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    Home > Active Ingredient News > Antitumor Therapy > JAMA: The effect of Capedabin maintenance therapy on the efficacy of early triple negative breast cancer

    JAMA: The effect of Capedabin maintenance therapy on the efficacy of early triple negative breast cancer

    • Last Update: 2020-12-23
    • Source: Internet
    • Author: User
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    Among all breast cancer subtypes, the recurrence rate of triple-negative breast cancer is higher and the prognosmation after standard treatment is poor.
    need to adopt effective strategies to reduce the risk of recurrence and death.
    the poor prognosmation of triple negative breast cancer (TNBC) is due to a lack of effective targeted treatment options, coupled with the subtype's aggressive biological behavior, associated with a high risk of early recurrence, especially organ metastasis.
    maintenance endocrine or ERBB2 (formerly HER2) targeted therapy has been used to significantly reduce the risk of recurrence and death in patients with early breast cancer who are hormone-positive or ERBB2 over-expressed.
    , however, chemotherapy was the only complementary treatment option for early TNBC patients.
    need effective maintenance therapy to reduce the risk of recurrence and death.
    is an oral chemotherapy drug widely used in the treatment of metastasis breast cancer and is a potential candidate for low-dose maintenance therapy to prevent recurrence.
    previous clinical trials have added large doses of carpentry to standard breast cancer-assisted chemotherapy programs and reported conflicting results, although these trials are not limited to women with TNBC.
    , a new study published in JAMA aims to assess the impact of low-dose carpentry maintenance therapy on the disease-free and total survival rates of early TNBC women after standard assisted therapy.
    SYSUCC-001 trial (ClinicalTrials.gov: NCT01112826) is an open, multi-center, randomized, phase III study that compares the efficacy and adverse events observed after low-dose carpedabin maintenance and standard complementary therapy in early TNBC patients.
    the trial was sponsored by Sun Yat-sen University and approved by the SYSUCC Ethics Committee and the Ethics Committees of the participating institutions.
    provide written informed consent to all patients.
    eligible test participants were women who were pathologically certified to have insulated breast catheter cancer, their hormones were negative (immune tissue chemically stained 1% positive cells) and ERBB2 was negative.
    main exclusion criteria include inflammatory or double breast cancer; Have a history of insumptive breast cancer or other malignant tumors; Receiving other biological agents or immunotherapy; Lactation or pregnancy; or a serious co-existence disease.
    the study's main endpoint was a five-year disease-free survival rate, which was the time between random grouping and the first occurrence of the following events: local recurrence, distant metastasis, lateral breast cancer, or death from any cause.
    secondary endpoints include distant disease-free lifetimes (time from randomization to distant recurrence, to lateral breast-immersive cancer or death for any reason), total lifetime (time from randomization to death for any cause), local area recurrence-free survival (time from randomization to local invasion recurrence or death), and adverse events.
    from April 2010 to December 2016, 443 patients from 13 Chinese study sites were included in the study, randomly divided into caperhambin groups (222 cases) and observation groups (221 cases).
    9 patients were excluded because of informed consent prior to discontinuation of intervention.
    the preliminary analysis included 434 patients (221 cases in the Capethabin group and 213 cases in the observation group).
    2 cases of missed visits, all of which exceeded the original plan by 3 years (1 case in the Capethabin group for 49 months and 1 case for 51 months in the observation group).
    two groups of patients, disease, and treatment characteristics were well balanced at the baseline.
    (SD) in random groupings was 46 (9.9) years (range 24-70) and 66.8% pre-menoanth.
    most patients underwent a mastectomy (86.4%) and received new complementary chemotherapy (5.8%) or complementary chemotherapy (78.8%), based on cyclocyclycol and yew alcohol.
    tumors were T1/T2 (93.1%), node negative (61.8%) and level 3 (72.8%).
    After 61 months of mid-level follow-up (44-82 quarter range), 94 incidents were observed, of which 38 events (37 recurrences and 32 deaths) were observed in the Capethon group and 56 incidents (56 recurrences and 40 deaths) in the observation group.
    compared with the observation group, the main result of the estimated five-year disease-free life was 82.8% vs. 73.0% (risk of recurrence or death HR was 0.64 (95% CI, 0.42-0.95); P = 0。
    ) For secondary endpoints, the five-year distant disease-free survival rate estimated by the Capentabin Group and the Observation Group was 85.8 per cent and 75.8 per cent, respectively (risk of distant transfer or death HR was 0.60 (95 per cent CI, 0.38-0.92).
    the estimated five-year total survival rate of the Kapetha Marina Group and the Observation Group was 85.5% and 81.3%, respectively (HR risk of death was 0.75 (95% CI, 0.47-1.19);
    the five-year relapse rate estimated by the Capethon Group and the Observer Group was 85.0% and 80.8%, respectively (the risk of recurrence or death in the Lo District was 0.72 (95% CI, 0.46-1.13);
    Kaplan-Meier estimated disease-specific mortality, total mortality, distant-specific mortality and local relapse-specific mortality in 434 patients with triple-negative breast cancer, and the low-dose Capethamil maintained generally good tolerance, with most participants completing one year of treatment without interruption.
    the most common adverse event in the treatment of carpedabin monotherapy was hand-foot syndrome, which occurred in 45.2% of patients.
    7.7 per cent of these levels had level 3, including foaming and disruption to daily activity.
    other adverse events include diarrhea, high bililinemia and decreased white blood cells, but the events were not serious.
    all toxic and adverse events except hand-foot syndrome are level 1 or 1.
    adverse events, the study showed that in early TNBC patients receiving standard complementary treatment, low-dose carpentry maintenance for one year significantly improved five-year disease-free survival compared to observations.
    : Wang X, Wang S, Huang H, et al. Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival Among Patients With Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial. JAMA. Published online December 10, 2020. doi:10.1001/jama.2020.23370MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that state "Source: Mets Medicine" or "Source: MedSci Originals" are owned by Mets Medical and are not authorized to be reproduced by any media, website or individual, and must be reproduced by Mes Medical.
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