Table 4.
Disease progression, progression-free survival, and overall survival with long-term follow-up
| Trial | Study arms | No. of patients | Median follow-up | Disease progression, n (%) | PFS | OS |
|---|---|---|---|---|---|---|
| IRIS* | Imatinib (400 mg) | 553 | 11 y | 38 (6.9%) | 92.1% | 83.3% |
| Interferon/cytarabine | 553 | 71 (12.8%) | — | 78.8% | ||
| German CML Study IV | Imatinib (400 mg) arm (all) | 400 (1551) | 9.5 y | 17 (4.2%) | 80.0% | 80.0% |
| DASISION | Dasatinib (100 mg) | 259 | 5 y | 12 (5%) | 85.0% | 91.0% |
| Imatinib (400 mg) | 260 | 19 (7%) | 86.0% | 90.0% | ||
| ENESTnd† | Nilotinib 300 mg twice daily | 282 | 5 y | 10 (4%) | 92.0% | 94.0% |
| Nilotinib 400 mg twice daily | 281 | 6 (2%) | 96.0% | 96.0% | ||
| Imatinib (400 mg) | 283 | 21 (7%) | 91.0% | 92.0% | ||
| BFORE‡ | Bosutinib (400 mg) | 268 | 2 y | 6 (2%) | — | 99.2% |
| Imatinib (400 mg) | 268 | 7 (3%) | — | 97.0% |
Data from 4 first-line phase 3 randomized registration studies (IRIS, DASISION, ENESTnd, and BFORE) and the first-line imatinib 400 mg daily arm of the German CML Study IV are shown. PFS, OS, and disease progression (defined as progression to accelerated phase or blast phase) are shown.
OS, overall survival; PFS, progression-free survival. Adapted with permission from the NCCN GuidelinesⓇ for Chronic Myeloid Leukemia V.1.2021. © 2021 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Survival outcomes include 363 patients who crossed over to imatinib.
†Progression to accelerated phase/blast phase during the study.
‡Twenty-four-month BFORE trial updates have been presented in abstract format.41