TY - JOUR
T1 - Brentuximab vedotin in transplant-naïve patients with relapsed or refractory Hodgkin lymphoma
T2 - Analysis of two phase I studies
AU - Forero-Torres, Andres
AU - Fanale, Michelle
AU - Advani, Ranjana
AU - Bartlett, Nancy L.
AU - Rosenblatt, Joseph D.
AU - Kennedy, Dana A.
AU - Younes, Anas
PY - 2012/8
Y1 - 2012/8
N2 - Background. Brentuximab vedotin is an antibody-drug conjugate designed to selectively deliver monomethyl auristatin E, a microtubule-disrupting agent, to CD30-expressing cells. Brentuximab vedotin induces durable objective responses in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplantation (ASCT). The objective of this post-hoc analysis was to characterize the safety and efficacy of brentuximab vedotin for patients with relapsed or refractoryHLwho refused or were ineligible for ASCT. Methods. This case series included 20 transplant-naïve patients who were enrolled in two phase I multicenter studies. Patients received brentuximab vedotin intravenously every 3 weeks or every week for 3 out of 4 weeks. Results. The majority of patients were transplant-naïve because of chemorefractory disease. Median age was 31.5 years (range, 12-87 years). Treatment-emergent adverse events in >20% of patients were peripheral neuropathy, fatigue, nausea, pyrexia, diarrhea, weight decreased, anemia, back pain, decreased appetite, night sweats, and vomiting; most events were grade 1 or 2. Six patients obtained objective responses: two complete remissions and four partial remissions. Median duration of response was not met; censored durations ranged from >6.8 to >13.8 months. Three of six responders subsequently received ASCT. Conclusion. Brentuximab vedotin was associated with manageable adverse events in transplant-naïve patients with relapsed or refractory HL. The objective responses observed demonstrate that antitumor activity is not limited to patients who received brentuximab vedotin after ASCT. The promising activity observed in this population warrants further study.
AB - Background. Brentuximab vedotin is an antibody-drug conjugate designed to selectively deliver monomethyl auristatin E, a microtubule-disrupting agent, to CD30-expressing cells. Brentuximab vedotin induces durable objective responses in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplantation (ASCT). The objective of this post-hoc analysis was to characterize the safety and efficacy of brentuximab vedotin for patients with relapsed or refractoryHLwho refused or were ineligible for ASCT. Methods. This case series included 20 transplant-naïve patients who were enrolled in two phase I multicenter studies. Patients received brentuximab vedotin intravenously every 3 weeks or every week for 3 out of 4 weeks. Results. The majority of patients were transplant-naïve because of chemorefractory disease. Median age was 31.5 years (range, 12-87 years). Treatment-emergent adverse events in >20% of patients were peripheral neuropathy, fatigue, nausea, pyrexia, diarrhea, weight decreased, anemia, back pain, decreased appetite, night sweats, and vomiting; most events were grade 1 or 2. Six patients obtained objective responses: two complete remissions and four partial remissions. Median duration of response was not met; censored durations ranged from >6.8 to >13.8 months. Three of six responders subsequently received ASCT. Conclusion. Brentuximab vedotin was associated with manageable adverse events in transplant-naïve patients with relapsed or refractory HL. The objective responses observed demonstrate that antitumor activity is not limited to patients who received brentuximab vedotin after ASCT. The promising activity observed in this population warrants further study.
KW - Antigens CD30
KW - Hodgkin disease
KW - Immunoconjugates
KW - Monoclonal antibodies
UR - http://www.scopus.com/inward/record.url?scp=84865235209&partnerID=8YFLogxK
U2 - 10.1634/theoncologist.2012-0133
DO - 10.1634/theoncologist.2012-0133
M3 - Article
C2 - 22855426
AN - SCOPUS:84865235209
SN - 1083-7159
VL - 17
SP - 1073
EP - 1080
JO - Oncologist
JF - Oncologist
IS - 8
ER -