2020 CCO |。 Prof. Zhang Qingxuan: Advances in the treatment of external T-cell lymphoma

External T-cell lymphoma (PTCL) is a group of heterogeneic, invasive non-Hodgkin lymphoma (NHL), which accounts for about 10-15% of non-Hodgkin's lymphoma in Europe and the United States, while in China it is about 21.4%.
most common PTCLs subtypes are extrinsic T-cell lymphoma non-special-fingered PTCL-NOS, vascular immuno-maternal T-cell lymphoma AITL, and ALC-plus or ALC-systemic mesodesis large T-cell lymphomas.
PTCL-NOS is most common in Europe and North America, while NKTCL is more common in China.
, these subtypes of treatment have often used similar first-line combined chemotherapy programs containing arachyclycing, i.e. CHOP or CHOP-like treatments.
, treatment options containing cyclocymoids have lower rates of complete remission (CR), no progression lifetime (PFS), and overall lifetime (OS).
even better prognostic APK-sALCL, 5 years of OS-lt;50% of patients with advanced age (40 years old) and adverse prognostic factors (IPI≥2).
oral report on the treatment status of T-cell lymphoma (PTCL) in the first incurable week and the breakthrough of EHA at the 2020 European Hematological Society reported on the Nordic lymphoma Epidemiology Group: 251 patients with limited exo-T-cell lymphoma (PTCL) were treated with CHOP (or CHOP-like) prognostic analysis.
limited PTCL patient CHOP treatment was mainly 6-8 cycles, except for ALCL, ALK-positive patients with better prognostication, the rest of the subtypes using traditional CHOP chemotherapy OS and PFS did not improve much compared to ten years ago.
a forward-looking NHL study in Germany compared CHOEP and CHOP programs and showed that CHOEP significantly improved 3-year EFS in patients with ALK-ALCL, but did not significantly benefit other subsystem patients.
show that there are still high unsolt treatment needs in PTCL patients.
CD30 expression is prevalent in systemic interdessive large cell lymphoma, and CD30 expression is its specific expression.
In the non-systemic mesodynatural large cell lymphoma subtype, there are differences in the expression of CD30, the estimated range is different, the non-special referential type of outer T-cell lymphoma is about 58% to 64%, the hemangiogenic mother-cell T-cell lymphoma is 43% to 63%, the adult T-cell leukemia/lymphoma is 55%, the enteropathy-related T-cell lymphoma is 0 to 100%.
Vibutoxi monoantigen is an antibody-drug joint, made up of an anti-CD30 monoclonal antibody coupled with a micro-tube destroyer (monomethyl auretatin E) by protease cutting bonds.
ECHELON-2 is a double-blind, double-simulated, randomized, placebo-controlled, active drug comparison Phase III. the
aims to compare the efficacy and safety of the Vibutoxidone, cyclophosphamide, amycin, and periphosphate (A-CHP) programmes with cytophosphamide, amycin, chrysanthromycin and pernisone (CHOP) programmes for the treatment of primary treatment of CD30-positive outer T-cell lymphoma.
included a total of 452 patients from 17 countries, randomly divided into the A-CHP group (n-226) and the CHOP group (n-226).
36.2 months after the mid-level follow-up, the A-CHP significantly improved the mid-PFS (48.2 vs. 20.8 months; HR 0.71 (95% CI 0.54-0.93) ;p-0.0110), which reduced the risk of SPF events in the A-CHP group by 29% compared to the CHOP group.
For patients with CD30-positive outer T-cell lymphoma, first-line treatment with A-CHP is better than CHOP, which can significantly improve progress-free survival and total survival, and has controllable safety characteristics.
the treatment of patients with relapse/refragoratic PTCL external T-cell lymphoma due to its very high invasiveness, patients can easily enter the stage of recurrence difficult treatment, in addition to ALCL ALK, the results of each PTCL subtype difficult to treat / recurrence patients are not different, survival rate is very low.
with the continuous development of targeting, molecular and cell therapy, bringing more clinical treatment options.
A phase II clinical study evaluated the long-term therapeutic effect of Vibtoxi monoantigen therapy recurring refractic systemic ALCL, with an estimated 5-year OS of 60% for the overall patient, 60% for the medium OS, 39% for the estimated five-year PFS and 20 months for the medium PFS.
A forward-looking, observational final analysis of the study (ODICE study) in France assessed the treatment of BV in patients with Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL), where the median cycle number of different PTCL subtypes for BV therapy was 4-7 lines, ORR was 37% to 71%, and median PFS was 3.6 to 8.4 months.
ALCANZA is an international, open-label, randomized Phase 3 clinical trial designed to compare the efficacy of vibtoxyntherapy with the standard treatment (PC) chosen by doctors - methotrexate or besarotin , for MF or pcALCL that has been treated.
results showed that Vibutoxi monoantigen was superior to PC in the medium follow-up time of 22.9 months.
significantly improved objective mitigation rate (ORR4) (56% vs 13% ;P<0.0001), significantly increased CR rate (16% vs 2%), Significant extension of PFS (medium 16.7 months vs 3.5 months; HR=0.270,95% CI: 0.169-0.430).
TipifarnibAITL and PTCL patients had 50% and 35% CXCL12:CXCR4 high expression, respectively, such patients received standard care treatment with poor prognostication, Tipifarnib is a FT inhibitor of faniki metastase, can reduce CXCL12 expression.
phase 2, multi-center, single-arm, open-label study was conducted in two phases to assess the efficacy, safety, and biomarkers of Tipifarnib in the treatment of AITL patients.
study analyzed 26 AITL patients, 20 patients were evaluated for efficacy, 5 CR, 5 PR, ORR was 50% (PPS analysis), and the clinical benefit rate was 65% (PPS analysis).
a Chinese study was published in ALK Kinase Inhibitor 2020EHA to assess the effectiveness and safety of ALK inhibitors (kerazini/altinib/serrettinib)±
ALK inhibitor monodride therapy (n-6): ORR was 83.3%, both CR, with an average CR duration of 6.9 (0-17) months.
ALK inhibitors and VBL (n-13): ORR is 100%, both CR, CR average duration is 13.3 (3-23) months, showing good effectiveness.
HDACi inhibitors are currently approved for use in the treatment of PTCL histone deacetylase inhibitors (HDACi) with lymidesin, sidabenamine, volinota, and bellista.
In a key Phase 2 clinical study, Lymidesin treated patients with relapsed PTCL with 25% ORR and CR15%; in his Phase 2 study, ORR 26%, CR 11% for recurring PTCL; and Sidabenamine benefited better than other drugs, with a medium OS of 21.4 months.
In addition, in addition to single-drug use, can also consider joint drug use, can greatly improve the survival of patients, such as Lymidesin combined Pratsa, ORR can reach 71%, Lymidesin combined 5-nitrogen hethytosine, ORR can reach 73%, bringing new clinical drug options.
transplant selection PTCL patients choose transplantation after first-line treatment remission? Self-transplantation or allogeneic transplantation? ALK-positive ALCL High Risk International Prognostic Index (IPI) patients and other types of patients with conditions can receive large doses of chemotherapy combined with ASCT consolidation after first-line treatment remission, but at present? Forward-looking large sample size studies confirm this conclusion.
PTCL (e.g. liver and spleen T-cell lymphoma) has a very poor prognosis and can be consolidated with a first-line allogeneic hematopoietic stem cell transplant (allo-SCT), but there is also a lack of large sample size research data support.
Swedish study, which counted 755 patients from 2000 to 2009, compared the transplanted group with the untested group, 5-year PFS 41% vs 20%, 5-year OS 48% vs. 26%, is the largest PTCL study ever reported in the real world, providing important information on PTCL results outside the scope of registered clinical trials and giving clinical reference.
PtCL patients need to consolidate treatment after transplantation, is also a more controversial issue, a multi-center Phase II trial, assessed in patients newly diagnosed as CD30 expression PTCL, in BV-CHP after the addition of etoposide to receive the safety and ability of the self-stem cell transplant, and BV consolidation therapy.
a total of 28 patients in the group, ORR 95%, CR 90%, the current study is still ongoing, we can look forward to long-term survival data.
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