Risk-Adapted Therapy in Adults with Burkitt Lymphoma: Preliminary Report of a Multicenter Prospective Phase II Study of DA-EPOCH-R

Background: Burkitt lymphoma (BL) is a highly aggressive B-cell lymphoma that is largely curable with intensive therapy. Previously, a single-center study of 30 patients demonstrated that DA-EPOCH-R based therapy was highly effective in adults with BL (N Engl J Med 2013; 369:1915-1925). We set out to validate these results in a multi-center study and assess if a risk-adapted approach using DA-EPOCH-R is effective.

Methods: Patients had newly diagnosed BL, age 18 years or older and HIV negative or positive. Low-risk (LR) patients (normal LDH, ECOG P.S. 0-1, stage I or II disease and a maximum tumor size < 7cm) received 3 cycles of DA-EPOCH-R (with no intrathecal prophylaxis) and all other patients (classified as high risk (HR)) received 6 cycles (with IT prophylaxis days 1 and 5 on cycles 3-6).

Results: 77 patients were enrolled. Characteristics include median (range) age 45 (19-78) years; male sex 63 (82%); stage III or IV disease 49 (64%); elevated LDH 41 (53%); CNS involvement 7 (10%); HIV positive 20 (26%). Eleven (14%) and 66 (86%) were classified as LR and HR respectively. There were 2 deaths on treatment in the HR arm secondary to infection. Other toxicities were similar to previous reports of DA-EPOCH-R. At a median follow-up time of 25 months, time to progression (TTP), progression-free survival (PFS) and overall survival (OS) were 92% (95% CI: 82.9-96.8%), 87% (95% CI: 76.2-93%) and 88% (95% CI: 77.1-93.8%) respectively for all patients. TTP, PFS and OS were not significantly different for HR versus LR disease, HIV positive versus negative and age over versus under 40y.

Conclusions: In a multicenter setting, both LR and HR patients have excellent outcomes with 3 and 6 cycles of therapy respectively. Risk group, HIV status and age are not associated with outcome (see table). Accrual to this study continues (NCT01092182).

		TTP	PFS	OS
Patients	N=77	92%	87%	88%
LR   HR    p	11 66	100%  91%  0.35	100%  85%  0.22	100%  86%  0.24
HIV -   HIV +    p	57 20	96%  84%  0.1	88%  84%  0.66	90%  83%  0.53
Age under 40   Age over 40    p	35 42	94%  91%  0.83	90%  84%  0.45	93%  83%  0.24

Disclosures: Link: Genentech: Consultancy , Research Funding ; Kite Pharma: Research Funding . Kahl: Roche/Genentech: Consultancy ; Seattle Genetics: Consultancy ; Millennium: Consultancy ; Cell Therapeutics: Consultancy ; Celgene: Consultancy ; Infinity: Consultancy ; Pharmacyclics: Consultancy ; Juno: Consultancy . Bartlett: Gilead: Consultancy , Research Funding ; Janssen: Research Funding ; Pharmacyclics: Research Funding ; Genentech: Research Funding ; Pfizer: Research Funding ; Novartis: Research Funding ; Millennium: Research Funding ; Colgene: Research Funding ; Medimmune: Research Funding ; Kite: Research Funding ; Insight: Research Funding ; Seattle Genetics: Consultancy , Research Funding ; MERC: Research Funding ; Dynavax: Research Funding ; Idera: Research Funding ; Portola: Research Funding ; Bristol Meyers Squibb: Research Funding ; Infinity: Research Funding ; LAM Theapeutics: Research Funding .

See more of: 623. Lymphoma: Chemotherapy, excluding Pre-Clinical Models: Aggressive NHL – MCL, Burkitt, T-cell
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