36%) in patients who achieved a CR following either tretinoin or chemotherapy induction therapy and 2 cycles of consolidation therapy in another randomized study.Ģ5 mg/m2/day PO in 2 divided doses until complete remission (CR) or a maximum of 90 days plus idarubicin 12 mg/m2/dose IV on days 2, 4, 6, and 8 has been evaluated in a clinical trial (AIDA 0493 study). The 5-year DFS rate was significantly improved with 1 year of tretinoin maintenance therapy compared with observation only (61% vs. 79.2%) but not with tretinoin compared with no tretinoin maintenance therapy (82.7% vs. 69.7%) in 318 patients who were (PCR)-negative for the PML-RARA fusion gene following induction therapy with tretinoin and idarubicin and 3 cycles of intensive consolidation therapy.The 10-year cumulative incidence of relapse was significantly decreased with 2 years of chemotherapy- and tretinoin-containing maintenance therapy in patients with a hematologic complete remission (CR) following either tretinoin or chemotherapy induction therapy and 2 cycles of consolidation therapy in another 4-arm trial however, the 10-year overall survival rate was significantly improved with chemotherapy compared with no chemotherapy maintenance therapy (85.2% vs. 69%) or in patients who received 2 years of tretinoin compared with no tretinoin (68.3% vs. In one 4-arm trial, the 12-year disease-free survival (DFS) rates were not significantly different in patients who received 2 years of chemotherapy compared with no chemotherapy (68.9% vs. Tretinoin was given daily for 1 year or for 15 days every 3 months alone or with 6-MP 90 mg/m2 PO daily plus methotrexate 15 mg/m2 PO once weekly for 2 years, or alternating every 3 months with 6-MP/methotrexate for 2 years. Ĥ5 mg/m2/day PO once daily or divided every 12 hours alone or with regimens containing 6-mercaptopurine and methotrexate for 1 to 2 years following induction and consolidation therapy has been studied in randomized clinical trials. Pregnancy testing and counseling should occur monthly during oral tretinoin therapy. Within one week of beginning tretinoin oral therapy, the patient should have a negative pregnancy test if possible, treatment with tretinoin should be delayed until pregnancy testing results are known. ![]() Contraception requirements must be followed even when there is a history of infertility or menopause, unless a hysterectomy has been performed. Females of childbearing potential must use two reliable forms of contraception simultaneously during oral tretinoin therapy and for one month following discontinuation of therapy, unless abstinence is the chosen method. There is a high risk of birth defects if oral tretinoin is administered during pregnancy. The benefit-risk profile should be considered before prescribing. Avoid use of topical tretinoin over large areas of skin or for prolonged periods. The significance of these spontaneous reports in terms of risk to the fetus is not known. There have been 30 case reports of temporally-associated, congenital malformations during 25 years of clinical use of Retin-A. Adequate and well-controlled trials have not been performed in humans, but increased spontaneous abortions and major human fetal abnormalities have occurred when pregnant women received other retinoids. Teratogenic and embryotoxic effects have been demonstrated in animals receiving oral tretinoin or large doses (i.e., many times greater than the normal human dose) of topical tretinoin. The majority of patients do not require discontinuation of tretinoin therapy during RA-APL syndrome.Ĭontraception requirements, pregnancy, pregnancy testing, reproductive risk Consideration could be given to adding chemotherapy (usually cytarabine and an anthracycline, if not contraindicated) to tretinoin therapy on day 1 or 2 for patients presenting with a WBC count > 5000/mm3 or immediately, for patients presenting with a WBC count of = 6000/mm3 by day 5, >= 10,000/mm3 by day 10, or >= 15,000/mm3 by day 28. Some clinicians routinely add chemotherapy to oral tretinoin therapy when patients present with a WBC count > 5000/mm3 or in the case of a rapid increase in WBC count in leukopenic patients at the start of treatment. The manufacturer recommends the immediate initiation of high-dose steroids if signs and symptoms of RA-APL are present together with leukocytosis. ![]() However, RA-APL syndrome has been observed with or without concomitant leukocytosis. High initial leukocyte counts or rapidly increasing leukocyte counts during treatment may be predictive of retinoic acid-acute promyelocytic leukemia (RA-APL) syndrome (see Adverse Reactions). In the treatment of acute promyelocytic leukemia, approximately 40% of patients will develop rapidly evolving leukocytosis, and these patients have a higher risk of life-threatening complications.
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