Blood: The efficacy of atropal monoantigen for the initial treatment of aaIPI≥1 in DLBCL patients was no better than lytocyclic monoantigen

Center point: Compared to lysic monoantigen, atojustum is used in newly diagnosed transplant-eligible DLBCL patients without providing any significant additional tumor control;
combination chemotherapy is the standard treatment for diffuse large B-cell lymphoma (DLBCL).
Obinutuzumab is a monoclonal antibody that targets CD20 antigens on the surface of forward B cells and mature B lymphocytes.
combined with CD20, Atoju monoantitor mediates B cell dissolution by participating in and directly activating in-cell death signaling pathlines or activating complement cascading reactions through immune-effect cells.
immune-effect cells include antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell-eating.
GAINED test is designed to compare atropulation with lysoxi monoantigen.
THE GAINED Test (NCT01659099) is a randomized Phase 3 trial with open labels.
DLBCL patients who met the transplant criteria (18-60 years old) and were treated with an untreated age-adjusted International Prognostic Index (aaIPI) ≥1 were randomly divided into two groups (1:1) to receive atropal or lysoxi monoantigen therapy, respectively.
patients are layered according to aaIPI (1 or 2-3) and chemotherapy (ACVBP or CHOP).
the consolidation treatment based on the response of the mid-term semi-quantitative PET assessment reviewed by the center.
after the 2nd and 4th cycles (PET2-/PET4-) received predetermined immuno-chemotherapy consolidation.
received a large dose of methotrexate plus transplantation only after the 4th cycle (PET2 plus/4-).
main objectives: two-year event-free survival (EFS) increased by 8% in the Atoju monoantitor group (HR s 0.73; 80% effective; α risk 2.5%; one-sided).
events include death, disease progression, PET 2 or 4 positive, and modification of treatment plans.
20 September 2012, 670 patients were recruited (336 in the Atoju monoantigroup and 334 in the lytoxi monoantigen group).
383 (57.2%) were treated with AAIPI 2-3, 339 (50.6%) with CHOP and 324 (48.4%) with ACVBP.
follow-up was 38.7 months.
the two-year EFS of the Atoju single resistance group and the lytoxi monoantigroup (59.8% vs 56.6% ;p s 0.123; HR s 0.88).
2-year full queue PFS was 83.1% (95% CI 80 to 85.8).
2-year PFS and OS equivalent to PET2-/4-patients (89.9% vs 83.9% vs 94.8% vs 92.8%).
2-year PFS and OS were 62% and 83.1%, respectively, in patients with PET4 plus.
3-5 infections were more common in the atojutamic group (21% vs 12%).
, in untreated aaIPI≥1 DLBCL patients, the effect of atropulation was no better than that of lytocyclic monoantigen.
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