title: A phase 2 study of inotuzumab ozogamicin and rituximab, followed by autologous stem cell transplant in patients with relapsed/refractory diffuse large B-cell lymphoma.
abstract: This study evaluated the safety and efficacy of inotuzumab ozogamicin (INO), a targeted humanized anti-CD22 antibody conjugated to calicheamicin, plus rituximab (R-INO) every 3 weeks, up to six cycles, followed by high dose therapy and autologous stem cell transplant (HDT-aSCT) in patients with high-risk relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The primary endpoint was overall response (OR) rate after three cycles of R-INO. Sixty-three patients were enrolled. Common grade 3/4 adverse events during R-INO treatment were thrombocytopenia, lymphopenia and neutropenia. OR rate after three cycles of R-INO was 28.6% (95% confidence interval: 17.9-41.4). Eighteen patients underwent HDT-aSCT; 2-year progression-free survival (PFS) for these patients was 61.1%. Serious infections and hepatic toxicity following aSCT occurred in 33% and 22%, respectively. One- and 2-year PFS rates for all enrolled patients were 28.9% and 25.3%, respectively (median, 3.0 months). R-INO had lower than expected activity as a salvage regimen for transplant eligible patients with DLBCL.
authors.affiliation: a Washington University School of Medicine , St Louis , MO , USA.
authors.forename: Nina D
authors.initials: ND
authors.lastname: Wagner-Johnston
authors.affiliation: b The Cancer Center at Hackensack University Medical Center , Hackensack , NJ , USA.
authors.forename: Andrè
authors.initials: A
authors.lastname: Goy
authors.affiliation: c University of Texas MD Anderson Cancer Center , Houston , TX , USA.
authors.forename: Maria A
authors.initials: MA
authors.lastname: Rodriguez
authors.affiliation: d Penn State Hershey Cancer Institute , Hershey , PA , USA.
authors.forename: W Christopher
authors.initials: WC
authors.lastname: Ehmann
authors.affiliation: e Memorial Sloan Kettering Cancer Center , New York , NY , USA.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Hamlin
authors.affiliation: f The University of Manchester and The Christie NHS Foundation Trust , Manchester , UK.
authors.forename: John
authors.initials: J
authors.lastname: Radford
authors.affiliation: g Hospital Saint Louis , Paris , France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Thieblemont
authors.affiliation: h Asan Medical Center, University of Ulsan College of Medicine , Seoul , Korea.
authors.forename: Cheolwon
authors.initials: C
authors.lastname: Suh
authors.affiliation: i Cleveland Clinic , Cleveland , OH , USA.
authors.forename: John
authors.initials: J
authors.lastname: Sweetenham
authors.affiliation: j Pfizer Oncology , (LaJolla, CA and Cambridge, MA) , USA.
authors.forename: Yifan
authors.initials: Y
authors.lastname: Huang
authors.affiliation: j Pfizer Oncology , (LaJolla, CA and Cambridge, MA) , USA.
authors.forename: Sharon T
authors.initials: ST
authors.lastname: Sullivan
authors.affiliation: j Pfizer Oncology , (LaJolla, CA and Cambridge, MA) , USA.
authors.forename: Erik R
authors.initials: ER
authors.lastname: Vandendries
authors.affiliation: g Hospital Saint Louis , Paris , France.
authors.forename: Christian
authors.initials: C
authors.lastname: Gisselbrecht
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm; D005260:Female; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods; D006801:Humans; D000080045:Inotuzumab Ozogamicin; D053208:Kaplan-Meier Estimate; D016403:Lymphoma, Large B-Cell, Diffuse / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016017:Odds Ratio; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods; D011379:Prognosis; D012008:Recurrence; D012074:Remission Induction; D019233:Retreatment; D000069283:Rituximab / Q000008:administration & dosage; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069283:Rituximab; D000080045:Inotuzumab Ozogamicin
keywords: DLBCL; Inotuzumab ozogamicin; autologous; immunotherapy; rituximab; transplant