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A randomized clinical trial (ALIENOR/ENGOT-ov7) reported by Ray Coquard of the University of Lyon, France, shows that weekly yew alcohol is a new option for relapsed interstital tumors.
in this international randomized clinical trial, the addition of bevaltin monoantigens to weekly yew alcohol did not improve clinical benefits for patients with relapsed sore tumors that were not suitable for surgery.
(JAMA Oncol. doi: 10.1001/jamaoncol.2020.4574) is the first randomized trial of ovarian interstitium tumors and establishes weekly yew alcohol as the standard treatment after platinum therapy.
The purpose of this study was to determine the efficacy of weekly beechol joint or non-combined beva bead anti-treatment of relapsed melanosophon tumors, and to assess whether adding beech bead monoantigen to weekly yew alcohol increased the rate of progression without progression for 6 months.
The open-label, international randomized Phase II. trial (ALIENOR) was conducted in 28 centres in France, Germany, Italy, Japan and Belgium in the Joint Committee on Rare Gynaecological Oncology and used an adaptive Bayes design.
study included 60 women with sexual interstitium tumors who relapsed after at least one platinum-based chemotherapy.
registration period is 2013-2016, and the final analysis database lock-in time is March 27, 2020 (the medium follow-up time is 38.9 months).
patients were randomly grouped to receive a single dose of yew alcohol (80 mg/m2, d1, 8, 15, q28), or a total of 6 cycles of violet alcohol combined with beva bead monoantigen (10 mg/kg, q14) followed by bevaldi (15 mg/kg, q21) to maintain treatment for up to 1 year or until progression or unacceptable toxicity.
only during or after the treatment of yew alcohol monodring, allowed to cross to the beval bead monoantigen group.
outcome was a six-month no-progress rate.
results showed that 60 patients (mainly ovarian granuloma) were randomly assigned, 32 received single-drug yew alcohol (middle age 60 years old), and 28 patients received yew alcohol-beva bead monoantigen (middle age 55 years old, 1 case without treatment).
estimated that the six-month progression rate of single-drug yew alcohol was 71%, compared with 72% in the yew alcohol-beval bead monoantigen group.
estimated that the distribution of the six-month non-progression rate of the combined drug was 57% higher than that of the single use of yew alcohol, which was less than the predetermined advantage threshold.
the objective mitigation rate increased from 25% to 44%.
patients in the combined treatment group stopped treatment within 6 months due to toxicity.
Zhang Shi former source: Zhang Shi former public number copyright notice: All the text, pictures and audio and video materials marked "Source: Mets Medicine" or "Source: MedSci Original" are owned by Mace Medical, without authorization, no media, website or individual may reproduce, authorized to reproduce must indicate "Source: Mets Medicine".
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