Current medical research and opinion · 2026
Zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma: health-related quality of life in a subgroup of Chinese patients in the ALPINE trial.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыСравнительное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
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.
Tam Constantine S, Shadman Mazyar, Ong Shin Yeu, Wu Ken, Salmi Tommi, Korde Rasika, Barnes Gisoo, Brown Jennifer R, Zhou Keshu, Qiu Lugui
Аннотация
OBJECTIVES: Zanubrutinib demonstrated superiority to ibrutinib in the ALPINE (NCT03734016) phase 3 trial for relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma (R/R CLL/SLL). This post hoc analysis examined patient-reported outcomes (PROs) in the Chinese subgroup.
METHODS: Adults with R/R CLL/SLL and ≥1 prior therapy were randomized 1:1 to zanubrutinib or ibrutinib. PROs, a secondary endpoint, were measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30. Differences between treatment arms from baseline to Cycles 7 and 13 for key PRO endpoints were assessed using a mixed model for repeated measures. Changes from baseline on the EQ visual analog scale (EQ-VAS) were examined descriptively.
RESULTS: As of February 28, 2024, 90 Chinese patients were randomized to zanubrutinib (n = 47) or ibrutinib (n = 43). Global health status/quality of life improved in both arms. Fatigue was reduced in both arms, with greater improvement in the zanubrutinib versus ibrutinib arm at Cycles 7 and 13. Nausea/vomiting scores generally remained unchanged, and all other symptoms showed similar improvement in both arms. Greater improvement in health status, measured by VAS score, was observed for the zanubrutinib arm at Cycle 13 (Cycle 7, 4.8 vs 4.1; Cycle 13, 5.7 vs 1.7).
CONCLUSIONS: In ALPINE, Chinese patients with R/R CLL/SLL treated with zanubrutinib showed better and faster PRO outcomes versus those treated with ibrutinib, particularly in fatigue. These results corroborate PRO findings in the intent-to-treat population and support the benefit of zanubrutinib as a valuable treatment option for Chinese patients with R/R CLL/SLL.
TRIAL REGISTRATION: NCT03734016. Registered 01 November, 2018 https://clinicaltrials.gov/study/NCT03734016.
METHODS: Adults with R/R CLL/SLL and ≥1 prior therapy were randomized 1:1 to zanubrutinib or ibrutinib. PROs, a secondary endpoint, were measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30. Differences between treatment arms from baseline to Cycles 7 and 13 for key PRO endpoints were assessed using a mixed model for repeated measures. Changes from baseline on the EQ visual analog scale (EQ-VAS) were examined descriptively.
RESULTS: As of February 28, 2024, 90 Chinese patients were randomized to zanubrutinib (n = 47) or ibrutinib (n = 43). Global health status/quality of life improved in both arms. Fatigue was reduced in both arms, with greater improvement in the zanubrutinib versus ibrutinib arm at Cycles 7 and 13. Nausea/vomiting scores generally remained unchanged, and all other symptoms showed similar improvement in both arms. Greater improvement in health status, measured by VAS score, was observed for the zanubrutinib arm at Cycle 13 (Cycle 7, 4.8 vs 4.1; Cycle 13, 5.7 vs 1.7).
CONCLUSIONS: In ALPINE, Chinese patients with R/R CLL/SLL treated with zanubrutinib showed better and faster PRO outcomes versus those treated with ibrutinib, particularly in fatigue. These results corroborate PRO findings in the intent-to-treat population and support the benefit of zanubrutinib as a valuable treatment option for Chinese patients with R/R CLL/SLL.
TRIAL REGISTRATION: NCT03734016. Registered 01 November, 2018 https://clinicaltrials.gov/study/NCT03734016.