What should I do after EGFR-TKI for treatment?The new choice scheme is here!

*For medical professionals for reading reference

1 minute every day, give you the professional "talk" in the tumor circle! (If the original text is required, you can add Xiaobian WeChat yxj_oncology)

Summary:

1.J Thorac Oncol: Befotrtinib has obvious effects and controllable toxicity for patients with EGFR T790M mutant non-small cell lung cancer that progress after the treatment of EGFR-TKI treatment

2. Jama sub -magazine: Enzalu amine treatment has good safety and effectiveness for patients with low and medium -risk limitations of prostate cancer.

1

J Thorac Oncol: Befotrtinib has obvious effects and controllable toxicity for patients with EGFR T790M mutant non-small cell lung cancer that progresses after the treatment of EGFR-TKI treatment.

▎ Clinical issue:

Is BEFOTERTINIB (D-0316) effective for patients with EGFR T790M mutant non-small cell lung carcinoma (NSCLC) patients developed after the treatment of EGFR-TKI? What is its safety?

BEFOTERTINIB (D-0316) is a new third-generation EGFR-TKI. A multi-center (49 hospitals in Mainland China), 2-stage, and open labels published in J Thorac oncol's authoritative journal (49 hospitals in Mainland China), one-arm, and open label. Befotrtinib develops disease progress after receiving the first or second-generation EGFR-TKI treatment, And produce the efficacy and safety of the local advanced or metastatic NSCLC patients in the EGFR T790M mutation.

▎ Research plan:

Studies have incorporated patients with advanced or transit patients with the first or second-generation EGFR-TKI treatment after treatment, and they carry the EGFR T790M mutation. Or 75-100mg (group B, 290 cases) Befotrtinib. The main endpoint is an objective relief rate (ORC) evaluated by the Independent Examination Committee (IRC) in the treatment of crowds.

▎ Main discovery:

The ORR evaluated in group B was 67.6%(95%CI: 61.9%to 72.9%).

Orr was 54.0%(95%CI: 46.3%to 61.5%) and 65.9%(95%CI: 60.1%to 71.3%) in group A and B, respectively.

The disease control rate was 93.2%in group A and B, respectively (95%CI: 88.4%to 96.4%) and 94.8%(95%CI: 91.6%to 97.1%).

The intracranial ORR was 26.7%(95%CI: 7.8%to 55.1%) and 57.1%(95%CI: 34.0%to 78.2%) in groups in group A and B, respectively.

The median no progressive survival period (PFS) in group A and B is 11.0 (95%CI: 9.6 to 12.5) and 12.5 (95%CI: 11.1 to 13.8) months.

The intracranial mid-position PFS is 16.5 (95%CI: 8.6- inappropriate [NE]) and NE (95%CI: 13.8 to NE) for a month in group A and B, respectively.

The total survival period (OS) is not yet mature.

Patients with level 3 and above in group A were 20.5%and 11.4%, respectively, and 29.3%and 10.0%in group B. Group B, respectively.

▎ Looking out:

In summary, 75-100mg Befotrtinib has obvious curative effects and controllable toxicability for patients with local advanced or metastatic NSCLC patients that carry T790M mutations and are resistant to the first or second-generation EGFR-TKIS resistance.

references:

[1] https://www.jto.org/article/s1556-0864 (22) 00297-0/fullText

2

Jama sub -magazine: Enzalu amine therapy has good safety and effectiveness for patients with low and medium -risk limitation prostate cancer.

▎ Clinical issue:

For patients with low and medium -critical prostate cancer, what are the efficacy and safety of Enshalu amine single drugs compared to active monitoring (AS)?

Enzalu is a kind ofrogen receptor signal conduction inhibitor that can directly target therogens receptor (AR) to treat prostate cancer. The existing results lack of forward -looking evaluation AS drug intervention in the progress of delayed prostate cancer.

A study from the Jama sub -magazine shows that the treatment of Enzalu amine has good safety and effectiveness for patients with low and medium -risk limitation prostate cancer.

▎ Research plan:

ENACT is a phase 2, open label, random clinical trial research. Including patients from 66 centers in the United States and Canada from June 2016 to August 2020. The standard age is 18 years old and above, and the tissue science is diagnosed as low -medium -risk -limited prostate cancer within 6 months after the screening, and patients with AS are performed. During the one -year treatment period, the patient status was monitored and followed up for 2 years.

The tumor risk level and the type of biopsy were layered, and the subject was randomly assigned to the Enshalide 160mg group single drug for 1 year or continued AS group at a ratio of 1: 1.

The main endpoint is the time for pathology or treatment of prostate cancer (pathology: primary or secondary Gleason grading scores increase ≥1, or tumor -positive core increases ≥15%; treatment: first time of prostate cancer for prostate cancer). The secondary endpoint includes biopsy negative rate, tumor -positive core proportion, first and two -year serum prostate special antigen (PSA) secondary increase rate, and PSA progress time. ▎ Main discovery:

1) Compared with AS, Enzalu amine can significantly reduces the risk of prostate cancer by 46%(danger ratio, 0.54; 95%CI, 0.33 to 0.89; P = 0.02); and compared with the AS group, Enzalu, Enzalu The results of the amine group negative biopsy are 3.5 times higher.

2) After 1 year of treatment with Enzalu amine, the proportion of tumor -positive cores and the incidence of serum PSA's secondary increase has decreased significantly; there is no significant difference in results in the second year.

3) Compared with AS, the treatment of Enzalu amine treatment also postponed PSA's progress significantly by 6 months (danger ratio, 0.71; 95%CI, 0.53 to 0.97; P = 0.03).

4) The most common adverse events during the treatment of Enzalu is fatigue [62 cases (55.4%)] and men's and female breast disease [41 cases (36.6%)].

5) Three patients in the Enzalu amine therapy group died and did not use research drugs when they died. Death has nothing to do with treatment.

▎ Looking out:

The results of this random clinical trial indicate that Erzalu amine single drugs have good tolerance and have good effect on patients with low -medium risk -limited prostate cancer. Therefore, Enzalu can be used as a substitute treatment for patients in AS.

references:

[1] https://jamnetwork.com/journals/jamaonCology/fullarticle/2793567

The top issue of the clinical literature is on the line.

1. Scan the QR code below

- END -