Study Background, Procedures, and Initial Efficacy/Safety Data
B-cell malignancies, non-Hodgkin’s lymphoma, Cancer
ADVERSE EVENTS, SECONDARY, CANCER
We conducted a secondary analysis of the Canadian Cancer Trials Group LY.12 randomized clinical trial (ClinicalTrials.gov Identifier: NCT00078949). LY.12 recruited participants in Canada, Italy, US, and Australia during 2003-2011. Eligible adults had an aggressive histology relapsed/ refractory non-Hodgkin’s lymphoma that had relapsed after one ­anthracycline-containing regimen. Patients were randomized 1:1 to receive 2-3 outpatient cycles of gemcitabine, dexamethasone, and cisplatin (GDP) vs. dexamethasone, cytarabine, and cisplatin (DHAP) prior to autologous stem cell transplant. The third cycle was permitted if response to 2 cycles was insufficient. A protocol amendment in 2005 allowed patients with B-cell malignancies in both arms to additionally receive rituximab. The therapies were delivered in 21-day cycles, as presented in Drugs and schedule of chemotherapy administration in both arms of the LY.12 trial.Each regimen was delivered in 21-day cycles. Dose adjustments and deferments, and addition of growth factor support was allowed.The primary trial endpoint was response rate with a ­non-inferiority design. Secondary endpoints included event-free survival, overall survival, rates of stem-cell mobilization, adverse events, quality-of-life, and healthcare utilization.A total of 619 patients were randomized. Initial primary results published in 2014 reported similar response rates (44%-45%) between arms, confirming the ­non-inferiority of GDP. Transplantation rates (49%-52%), 4-year ­event-free-survival (26%), and 4-year overall survival (39%) were also similar between arms.