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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
Yuan Zhongyu et al
Yuan Zhongyu et alDepartment 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
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
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
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
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
medsci.
cn/ASCO2020
Reference source: https://meetinglibrary.
asco.
org/results?meetingView=2021%20ASCO%20Annual%20Meeting
asco.
org/results?meetingView=2021%20ASCO%20Annual%20Meeting
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