JCO: The treatment of rhonamide combined with R-CHOP can prolong the survival of patients with untreated diffuse large B-cell lymphoma

For untreated patients with diffuse large B-cell lymphoma (DLBCL) (including COO and ABC-DLBCL subtypes), the Synadamic Unilidoxi monoantigen-cyclophosphamide-dorobi-star-changchun-neo-alkali-pernisson (R-CHOP) program (R2CHOP) can extend its lifetime.
February 8, Journal of Clinical Oncology published the results of the Phase II clinical trial online.
the study included newly diagnosed and untreated, histologically proven measurable stage II large bodies (10 cm) to phase IV, with ANEG performance status of 0-2 and international prognostic index (IPI) of 2-5 in adult DLBCL patients.
280 patients (145 out of R2CHOP and 135 in R-CHOP) can be evaluated (eligible and treated) for efficacy analysis.
baseline patients in two groups, with a median age of 66 years (range 24-92).
most patients had a relatively high risk of disease, with 96% in stage III or IV, 46% in ≥2, and 24% in 4 or 5 IPS.
all subjects, 94 patients were active subtypes (ABC-DLBCL) and 122 were hair-centered DLBCL.
results show that the ORR and CR rates of R-CHOP are 92% and 68%, respectively, and the ORR and CR rates of R2-CHOP groups are 97% (P s 0.06) and 73% (P s 0 .43), respectively.
follow-up time for the study was 3.0 years.
the R-CHOP treatment group, the risk of disease progressity or death in the R2CHOP treatment group was reduced by 34% (HR was 0.66, one-sided 90% CI -lt;0.88 (95% CI, 0.43 to 1.01), P (one-sided) was 0.03).
3-year PFS in the R2CHOP and R-CHOP treatment groups was 73% and 61%, respectively, and the three-year OS was 83% and 75%, respectively.
visible OS using R2CHOP is also better than 3-year OS using R-CHOP (one-sided P s 0.05).
analysis of PFS using GEP's COO showed that in 94 ABC patients, R2CHOP improved outcomes (HR s 0.64; one-sided 90% CI capped at 1.01; one-sided 95% CI with 0.31 to 1.29; single-sided P s .1).
122 GCB patients, HR was 0.82 (one-sided 90% CI upper limit was 1.27; One-sided 95% CI is 0.43 to 1.59).
analysis of PFS shows that R2CHOP is associated with benefits in most groups.
the benefits of adding amine to each clinical subgroup were generally consistent, although a small number of patients in each subgroup needed to be careful in interpreting it.
similar subset analysis of E1412 showed a significant increase in benefits from the addition of amines to young patients.
events are largely in line with R-CHOP expectations.
found significant differences in the occurrence of level 3 AE ≥ R2CHOP and R-CHOP groups.
are diarrhea (6%v 1%, P s .005), anemia (29% v 20%, P s 0.03), fever neutral granulocytosis (25 %v 14%, P s 0 .003), plateiasis (34%v 13%, P.<.001> The amine has been a major candidate for R-CHOP (R2CHOP).
R2CHOP has been tested in two separate randomized trials, a Phase III study of activated B-cell samples (ABC)-DLBCL (ROBUST) and a Phase II study of all DLBCL (E1412).
other differences, E1412 also used a higher dose of amine.
Although E1412 shows the potential benefits of adding that amine to R-CHOP in the future, the results observed in E1412 have not changed, considering that this is a signal-seeking study, and the larger ROBUST study does not show any benefits.
E1412 results provided impetus for the study of amines and new lynamic similars, and highlighted the importance of experimental design when biomarkers were included in first-line studies.
overall, ECOG-ACRIN E1412 studies have shown potential clinical benefits of adding amine to R-CHOP in the future in newly diagnosed patients, including COO and ABC-DLBCL patients.
this advantage is consistent across subgroups and translates to the OS advantage of R2CHOP.
no new safety signals were observed.
Although the results of E1412 have not changed in practice, these results support further research into the first-line treatment of DLBCL, taking into account its signal-seeking properties and contradictory results from phase III ROBUST studies.
Reference：Grzegorz S. Nowakowski, Fangxin Hong, David W. Scott, et al. Addition of Lenalidomide to R-CHOP Improves Outcomes in Newly Diagnosed Diffuse Large B-Cell Lymphoma in a Randomized Phase II US Intergroup Study ECOG-ACRIN E1412. Journal of Clinical Oncology. Published on February 08, 2021.MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Met Medical" or "Source: MedSci Original" are owned by Mets Medical and are not authorized to be reproduced by any media, website or individual, and are authorized to be reproduced with the words "Source: Met Medical".
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