DOI

  • Timothy P Hughes
  • Nelma Cristina D Clementino
  • Mikhail Fominykh
  • Jeffrey H Lipton
  • Anna G Turkina
  • Elena Beatriz Moiraghi
  • Franck E Nicolini
  • Naoto Takahashi
  • Tomasz Sacha
  • Dong-Wook Kim
  • Rafik Fellague-Chebra
  • Ranjan Tiwari
  • Catherine Bouard
  • Francois-Xavier Mahon

The ENESTop study evaluated treatment-free remission (TFR) in patients with chronic myeloid leukemia (CML) in chronic phase who had received ≥3 years of tyrosine kinase inhibitor therapy and achieved sustained deep molecular response only after switching from imatinib to nilotinib. After 1-year nilotinib consolidation, 126 patients attempted TFR. At 48 weeks (primary analysis), 57.9% (73/126) were in TFR. In the present analysis at 5 years, 42.9% (54/126) were in TFR. Since the 48-week analysis, among patients who left the TFR phase, 58% (11/19) did not have a loss of molecular response and discontinued for other reasons. Of the 59 patients who reinitiated nilotinib upon loss of major molecular response (MMR) or confirmed loss of MR4, 98.3% regained MMR, 94.9% regained MR4, and 93.2% regained MR4.5. Overall adverse event rates decreased over the 5 years of TFR. In patients reinitiating nilotinib, there was a cumulative increase in cardiovascular events with longer nilotinib exposure. No disease progression or CML-related deaths were reported. Overall, these results confirm the durability and safety of TFR for patients receiving second-line nilotinib. Cardiovascular risk should be carefully managed, particularly when reinitiating treatment after TFR.

Язык оригиналаанглийский
Страницы (с-по)1631-1642
Число страниц12
ЖурналLeukemia
Том35
Номер выпуска6
Дата раннего онлайн-доступа12 мая 2021
DOI
СостояниеОпубликовано - июн 2021

    Предметные области Scopus

  • Гематология
  • Онкология
  • Исследования рака

ID: 76914286