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
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 p...
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| Published in | Haematologica (Roma) Vol. 103; no. 9; pp. 1502 - 1510 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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Italy
Ferrata Storti Foundation
01.09.2018
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| Abstract | 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
chlorambucil (median, not reached
15 months; hazard ratio, 0.12; 95% confidence interval, 0.07-0.20;
<0.0001). The 24-month progression-free survival was 89% with ibrutinib (97% and 89% in patients with del[11q] and unmutated immunoglobulin heavy chain variable region gene, respectively). Progression-free survival rates at 24 months were also similar regardless of age (<75 years [88%], ≥75 years [89%]). Overall response rate was 92% (125/136). Rate of complete response increased substantially from 7% at 12 months to 18% with extended follow up. Greater quality of life improvements occurred with ibrutinib
chlorambucil in Functional Assessment of Chronic Illness Therapy-Fatigue (
=0.0013). The most frequent grade ≥3 adverse events were neutropenia (12%), anemia (7%), and hypertension (5%). Rate of discontinuations due to adverse events was 12%. Results demonstrated that first-line ibrutinib for elderly patients with chronic lymphocytic leukemia provides sustained response and progression-free survival benefits over chemotherapy, with depth of response improving over time without new toxicity concerns. This trial was registered at
and
. |
|---|---|
| AbstractList | 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<0.0001). The 24-month progression-free survival was 89% with ibrutinib (97% and 89% in patients with del[11q] and unmutated immunoglobulin heavy chain variable region gene, respectively). Progression-free survival rates at 24 months were also similar regardless of age (<75 years [88%], ≥75 years [89%]). Overall response rate was 92% (125/136). Rate of complete response increased substantially from 7% at 12 months to 18% with extended follow up. Greater quality of life improvements occurred with ibrutinib versus chlorambucil in Functional Assessment of Chronic Illness Therapy-Fatigue (P=0.0013). The most frequent grade ≥3 adverse events were neutropenia (12%), anemia (7%), and hypertension (5%). Rate of discontinuations due to adverse events was 12%. Results demonstrated that first-line ibrutinib for elderly patients with chronic lymphocytic leukemia provides sustained response and progression-free survival benefits over chemotherapy, with depth of response improving over time without new toxicity concerns. This trial was registered at clinicaltrials.gov identifier 01722487 and 01724346.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<0.0001). The 24-month progression-free survival was 89% with ibrutinib (97% and 89% in patients with del[11q] and unmutated immunoglobulin heavy chain variable region gene, respectively). Progression-free survival rates at 24 months were also similar regardless of age (<75 years [88%], ≥75 years [89%]). Overall response rate was 92% (125/136). Rate of complete response increased substantially from 7% at 12 months to 18% with extended follow up. Greater quality of life improvements occurred with ibrutinib versus chlorambucil in Functional Assessment of Chronic Illness Therapy-Fatigue (P=0.0013). The most frequent grade ≥3 adverse events were neutropenia (12%), anemia (7%), and hypertension (5%). Rate of discontinuations due to adverse events was 12%. Results demonstrated that first-line ibrutinib for elderly patients with chronic lymphocytic leukemia provides sustained response and progression-free survival benefits over chemotherapy, with depth of response improving over time without new toxicity concerns. This trial was registered at clinicaltrials.gov identifier 01722487 and 01724346. 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 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 <0.0001). The 24-month progression-free survival was 89% with ibrutinib (97% and 89% in patients with del[11q] and unmutated immunoglobulin heavy chain variable region gene, respectively). Progression-free survival rates at 24 months were also similar regardless of age (<75 years [88%], ≥75 years [89%]). Overall response rate was 92% (125/136). Rate of complete response increased substantially from 7% at 12 months to 18% with extended follow up. Greater quality of life improvements occurred with ibrutinib versus chlorambucil in Functional Assessment of Chronic Illness Therapy-Fatigue ( P =0.0013). The most frequent grade ≥3 adverse events were neutropenia (12%), anemia (7%), and hypertension (5%). Rate of discontinuations due to adverse events was 12%. Results demonstrated that first-line ibrutinib for elderly patients with chronic lymphocytic leukemia provides sustained response and progression-free survival benefits over chemotherapy, with depth of response improving over time without new toxicity concerns. This trial was registered at clinicaltrials.gov identifier 01722487 and 01724346 . 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 chlorambucil (median, not reached 15 months; hazard ratio, 0.12; 95% confidence interval, 0.07-0.20; <0.0001). The 24-month progression-free survival was 89% with ibrutinib (97% and 89% in patients with del[11q] and unmutated immunoglobulin heavy chain variable region gene, respectively). Progression-free survival rates at 24 months were also similar regardless of age (<75 years [88%], ≥75 years [89%]). Overall response rate was 92% (125/136). Rate of complete response increased substantially from 7% at 12 months to 18% with extended follow up. Greater quality of life improvements occurred with ibrutinib chlorambucil in Functional Assessment of Chronic Illness Therapy-Fatigue ( =0.0013). The most frequent grade ≥3 adverse events were neutropenia (12%), anemia (7%), and hypertension (5%). Rate of discontinuations due to adverse events was 12%. Results demonstrated that first-line ibrutinib for elderly patients with chronic lymphocytic leukemia provides sustained response and progression-free survival benefits over chemotherapy, with depth of response improving over time without new toxicity concerns. This trial was registered at and . |
| Author | Barr, Paul M. Zhou, Cathy Offner, Fritz Li, Jianyong Grosicki, Sebastian James, Danelle Robak, Tadeusz Bairey, Osnat Moreno, Carol Burger, Jan A. Hillmen, Peter McCarthy, Helen Owen, Carolyn Tedeschi, Alessandra Kipps, Thomas J. Simpson, David Coutre, Steven Bartlett, Nancy L. Ghia, Paolo Styles, Lori Devereux, Stephen |
| AuthorAffiliation | 4 ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy 13 Royal Bournemouth Hospital, UK 5 Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel 19 University of California, San Diego, Moores Cancer Center, La Jolla, CA, USA 6 Sackler Faculty of Medicine, Tel Aviv University, Israel 12 School of Public Health, Silesian Medical University, Katowice, Poland 15 North Shore Hospital, Auckland, New Zealand 2 Medical University of Lodz, Poland 11 Kings College Hospital, NHS Foundation Trust, London, UK 17 Hospital de la Santa Creu i Sant Pau, Barcelona, Spain 16 Universitair Ziekenhuis Gent, Belgium 10 Stanford University School of Medicine, CA, USA 14 Jiangsu Province Hospital, Nanjing, China 3 Tom Baker Cancer Centre, Calgary, AB, Canada 1 University of Rochester, NY, USA 9 The Leeds Teaching Hospitals, St. James Institute of Oncology, UK 7 Washington University School of Medicine, St. Louis, MO, USA 18 Pharmacyclics, LLC, an AbbVie Company, Sunnyvale, CA, USA 20 Università Vita-Salute San Raffae |
| AuthorAffiliation_xml | – name: 7 Washington University School of Medicine, St. Louis, MO, USA – name: 1 University of Rochester, NY, USA – name: 10 Stanford University School of Medicine, CA, USA – name: 20 Università Vita-Salute San Raffaele and IRCCS Istituto Scientifico San Raffaele, Milan, Italy – name: 3 Tom Baker Cancer Centre, Calgary, AB, Canada – name: 18 Pharmacyclics, LLC, an AbbVie Company, Sunnyvale, CA, USA – name: 16 Universitair Ziekenhuis Gent, Belgium – name: 6 Sackler Faculty of Medicine, Tel Aviv University, Israel – name: 8 University of Texas MD Anderson Cancer Center, Houston, TX, USA – name: 13 Royal Bournemouth Hospital, UK – name: 15 North Shore Hospital, Auckland, New Zealand – name: 11 Kings College Hospital, NHS Foundation Trust, London, UK – name: 9 The Leeds Teaching Hospitals, St. James Institute of Oncology, UK – name: 19 University of California, San Diego, Moores Cancer Center, La Jolla, CA, USA – name: 17 Hospital de la Santa Creu i Sant Pau, Barcelona, Spain – name: 12 School of Public Health, Silesian Medical University, Katowice, Poland – name: 14 Jiangsu Province Hospital, Nanjing, China – name: 2 Medical University of Lodz, Poland – name: 5 Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel – name: 4 ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy |
| Author_xml | – sequence: 1 givenname: Paul M. surname: Barr fullname: Barr, Paul M. – sequence: 2 givenname: Tadeusz surname: Robak fullname: Robak, Tadeusz – sequence: 3 givenname: Carolyn surname: Owen fullname: Owen, Carolyn – sequence: 4 givenname: Alessandra surname: Tedeschi fullname: Tedeschi, Alessandra – sequence: 5 givenname: Osnat surname: Bairey fullname: Bairey, Osnat – sequence: 6 givenname: Nancy L. surname: Bartlett fullname: Bartlett, Nancy L. – sequence: 7 givenname: Jan A. surname: Burger fullname: Burger, Jan A. – sequence: 8 givenname: Peter surname: Hillmen fullname: Hillmen, Peter – sequence: 9 givenname: Steven surname: Coutre fullname: Coutre, Steven – sequence: 10 givenname: Stephen surname: Devereux fullname: Devereux, Stephen – sequence: 11 givenname: Sebastian surname: Grosicki fullname: Grosicki, Sebastian – sequence: 12 givenname: Helen surname: McCarthy fullname: McCarthy, Helen – sequence: 13 givenname: Jianyong surname: Li fullname: Li, Jianyong – sequence: 14 givenname: David surname: Simpson fullname: Simpson, David – sequence: 15 givenname: Fritz surname: Offner fullname: Offner, Fritz – sequence: 16 givenname: Carol surname: Moreno fullname: Moreno, Carol – sequence: 17 givenname: Cathy surname: Zhou fullname: Zhou, Cathy – sequence: 18 givenname: Lori surname: Styles fullname: Styles, Lori – sequence: 19 givenname: Danelle surname: James fullname: James, Danelle – sequence: 20 givenname: Thomas J. surname: Kipps fullname: Kipps, Thomas J. – sequence: 21 givenname: Paolo surname: Ghia fullname: Ghia, Paolo |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29880603$$D View this record in MEDLINE/PubMed |
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| SubjectTerms | Aged Aged, 80 and over Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biomarkers, Tumor Female Follow-Up Studies Humans Leukemia, Lymphocytic, Chronic, B-Cell - diagnosis Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy Leukemia, Lymphocytic, Chronic, B-Cell - genetics Male Molecular Targeted Therapy Mutation Neoplasm Staging Prognosis Protein Kinase Inhibitors - administration & dosage Protein Kinase Inhibitors - adverse effects Protein Kinase Inhibitors - therapeutic use Pyrazoles - administration & dosage Pyrazoles - adverse effects Pyrazoles - therapeutic use Pyrimidines - administration & dosage Pyrimidines - adverse effects Pyrimidines - therapeutic use Treatment Outcome |
| Title | 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 |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/29880603 https://www.proquest.com/docview/2052805022 https://pubmed.ncbi.nlm.nih.gov/PMC6119145 https://doaj.org/article/379cf031951e46cc9409fd9b6d097879 |
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