The promoter of the SPIRIT trial is the University Hospital of Poitiers.
Tolerability and efficacy of pegylated interferon-α-2a in combination with imatinib for patients with chronic-phase chronic myeloid leukemia
Version of Record online: 16 SEP 2013
© 2013 American Cancer Society
Volume 119, Issue 24, pages 4284–4289, 15 December 2013
How to Cite
Johnson-Ansah, H., Guilhot, J., Rousselot, P., Rea, D., Legros, L., Rigal-Huguet, F., Nicolini, F. E., Mahon, F.-X., Preudhomme, C. and Guilhot, F. (2013), Tolerability and efficacy of pegylated interferon-α-2a in combination with imatinib for patients with chronic-phase chronic myeloid leukemia. Cancer, 119: 4284–4289. doi: 10.1002/cncr.28328
- Issue online: 3 DEC 2013
- Version of Record online: 16 SEP 2013
- Manuscript Accepted: 22 JUL 2013
- Manuscript Revised: 30 JUN 2013
- Manuscript Received: 13 JUN 2013
- chronic myeloid leukemia;
- clinical trial;
- molecular response
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.
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.
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).
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.