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Low relapse rate after intensified induction therapy including high dose ara-C and all-trans retinoic acid in patients with acute promyelocytic leukemia



Low relapse rate after intensified induction therapy including high dose ara-C and all-trans retinoic acid in patients with acute promyelocytic leukemia



Blood 98(11 Part 1): 765a-766a



The addition of a potent chemotherapy to all-trans retinoic acid (ATRA) is essential for cure in patients with acute promyelocytic leukemia (APL). The optimal modification of the chemotherapy is discussed. In studies using ATRA and anthracycline based treatment regimens with or without standard dose ara-C, an initially higher WBC count of >5000 to >10000/mul proved to be a poor prognostic factor due to a higher early death and relapse rate. In contrast to these regimens, in the treatment protocol of the AMLCG, the induction chemotherapy is intensified by the inclusion of high dose ara-C. The therapy consists of TAD/HAM double induction and ATRA simultaneously until complete remission (CR), followed by TAD consolidation and 3 years cyclic monthly maintenance chemotherapy. TAD: Thioguanine 200 mg/sqm/d days 3-9, ara-C 100 mg/sqm/d days 1-2 as continuous infusion, and 100 mg/sqm/d q12 hrs days 3-8, daunorubicin 60 mg/sqm/d days 3-5. HAM: Ara-C 3g/sqm/d q12 hrs days 1-3, mitoxantrone 10 mg/sqm/d days 3-5. Since November 1994, 76 patients aged under 60 years with newly diagnosed APL were treated according to the protocol. Confirmation of the morphologic diagnosis APL (M3 71%, M3v 29%) by the translocation t(15;17) (n=68) or PML/RARalpha (n=67) was mandatory for elegibility. If material was available, the status of hematological remission was molecularly characterized by RT-PCR of PML/RARalpha (sensitivity 10-4) and of RARalpha/PML (sensitivity 10-6). The median observation time of all patients was 33 months (1 day to 6.0 years). After induction therapy, the RT-PCR of PML/RARalpha became negative in 46 of 50 (92%) and of RARalpha/PML in 21 of 28 (75%) evaluated patients. Two hematological relapses occurred after a duration of CR of 3.5 and 3.6 years, respectively. The clinical and molecular data indicate a high antileukemic effectiveness of the intensified induction chemotherapy including high dose ara-C in APL. A higher initial WBC count was not reproduced as a prognostic factor for relapse in our study. In contrast to treatment regimens combining standard chemotherapy and ATRA, a low relapse rate was also seen in our patients with initially higher WBC counts.

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