Laparoscopic and open distal gastrectomy are the same for patients with locally advanced gastric cancer; another phase III clinical trial of an oral drug for breast cancer is successful!

*Only for medical professionals to read for reference, 1 minute a day, to give you professional "talking information" in the tumor circle! (If you need the original text of the literature, you can add the editor WeChat yxj_oncology to obtain) Key points JAMA Surgery: There is no difference in the five-year survival rate of patients with locally advanced gastric cancer through laparoscopic and open distal gastrectomy! Cancer Communications: RC48 performs well in the treatment of advanced gastric cancer with HER2 overexpression.
New drug: Oral estrogen receptor degrading agent significantly delays the disease progression of breast cancer patients! New drug: The domestically-made CDK4/6 inhibitor that has been certified as an orphan drug in Europe and the United States has started clinical trials in China.
01JAMA Surgery: There is no difference in the five-year survival rate of patients with locally advanced gastric cancer through laparoscopic and open distal gastrectomy! It is unclear whether laparoscopic and open distal gastrectomy have similar outcomes in patients with locally advanced gastric cancer
.

Data from a multicenter, randomized clinical trial [Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS-01)] showed that the 3-year disease-free survival rate of laparoscopic distal gastrectomy is not inferior to that of open distal gastrectomy In this study, the 5-year overall survival (OS) data of the CLASS-01 trial was updated
.

The results show that in patients with locally advanced gastric cancer, the 5-year overall survival rate of laparoscopic distal gastrectomy combined with D2 lymph node dissection performed by experienced surgeons in high-volume specialized institutions is similar to that of open distal gastrectomy
.

Screenshot from the official website This study is a non-inferiority, open, randomized clinical trial conducted in 14 research centers in China.
From September 12, 2012 to December 3, 2014, a total of 1056 patients were enrolled in clinical stages of T2.
Gastric cancer patients with T3 or T4a, without giant lymph nodes or distant metastases
.

When the 1039 patients who received radical treatment were followed up for 5 years, the overall survival rate of the laparoscopic distal gastrectomy group was 72.
6%, and that of the open distal gastrectomy group was 76.
3% (log rank P=0.
19; HR, 1.
17; 95% CI, 0.
93-1.
48; P=0.
19)
.

After comparing competing risk events, gastric cancer-related deaths (HR, 1.
14; 95%CI, 0.
87-1.
49; P=0.
34) and deaths caused by other causes (HR, 1.
23; 95%CI, 0.
74-2.
05; P=0.
42) group There is no significant difference between them
.

There was no significant difference in overall survival rate between groups of each tumor stage
.

02Cancer Communications: RC48 performs well in the treatment of HER2 overexpression advanced gastric cancer.
The current third-line treatment options for human epidermal growth factor receptor 2 (HER2) overexpression gastric cancer show limited clinical benefit, and HER2 immunohistochemistry (IHC) 2+ and fluorescence in situ There is no specific treatment for hybrid-negative patients
.

This study reported the efficacy and safety of HER2 antibody-conjugated drug (ADC) RC48 in the treatment of patients with advanced gastric cancer or gastroesophageal junction cancer with overexpression of HER2
.

The results show that the drug has good activity and manageable safety, and has potential application value in patients with advanced gastric cancer or gastroesophageal junction cancer who have received at least two lines of chemotherapy in the past with HER2 overexpression
.

Official website screenshots The enrolled patients were HER2 overexpression (IHC 2+ or 3+), locally advanced or metastatic gastric cancer or gastroesophageal junction cancer who received at least second-line treatment, and received RC48 2.
5 mg/kg monotherapy, once every 2 weeks
.

The primary endpoint is the objective response rate (ORR) assessed by the independent review committee
.

Secondary endpoints include progression-free survival (PFS), OS, duration of remission, time to progression, disease control rate, and safety
.

125 enrolled patients qualified and received RC48 treatment, ORR was 24.
8% (95%CI: 17.
5%-33.
3%); median PFS and OS were 4.
1 months (95%CI: 3.
7-4.
9 months) and 7.
9, respectively Months (95%CI: 6.
7-9.
9 months)
.

The most frequently reported adverse events were decreased white blood cell count (53.
6%), weakness (53.
6%), alopecia (53.
6%), decreased neutrophil count (52.
0%), anemia (49.
6%), and aspartate aminotransferase levels Increase (43.
2%)
.

Serious adverse events (SAE) occurred in 45 patients (36.
0%).
The SAE related to RC48 was mainly a decrease in neutrophil count (3.
2%)
.

03New drug: Oral estrogen receptor degrading agent significantly delays the disease progression of breast cancer patients! On October 20, 2021, Menarini Group and Radius Health announced that the selective estrogen receptor degrading agent (SERD) elacestrant has obtained positive results in a phase III clinical trial
.

The trial aims to evaluate the efficacy of elacestrant as a single-agent treatment compared with standard treatment (SoC) in the treatment of patients with ER+/HER2- advanced or metastatic breast cancer
.

The trial reached two primary endpoints.
The PFS of the total subjects and the PFS of patients with tumors with estrogen receptor 1 (ESR1) mutations showed statistically significant improvements, and the safety characteristics of the drug were similar to previous studies
.

04 New drug: The domestically-made CDK4/6 inhibitor that has been certified as an orphan drug in Europe and the United States starts clinical trials in China.
On October 19, the CDK4/6 inhibitor GLR2007 independently developed by Ganli Pharmaceutical launched a phase Ib/II clinical trial in China for the first time.
In advanced solid tumors
.

As early as July 2020, this new drug has taken the lead in launching phase I clinical trials in the United States, and obtained the U.
S.
Food and Drug Administration (FDA) orphan drug qualification in September 2020, and obtained FDA fast track review in January 2021.
Evaluation of qualifications for the treatment of glioblastoma (GBM)
.

In April 2021, the drug was approved by the European Medicines Agency (EMA) as an orphan drug for the treatment of glioma
.

References: [1]Huang C, et al.
JAMA Surg.
2021 Oct 20.
doi:10.
1001/jamasurg.
2021.
5104.
Epub ahead of print.
PMID:34668963.
[2]Peng Z, et al.
Cancer Commun (Lond) .
2021 Oct 19.
doi:10.
1002/cac2.
12214.
Epub ahead of print.
PMID:34665942.
[3]https://mp.
weixin.
qq.
com/s/4-nbvJS3mh2-LTBl9UQSbQ.
[4]https: //mp.
weixin.
qq.
com/s/SHt-w1jUT4mHAH7_Mfnxsw.