title: A prospective, observational study of added medium-dose cytosine arabinoside versus As2O3 for elderly patients with acute promyelocytic leukemia.
abstract: This open-label, prospective, observational study aimed to evaluate disease-free survival (DFS), overall survival (OS), PML-RARα polymerase chain reaction (PCR) monitoring and safety in elderly patients with de novo acute promyelocytic leukemia (APL) who were treated with either arsenic trioxide (As2O3) or medium-dose cytosine arabinoside (MiDAC) as frontline consolidation regimens. A total of 167 patients (age≥65 years old) received all-trans retinoic acid + daunorubicin as induction therapy. Of these patients, 22 died before attaining complete remission; the remaining 145 subjects received MiDAC- or As2O3-based consolidation therapy. As2O3 was superior to MiDAC for improving DFS and OS. This benefit appeared to result from the longer 5-year DFS (92.0 vs. 69.1%, P<0.01) and OS (94.5 vs. 79.7%, P<0.05) of As2O3 compared to MiDAC. PCR monitoring demonstrated that As2O3 promoted a lower positive rate than MiDAC (21.7 vs. 4.5%, P<0.05), but this treatment had no advantage for maintaining a low positive rate in the high-risk group. The most common life-threatening adverse drug effects in patients with MiDAC were platelet counts<25×10(9)/L (85.7%), leukocyte counts<1.0×10(9)/L (81.4%) and severe infection (84.3%). In contrast, the As2O3 regimen rarely caused leukocyte counts<1.0×10(9)/L (22.7%, P<0.01), platelet counts<25×10(9)/L (37.3%, P<0.01) or severe infection (21.3%, P<0.01). These data confirm that MiDAC should not be added during the initial consolidation of patients with APL because this treatment is far less effective, particularly in patients with a low-risk profile, and far more toxic than As2O3.
authors.affiliation: Department of Hematology, The Affiliated Hospital of Inner Mongolia Medical University, 1 TongDao Avenue North, Hohhot, 010059, People's Republic of China, huangbintao1979@sina.com.
authors.forename: Bin-Tao
authors.initials: BT
authors.lastname: Huang
authors.forename: Qing-Chun
authors.initials: QC
authors.lastname: Zeng
authors.forename: Wei-Hong
authors.initials: WH
authors.lastname: Zhao
authors.forename: Bing-Sheng
authors.initials: BS
authors.lastname: Li
authors.forename: Rui-lin
authors.initials: RL
authors.lastname: Chen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077237:Arsenic Trioxide; D001152:Arsenicals / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D010087:Oxides / Q000008:administration & dosage; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D015996:Survival Rate; D014212:Tretinoin / Q000008:administration & dosage
chemical_list: D001152:Arsenicals; D010087:Oxides; D003561:Cytarabine; D014212:Tretinoin; D000077237:Arsenic Trioxide; D003630:Daunorubicin