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

被引：387

作者：

Crump, Michael ^{[1
]}

Kuruvilla, John ^{[1
]}

Couban, Stephen ^{[9
,10
]}

MacDonald, David A. ^{[9
,10
]}

Kukreti, Vishal ^{[1
]}

Kouroukis, C. Tom ^{[4
]}

Rubinger, Morel ^{[11
]}

Buckstein, Rena ^{[2
,3
]}

Imrie, Kevin R. ^{[2
,3
]}

Federico, Massimo ^{[15
]}

Di Renzo, Nicola ^{[16
]}

Howson-Jan, Kang ^{[5
]}

Baetz, Tara ^{[6
]}

Kaizer, Leonard ^{[8
]}

Voralia, Michael ^{[12
]}

Olney, Harold J. ^{[13
]}

Turner, A. Robert ^{[14
]}

Sussman, Jonathan ^{[4
]}

Hay, Annette E. ^{[7
]}

Djurfeldt, Marina S. ^{[7
]}

Meyer, Ralph M. ^{[4
,7
]}

Chen, Bingshu E. ^{[7
]}

Shepherd, Lois E. ^{[7
]}

机构：

[1] Princess Margaret Canc Ctr, Toronto, ON M5G 2M9, Canada

[2] Odette Canc Ctr, Toronto, ON, Canada

[3] Sunnybrook Hlth Sci Ctr, Toronto, ON M4N 3M5, Canada

[4] Margaret & Charles Juravinski Canc Ctr, Hamilton, ON, Canada

[5] London Hlth Sci Ctr, London, ON, Canada

[6] Kingston Gen Hosp, Canc Ctr Southeastern Ontario, Kingston, ON K7L 2V7, Canada

[7] NCIC Clin Trials Grp, Kingston, ON, Canada

[8] Credit Valley Hosp, Mississauga, ON, Canada

[9] Queen Elizabeth 2 Hlth Sci Ctr, Halifax, NS, Canada

[10] Dalhousie Univ, Halifax, NS, Canada

[11] Cancercare Manitoba, Winnipeg, MB, Canada

[12] Saskatoon Canc Ctr, Saskatoon, SK, Canada

[13] Ctr Hosp Univ Montreal, Hop Notre Dame, Montreal, PQ, Canada

[14] Cross Canc Inst, Edmonton, AB T6G 1Z2, Canada

[15] Univ Modena & Reggio Emilia, Modena, Italy

[16] Osped Vito Fazzi, Lecce, Italy

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2014年 / 32卷 / 31期

关键词：

NON-HODGKINS-LYMPHOMA; NATIONAL-CANCER-INSTITUTE; CLINICAL-TRIALS-GROUP; BONE-MARROW TRANSPLANTATION; PHASE-II; SALVAGE CHEMOTHERAPY; RESPONSE CRITERIA; PARMA TRIAL; THERAPY; RITUXIMAB;

D O I：

10.1200/JCO.2013.53.9593

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

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. (C) 2014 by American Society of Clinical Oncology

引用

页码：3490 / +

页数：8

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