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Imatinib discontinuation safe in CML patients with durable response
Imatinib treatment may be discontinued safely and reinitiated effectively in patients with chronic myeloid leukemia who demonstrate durable molecular response, according to results of a phase 2 study.
The analysis included 33 patients enrolled on the Dutch-Belgian Cooperative Trial for Hemato-Oncology 51 (HOVON) trial. All patients had chronic myeloid leukemia, underwent prior combination therapy with imatinib (Gleevec, Novartis) and cytarabine, and were continuing to receive imatinib. All patients demonstrated molecular response for at least 2 years.
Researchers randomly assigned the patients to continue treatment with imatinib (n=18) or to discontinue treatment (n=15).
Twelve months after randomization, the rate of relapse was 0% in the continuation group vs. 53% in the discontinuation group.
At 36 months, molecular relapse occurred in three (17%) patients in the continuation group and 10 (67%) patients in the discontinuation group. The three patients in the continuation group who relapsed also had stopped imatinib after randomization.
An as-treated analysis showed 56% of patients in the discontinuation group relapsed at 1 year and 61% relapsed at 2 years, compared with 0% of patients who continued imatinib.
Overall, 12 of the 13 patients who relapsed did so within 7 months of imatinib discontinuation.
"All evaluable patients remained sensitive to imatinib after reinitiation and regained a molecular response," the researchers wrote. "Our data suggest that discontinuation of imatinib is safe in patients with durable molecular response."
Disclosure: See the study for a full list of the researchers' relevant financial disclosures.
Imatinib treatment may be discontinued safely and reinitiated effectively in patients with chronic myeloid leukemia who demonstrate durable molecular response, according to results of a phase 2 study.
The analysis included 33 patients enrolled on the Dutch-Belgian Cooperative Trial for Hemato-Oncology 51 (HOVON) trial. All patients had chronic myeloid leukemia, underwent prior combination therapy with imatinib (Gleevec, Novartis) and cytarabine, and were continuing to receive imatinib. All patients demonstrated molecular response for at least 2 years.
Researchers randomly assigned the patients to continue treatment with imatinib (n=18) or to discontinue treatment (n=15).
Twelve months after randomization, the rate of relapse was 0% in the continuation group vs. 53% in the discontinuation group.
At 36 months, molecular relapse occurred in three (17%) patients in the continuation group and 10 (67%) patients in the discontinuation group. The three patients in the continuation group who relapsed also had stopped imatinib after randomization.
An as-treated analysis showed 56% of patients in the discontinuation group relapsed at 1 year and 61% relapsed at 2 years, compared with 0% of patients who continued imatinib.
Overall, 12 of the 13 patients who relapsed did so within 7 months of imatinib discontinuation.
"All evaluable patients remained sensitive to imatinib after reinitiation and regained a molecular response," the researchers wrote. "Our data suggest that discontinuation of imatinib is safe in patients with durable molecular response."
Disclosure: See the study for a full list of the researchers' relevant financial disclosures.
