1. Combination of pegylated IFN-α2b with imatinib increases molecular response rates in patients with low- or intermediate-risk chronic myeloid leukemia
- Author
-
Simonsson, Bengt, Gedde-Dahl, Tobias, Markevärn, Berit, Remes, Kari, Stentoft, Jesper, Almqvist, Anders, Björeman, Mats, Flogegård, Max, Koskenvesa, Perttu, Lindblom, Anders, Malm, Claes, Mustjoki, Satu, Myhr-Eriksson, Kristina, Ohm, Lotta, Räsänen, Anu, Sinisalo, Marjatta, Själander, Anders, Strömberg, Ulla, Bjerrum, Ole Weiss, Ehrencrona, Hans, Gruber, Franz, Kairisto, Veli, Olsson, Karin, Sandin, Fredrik, Nagler, Arnon, Nielsen, Johan Lanng, Hjorth-Hansen, Henrik, and Porkka, Kimmo
- Abstract
Biologic and clinical observations suggest that combining imatinib with IFN-α may improve treatment outcome in chronic myeloid leukemia (CML). We randomized newly diagnosed chronic-phase CML patients with a low or intermediate Sokal risk score and in imatinib-induced complete hematologic remission either to receive a combination of pegylated IFN-α2b (Peg–IFN-α2b) 50 μg weekly and imatinib 400 mg daily (n = 56) or to receive imatinib 400 mg daily monotherapy (n = 56). The primary endpoint was the major molecular response (MMR) rate at 12 months after randomization. In both arms, 4 patients (7%) discontinued imatinib treatment (1 because of blastic transformation in imatinib arm). In addition, in the combination arm, 34 patients (61%) discontinued Peg–IFN-α2b, most because of toxicity. The MMR rate at 12 months was significantly higher in the imatinib plus Peg–IFN-α2b arm (82%) compared with the imatinib monotherapy arm (54%; intention-to-treat, P= .002). The MMR rate increased with the duration of Peg–IFN-α2b treatment (< 12-week MMR rate 67%, > 12-week MMR rate 91%). Thus, the addition of even relatively short periods of Peg–IFN-α2b to imatinib markedly increased the MMR rate at 12 months of therapy. Lower doses of Peg–IFN-α2b may enhance tolerability while retaining efficacy and could be considered in future protocols with curative intent.
- Published
- 2011
- Full Text
- View/download PDF