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    Home > Active Ingredient News > Antitumor Therapy > 2021 ASCO Voice of China in the field of breast cancer!

    2021 ASCO Voice of China in the field of breast cancer!

    • Last Update: 2021-06-16
    • Source: Internet
    • Author: User
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    From June 4th to 8th, one of the largest events in global cancer research-the American Society of Clinical Oncology ( ASCO ) annual meeting will be held.


    From June 4th to 8th, one of the largest events in global cancer research-the American Society of Clinical Oncology ( ASCO ) annual meeting will be held.


    The 2021ASCO annual meeting continues to be exciting


    National Cancer Center/National Cancer Research Center/Chinese Academy of Medical Sciences, Peking Union Medical College Medical Oncology Department

    Abstract Number: 1002

    Dalpiciclib (SHR6390) is a new type of CDK4/6 inhibitor.


    In this randomized, double-blind, phase 3 trial, patients with HR+/HER2− locally advanced or metastatic breast cancer (pts) were recruited who had relapsed or progressed from previous endocrine therapy


    Overall, 361 patients were randomized to receive dalp-fulv (n = 241) or PBO-fulv (n = 120)


    The study reached the primary endpoint, showing that dalpiciclib plus fulvestrant can significantly improve PFS compared with placebo plus fulvestrant, and the safety is controllable


    • Trastuzumab plus endocrine therapy or chemotherapy as first-line treatment for hormone receptor-positive and HER2-positive metastatic breast cancer: sysucc-002 randomized clinical trial
  • Trastuzumab plus endocrine therapy or chemotherapy as first-line treatment for hormone receptor-positive and HER2-positive metastatic breast cancer: sysucc-002 randomized clinical trial
  • Trastuzumab plus endocrine therapy or chemotherapy as first-line treatment for hormone receptor-positive and HER2-positive metastatic breast cancer: sysucc-002 randomized clinical trial trastuzumab plus endocrine therapy or chemotherapy as hormone receptor-positive and HER2-positive First-line treatment of metastatic breast cancer: sysucc-002 randomized clinical trial

    Yuan Zhongyu et al

    Yuan Zhongyu et al

    Department of Oncology, Sun Yat-sen University Cancer Center

    Abstract Number: 1000

    For hormone receptor-positive and HER2-positive metastatic breast cancer, there is no evidence to show which first-line treatment is better, whether it is anti-HER2 therapy plus endocrine therapy or anti-HER2 therapy plus chemotherapy


    We conducted an open-label, non-inferiority, phase 3, randomized controlled trial in 9 hospitals in China


    From September 16, 2013 to December 28, 2019, 392 patients were enrolled and randomly assigned to receive trastuzumab plus endocrine therapy (n = 196) or trastuzumab plus chemotherapy (n = 196)


    Studies have shown that in patients with hormone receptor-positive and HER2-positive metastatic breast cancer, trastuzumab plus endocrine therapy is not inferior to trastuzumab plus chemotherapy, and the toxicity is reduced


    • Famitinib combined with carrelizumab plus albumin-bound paclitaxel as the first-line treatment for patients with immunomodulatory advanced triple-negative breast cancer (FUTURE-C-PLUS): a prospective, one-arm, phase 2 study
  • Famitinib combined with carrelizumab plus albumin-bound paclitaxel as the first-line treatment for patients with immunomodulatory advanced triple-negative breast cancer (FUTURE-C-PLUS): a prospective, one-arm, phase 2 study
  • Method United erlotinib m Carey natalizumab plus nab-paclitaxel as first-line treatment of advanced immunomodulatory triple negative breast cancer (FUTURE-C-PLUS) the patient: a prospective, single-arm, two studies Method for m Ni-caribizumab plus albumin-bound paclitaxel as the first-line treatment for patients with immunomodulatory advanced triple-negative breast cancer (FUTURE-C-PLUS): a prospective, one-arm, phase 2 study

    Chen Li, Shao Zhimin, etc.


    Fudan University Cancer Hospital

    Abstract Number: 1007

    Camrelizumab (anti-PD-1 antibody) and albumin-bound paclitaxel (nab-P) show promising antitumor activity in immunomodulatory (IM) subtype metastatic triple-negative breast cancer (TNBC) patients, in severe patients 52.


    In this prospective, one-arm, phase 2 study, eligible patients were between 18-70 years of age and had locally advanced or metastatic TNBC with unresectable IM subtype


    From October 2019 to October 2020, a total of 48 patients were recruited


    The addition of famitinib to carrelizumab and albumin-bound paclitaxel as a first-line therapy has shown promising anti-tumor activity and has a controllable toxicity profile for patients with IM subtype advanced TNBC


    • Pilotinib as a neoadjuvant treatment for HER2+ breast cancer: a multicenter, randomized, controlled, phase II trial
  • Pilotinib as a neoadjuvant treatment for HER2+ breast cancer: a multicenter, randomized, controlled, phase II trial
  • Pilotinib as a neoadjuvant treatment for HER2+ breast cancer: a multicenter, randomized, controlled, phase II trial Pilotinib as a neoadjuvant treatment for HER2+ breast cancer: a multicenter, randomized, controlled, phase II trial

    Ding Xiaowen, Yang Hongjian, etc.

    Abstract Number: 574

    Pilotinib is a new type of irreversible tyrosine kinase inhibitor (TKI) that can significantly improve the progression-free survival (PFS) of patients with HER2+ metastatic breast cancer (MBC)
    .
    In this study, we aimed to investigate the effectiveness and safety of pirotinib in neoadjuvant therapy
    .

    This is an open-label, multi-center, randomized controlled trial
    .
    Eligible patients (pts) are 18-70 years old, have invasive cancer, cT 2-3 N 0-3 M0 staging, and HER2-positive breast cancer
    .
    From 2019 to 2021, we randomly divided 34 patients into a treatment group and 33 patients
    .
    Patients in the treatment group received pirotinib 400mg + trastuzumab 6mg/kg (LD 8mg/kg) + docetaxel 75mg/m 2 + carboplatin (AUC=6mg/ml·min) (TCbH+Py) 6 The control group received 6 cycles of trastuzumab 6 mg/kg (LD 8 mg/kg) + docetaxel 75 mg/m 2 + carboplatin (AUC = 6 mg/ml·min) (TCbH)
    .
    Total pathological complete response (tpCR) was defined as noninvasive or in situ disease of the breast or axilla (ypT0/Tis, ypN0) and was designated as the primary outcome
    .

    51 cases completed 6 cycles of neoadjuvant treatment and successfully operated (21 cases in the treatment group and 30 cases in the control group)
    .
    In the treatment group, 6 patients did not complete neoadjuvant treatment, 6 patients withdrew due to poor compliance, and 1 patient had not yet received surgery
    .
    In the control group, 3 patients did not complete neoadjuvant therapy
    .
    The tpCR rate of the treatment group was 71.
    4% (15/21), while that of the control group was 36.
    7% (11/30)
    .
    A significant difference between the two groups was determined (p <0.
    05)
    .
    All patients achieved an objective response in the treatment group, and about 83.
    3% (25/30) in the control group
    .
    In the control group, 4 cases had stable disease (SD) and 1 case had progressed disease (PD)
    .
    The most common AE in the treatment group was diarrhea, grade 3 occurred in 6 cases (28.
    6%), most of which occurred within the first treatment cycle
    .
    In the control group, 3 patients (10%) experienced grade 3 diarrhea
    .

    In this study, TCBH+Py neoadjuvant therapy significantly increased the tpCR rate of HER2+ breast cancer patients, which was about two times higher than TCBH, and its safety was controllable
    .

    • Predicting the benefits of capecitabine rhythm maintenance therapy for early triple-negative breast cancer: results from the SYSUCC-001 study
  • Predicting the benefits of capecitabine rhythm maintenance therapy for early triple-negative breast cancer: results from the SYSUCC-001 study
  • Predicting the benefits of capecitabine rhythm maintenance therapy for early triple-negative breast cancer: results from the SYSUCC-001 study predicting the benefits of capecitabine rhythm maintenance therapy for early triple-negative breast cancer: results from the SYSUCC-001 study

    Yuan Zhongyu et al

    Department of Oncology, Sun Yat-sen University Cancer Center

    Abstract Number: 521

    Recent clinical trials and meta-analysis have shown that adding capecitabine to standard chemotherapy for early triple-negative breast cancer (TNBC) is beneficial
    .
    We aim to develop a personalized predictive model to quantify the clinical benefits maintained by the capecitabine metronome in TNBC
    .

    Patients from the SYSUCC-001 trial were randomly assigned to the standard treatment group, with or without capecitabine metronome maintenance therapy
    .
    Candidate covariates include age, tumor size, lymph nodes, histological grade, Ki-67 percentage, lymphatic vascular invasion, chemotherapy regimens, and capecitabine drugs
    .
    The primary endpoint is disease-free survival (DFS)
    .
    The nonlinear effects of continuous covariates are modeled by restricted cubic splines
    .
    We developed a survival prediction model using the Cox proportional hazards model
    .

    A total of 434 patients were recruited (306 in the development cohort and 128 in the validation cohort)
    .
    The estimated 5-year DFS in the development cohort and validation cohort were 77.
    8% (95% CI, 72.
    9-82.
    7%) and 78.
    2% (95% CI, 70.
    9-85.
    5%), respectively
    .
    Age and lymph nodes have a significant non-linear effect on DFS
    .
    The four covariates that were significantly associated with DFS in the final prediction model were age, lymph nodes, lymphatic vascular invasion, and capecitabine treatment
    .
    The model showed appropriate calibration and fair discrimination capabilities in the development cohort and validation cohort.
    The C index was 0.
    722 (95% CI, 0.
    662-0.
    781) and 0.
    764 (95% CI, 0.
    668-0.
    859), respectively
    .
    Based on this model, we designed an easy-to-use online calculator that can predict the maintenance benefits of capecitabine
    .

    Evidence-based predictive models can identify those patients most in need of capecitabine beat maintenance therapy, thereby helping to make treatment decisions in daily clinical practice
    .

    • Efficacy and safety analysis of Chinese patients in monarchE: Abemaciclib combined with adjuvant endocrine therapy for high-risk HR+, HER2-early breast cancer
  • Efficacy and safety analysis of Chinese patients in monarchE: Abemaciclib combined with adjuvant endocrine therapy for high-risk HR+, HER2-early breast cancer
  • Efficacy and safety analysis of Chinese patients in monarchE: Abemaciclib combined with adjuvant endocrine therapy for high-risk HR+, HER2-early breast cancer Efficacy and safety analysis of Chinese patients in monarchE: Abemaciclib combined with adjuvant endocrine therapy for high-risk HR+, HER2- early breast cancer

    Shao Zhimin, Zhang Qingyuan, such as Song Zhuangui
    .

    Abstract Number: 522

    In monarchE, abemaciclib (oral CDK4&6 inhibitor) plus endocrine therapy (ET) is used as an adjuvant therapy for HR+ and HER2-high-risk early breast cancer (EBC).
    Compared with ET alone, it is in terms of aggressive disease-free survival (IDFS) There is a statistically significant improvement.
    Here, we introduce the efficacy and safety analysis of Chinese patients from MonarchE
    .

    The overall research design has been previously reported
    .
    Eligible patients were randomized to receive abemaciclib (150 mg BID for 2 years) combined with standard supplementary ET or ET alone
    .
    The primary endpoint is IDFS according to the STEEP standard
    .
    Secondary endpoints include remote recurrence-free survival (DRFS), overall survival, and safety
    .
    In the intention-to-treat (ITT) population, an exploratory subgroup analysis was performed on Chinese patients from mainland China, Hong Kong, and Taiwan
    .

    A total of 501 Chinese patients were randomly assigned to receive abemaciclib plus ET (259 patients) or ET alone (242 patients)
    .
    At the time of the data cutoff (July 8, 2020), 356 (71.
    1%) patients were still in the 2-year treatment period
    .
    A total of 26 IDFS events were observed (11 and 15 events in the ET and ET groups of Abemas Liboga, respectively)
    .
    Compared with ET alone, abemaciclib combined with ET reduces the risk of invasive disease or death in Chinese patients by 34.
    3% (HR: 0.
    657, 95% CI: 0.
    301, 1.
    435), and the 2-year IDFS rate also has a clinically significant improvement ( 95.
    6% vs 92.
    1%)
    .
    The addition of abemaciclib on the basis of ET also improved the DRFS of Chinese patients (HR: 0.
    601, 95% CI: 0.
    245, 1.
    477), and the 2-year DRFS rate was 96.
    7% (ET alone: ​​93.
    4%)
    .
    In the abemaciclib treatment group, the most common treatment emergent adverse events (TEAEs) and grade 3 TEAEs were diarrhea (90.
    3% and 5.
    0%), leukopenia (76.
    8% and 21.
    2%), and neutropenia (76.
    4% and 23.
    9%)
    .

    bemaciclib combined with adjuvant ET has shown clinically significant IDFS and DRFS benefits in Chinese HR+, HER2-, and high-risk EBC patients, which is consistent with the previously reported ITT population
    .
    The safety of abemaciclib in Chinese EBC patients is consistent with the global population, and is also consistent with that observed in Chinese patients with metastatic breast cancer
    .

     

    For more information, follow the ASCO special page of Metz Medicine: https://meeting.
    medsci.
    cn/ASCO2020

    https://meeting.
    medsci.
    cn/ASCO2020

    Reference source: https://meetinglibrary.
    asco.
    org/results?meetingView=2021%20ASCO%20Annual%20Meeting

    https://meetinglibrary.
    asco.
    org/results?meetingView=2021%20ASCO%20Annual%20Meeting

     



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