6533b862fe1ef96bd12c649b
RESEARCH PRODUCT
Tamibarotene in patients with acute promyelocytic leukaemia relapsing after treatment with all-trans retinoic acid and arsenic trioxide
Miguel A. SanzFarhad RavandiMeir WetzlerEros Di BonaDavid SanfordSteven L. AllenFrancesco Lo-cocoHagop M. KantarjianJessica K. AltmanJorge E. CortesSteven Coutresubject
MaleOncogene Proteins Fusionmedicine.medical_treatmentDrug ResistancePhases of clinical researchSalvage therapyKaplan-Meier EstimatePharmacologyGastroenterologyBenzoatesArsenicalschemistry.chemical_compoundLeukemia Promyelocytic AcuteRecurrenceAntineoplastic Combined Chemotherapy ProtocolsMedicineArsenic trioxidePromyelocyticOncogene ProteinsTumorLeukemiaRemission InductionHematopoietic Stem Cell TransplantationCell DifferentiationOxidesclinical trialHematologyMiddle AgedCombined Modality Therapyall-trans retinoic acidarsenic trioxideLeukemiaCardiovascular DiseasesFemalemedicine.drugAdultmedicine.medical_specialtyTetrahydronaphthalenesAcute promyelocytic leukaemia; all-trans retinoic acid; arsenic trioxide; clinical trial; tamibarotene; Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Arsenicals; Benzoates; Biomarkers Tumor; Cardiovascular Diseases; Cell Differentiation; Combined Modality Therapy; Consolidation Chemotherapy; Disease-Free Survival; Drug Resistance Neoplasm; Febrile Neutropenia; Female; Hematopoietic Stem Cell Transplantation; Humans; Kaplan-Meier Estimate; Leukemia Promyelocytic Acute; Male; Middle Aged; Oncogene Proteins Fusion; Oxides; Recurrence; Remission Induction; Salvage Therapy; Tetrahydronaphthalenes; TretinoinAntineoplastic AgentsTretinoinAcuteArticleDisease-Free SurvivalTretinoinInternal medicineBiomarkers TumorHumansFusionneoplasmsAgedFebrile NeutropeniaSalvage TherapyChemotherapybusiness.industrymedicine.diseasetamibaroteneAcute promyelocytic leukaemiaConsolidation ChemotherapychemistryDrug Resistance NeoplasmNeoplasmTamibarotenebusinessSettore MED/15 - Malattie del SangueFebrile neutropeniaBiomarkersdescription
Treatment of acute promyelocytic leukaemia (APL) with arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) is highly effective first-line therapy, although approximately 5-10% of patients relapse. Tamibarotene is a synthetic retinoid with activity in APL patients who relapse after chemotherapy and ATRA, but has not been studied in relapse after treatment with ATO and ATRA. We report on a phase II study of tamibarotene in adult patients with relapsed or refractory APL after treatment with ATRA and ATO (n = 14). Participants were treated with tamibarotene (6 mg/m(2) /d) during induction and for up to six cycles of consolidation. The overall response rate was 64% (n = 9), the rate of complete cytogenetic response was 43% (n = 6) and the rate of complete molecular response was 21% (n = 3). Relapse was frequent with 7 of 9 responders relapsing after a median of 4·6 months (range 1·6-26·8 months). The median event-free survival (EFS) was 3·5 months [95% confidence interval (CI) 0-8·6 months] and the median overall survival (OS) was 9·5 months (95% CI 5·9-13·1 months). These results demonstrate that tamibarotene has activity in relapsed APL after treatment with ATO and ATRA and further studies using tamibarotene as initial therapy and in combination with ATO are warranted.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2015-07-24 |