Phase I trial of low-dose oral Clofarabine in myelodysplastic syndromes patients who have failed frontline therapy
| Autor: | Venkatesh K. Rudrapatna, Kenneth M. Boucher, Kimberly A. Morley, Andrew S. Pierson, James P. Kushner, Paul J. Shami, Christian T. Shull |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Administration Oral Antineoplastic Agents Internal medicine medicine Clofarabine Humans Treatment Failure Aged Aged 80 and over Dose-Response Relationship Drug business.industry Adenine Nucleotides Myelodysplastic syndromes Hematology Middle Aged medicine.disease Pancytopenia Neoadjuvant Therapy Surgery Regimen medicine.anatomical_structure Prior Therapy Oncology International Prognostic Scoring System Myelodysplastic Syndromes Toxicity Female Bone marrow Arabinonucleosides business medicine.drug |
| Zdroj: | Leukemia research. 39(8) |
| ISSN: | 1873-5835 |
| Popis: | We investigated protracted low-dose oral Clofarabine for the treatment of myelodysplastic syndromes (MDS). Adults with an International Prognostic Scoring System (IPSS) score of INT-1 or higher who had failed first line therapy were eligible. INT-1 patients had to be transfusion-dependent. We started with oral Clofarabine at 5mg (fixed dose) daily for 10 consecutive days on a 28-day cycle. Toxicity prompted a modification to 1mg PO daily for 10 days and then 1mg PO daily for 7 days. Patients received treatment indefinitely until loss of response or unacceptable toxicity. Nine patients (5 women) were enrolled and evaluable (median age 65 years; range 55-81). A 10-day regimen of oral Clofarabine at 5mg/day induced Grade IV pancytopenia. A dose of 1 mg/day for 7/28 days was very well tolerated without significant toxicity. Three patients had responses (2 with responses lasting up to 21 and 51 cycles) defined as stable disease in spite of no significant change on bone marrow evaluation. Low-dose oral Clofarabine (1mg daily for 7/28 days) proved both effective and safe for patients with MDS who had failed prior therapy. This patient population is particularly sensitive to more protracted Clofarabine treatment schedules. |
| Databáze: | OpenAIRE |
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