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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 3 | 43% |
Canada | 1 | 14% |
United Kingdom | 1 | 14% |
Unknown | 2 | 29% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 4 | 57% |
Scientists | 2 | 29% |
Practitioners (doctors, other healthcare professionals) | 1 | 14% |
Mendeley readers
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% |