title: Phase II trial of ofatumumab plus ESHAP (O-ESHAP) as salvage treatment for patients with relapsed or refractory classical Hodgkin lymphoma after first-line chemotherapy.
abstract: The management of recurrent/refractory (R/R) Hodgkin lymphoma (HL) remains challenging. Previously published data have shown some efficacy of rituximab in this setting. The purpose of this phase II trial was to investigate the activity of ofatumumab in combination with etoposide, steroids, cytarabine and cisplatin (O-ESHAP) in 62 patients with R/R classical HL. Treatment consisted of ESHAP plus ofatumumab 1000 mg on days 1 and 8 of the first cycle and day 1 of the second and third cycles. O-ESHAP was well tolerated with only 3% of patients requiring treatment discontinuation because of adverse events. Overall response rate was 73% (44% complete metabolic response). In multivariate analysis, early relapse (P < 0·001), bulky disease (P < 0·001) and B symptoms (P < 0·001) were the most important prognostic factors for response. No failures of stem cell mobilization were observed. The high response rate, particularly the complete metabolic response rate, the low toxicity profile, and the high mobilizing potential of the O-ESHAP regimen suggest that patients with R/R HL may benefit from this salvage regimen. However, with the encouraging results observed with other new therapeutic agents in HL, the O-ESHAP regimen could be restricted to patients failing these agents or to those with R/R nodular lymphocyte-predominant HL.
authors.affiliation: Department of Haematology, Hospital Clínic of Barcelona, Barcelona, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Martínez
authors.affiliation: Pathology Department, MD Anderson Cancer Centre, Madrid, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Díaz-López
authors.affiliation: Department of Haematology, Complejo Hospitalario de Navarra, Pamplona, Spain.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Rodriguez-Calvillo
authors.affiliation: Department of Haematology, Hospital Clínico of Salamanca, Salamanca, Spain.
authors.forename: Ramón
authors.initials: R
authors.lastname: García-Sanz
authors.affiliation: Department of Haematology, Hospital Clínico of Valencia, Valencia, Spain.
authors.forename: María José
authors.initials: MJ
authors.lastname: Terol
authors.affiliation: Department of Haematology, Hospital Morales Messeguer of Murcia, Murcia, Spain.
authors.forename: Elena
authors.initials: E
authors.lastname: Pérez-Ceballos
authors.affiliation: Department of Haematology, Hospital Germans Trias i Pujol of Barcelona, Barcelona, Spain.
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Jiménez
authors.affiliation: Department of Haematology, Hospital Río Hortega of Valladolid, Valladolid, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Cantalapiedra
authors.affiliation: Department of Haematology, Hospital Duran i Reynals of Barcelona, Barcelona, Spain.
authors.forename: Eva
authors.initials: E
authors.lastname: Domingo-Domenech
authors.affiliation: Department of Haematology, Hospital Universitario de Canarias, Tenerife, Spain.
authors.forename: María José
authors.initials: MJ
authors.lastname: Rodriguez
authors.affiliation: Department of Haematology, Hospital Universitari Son Espases of Mallorca, Palma Mallorca, Spain.
authors.forename: Antonia
authors.initials: A
authors.lastname: Sampol
authors.affiliation: Department of Haematology, Complejo Hospitalario Carlos Haya of Málaga, Malaga, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Espeso
authors.affiliation: Department of Haematology, Hospital Ramón y Cajal of Madrid, Madrid, Spain.
authors.forename: Francisco-Javier
authors.initials: FJ
authors.lastname: López
authors.affiliation: Department of Haematology, Hospital de la Santa Creu i Sant Pau of Barcelona, Barcelona, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Briones
authors.affiliation: Pathology Department, MD Anderson Cancer Centre, Madrid, Spain.
authors.forename: Juan F
authors.initials: JF
authors.lastname: García
authors.affiliation: Department of Haematology, Hospital Duran i Reynals of Barcelona, Barcelona, Spain.
authors.forename: Anna
authors.initials: A
authors.lastname: Sureda
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003561:Cytarabine / Q000009:adverse effects / Q000627:therapeutic use; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D005047:Etoposide / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006689:Hodgkin Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence; D019233:Retreatment; D016879:Salvage Therapy; D016019:Survival Analysis; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003561:Cytarabine; D005047:Etoposide; C527517:ofatumumab; D002945:Cisplatin; D011241:Prednisone
keywords: ESHAP; Hodgkin lymphoma; ofatumumab; relapse; salvage therapy