Sustained efficacy and detailed clinical follow-up of first-line ibrutinib treatment in older patients with chronic lymphocytic leukemia: extended phase 3 results from RESONATE-2
Paul M. Barr,
Tadeusz Robak,
Carolyn Owen,
Alessandra Tedeschi,
Osnat Bairey,
Nancy L. Bartlett,
Jan A. Burger,
Peter Hillmen,
Steven Coutre,
Stephen Devereux,
Sebastian Grosicki,
Helen McCarthy,
Jianyong Li,
David Simpson,
Fritz Offner,
Carol Moreno,
Cathy Zhou,
Lori Styles,
Danelle James,
Thomas J. Kipps,
Paolo Ghia
Affiliations
Paul M. Barr
University of Rochester, NY, USA
Tadeusz Robak
Medical University of Lodz, Poland
Carolyn Owen
Tom Baker Cancer Centre, Calgary, AB, Canada
Alessandra Tedeschi
ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
Osnat Bairey
Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel;Sackler Faculty of Medicine, Tel Aviv University, Israel
Nancy L. Bartlett
Washington University School of Medicine, St. Louis, MO, USA
Jan A. Burger
University of Texas MD Anderson Cancer Center, Houston, TX, USA
Peter Hillmen
The Leeds Teaching Hospitals, St. James Institute of Oncology, UK
Steven Coutre
Stanford University School of Medicine, CA, USA
Stephen Devereux
Kings College Hospital, NHS Foundation Trust, London, UK
Sebastian Grosicki
School of Public Health, Silesian Medical University, Katowice, Poland
Helen McCarthy
Royal Bournemouth Hospital, UK
Jianyong Li
Jiangsu Province Hospital, Nanjing, China
David Simpson
North Shore Hospital, Auckland, New Zealand
Fritz Offner
Universitair Ziekenhuis Gent, Belgium
Carol Moreno
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Cathy Zhou
Pharmacyclics, LLC, an AbbVie Company, Sunnyvale, CA, USA
Lori Styles
Pharmacyclics, LLC, an AbbVie Company, Sunnyvale, CA, USA
Danelle James
Pharmacyclics, LLC, an AbbVie Company, Sunnyvale, CA, USA
Thomas J. Kipps
University of California, San Diego, Moores Cancer Center, La Jolla, CA, USA
Paolo Ghia
Università Vita-Salute San Raffaele and IRCCS Istituto Scientifico San Raffaele, Milan, Italy
Results of RESONATE-2 (PCYC-1115/1116) supported approval of ibrutinib for first-line treatment of chronic lymphocytic leukemia. Extended analysis of RESONATE-2 was conducted to determine long-term efficacy and safety of ibrutinib in older patients with chronic lymphocytic leukemia. A total of 269 patients aged ≥65 years with previously untreated chronic lymphocytic leukemia without del(17p) were randomized 1:1 to ibrutinib (n=136) or chlorambucil (n=133) on days 1 and 15 of a 28-day cycle for 12 cycles. Median ibrutinib treatment duration was 28.5 months. Ibrutinib significantly prolonged progression-free survival versus chlorambucil (median, not reached vs. 15 months; hazard ratio, 0.12; 95% confidence interval, 0.07-0.20; P
