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Hodgkin's lymphoma (HL) is likely to be cured.
but 15-35% of older patients had lower remission rates, poorer survival prognostics and greater toxic reactions than younger patients.
brentuximab vedotin (Vibutoxi monoanti) and Navuliyu monoantiactive in patients with relapsed or refractive HL.
study was designed to assess the activity and safety of Vibutosi and Navuliyu monoantigens in untreated HL elderly patients or young patients who did not apply standard ABVD therapy.
the study was a multi-center, one-arm Phase 2 trial conducted at eight cancer centers in USA.
to recruit older patients (≥60 years old) who have not been treated in the past, or younger patients who do not have ABVD therapy.
21-day one-day course of 8 sessions is provided with Vibtoxi monoanti (1.8 mg/kg) and Navuliyu monoanti (3 mg/kg).
end point is the overall mitigation rate.
May 13, 2016 - January 30, 2019, 46 patients were recruited, with a middle age of 71.5 years, of whom 2 (4%) were 60 years old.
21.2 months, 35 (76%) patients completed 8 courses of treatment.
mid-term analysis on 11 October 2019, the overall remission rate of the first 25 patients assessed was 64% (16/25), of which 13 (52%) received full metabolic remission and 3 (12%) received partial metabolic remission.
stopped recruiting patients because the results of the interim analysis did not meet expectations.
of all assessable patients (46), 22 (48%) received complete metabolic remission and 6 (13%) received partial metabolic remission (overall remission rate of 61%).
16 dose adjustments were performed in 14 (30%) patients.
mainly because of neurotoxicity.
22 patients (48%) developed peripheral neuropathy (5 for level 3).
level 4 adverse reactions were elevated transaminase (1 case ( 2%), lipase or amylase elevation (2 cases ( 4%) and pancreatitis (1 case ( 2%).
(2%) of patients died of cardiac arrest, which may be related to treatment.
addition, although the trial did not meet the expected efficacy standards, but Vibutoxi monoantigen Narvulyu monoantigen in the previously untreated HL elderly patients have a certain efficacy, and good tolerance.
trials should be based on optimal dosages and programmes, possibly in combination with other targeted drugs, allowing older patients with Hodgkin's lymphoma to adopt chemotherapy-free options.
.