| Title: |
Treatment-free remission in chronic myeloid leukemia patients treated front-line with nilotinib: 10-year followup of the GIMEMA CML 0307 study |
| Authors: |
Gugliotta G.; Castagnetti F.; Breccia M.; Levato L.; Intermesoli T.; D'Adda M.; Salvucci M.; Stagno F.; Rege-Cambrin G.; Tiribelli M.; Martino B.; Bocchia M.; Cedrone M.; Trabacchi E.; Cavazzini F.; Porretto F.; Sora F.; Simula M. P.; Albano F.; Soverini S.; Foa R.; Pane F.; Cavo M.; Saglio G.; Baccarani M.; Rosti G. |
| Contributors: |
Gugliotta, G.; Castagnetti, F.; Breccia, M.; Levato, L.; Intermesoli, T.; D'Adda, M.; Salvucci, M.; Stagno, F.; Rege-Cambrin, G.; Tiribelli, M.; Martino, B.; Bocchia, M.; Cedrone, M.; Trabacchi, E.; Cavazzini, F.; Porretto, F.; Sora, F.; Simula, M. P.; Albano, F.; Soverini, S.; Foa, R.; Pane, F.; Cavo, M.; Saglio, G.; Baccarani, M.; Rosti, G. |
| Publication Year: |
2022 |
| Collection: |
Università degli Studi di Siena: USiena air |
| Description: |
We report the final analysis, with a 10-year follow-up, of the phase II study GIMEMA CML 0307 (NCT 00481052), which enrolled 73 adult patients (median age 51 years; range, 18-83) with newly diagnosed chronic-phase chronic myeloid leukemia to in-vestigate the efficacy and the toxicity of front-line treatment with nilotinib. The initial dose was 400 mg twice daily; the dose was reduced to 300 mg twice daily as soon as this dose was approved and registered. The 10-year overall survival and pro-gression-free survival were 94.5%. At the last contact, 36 (49.3%) patients were continuing nilotinib (22 patients at 300 mg twice daily, 14 at lower doses), 18 (24.7%) patients were in treatment-free remission, 14 (19.2%) were receiving other tyrosine-kinase inhibitors and four (5.5%) patients have died. The rates of major and deep molecular responses by 10 years were 96% and 83%, respectively. The median times to major and deep molecular response were 6 and 18 months, respectively. After a median duration of nilotinib treatment of 88 months, 24 (32.9%) patients discontinued nilotinib while in stable deep molecular response. In these patients, the 2-year estimated treatment-free survival was 72.6%. The overall treatment-free remission rate, calculated on all enrolled patients, was 24.7% (18/73 patients). Seventeen patients (23.3%), at a median age of 69 years, had at least one arterial obstructive event. In conclusion, the use of nilotinib front-line in chronic phase chronic myeloid leukemia can induce a stable treatment-free remission in a relevant number of patients, although cardiovascular toxicity re-mains of concern. |
| Document Type: |
article in journal/newspaper |
| File Description: |
STAMPA |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/35385922; info:eu-repo/semantics/altIdentifier/wos/WOS:000870533100011; volume:107; issue:10; firstpage:2356; lastpage:2364; numberofpages:9; journal:HAEMATOLOGICA; https://hdl.handle.net/11365/1255624; https://haematologica.org/article/view/haematol.2021.280175; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9521223/ |
| DOI: |
10.3324/haematol.2021.280175 |
| Availability: |
https://hdl.handle.net/11365/1255624; https://doi.org/10.3324/haematol.2021.280175; https://haematologica.org/article/view/haematol.2021.280175; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9521223/ |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.1538F579 |
| Database: |
BASE |