Experts Establish Optimal Dosing of Nilotinib for Newly Diagnosed CML
Research supports administering nilotinib at a dosage of 300 mg daily for newly diagnosed patients with chronic myeloid leukemia (CML) in chronic phase (Cancer Med. 2020 Apr 6. Epub ahead of print).
“In previous studies which compared outcomes associated with nilotinib or imatinib treatment, nilotinib achieved a higher rate of deep molecular response,” explained Kaishi Nishiwaki, MD, Division of Oncology and Hematology, Jikei University Kashiwa Hospital, Japan, and co-investigators, who conducted a phase 2, multi-center study to evaluate a nilotinib dose-escalation strategy for early-diagnosed chronic-phase CML.
The primary end point was achievement of deep molecular response by 24 months following initiation of nilotinib 300 mg twice daily. Patients could increase their treatment dose to nilotinib 400 mg twice daily if they did not achieve an optimal response at any point, and the median dose intensity was 600 mg daily.
A total of 51 patients were enrolled in the study and given nilotinib, with 37 completing treatment.
The 24-month molecular response rate was 45.7%, and progression-free survival, overall survival, and event-free survival were each 97.6%. Of 46 evaluable patients, 18 achieved an optimal response and 28 did not.
Nineteen of these 28 patients could not undergo dose-escalation due to adverse events or other reasons, and 4 achieved deep molecular responses.
Overall, 9 patients had their doses escalated to 400 mg twice daily, none of whom achieved a deep molecular response.
There were no new safety concerns observed.
“Our findings support the use of continuous nilotinib at a dose of 300 mg [twice daily] for newly diagnosed patients with [chronic-phase CML],” Dr Nishiwaki and colleagues concluded.—Kaitlyn Manasterski
