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Nilotinib for Chronic Phase CML: Japanese Dose-Escalation Study

By: Celeste L. Dixon
Posted: Wednesday, May 20, 2020

In newly diagnosed patients with chronic myeloid leukemia (CML), nilotinib has been shown to achieve higher rates of deep molecular response (MR) than imatinib. So, a research team conducted a phase II, open‐label, multicenter study called N-Road to investigate an intrapatient nilotinib dose‐escalation strategy based on early MR4.5 achievement.

“The primary endpoint was achievement of MR4.5 by 24 months following the initiation of nilotinib 300 mg twice daily,” wrote Kaichi Nishiwaki, MD, PhD, of Jikei University Kashiwa Hospital, Japan, and colleagues in Cancer Medicine. Their findings did in fact support the use of continuous nilotinib at the 300-mg dose twice daily for newly diagnosed patients.

Of 51 patients who initially received nilotinib at 300 mg twice daily, 46 were evaluable: 18 achieved an optimal response; 28 did not. “Of the latter, nine patients underwent dose escalation to 400 mg twice daily, and none achieved MR4.5,” noted Dr. Nishiwaki and colleagues. “The remaining 19 patients could not undergo dose escalation,” 12 because of adverse events, but “4 of these patients achieved MR4.5.”

Ultimately, the MR4.5 rate at 24 months was 45.7%, and the progression‐free survival, overall survival, and event‐free survival rates were each 97.6%. No new safety signals were seen.

The results “do not support an early dose increase of nilotinib for individuals who do not manage to achieve an optimal response [but do] suggest the importance of continuing…at a dose of 300 mg twice daily” to potentially achieve early and durable molecular response, the researchers concluded.

Disclosure: The study authors’ disclosure information can be found at wiley.com.



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