Bortezomib in combination with fludarabine plus cyclophosphamide for patients with relapsed or refractory mantle-cell lymphoma: results of the LYM-4003 study

This study aimed to identify the maximum-tolerated dose (MTD) of cyclophosphamide when combined with bortezomib and fludarabine (B-FC) in a phase 1b trial, and to assess the efficacy and safety of this combination in a phase 2 trial in patients with relapsed or refractory MCL (rrMCL). Forty patients...

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Bibliographic Details
Published in:Annals of hematology 2021-12, Vol.100 (12), p.2961-2968
Main Authors: Wang, Xiao-Xiao, Gao, Yan, Jin, Jie, Cao, Jun-Ning, Feng, Ji-Feng, Wang, Hua-Qing, Zhang, Hui-Lai, Cai, Qing-Qing, Li, Zhi-Ming, Jiang, Wen-Qi, Huang, Hui-Qiang
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Bortezomib - adverse effects
Bortezomib - therapeutic use
Cancer therapies
Creatinine
Cyclophosphamide - adverse effects
Cyclophosphamide - therapeutic use
Female
Heart failure
Hematology
Hospitals
Humans
Inhibitor drugs
Lymphoma
Lymphoma, Mantle-Cell - drug therapy
Male
Maximum Tolerated Dose
Medical prognosis
Medicine
Medicine & Public Health
Middle Aged
Neoplasm Recurrence, Local - drug therapy
Neutropenia
Neutrophils
Oncology
Original Article
Pain
Patients
Targeted cancer therapy
Thrombocytopenia
Treatment Outcome
Vidarabine - adverse effects
Vidarabine - analogs & derivatives
Vidarabine - therapeutic use
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Summary:This study aimed to identify the maximum-tolerated dose (MTD) of cyclophosphamide when combined with bortezomib and fludarabine (B-FC) in a phase 1b trial, and to assess the efficacy and safety of this combination in a phase 2 trial in patients with relapsed or refractory MCL (rrMCL). Forty patients were enrolled between April 8, 2011, and October 10, 2015. The MTD of cyclophosphamide was identified to be 250 mg/m 2 days 1–2. At a median follow-up of 31.6 months (13.5–47.4), among 32 patients in phase 2, 10 (31%) had a complete response and 13 (41%) had a partial response. The median progression-free survival was 21 months (95% CI 7.3–34.7), and the median overall survival was 32.4 months (95% CI 17.8–47.0). Grade 3–4 hematologic AEs included neutropenia (27%) and thrombocytopenia (39%). The B-FC regimen has satisfactory responses and manageable toxicities in rrMCL patients (ClinicalTrials.gov NCT01322776).
ISSN:0939-5555
1432-0584
DOI:10.1007/s00277-021-04619-4