Authors
Michael Crump, John Kuruvilla, Stephen Couban, David A MacDonald, Vishal Kukreti, C Tom Kouroukis, Morel Rubinger, Rena Buckstein, Kevin R Imrie, Massimo Federico, Nicola Di Renzo, Kang Howson-Jan, Tara Baetz, Leonard Kaizer, Michael Voralia, Harold J Olney, A Robert Turner, Jonathan Sussman, Annette E Hay, Marina S Djurfeldt, Ralph M Meyer, Bingshu E Chen, Lois E Shepherd
Publication date
2014/11/1
Journal
Journal of Clinical Oncology
Volume
32
Issue
31
Pages
3490-3496
Publisher
American Society of Clinical Oncology
Description
Purpose
For patients with relapsed or refractory aggressive lymphoma, we hypothesized that gemcitabine-based therapy before autologous stem-cell transplantation (ASCT) is as effective as and less toxic than standard treatment.
Patients and Methods
We randomly assigned 619 patients with relapsed/refractory aggressive lymphoma to treatment with gemcitabine, dexamethasone, and cisplatin (GDP) or to dexamethasone, cytarabine, and cisplatin (DHAP). Patients with B-cell lymphoma also received rituximab. Responding patients proceeded to stem-cell collection and ASCT. Coprimary end points were response rate after two treatment cycles and transplantation rate. The noninferiority margin for the response rate to GDP relative to DHAP was set at 10%. Secondary end points included event-free and overall survival, treatment toxicity, and quality of life.
Results
For the intention-to-treat population, the response …
Scholar articles
M Crump, J Kuruvilla, S Couban, DA MacDonald… - Journal of Clinical Oncology, 2014