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J Clin Oncol. 2014 Nov 1;32(31):3490-6. doi: 10.1200/JCO.2013.53.9593. Epub 2014 Sep 29.

Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12.

Author information

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 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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00078949.

PMID:
25267740
DOI:
10.1200/JCO.2013.53.9593
[Indexed for MEDLINE]

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