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- Title
A phase II study of etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin (ESHAOx) for patients with refractory or relapsed Hodgkin's lymphoma.
- Authors
Won, Young-Woong; Lee, Hyewon; Eom, Hyeon-Seok; Kim, Jin Seok; Suh, Cheolwon; Yoon, Dok Hyun; Hong, Jung Yong; Kang, Hye Jin; Lee, Jae Hoon; Kim, Won Seog; Kim, Seok Jin; Lee, Won-Sik; Chang, Myung Hee; Do, Young Rok; Yi, Jun Ho; Kim, Inho; Won, Jong-Ho; Kim, Kyoungha; Oh, Sung Yong; Jo, Jae-Cheol
- Abstract
We assessed the efficacy and toxicity of etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin (ESHAOx) combination chemotherapy in patients with refractory or relapsed Hodgkin's lymphoma (HL). This was an open-label, non-randomized, multi-center phase II study. The ESHAOx regimen consisted of intravenous (i.v.) etoposide 40 mg/m2 on days 1 to 4, i.v. methylprednisolone 500 mg on days 1 to 5, i.v. cytarabine 2 g/m2 on day 5, and i.v. oxaliplatin 130 mg/m2 on day 1. Cycles (up to six) were repeated every 3 weeks. In an effort to identify prognostic markers, the serum levels of cytokines including tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and vascular endothelial growth factor (VEGF) were measured at the time of study entry. A total of 37 patients were enrolled, and 36 were available for evaluation of tumor response. The overall response rate was 72.2% (26/36) (complete response, 33.3% [12/36]; partial response, 38.9% [14/36]). The median time to progression was 34.9 months (95% confidence interval, 23.1-46.7 months). The most common grade 3 or 4 hematological adverse events were neutropenia (16/37, 43.2%), followed by thrombocytopenia (10/37, 27.0%). Grade 3 or 4 non-hematological adverse events were nausea (3/37, 8.1%), anorexia (2/37, 5.4%), mucositis (1/37, 2.7%), and skin rash (1/37, 2.7%). There were no treatment-related deaths. High levels of TNF-α and CRP were significantly associated with poorer overall survival (p = 0.00005 for TNF-α, p = 0.0004 for CRP, respectively). The ESHAOx regimen exhibited antitumor activity and an acceptable safety profile in patients with refractory or relapsed HL. Trial Registration: ClinicalTrials.gov. Registered February 21, 2011, https://clinicaltrials.gov/ct2/show/NCT01300156.
- Subjects
HODGKIN'S disease; VASCULAR endothelial growth factors; METHYLPREDNISOLONE; PATIENT safety; C-reactive protein; PROTEINS; ETOPOSIDE; RESEARCH; CLINICAL trials; TIME; RESEARCH methodology; ANTINEOPLASTIC agents; PROGNOSIS; EVALUATION research; MEDICAL cooperation; DISEASE relapse; COMPARATIVE studies; TUMOR necrosis factors; RESEARCH funding; CYTARABINE
- Publication
Annals of Hematology, 2020, Vol 99, Issue 2, p255
- ISSN
0939-5555
- Publication type
journal article
- DOI
10.1007/s00277-019-03891-9