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Dasatinib in imatinib‐resistant or ‐intolerant chronic‐phase, chronic myeloid leukemia patients: 7‐year follow‐up of study CA180‐034
| Content Provider | Semantic Scholar |
|---|---|
| Author | Shah, Neil Pravin Rousselot, Philippe Schiffer, Charles A. Réa, Delphine Cortes, Jorge E. Milone, Jorge H. Mohamed, Hesham Healey, Diane Kantarjian, Hagop M. Hochhaus, Andreas Saglio, Giuseppe |
| Copyright Year | 2016 |
| Abstract | Dasatinib was approved at 100 mg once daily for imatinib-resistant or -intolerant patients with chronic myeloid leukemia (CML) in chronic phase, based on results of the phase 3 CA180-034 (NCT00123474) study. Here we present the final 7-year analysis of this pivotal study, the longest follow-up to date of any second-generation BCR-ABL1 tyrosine kinase inhibitor (TKI). Patients (n = 670) with imatinib-resistant or -intolerant CML in chronic phase received dasatinib. Nineteen percent of patients continued on study treatment, with a greater proportion in the 100 mg once daily arm remaining on therapy. Seven-year rates for major molecular response (MMR), progression-free survival (PFS), and overall survival (OS) were similar across doses; MMR, PFS, and OS results were 46, 42, and 65% at 100 mg once daily, respectively. Improved PFS and OS rates were reported in patients who achieved BCR-ABL1 ≤10% at 3 and 6 months. No new safety signals were identified. The incidence of drug-related pleural effusion was 28% at 100 mg once daily and 35% at the other three dose groups. Incidence of drug-related pulmonary hypertension and pulmonary arterial hypertension remained low (≤3% across all doses). Arterial ischemic events occurred in ≤4% of patients across all doses. These data support the long-term efficacy and well-established safety profile of dasatinib for patients with imatinib-resistant or -intolerant CML in chronic phase. Am. J. Hematol. 91:869-874, 2016. © 2016 Wiley Periodicals, Inc. |
| Starting Page | 869 |
| Ending Page | 874 |
| Page Count | 6 |
| File Format | PDF HTM / HTML |
| DOI | 10.1002/ajh.24423 |
| Alternate Webpage(s) | https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/46/07/AJH-91-869.PMC5094534.pdf |
| Alternate Webpage(s) | https://iris.unito.it/retrieve/handle/2318/1586314/210834/ajh24423.pdf |
| PubMed reference number | 27192969 |
| Alternate Webpage(s) | https://doi.org/10.1002/ajh.24423 |
| Journal | Medline |
| Volume Number | 91 |
| Journal | American journal of hematology |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |