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Phase II Multicenter Study of Arsenic Trioxide in Patients With Myelodysplastic Syndromes
- Source :
- Journal of Clinical Oncology. 24:2456-2464
- Publication Year :
- 2006
- Publisher :
- American Society of Clinical Oncology (ASCO), 2006.
-
Abstract
- Purpose To evaluate the efficacy and safety of arsenic trioxide monotherapy in patients with myelodysplastic syndromes (MDS). Patients and Methods Patients received arsenic trioxide (0.25 mg/kg/d) on 5 consecutive days per week for 2 weeks, followed by 2 weeks’ rest (one cycle). Two patient cohorts were established according to International Prognostic Scoring System risk category: lower-risk (low or intermediate-1) or higher-risk MDS (intermediate-2 or high). For lower-risk MDS, hematologic improvement (HI) was the primary response end point. For higher-risk MDS, additional end points included complete or partial remission. Based on the expected time to response, patients receiving two or more cycles were prospectively evaluated. Results Hematologic adverse events included neutropenia, thrombocytopenia, and febrile neutropenia. Two patients died during the study due to treatment-related toxicities. Most common grade 3/4 nonhematologic events were pneumonia, fatigue, hemorrhage, pain, and dyspnea. Among patients who received one or more doses (n = 70) or completed two or more cycles (n = 51), the HI rates were 34% and 39% in lower-risk patients, and 6% and 9% in higher-risk patients, respectively; the overall major HI rates were 20% and 22%. One higher-risk patient achieved a complete remission (3%). Major HIs were observed in all hematologic lineages; erythroid responses were the most common. Transfusion independence or reduction by ≥ 50% occurred in 33% of patients dependent on RBC transfusions. The overall median duration of HI was 6.8 months (range, 2 to 40 months). Conclusion Arsenic trioxide monotherapy has moderate activity against MDS, with a manageable adverse effect profile. The further study of arsenic trioxide in MDS, particularly in combination with other agents, is warranted.
- Subjects :
- Cancer Research
medicine.medical_specialty
business.industry
Myelodysplastic syndromes
Neutropenia
medicine.disease
Surgery
chemistry.chemical_compound
Oncology
chemistry
International Prognostic Scoring System
Internal medicine
medicine
Arsenic trioxide
Adverse effect
business
Prospective cohort study
Febrile neutropenia
Survival analysis
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 24
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi...........57e20ce9c6b9e957ed751753675630e9