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Imatinib compared with chemotherapy as front‐line treatment of elderly patients with Philadelphia chromosome‐positive acute lymphoblastic leukemia (Ph+ALL)
Author(s) -
Ottmann Oliver G.,
Wassmann Barbara,
Pfeifer Heike,
Giagounidis Aristoteles,
Stelljes Matthias,
Dührsen Ulrich,
Schmalzing Marc,
Wunderle Lydia,
Binckebanck Anja,
Hoelzer Dieter
Publication year - 2007
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.22631
Subject(s) - medicine , imatinib , chemotherapy , induction chemotherapy , philadelphia chromosome , gastroenterology , acute lymphocytic leukemia , adverse effect , imatinib mesylate , surgery , toxicity , leukemia , oncology , lymphoblastic leukemia , myeloid leukemia , chromosomal translocation , biochemistry , chemistry , gene
BACKGROUND Elderly patients with Philadelphia chromosome‐positive acute lymphoblastic leukemia (Ph+ALL) have a poor prognosis, with a low complete remission (CR) rate, high induction mortality, and short remission duration. Imatinib (IM) has a favorable toxicity profile but limited antileukemic activity in advanced Ph+ALL. Imatinib in combination with intensive chemotherapy has yielded promising results as front‐line therapy, but its value as monotherapy in newly diagnosed Ph+ALL is not known. METHODS Patients with de novo Ph+ALL were randomly assigned to induction therapy with either imatinib (Ind IM ) or multiagent, age‐adapted chemotherapy (Ind chemo ). Imatinib was subsequently coadministered with consolidation chemotherapy. RESULTS In all, 55 patients (median age, 68 years) were enrolled. The overall CR rate was 96.3% in patients randomly assigned to Ind IM and 50% in patients allocated to Ind chemo ( P = .0001). Nine patients (34.6%) were refractory and 2 patients died during Ind chemo ; none failed imatinib induction. Severe adverse events were significantly more frequent during Ind chemo (90% vs 39%; P = .005). The estimated overall survival (OS) of all patients was 42% ± 8% at 24 months, with no significant difference between the 2 cohorts. Median disease‐free survival was significantly longer in the 43% of patients (21 of 49 evaluable) in whom BCR‐ABL transcripts became undetectable (18.3 months vs 7.2 months; P = .002). CONCLUSIONS In elderly patients with de novo Ph+ALL, imatinib induction results in a significantly higher CR rate and lower toxicity than induction chemotherapy. With subsequent combined imatinib and chemotherapy consolidation, this initial benefit does not translate into improved survival compared with chemotherapy induction. Cancer 2007. © 2007 American Cancer Society.