Platinum-sensitive relapsed ovarian cancer: Capra-Dorobi-Beval bead monoantin may be the new standard treatment

A randomized, open-label Phase III.phase III clinical trial reported by Pfisterer at the Gynaecological Oncology Center in Kiel, Germany, showed that carptonin-polyglycol liposome polyflexostar-beva bead monoantigen is a new standard treatment option for platinum-type relapsed ovarian cancer.
[Lancet Oncol. doi:10.1016/S1470-2045(20)30142-X.] For relapsed ovarian cancers with platinum-containing retreated treatments, the latest treatments include a combination of beva bead monoantigens (e.g., beva beads mono-combination-platinum-yew alcohol or carpton-gisithamin) or the most popular non-beval-bead monoantigens: carpton-dorobi.
the purpose of this head-to-head test is to compare the standard scheme containing beech mono-resistance with the scheme of carb-dorobie combined beval bead mono-resistance.
the multi-center, open-label, randomized, Phase III. trial was conducted at 159 academic centres in Germany, France, Australia, Austria and the United Kingdom.
group conditions: age ≥18 years old, histological confirmation of epithelitis ovarian cancer, or the first recurrence of primary peritonal cancer or fallopian tube cancer after 6 cycles of first-line platinum chemotherapy, and ECOG-PS score of 0 to 2 points.
The patients were strated according to the non-platinum interstitial period, residual tumors and past angiogenesic therapy, and the patients were randomly assigned according to the ratio of 1.1, and received 6 cycles of beva bead monovenous treatment (15 mg/kg, d1) plus kaka platinum (AUC=4,d1) Gagesithamin (1000 mg/m2, d1, 8), once every 3 weeks; Or 6 cycles of beva bead monoantin (10 mg/kg, d1, 15) plus cara platinum (AUC-5,d1) plus dorobi star (30mg/m2,d1), once every 4 weeks, followed by both groups receiving beval bead monoantin (15 mg/kg, once every 3 weeks) to maintain treatment until the disease progresses or becomes unacceptable toxicity.
study endpoints were non-progressive lifetimes assessed by the researchers on the basis of Version 1.1 of the Solid Tumor Response Assessment Standard.
data were analyzed in people with intentional treatment.
safety in all patients who were receiving at least one dose of the drug.
the completed study is registered at clinicaltrials.gov under the number NCT01837251.
between August 1, 2013 and July 31, 2015, a total of 682 eligible patients were included, of which 345 were randomly assigned to receive carabin-dorobi-beva bead monoantigen (trial group) and 337 were treated with capratin-gisythabin-beval beval bead monoantigen (standard group).
as of July 10, 2018, the pilot group had a medium follow-up time of 12.4 months (IQR:8.3 to 21.7 months) and a standard group of 11.3 months (IQR:8.0 to 18.4 months).
non-progress life of the test group was 13.3 months (95% CI 11.7 to 14.2 months), while the standard group was 11.6 months (95% CI) 11.0 to 12.7 months; HR s 0.81, 95% CI 0.68 to 0.96, P s 0.012).
most common level 3 to 4 adverse events were hypertension (88 cases in the trial group, 27%; 67 cases in the standard group, 20%), and neutral granulocyte reduction (40 cases, 12%; 73 cases, 22%).
serious adverse events occurred in 332 patients (10%) of the 332 patients in the test group, and 28 of the 329 patients (9%) in the standard group had serious adverse events.
treatment-related deaths occurred in 1 patient in the trial group (-lt;1%, large intestine perforation) and 2 patients in the standard group (1%, permeable demyelination syndrome and 1 case per cent intracranial hemorrhage).
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