Molecular response and quality of life in chronic myeloid leukemia patients treated with intermittent TKIs: First interim analysis of OPTkIMA study.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
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
Аннотация
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 (MR3.0 ) and to improve Health Related Quality of Life (HRQoL).
RESULTS: Up to December 2018, 166/185 (90%) elderly CML patients in stable MR3.0 /MR4.0 completed the first year of any TKI intermittent schedule 1 month ON and 1 month OFF. The first year probability of maintaining the MR3.0 was 81% and 23.5% of the patients who lost the molecular response regained the MR3.0 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 MR3.0 /MR4.0 in 81% of the patients during the first 12-24 months. No patients progressed to accelerated/blastic phase, all the patients (23.5%) losing MR3.0 regained the MR3.0 and none suffered from TKI withdrawn syndrome.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.