Details

Autor(en) / Beteiligte

• Nakamae, Hirohisa
• Yamamoto, Masahide
• Sakaida, Emiko
• Kanda, Yoshinobu
• Ohmine, Ken
• Ono, Takaaki
• Matsumura, Itaru
• Ishikawa, Maho
• Aoki, Makoto
• Maki, Akio
• Shibayama, Hirohiko

Titel

Nilotinib vs. imatinib in Japanese patients with newly diagnosed chronic myeloid leukemia in chronic phase: 10-year follow‑up of the Japanese subgroup of the randomized ENESTnd trial

Ist Teil von

• International journal of hematology, 2022, Vol.115 (1), p.33-42

Ort / Verlag

Singapore: Springer Singapore

Erscheinungsjahr

2022

Quelle

MEDLINE

Beschreibungen/Notizen

• In the 10-year analysis of Japanese patients with newly diagnosed CML-CP in the ENESTnd trial, nilotinib yielded higher cumulative response rates. There were no new occurrences of disease progression or deaths since the 5-year analysis. Cumulative 10-year rates of MMR and MR 4.5 were higher in the nilotinib arms [300 mg twice daily (BID), 86.2% and 69.0%, respectively; 400 mg BID, 78.3% and 69.6%, respectively] than the imatinib arm (400 mg once daily, 60.0% and 48.0%, respectively). Nasopharyngitis (85.7%, 77.3%, 79.2%), rash (50.0%, 68.2%, 37.5%), headache (39.3%, 45.5%, 25.0%), and back pain (39.3%, 50.0%, 29.2%) were the most frequently reported all-grade adverse events (AEs) for nilotinib 300 and 400 mg BID and imatinib, respectively. Cardiovascular AEs were more common with nilotinib than with imatinib. More patients on nilotinib had pre-diabetic and diabetic levels of HbA1c (300 mg BID, 17.9% and 10.7%, respectively; 400 mg BID, 22.7% and 18.2%, respectively) compared with imatinib (4.2% each). Overall, 10-year results from the Japanese cohort are consistent with prior results from the full ENESTnd cohort and the Japanese subgroup, and continue to support the long-term use of nilotinib in Japanese patients with newly diagnosed CML-CP, but with proper monitoring and management of comorbidities.