Michael Crump1, John Kuruvilla2, Stephen Couban2, David A MacDonald2, Vishal Kukreti2, C Tom Kouroukis2, Morel Rubinger2, Rena Buckstein2, Kevin R Imrie2, Massimo Federico2, Nicola Di Renzo2, Kang Howson-Jan2, Tara Baetz2, Leonard Kaizer2, Michael Voralia2, Harold J Olney2, A Robert Turner2, Jonathan Sussman2, Annette E Hay2, Marina S Djurfeldt2, Ralph M Meyer2, Bingshu E Chen2, Lois E Shepherd2. 1. Michael Crump, John Kuruvilla, and Vishal Kukreti, Princess Margaret Cancer Centre; Rena Buckstein and Kevin R. Imrie, Odette Cancer Centre and Sunnybrook Health Sciences Centre, Toronto; C. Tom Kouroukis, Jonathan Sussman, and Ralph M. Meyer, Margaret and Charles Juravinski Cancer Centre, Hamilton; Kang Howson-Jan, London Health Sciences Centre, London; Tara Baetz, Cancer Centre of Southeastern Ontario at Kingston General Hospital; Annette E. Hay, Marina S. Djurfeldt, Ralph M. Meyer, Bingshu E. Chen, and Lois E. Shepherd, NCIC Clinical Trials Group, Kingston; Leonard Kaizer, Credit Valley Hospital, Mississauga, Ontario; Stephen Couban and David A. MacDonald, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia; Morel Rubinger, Cancercare Manitoba, Winnipeg, Manitoba; Michael Voralia, Saskatoon Cancer Centre, Saskatoon, Saskatchewan; Harold J. Olney, Centre Hospitalier de l'Université de Montréal-Hopital Notre Dame, Montreal, Quebec; A. Robert Turner, Cross Cancer Institute, Edmonton, Alberta, Canada; Massimo Federico, University of Modena and Reggio Emilia, Modena; Nicola Di Renzo, Ospedale Vito Fazzi, Leece, Italy. michael.crump@uhn.on.ca. 2. Michael Crump, John Kuruvilla, and Vishal Kukreti, Princess Margaret Cancer Centre; Rena Buckstein and Kevin R. Imrie, Odette Cancer Centre and Sunnybrook Health Sciences Centre, Toronto; C. Tom Kouroukis, Jonathan Sussman, and Ralph M. Meyer, Margaret and Charles Juravinski Cancer Centre, Hamilton; Kang Howson-Jan, London Health Sciences Centre, London; Tara Baetz, Cancer Centre of Southeastern Ontario at Kingston General Hospital; Annette E. Hay, Marina S. Djurfeldt, Ralph M. Meyer, Bingshu E. Chen, and Lois E. Shepherd, NCIC Clinical Trials Group, Kingston; Leonard Kaizer, Credit Valley Hospital, Mississauga, Ontario; Stephen Couban and David A. MacDonald, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia; Morel Rubinger, Cancercare Manitoba, Winnipeg, Manitoba; Michael Voralia, Saskatoon Cancer Centre, Saskatoon, Saskatchewan; Harold J. Olney, Centre Hospitalier de l'Université de Montréal-Hopital Notre Dame, Montreal, Quebec; A. Robert Turner, Cross Cancer Institute, Edmonton, Alberta, Canada; Massimo Federico, University of Modena and Reggio Emilia, Modena; Nicola Di Renzo, Ospedale Vito Fazzi, Leece, Italy.
Abstract
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 withgemcitabine, dexamethasone, and cisplatin (GDP) or to dexamethasone, cytarabine, and cisplatin (DHAP). Patients with B-cell lymphoma also receivedrituximab. 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 rate with GDP was 45.2%; with DHAP the response rate was 44.0% (95% CI for difference, -9.0% to 6.7%), meeting protocol-defined criteria for noninferiority of GDP (P = .005). Similar results were obtained in a per-protocol analysis. The transplantation rates were 52.1% with GDP and 49.3% with DHAP (P = .44). At a median follow-up of 53 months, no differences were detected in event-free survival (HR, 0.99; stratified log-rank P = .95) or overall survival (HR, 1.03; P = .78) between GDP and DHAP. Treatment with GDP was associated with less toxicity (P < .001) and need for hospitalization (P < .001), and preserved quality of life (P = .04). CONCLUSION: For patients with relapsed or refractory aggressive lymphoma, in comparison with DHAP, treatment with GDP is associated with a noninferior response rate, similar transplantation rate, event-free survival, and overall survival, less toxicity and hospitalization, and superior quality of life.
RCT Entities:
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 rate with GDP was 45.2%; with DHAP the response rate was 44.0% (95% CI for difference, -9.0% to 6.7%), meeting protocol-defined criteria for noninferiority of GDP (P = .005). Similar results were obtained in a per-protocol analysis. The transplantation rates were 52.1% with GDP and 49.3% with DHAP (P = .44). At a median follow-up of 53 months, no differences were detected in event-free survival (HR, 0.99; stratified log-rank P = .95) or overall survival (HR, 1.03; P = .78) between GDP and DHAP. Treatment with GDP was associated with less toxicity (P < .001) and need for hospitalization (P < .001), and preserved quality of life (P = .04). CONCLUSION: For patients with relapsed or refractory aggressive lymphoma, in comparison with DHAP, treatment with GDP is associated with a noninferior response rate, similar transplantation rate, event-free survival, and overall survival, less toxicity and hospitalization, and superior quality of life.
Authors: Michael Crump; Sattva S Neelapu; Umar Farooq; Eric Van Den Neste; John Kuruvilla; Jason Westin; Brian K Link; Annette Hay; James R Cerhan; Liting Zhu; Sami Boussetta; Lei Feng; Matthew J Maurer; Lynn Navale; Jeff Wiezorek; William Y Go; Christian Gisselbrecht Journal: Blood Date: 2017-08-03 Impact factor: 22.113
Authors: E Van Den Neste; N Schmitz; N Mounier; D Gill; D Linch; M Trneny; N Milpied; J Radford; N Ketterer; O Shpilberg; U Dührsen; D Ma; J Brière; C Thieblemont; G Salles; C H Moskowitz; B Glass; C Gisselbrecht Journal: Bone Marrow Transplant Date: 2015-09-14 Impact factor: 5.483
Authors: Narendranath Epperla; Talha Badar; Aniko Szabo; John Vaughn; Steve Borson; Neeraj Y Saini; Romil D Patel; Nirav N Shah; Mehdi Hamadani; Sairah Ahmed; Amanda F Cashen; Timothy S Fenske Journal: Blood Adv Date: 2019-06-11
Authors: Nirav N Shah; Kwang W Ahn; Carlos Litovich; Yizeng He; Craig Sauter; Timothy S Fenske; Mehdi Hamadani Journal: Blood Date: 2021-03-11 Impact factor: 22.113
Authors: S P Robinson; A Boumendil; H Finel; D Blaise; X Poiré; E Nicolas-Virelizier; R Or; R Malladi; A Corby; L Fornecker; D Caballero; D Pohlreich; A Nagler; C Thieblemont; J Finke; E Bachy; L Vincent; W Schroyens; H Schouten; P Dreger Journal: Bone Marrow Transplant Date: 2015-11-30 Impact factor: 5.483