Patients with relapsed or refractory aggressive lymphomas treated with gemcitabine, dexamethasone and cisplatin prior to autologous stem cell transplantation achieved similar outcomes with less toxicity than those treated with dexamethasone, cytarabine and cisplatin, according to results of a randomized trial.
The analysis included 619 adults aggressive-histology lymphomas.
Researchers randomly assigned patients to the experimental arm — which consisted of gemcitabine, dexamethasone and cisplatin (GDP) — or the control arm, which consisted of dexamethasone, cytarabine and cisplatin (DHAP). Patients with B-cell lymphoma also underwent treatment with rituximab (Rituxan; Genentech, Biogen Idec).
Response after two treatment cycles and the transplantation rate served as co-primary endpoints. Secondary endpoints included EFS, OS, treatment-related toxicity and quality of life.
Researchers established a 10% noninferiority margin for the response rate to GDP relative to DHP.
Median follow-up was 53 months. Ninety percent of patients assigned GDP and 87% of patients assigned DHAP underwent at least two cycles of therapy.
In the intention-to-treat population, researchers reported response rates of 42.5% in the GDP arm and 44% in the DHAP arm, which met the defined criteria for GDP noninferiority (95% CI, -9% to 6.7%; P=.005). A per-protocol analysis revealed similar results.
Researchers reported transplantation rates of 52.1% in the GDP arm and 48.3% in the DHAP arm (P=.44). Results showed no differences in EFS (HR=0.99; P=.95) or OS (HR=1.03; P=.78) between the GDP and DHAP groups.
Researchers reported less toxicity (P<.001) and decreased need for hospitalization (P<.001) in the GDP arm. Fewer patients assigned GDP experienced decrements in quality of life (P=.04).
The study “provides a rationale” to replace DHAP with GDP, Christian Gisselbrecht, MD, of Hôpital Saint Louis Paris in France, wrote in an accompanying editorial.
“However, more studies need to be performed,” Gisselbrecht wrote. “New drugs that increase the response rate of salvage regimens and new approaches, including allogeneic transplantation, should be explored. GDP can serve as the backbone for new combinations by relying on novel targeted therapies that are identified from an improved understanding of the disease biology.”
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Disclosure: The researchers report research funding/honoraria from Roche and Roche Canada. They also report consultant or advisory roles with Eli Lilly and Roche Canada.