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Phase II Trial of High-Dose Gemcitabine/Busulfan/Melphalan with Autologous Stem Cell Transplantation for Primary Refractory or Poor-Risk Relapsed Hodgkin Lymphoma

Overview of attention for article published in Transplantation and Cellular Therapy, March 2018
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Title
Phase II Trial of High-Dose Gemcitabine/Busulfan/Melphalan with Autologous Stem Cell Transplantation for Primary Refractory or Poor-Risk Relapsed Hodgkin Lymphoma
Published in
Transplantation and Cellular Therapy, March 2018
DOI 10.1016/j.bbmt.2018.02.020
Pubmed ID
Authors

Yago Nieto, Peter F Thall, Junsheng Ma, Benigno C Valdez, Sairah Ahmed, Paolo Anderlini, Uday Popat, Roy B Jones, Elizabeth J Shpall, Chitra Hosing, Muzaffar Qazilbash, Partow Kebriaei, Amin Alousi, Melissa Timmons, Alison Gulbis, Alan Myers, Yasuhiro Oki, Michelle Fanale, Bouthaina Dabaja, Chelsea Pinnix, Sarah Milgrom, Richard Champlin, Borje S Andersson

Abstract

We conducted a prospective phase 2 trial of gemcitabine, busulfan and melphalan (Gem/Bu/Mel) with autologous stem-cell transplantation (ASCT) in Hodgkin's lymphoma (HL) patients with primary refractory or poor-risk relapsed disease (extranodal relapse or within 1 year of frontline therapy). The trial was powered to detect a 2-year progression-free survival (PFS) rate improvement from a historical 50% (using BEAM) to 65%. We compared the study population with all other concurrent patients who were eligible for the trial but instead received BEAM at our center. No patient received post-ASCT maintenance. The Gem/Bu/Mel trial enrolled 80 patients: median age 31, 41% primary refractory and 59% relapsed (36% extranodal relapses), and 30% PET-positive lesions at ASCT. The concurrent BEAM (N=45) and Gem/Bu/Mel cohorts were well balanced except for more Gem/Bu/Mel patients with bulky relapses and PET-positive tumors. There were no transplant-related deaths in either cohort. At median follow-up of 34.5 months (range, 26-72), Gem/Bu/Mel resulted in improved 2-year PFS (65% vs. 51%) (P=0.008) and overall survival (89% vs. 73%, P=0.0003). In conclusion, Gem/Bu/Mel is safe, yielding, in this nonrandomized comparison, improved outcomes compared with a concurrently treated and prognostically matched cohort of primary refractory or poor-risk relapsed HL patients receiving BEAM.

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Geographical breakdown

Country Count As %
Unknown 37 100%

Demographic breakdown

Readers by professional status Count As %
Other 7 19%
Student > Doctoral Student 3 8%
Student > Bachelor 3 8%
Student > Postgraduate 3 8%
Researcher 3 8%
Other 5 14%
Unknown 13 35%
Readers by discipline Count As %
Medicine and Dentistry 12 32%
Biochemistry, Genetics and Molecular Biology 3 8%
Agricultural and Biological Sciences 2 5%
Pharmacology, Toxicology and Pharmaceutical Science 1 3%
Social Sciences 1 3%
Other 3 8%
Unknown 15 41%