التفاصيل البيبلوغرافية
| العنوان: |
Ibrutinib Treatment for First-Line and Relapsed/Refractory Chronic Lymphocytic Leukemia: Final Analysis of the Pivotal Phase Ib/II PCYC-1102 Study |
| المؤلفون: |
Byrd, John C, Furman, Richard R, Coutre, Steven E, Flinn, Ian W, Burger, Jan A, Blum, Kristie, Sharman, Jeff P, Wierda, William, Zhao, Weiqiang, Heerema, Nyla A, Luan, Ying, Liu, Emily A, Dean, James P, O'Brien, Susan |
| المصدر: |
Clinical Cancer Research, vol 26, iss 15 |
| بيانات النشر: |
eScholarship, University of California |
| سنة النشر: |
2020 |
| المجموعة: |
University of California: eScholarship |
| مصطلحات موضوعية: |
Rare Diseases, Cancer, Hematology, Lymphoma, Clinical Research, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Adenine, Adult, Agammaglobulinaemia Tyrosine Kinase, Aged, 80 and over, Disease-Free Survival, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Resistance, Neoplasm, Female, Follow-Up Studies, Humans, Hypertension, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Neoplasm Recurrence, Local |
| الوقت: |
3918 - 3927 |
| الوصف: |
PurposeThe safety and efficacy of ibrutinib, a once-daily Bruton's tyrosine kinase (BTK) inhibitor, in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) was demonstrated in this phase Ib/II study. Extended follow-up up to 8 years is described, representing the longest follow-up for single-agent ibrutinib, or any BTK inhibitor, to date.Patients and methodsPhase Ib/II PCYC-1102 (NCT01105247) and extension study PCYC-1103 (NCT01109069) included patients receiving single-agent ibrutinib in first-line or relapsed/refractory CLL/SLL.ResultsOverall response rate was 89%, with similar rates in first-line (87%; complete response, 35%) and relapsed/refractory settings (89%; 10%). Estimated 7-year progression-free survival (PFS) rates were 83% in first-line and 34% in relapsed/refractory settings. Forty-one patients had CLL progression (n = 11 with Richter's transformation). Median PFS was not reached with first-line ibrutinib. In relapsed/refractory CLL/SLL, median PFS was 52 months overall, 26 months in patients with chromosome 17p deletion, 51 months with 11q deletion, not reached with trisomy 12 or 13q deletion, and 88 months in patients without these cytogenetic abnormalities. Estimated 7-year overall survival rates were 84% in first-line and 55% in relapsed/refractory settings. Grade ≥3 adverse events (AE) in >15% of patients were hypertension (28%), pneumonia (24%), and neutropenia (18%). These grade ≥3 AEs generally declined over time, except hypertension. AEs leading to discontinuation in ≥2 patients were observed only in the relapsed/refractory setting (sepsis, diarrhea, subdural hematoma, and Richter's transformation).ConclusionsWith up to 8 years of follow-up, sustained responses and long-term tolerability of single-agent ibrutinib were observed with treatment of first-line or relapsed/refractory CLL/SLL, including high-risk CLL/SLL. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
unknown |
| العلاقة: |
qt2m8442sc; https://escholarship.org/uc/item/2m8442scTest |
| الإتاحة: |
https://escholarship.org/uc/item/2m8442scTest |
| حقوق: |
CC-BY |
| رقم الانضمام: |
edsbas.3BF8C09F |
| قاعدة البيانات: |
BASE |
