Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma

Presented here are the 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation. At 5 years, the overall patient population (N = 102) had an estim...

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Vydáno v:	Blood Ročník 128; číslo 12; s. 1562
Hlavní autoři:	Chen, Robert, Gopal, Ajay K, Smith, Scott E, Ansell, Stephen M, Rosenblatt, Joseph D, Savage, Kerry J, Connors, Joseph M, Engert, Andreas, Larsen, Emily K, Huebner, Dirk, Fong, Abraham, Younes, Anas
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States 22.09.2016
Témata:	Adult Brentuximab Vedotin Female Hodgkin Disease - drug therapy Hodgkin Disease - mortality Hodgkin Disease - pathology Humans Immunoconjugates - therapeutic use Male Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - mortality Neoplasm Recurrence, Local - pathology Neoplasm Staging Prognosis Remission Induction Salvage Therapy Survival Rate
ISSN:	1528-0020, 1528-0020
On-line přístup:	Zjistit podrobnosti o přístupu
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Abstract	Presented here are the 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation. At 5 years, the overall patient population (N = 102) had an estimated overall survival (OS) rate of 41% (95% confidence interval [CI]: 31-51) and progression-free survival (PFS) rate of 22% (95% CI: 13-31). Patients who achieved a complete response (CR) to brentuximab vedotin (N = 34) had estimated OS and PFS rates of 64% (95% CI: 48-80%) and 52% (95% CI: 34-69%), respectively. The median OS and PFS were not reached in CR patients, with 13 patients (38% of all CR patients) remaining in follow-up and in remission at study closure. Of the 13 patients, 4 received consolidative hematopoietic allogeneic stem cell transplant, and 9 (9% of all enrolled patients) remain in sustained CR without receiving any further anticancer therapy after treatment with brentuximab vedotin. Of the patients who experienced treatment-emergent peripheral neuropathy, 88% experienced either resolution (73%) or improvement (14%) in symptoms. These 5-year follow-up data demonstrate that a subset of patients with R/R HL who obtained CR with single-agent brentuximab vedotin achieved long-term disease control and may potentially be cured. The trial was registered at www.clinicaltrials.gov as #NCT00848926.
AbstractList	Presented here are the 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation. At 5 years, the overall patient population (N = 102) had an estimated overall survival (OS) rate of 41% (95% confidence interval [CI]: 31-51) and progression-free survival (PFS) rate of 22% (95% CI: 13-31). Patients who achieved a complete response (CR) to brentuximab vedotin (N = 34) had estimated OS and PFS rates of 64% (95% CI: 48-80%) and 52% (95% CI: 34-69%), respectively. The median OS and PFS were not reached in CR patients, with 13 patients (38% of all CR patients) remaining in follow-up and in remission at study closure. Of the 13 patients, 4 received consolidative hematopoietic allogeneic stem cell transplant, and 9 (9% of all enrolled patients) remain in sustained CR without receiving any further anticancer therapy after treatment with brentuximab vedotin. Of the patients who experienced treatment-emergent peripheral neuropathy, 88% experienced either resolution (73%) or improvement (14%) in symptoms. These 5-year follow-up data demonstrate that a subset of patients with R/R HL who obtained CR with single-agent brentuximab vedotin achieved long-term disease control and may potentially be cured. The trial was registered at www.clinicaltrials.gov as #NCT00848926.Presented here are the 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation. At 5 years, the overall patient population (N = 102) had an estimated overall survival (OS) rate of 41% (95% confidence interval [CI]: 31-51) and progression-free survival (PFS) rate of 22% (95% CI: 13-31). Patients who achieved a complete response (CR) to brentuximab vedotin (N = 34) had estimated OS and PFS rates of 64% (95% CI: 48-80%) and 52% (95% CI: 34-69%), respectively. The median OS and PFS were not reached in CR patients, with 13 patients (38% of all CR patients) remaining in follow-up and in remission at study closure. Of the 13 patients, 4 received consolidative hematopoietic allogeneic stem cell transplant, and 9 (9% of all enrolled patients) remain in sustained CR without receiving any further anticancer therapy after treatment with brentuximab vedotin. Of the patients who experienced treatment-emergent peripheral neuropathy, 88% experienced either resolution (73%) or improvement (14%) in symptoms. These 5-year follow-up data demonstrate that a subset of patients with R/R HL who obtained CR with single-agent brentuximab vedotin achieved long-term disease control and may potentially be cured. The trial was registered at www.clinicaltrials.gov as #NCT00848926. Presented here are the 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation. At 5 years, the overall patient population (N = 102) had an estimated overall survival (OS) rate of 41% (95% confidence interval [CI]: 31-51) and progression-free survival (PFS) rate of 22% (95% CI: 13-31). Patients who achieved a complete response (CR) to brentuximab vedotin (N = 34) had estimated OS and PFS rates of 64% (95% CI: 48-80%) and 52% (95% CI: 34-69%), respectively. The median OS and PFS were not reached in CR patients, with 13 patients (38% of all CR patients) remaining in follow-up and in remission at study closure. Of the 13 patients, 4 received consolidative hematopoietic allogeneic stem cell transplant, and 9 (9% of all enrolled patients) remain in sustained CR without receiving any further anticancer therapy after treatment with brentuximab vedotin. Of the patients who experienced treatment-emergent peripheral neuropathy, 88% experienced either resolution (73%) or improvement (14%) in symptoms. These 5-year follow-up data demonstrate that a subset of patients with R/R HL who obtained CR with single-agent brentuximab vedotin achieved long-term disease control and may potentially be cured. The trial was registered at www.clinicaltrials.gov as #NCT00848926.
Author	Rosenblatt, Joseph D Ansell, Stephen M Fong, Abraham Engert, Andreas Gopal, Ajay K Smith, Scott E Larsen, Emily K Huebner, Dirk Connors, Joseph M Savage, Kerry J Chen, Robert Younes, Anas
Author_xml	– sequence: 1 givenname: Robert surname: Chen fullname: Chen, Robert organization: City of Hope National Medical Center, Duarte, CA – sequence: 2 givenname: Ajay K surname: Gopal fullname: Gopal, Ajay K organization: Division of Medical Oncology, Department of Medicine, University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA – sequence: 3 givenname: Scott E surname: Smith fullname: Smith, Scott E organization: Division of Hematology and Medical Oncology, Department of Medicine, Loyola University Medical Center, Maywood, IL – sequence: 4 givenname: Stephen M surname: Ansell fullname: Ansell, Stephen M organization: Mayo Clinic, Rochester, MN – sequence: 5 givenname: Joseph D surname: Rosenblatt fullname: Rosenblatt, Joseph D organization: Division of Hematology and Oncology, Department of Medicine, University of Miami Sylvester Comprehensive Cancer Center, Miami, FL – sequence: 6 givenname: Kerry J surname: Savage fullname: Savage, Kerry J organization: British Columbia Cancer Agency Centre for Lymphoid Cancer, Vancouver, BC, Canada – sequence: 7 givenname: Joseph M surname: Connors fullname: Connors, Joseph M organization: British Columbia Cancer Agency Centre for Lymphoid Cancer, Vancouver, BC, Canada – sequence: 8 givenname: Andreas surname: Engert fullname: Engert, Andreas organization: German Hodgkin Study Group, Department of Internal Medicine I, University Hospital of Cologne, Cologne, Germany – sequence: 9 givenname: Emily K surname: Larsen fullname: Larsen, Emily K organization: Seattle Genetics, Inc., Bothell, WA – sequence: 10 givenname: Dirk surname: Huebner fullname: Huebner, Dirk organization: Millenium Pharmaceuticals, Inc., Cambridge, MA; and – sequence: 11 givenname: Abraham surname: Fong fullname: Fong, Abraham organization: Seattle Genetics, Inc., Bothell, WA – sequence: 12 givenname: Anas surname: Younes fullname: Younes, Anas organization: Memorial Sloan Kettering Cancer Center, New York, NY
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/27432875$$D View this record in MEDLINE/PubMed
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Snippet	Presented here are the 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin...
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SubjectTerms	Adult Brentuximab Vedotin Female Hodgkin Disease - drug therapy Hodgkin Disease - mortality Hodgkin Disease - pathology Humans Immunoconjugates - therapeutic use Male Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - mortality Neoplasm Recurrence, Local - pathology Neoplasm Staging Prognosis Remission Induction Salvage Therapy Survival Rate
Title	Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma
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