دورية أكاديمية
أعرض في EDS

ASCEND-7: Efficacy and Safety of Ceritinib Treatment in Patients with ALK-Positive Non-Small Cell Lung Cancer Metastatic to the Brain and/or Leptomeninges

التفاصيل البيبلوغرافية
العنوان: ASCEND-7: Efficacy and Safety of Ceritinib Treatment in Patients with ALK-Positive Non-Small Cell Lung Cancer Metastatic to the Brain and/or Leptomeninges
المؤلفون: Chow, Laura Q. M., Barlesi, Fabrice, Bertino, Erin M., van den Bent, Martin J., Wakelee, Heather A., Wen, Patrick Y., Chiu, Chao-Hua, Orlov, Sergey, Chiari, Rita, Majem, Margarita, McKeage, Mark, Yu, Chong-Jen, Garrido, Pilar, Hurtado, Felipe K., Arratia, Pilar Cazorla, Song, Yuanbo, Branle, Fabrice, Shi, Michael, Kim, Dong-Wan
المساهمون: Kim, Dong-Wan
بيانات النشر: American Association for Cancer Research
سنة النشر: 2022
المجموعة: Seoul National University: S-Space
مصطلحات موضوعية: TYROSINE KINASE INHIBITORS, OPEN-LABEL, CRIZOTINIB, CHEMOTHERAPY, SURVIVAL, MANAGEMENT, DIAGNOSIS, CARCINOMATOSIS, ALECTINIB, OUTCOMES
الوصف: Purpose: Central nervous system metastases are a prominent cause of morbidity and mortality in patients with ALK-positive (ALK(+)) non-small cell lung cancer (NSCLC). The phase II ASCEND-7 (NCT02336451) study was specifically designed to assess the efficacy and safety of the ALK inhibitor (ALKi) ceritinib in patients with ALK(+) NSCLC metastatic to the brain and/or leptomeninges. Patients and Methods: Patients with active brain metastases were allocated to study arms 1 to 4 based on prior exposure to an ALKi and/or prior brain radiation (arm 1: prior radiotherapy/ALKi-pretreated; arm 2: no radiotherapy/ALKi-pretreated; arm 3: prior radiotherapy/ALKi-naive; arm 4: no radiotherapy/ALKi-naive). Arm 5 included patients with leptomeningeal carcinomatosis. Patients received ceritinib 750 mg once daily (fasted condition). Primary endpoint was investigator-assessed whole-body overall response rate (ORR) per RECIST v1.1. Secondary endpoints included disease control rate (DCR) and intracranial/extracranial responses. Results: Per investigator assessment, in arms 1 (n = 42), 2 (n = 40), 3 (n = 12), and 4 (n = 44), respectively: whole-body ORRs [95% confidence interval (CI)] were 35.7% (21.6-52.0), 30.0% (16.6-46.5), 50.0% (21.1-78.9), and 59.1% (43.2-73.7); whole-body DCR (95% CI): 66.7% (50.5-80.4), 82.5% (67.2-92.7), 66.7% (34.9-90.1), and 70.5% (54.8-83.2); intracranial ORRs 95%) CI): 39.3% (21.5-59.4), 27.6% (12.7-47.2), 28.6% (3.7-71.0), and 51.5% (33.5-69.2). In arm 5 (n = 18), whole-body ORR was 16.7% (95% CI, 3.6-41.4) and DCR was 66.7% (95% CI, 41.0-86.7). Paired cerebrospinal fluid and plasma sampling revealed that ceritinib penetrated the human blood-brain barrier. Conclusions: Ceritinib showed antitumor activity in patients with ALK+ NSCLC with active brain metastases and/or leptomeningeal disease, and could be considered in the management of intracranial disease. ; N ; 1
نوع الوثيقة: article in journal/newspaper
اللغة: unknown
تدمد: 1078-0432
العلاقة: Clinical Cancer Research, Vol.28 No.12, pp.2506-2516; https://hdl.handle.net/10371/184627Test; 000813269600001; 2-s2.0-85131604877; 165769
DOI: 10.1158/1078-0432.CCR-21-1838
الإتاحة: https://doi.org/10.1158/1078-0432.CCR-21-1838Test
https://hdl.handle.net/10371/184627Test
رقم الانضمام: edsbas.5E44DFF0
قاعدة البيانات: BASE
الوصف
تدمد:10780432
DOI:10.1158/1078-0432.CCR-21-1838