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A phase I/II trial of Erlotinib in higher risk myelodysplastic syndromes and acute myeloid leukemia after azacitidine failure
- Source :
- Leukemia Research. 38:1430-1434
- Publication Year :
- 2014
- Publisher :
- Elsevier BV, 2014.
-
Abstract
- Survival after azacitidine (AZA) failure in higher-risk myelodysplastic syndromes (MDS) is poor and new treatment options are needed. Erlotinib, an oral inhibitor of the epidermal-growth-factor-receptor (EGFR), has shown in preclinical models some efficacy in higher risk MDS and acute myeloid leukemia (AML). In this phase I/II trial, 30 patients received 100 mg/day ( n = 5) or 150 mg/day ( n = 25) of Erlotinib orally after primary or secondary resistance to AZA treatment. Eighteen MDS and 12 AML patients were treated. This outpatient treatment was well tolerated with limited grade III–IV extra hematological toxicities (skin ( n = 1), and diarrhea ( n = 3). Response was observed in 6 patients (20%) including 1 complete remission (CR), 1 marrow CR and 4 hematological improvement (2 erythroid and 2 on platelets). Median duration of response was 5 months. Erlotinib appears to induce a significant number of responses in higher risk MDS/AML having failed AZA treatment. Given the good safety profile of Erlotinib, its combination with other drugs could be tested in the future in MDS and AML.
- Subjects :
- Male
Oncology
Antimetabolites, Antineoplastic
Cancer Research
medicine.medical_specialty
Azacitidine
Pharmacology
Erlotinib Hydrochloride
Bone Marrow
hemic and lymphatic diseases
Internal medicine
medicine
Humans
Protein Kinase Inhibitors
neoplasms
Aged
Aged, 80 and over
business.industry
Myelodysplastic syndromes
Remission Induction
Complete remission
Myeloid leukemia
Hematology
Middle Aged
medicine.disease
ErbB Receptors
Leukemia, Myeloid, Acute
Safety profile
Diarrhea
Phase i ii
Myelodysplastic Syndromes
Quinazolines
Female
Erlotinib
medicine.symptom
business
medicine.drug
Subjects
Details
- ISSN :
- 01452126
- Volume :
- 38
- Database :
- OpenAIRE
- Journal :
- Leukemia Research
- Accession number :
- edsair.doi.dedup.....78b89383494e03ba35d31fdcf1beeaf6