3%) and 31.8% (95% CI, 14.2%-51.1%), respectively, and the overall response rates were 77.3% and 40.9%, respectively. The 3-year overall survival (OS) was 70.0% (95% CI, 44.9%-85.4%) in the BD, and 48.8% (95% CI, 25.1%-69.0%) in the TD arm. Among grade 3/4 adverse events, thrombocytopenia (54.5% vs 0.0%) and sensory peripheral neuropathy (22.7% vs 9.1%) were more frequent in BD when compared with the TD arm. Patients treated with BD had better outcomes than those treated with TD with regard to 1-year PFS and 3-year OS. Thus, BD was prioritized over TD for further investigations in Bor and Thal-naïve RRMM patients. (Clinical trial registration no. UMIN000003135.).

KEYWORDS:

bortezomib; dexamethasone; randomized phase II study; relapsed or refractory multiple myeloma; thalidomide

PMID:
29478257
PMCID:
PMC5980148
DOI:
10.1111/cas.13550
[Indexed for MEDLINE]
Free PMC Article

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