TY - JOUR
T1 - Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas
T2 - NCIC-CTG LY.12
AU - Crump, Michael
AU - Kuruvilla, John
AU - Couban, Stephen
AU - MacDonald, David A.
AU - Kukreti, Vishal
AU - Kouroukis, C. Tom
AU - Rubinger, Morel
AU - Buckstein, Rena
AU - Imrie, Kevin R.
AU - Federico, Massimo
AU - Di Renzo, Nicola
AU - Howson-Jan, Kang
AU - Baetz, Tara
AU - Kaizer, Leonard
AU - Voralia, Michael
AU - Olney, Harold J.
AU - Turner, A. Robert
AU - Sussman, Jonathan
AU - Hay, Annette E.
AU - Djurfeldt, Marina S.
AU - Meyer, Ralph M.
AU - Chen, Bingshu E.
AU - Shepherd, Lois E.
N1 - Publisher Copyright:
© 2014 by American Society of Clinical Oncology.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - Purpose: For patients with relapsed or refractory aggressive lymphoma, we hypothesized that gemcitabinebased 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.
AB - Purpose: For patients with relapsed or refractory aggressive lymphoma, we hypothesized that gemcitabinebased 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.
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U2 - 10.1200/JCO.2013.53.9593
DO - 10.1200/JCO.2013.53.9593
M3 - Article
C2 - 25267740
AN - SCOPUS:84911498561
SN - 0732-183X
VL - 32
SP - 3490
EP - 3496
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 31
ER -