Nilotinib vs. imatinib in Japanese patients with newly diagnosed chronic myeloid leukemia in chronic phase: long-term follow-up of the Japanese subgroup of the randomized ENESTnd trial
| Autor: | Ken Ohmine, Chiaki Nakaseko, Takaaki Ono, Makoto Aoki, Akira Matsuda, Kazuo Ito, Tetsuya Fukuda, Yoshinobu Kanda, Hirohiko Shibayama, Hirohisa Nakamae, Itaru Matsumura |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors medicine.drug_class Antineoplastic Agents 030204 cardiovascular system & hematology Drug Administration Schedule Tyrosine-kinase inhibitor Young Adult 03 medical and health sciences 0302 clinical medicine Asian People Leukemia Myelogenous Chronic BCR-ABL Positive Internal medicine Back pain Humans Medicine Adverse effect neoplasms Aged Randomized Controlled Trials as Topic Aged 80 and over Hematology business.industry Imatinib Middle Aged Rash Surgery Pyrimidines Treatment Outcome Nilotinib 030220 oncology & carcinogenesis Cohort Imatinib Mesylate Female medicine.symptom business Follow-Up Studies medicine.drug |
| Zdroj: | International Journal of Hematology. 107:327-336 |
| ISSN: | 1865-3774 0925-5710 |
| DOI: | 10.1007/s12185-017-2353-7 |
| Popis: | 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 MR4.5 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. |
| Databáze: | OpenAIRE |
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