Premium
Tolerability and efficacy of pegylated interferon‐α‐2a in combination with imatinib for patients with chronic‐phase chronic myeloid leukemia
Author(s) -
JohnsonAnsah Hyacinthe,
Guilhot Joelle,
Rousselot Philippe,
Rea Delphine,
Legros Laurence,
RigalHuguet Françoise,
Nicolini Franck Emmanuel,
Mahon FrançoisXavier,
Preudhomme Claude,
Guilhot François
Publication year - 2013
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.28328
Subject(s) - medicine , tolerability , discontinuation , imatinib , gastroenterology , myeloid leukemia , pegylated interferon , toxicity , alpha interferon , subgroup analysis , pharmacology , adverse effect , oncology , interferon , immunology , confidence interval , hepatitis c virus , virus , ribavirin
BACKGROUND The pegylated form of interferon‐α‐2a (PegIFNa2a) in combination with imatinib has demonstrated a molecular improvement in patients with chronic‐phase chronic myeloid leukemia. However, to the authors' knowledge, the appropriate dose of PegIFNa2a has not been established to date. METHODS In the French SPIRIT trial, the authors compared 2 initial doses of PegIFNa2a, taking into account an amendment that recommended reducing that dose from 90 μg/week to 45 μg/week because of toxicities. Accordingly, 2 subgroups of patients were identified: the PegIFN90 group (171 patients who were treated with the 90‐μg/week dose) and the PegIFN45 group (50 patients who were treated with the 45‐μg/week dose). Both groups were compared for toxicity and efficacy. RESULTS PegIFNa2a at a dose of 90 μg/week resulted in a rate of 54% of grade 3 to 4 hematologic toxicity compared with 27% with the dose of 45 μg/week ( P < .001), leading to discontinuation rates of 40% and 10%, respectively, before 6 months. The dose reduction did not significantly affect the efficacy of the combination. By 12 months, the cumulative molecular response rates (ie, BCR‐ABL/abl ≤ 0.01 [IS: molecular responses graded as molecular response 4 (MR4)]) were 14% and 25%, respectively, for the subgroup treated with imatinib at a dose of 400 mg and the PegIFN90 subgroup. After the amendment, the MR4 rates were 10% and 28%, respectively, for the subgroup treated with imatinib at the 400‐mg dose and PegIFN45 subgroup ( P < .0001). CONCLUSIONS The results of the current study demonstrate that in combination with imatinib, the efficient dose of PegIFNa2a appears to be 45 μg/week. Cancer 2013;119:4284–4289 . © 2013 American Cancer Society .