Rates of deep molecular response by digital and conventional PCR with frontline nilotinib in newly diagnosed chronic myeloid leukemia: a landmark analysis.
Published
Journal Article
ENESTnext (NCT01227577) was a single-arm, multicenter trial evaluating the rate of deep molecular response by 2 years in patients with newly diagnosed (within 6 months) chronic myeloid leukemia in chronic phase (CML-CP) treated with nilotinib 300 mg twice daily. Among 128 enrolled patients, 94 (73%) achieved major molecular response (MMR; BCR-ABL1 ≤ 0.1% on the International Scale [BCR-ABL1IS]) and 34 (27%) achieved confirmed MR4.5 (BCR-ABL1IS ≤0.0032% detectable or undetectable; primary endpoint) by 2 years. Three-month BCR-ABL1 levels were predictive of later responses. In exploratory analyses, digital polymerase chain reaction (PCR) detected BCR-ABL1 in 39.4% of samples from patients with confirmed MR4.5 and identified further decreases in BCR-ABL1 with continued nilotinib. Safety results, including cardiovascular events, were consistent with those in other nilotinib trials. These results further substantiate the molecular response rates associated with frontline nilotinib therapy and demonstrate the feasibility of monitoring very low BCR-ABL1 transcript levels using digital PCR.
Full Text
Duke Authors
Cited Authors
- Berdeja, JG; Heinrich, MC; Dakhil, SR; Goldberg, SL; Wadleigh, M; Kuriakose, P; Cortes, J; Radich, J; Helton, B; Rizzieri, D; Paley, C; Dautaj, I; Mauro, MJ
Published Date
- October 2019
Published In
Volume / Issue
- 60 / 10
Start / End Page
- 2384 - 2393
PubMed ID
- 30912699
Pubmed Central ID
- 30912699
Electronic International Standard Serial Number (EISSN)
- 1029-2403
Digital Object Identifier (DOI)
- 10.1080/10428194.2019.1590569
Language
- eng
Conference Location
- United States