Open AccessMolecular response and quality of life in chronic myeloid leukemia patients treated with intermittent TKIs: First interim analysis of OPTkIMA study
Author(s) -
Malagola Michele,
Iurlo Alessandra,
Abruzzese Elisabetta,
Bonifacio Massimiliano,
Stagno Fabio,
Binotto Gianni,
D’Adda Mariella,
Lunghi Monia,
Crugnola Monica,
Ferrari Maria Luisa,
Lunghi Francesca,
Castagnetti Fausto,
Rosti Gianantonio,
Lemoli Roberto M.,
Sancetta Rosaria,
Coppi Maria Rosaria,
Corsetti Maria Teresa,
Rege Cambrin Giovanna,
Romano Atelda,
Tiribelli Mario,
Russo Rossi Antonella,
Russo Sabina,
Aprile Lara,
Bocchia Monica,
Gandolfi Lisa,
Farina Mirko,
Bernardi Simona,
Polverelli Nicola,
Roccaro Aldo M.,
De Vivo Antonio,
Baccarani Michele,
Russo Domenico
Publication year - 2021
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.3778
Subject(s) - medicine , discontinuation , quality of life (healthcare) , dasatinib , nilotinib , interim analysis , health related quality of life , imatinib , myeloid leukemia , population , surgery , oncology , pediatrics , randomized controlled trial , disease , nursing , environmental health
Background Intermittent treatment with TKIs is an option for the great majority (70%–80%) of CML patients who do not achieve a stable deep molecular response and are not eligible for treatment discontinuation. For these patients, the only alternative is to assume TKI continuously, lifelong. Methods The Italian phase III multicentric randomized OPTkIMA study started in 2015, with the aim to evaluate if a progressive de‐escalation of TKIs (imatinib, nilotinib, and dasatinib) is able to maintain the molecular response (MR 3.0 ) and to improve Health Related Quality of Life (HRQoL). Results Up to December 2018, 166/185 (90%) elderly CML patients in stable MR 3.0 /MR 4.0 completed the first year of any TKI intermittent schedule 1 month ON and 1 month OFF. The first year probability of maintaining the MR 3.0 was 81% and 23.5% of the patients who lost the molecular response regained the MR 3.0 after resuming TKI continuously. Patients’ HRQoL at baseline was better than that of matched peers from healthy population. Women was the only factor independently associated with worse baseline HRQoL ( p > 0.0001). Overall, global HRQoL worsened at 6 ( p < 0.001) but returned to the baseline value at 12 months and it was statistically significantly worse in women ( p = 0.001). Conclusions De‐escalation of any TKI by 1 month ON/OFF schedule maintains the MR 3.0 /MR 4.0 in 81% of the patients during the first 12–24 months. No patients progressed to accelerated/blastic phase, all the patients (23.5%) losing MR 3.0 regained the MR 3.0 and none suffered from TKI withdrawn syndrome. The study firstly report on HRQoL in elderly CML patients moving from a continuous daily therapy to a de‐escalated intermittent treatment.