A phase I/II study of bortezomib plus CHOP every 2 weeks (CHOP-14) in patients with advanced-stage diffuse large B-cell lymphomas
- Authors
- Kim, J.E.; Yoon, D.H.; Jang, G.; Lee, D.H.; Kim, S.; Park, C.-S.; Huh, J.; Kim, W.S.; Park, J.; Lee, J.H.; Lee, S.I.; Suh, C.
- Issue Date
- Mar-2012
- Publisher
- 대한혈액학회
- Keywords
- Bortezomib; Chop-14; Diffuse large b-cell lymphoma
- Citation
- Korean Journal of Hematology, v.47, no.1, pp.53 - 59
- Journal Title
- Korean Journal of Hematology
- Volume
- 47
- Number
- 1
- Start Page
- 53
- End Page
- 59
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/17437
- DOI
- 10.5045/kjh.2012.47.1.53
- ISSN
- 1738-7949
- Abstract
- Background Bortezomib targets molecular dysregulation of nuclear factor-κB activation and cell cycle control, which are characteristic features of diffuse large B-cell lymphoma (DLBCL). We evaluated the safety and efficacy of bortezomib treatment with dose-dense cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks(CHOP-14). Methods Untreated DLBCL patients were enrolled. A phase I dose-escalation study with 1.0, 1.3, and 1.6 mg/m 2 bortezomib administration on day 1 and 4 in addition to the CHOP-14regimen was performed to determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT). Lenograstim 5 μg/kg/d was administered on day 4-13. The bortezomib dose from the phase I study was used in the phase II study. Results Nine and 37 patients were enrolled in the phase I and phase II studies, respectively. The analysis of the phase II results (40 patients) included data of the 3 patients in the last MTD dose cohort of the phase I trial. During the phase I trial, no DLT was observed at any bortezomib dose; therefore, the recommended dose was 1.6 mg/m 2. In phase II, the overall response rate was 95% (complete response: 80%; partial response: 15%). Nine out of the 40 patients showed grade 3 sensory neuropathy, and 22 required at least 1 dose reduction. Three patients could not complete the intended 6 cycles of treatment because of severe neuropathy. Conclusion Bortezomib plus CHOP-14 was highly effective for the treatment of untreated DLBCL patients, but in many cases, dose or schedule modification was required to reduce neurotoxicity. © 2012 Korean Society of Hematology.
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