Premium
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
Author(s) -
Martínez Carmen,
DíazLópez Antonio,
RodriguezCalvillo Mercedes,
GarcíaSanz Ramón,
Terol María José,
PérezCeballos Elena,
Jiménez Maria J.,
Cantalapiedra Alberto,
DomingoDomenech Eva,
Rodriguez María José,
Sampol Antonia,
Espeso Manuel,
López FranciscoJavier,
Briones Javier,
García Juan F.,
Sureda Anna
Publication year - 2016
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.14133
Subject(s) - medicine , cytarabine , etoposide , ofatumumab , regimen , salvage therapy , gastroenterology , oncology , rituximab , phases of clinical research , alemtuzumab , chemotherapy , lymphoma , transplantation
Summary 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 .