Publications

Authors:

Malagola, Michele; Iurlo, Alessandra; Bucelli, Cristina; Abruzzese, Elisabetta; Bonifacio, Massimiliano; Stagno, Fabio; Binotto, Gianni; D'Adda, Marienlla; Lunghi, Monia; Crugnola, Monica; Ferrari, Maria Luisa; Lunghi, Francesca; Castagnetti, Fausto; Rosti, Gianantonio; Lemoli, Roberto Massimo; Sancetta, Rosaria; Coppi, Maria Rosaria; Corsetti, Maria Teresa; De Gobbi, Marco; Romano, Atelda; Tiribelli, Mario; Russo Rossi, Antonella; Russo, Sabina; Defina, Marzia; Farina, Mirko; Bernardi, Simona; Butturini, Giulia; Pellizzeri, Simone; Roccaro, Aldo Maria; Russo, Domenico

Title:

The Italian Multicentric Randomized OPTkIMA Trial on Fixed vs Progressive Intermittent TKI Therapy in CML Elderly Patients: 3-Years of Molecular Response and Quality of Life Monitoring After Completing the Treatment Plan

Year:

2024

Type of item:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Language:

Inglese

Referee:

No

Name of journal:

CLINICAL LYMPHOMA MYELOMA & LEUKEMIA

ISSN of journal:

2152-2650

N° Volume:

24

Number or Folder:

5

Page numbers:

323-331

Keyword:

Chronic myeloid leukemia; Health-Related Quality of Life (HRQoL); Intermittent; Tyrosine kinase inhibitor

Short description of contents:

Background: Intermittent treatment with tyrosine kinase inhibitors (TKIs) is an option for elderly chronic myeloid leukemia (CML) patients who are often candidates for life-long treatment. Materials and methods: The Italian phase III multicentric randomized Optimize TKIs Multiple Approaches (OPTkIMA) study aimed to evaluate if a progressive de-escalation of TKIs is able to maintain the molecular remission (MR)3.0 and to improve Health-Related Quality of Life (HRQoL) in CML elderly patients. Results: A total of 215 patients in stable MR3.0/MR4.0 were randomized to receive an intermittent TKI schedule 1 month ON-1 month OFF for 3 years (FIXED arm; n = 111) vs. a progressive de-escalation TKI dose up to one-third of the starting dose at the 3rd year (PROGRESSIVE arm; n = 104). Two hundred three patients completed the 3rd year of OPTkIMA study. At the last follow-up, MR3.0 loss was 27% vs. 46% (P = .005) in the FIXED vs PROGRESSIVE arm, respectively. None of these patients experienced disease progression. The 3-year probability of maintaining the MR3.0 was 59% vs. 53%, respectively (P = .13). HRQoL globally improved from the baseline to the 3rd year, without any significant difference between the 2 arms. After the 3rd year, the proportion of patients who was address to TKI discontinuation in the 2 arms was 36% (FIXED) vs. 58% (PROGRESSIVE) (P = .03). Conclusions: The intensification of intermittent TKI therapy is associated with a higher incidence of MR3.0 loss, but those patients who maintain the MR3.0 molecular response at the end of the study have been frequently considered eligible for TFR. The HRQoL generally improved during the de-escalation therapy in both randomization arms.

Product ID:

139901

Handle IRIS:

11562/1127395

Last Modified:

December 21, 2024

Bibliographic citation:

Malagola, Michele; Iurlo, Alessandra; Bucelli, Cristina; Abruzzese, Elisabetta; Bonifacio, Massimiliano; Stagno, Fabio; Binotto, Gianni; D'Adda, Marienlla; Lunghi, Monia; Crugnola, Monica; Ferrari, Maria Luisa; Lunghi, Francesca; Castagnetti, Fausto; Rosti, Gianantonio; Lemoli, Roberto Massimo; Sancetta, Rosaria; Coppi, Maria Rosaria; Corsetti, Maria Teresa; De Gobbi, Marco; Romano, Atelda; Tiribelli, Mario; Russo Rossi, Antonella; Russo, Sabina; Defina, Marzia; Farina, Mirko; Bernardi, Simona; Butturini, Giulia; Pellizzeri, Simone; Roccaro, Aldo Maria; Russo, Domenico, The Italian Multicentric Randomized OPTkIMA Trial on Fixed vs Progressive Intermittent TKI Therapy in CML Elderly Patients: 3-Years of Molecular Response and Quality of Life Monitoring After Completing the Treatment Plan «CLINICAL LYMPHOMA MYELOMA & LEUKEMIA» , vol. 24 , n. 5 , 2024 , pp. 323-331

Consulta la scheda completa presente nel repository istituzionale della Ricerca di Ateneo