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Association details:
| Biomarker: | HER-2 mutation |
|---|---|
| Cancer: | Gastric Cancer |
| Drug: | Irene (pyrotinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors
Excerpt:
...HER2 mutated non-small cell lung cancer , gastric and gastroesophageal junction adenocarcinoma or Adenocarcinoma of the colon has been confirmed by Pathology....
Trial ID:
Source:
Title:
Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Excerpt:
...- have confirmed HER2 gene amplified tumor fluorescence in-situ hybridization (FISH, HER2/cep17 ratio > 2) or HER2 overexpression (IHC 3+) or documented HER2 gene mutation....
Trial ID:
More C2 evidence
Source:
Title:
An exploratory basket study of non-breast cancer patients with HER2 mutation or amplification who failed in standard treatment with pyrotinib maleate tablets
Excerpt:
...Cancer tissue pathology is clearly HER2 positive: including IHC2+/ISH+, IHC 3+ or HER2 mutations (the results obtained by NGS method, PCR method, Sanger method, mass spectrometry sequencing and other measurement methods are all acceptable). ...
Trial ID:
Less C2 evidence
Source:
Title:
1511P - A real world study of pyrotinib in patients with HER-2 positive/mutations tumors excluding breast cancer
Published date:
09/14/2020
Excerpt:
Total 25 pts with HER-2 positive/mutations were enrolled….21 (84.0%) pts received 400 mg pyrotinib once daily as initial dose, 2 (8%) pts received 320 mg, 2 (8%) pts received 160 mg. Total 23 pts were eligible for efficacy evaluation, 12 pts achieved PR (4 pts with lung cancer, 4 pts with gastric cancer, 2 pts with colorectal cancer, 2 pts with thymic cancer), 9 pts were SD and 2 pts were PD. The ORR was 52.2% and the DCR was 91.3%. The mPFS was 3.5 months (95%CI: 2.2-5.0 months), mOS was 9.6 months (95%CI: 4.4 months-NR)....The retrospective study showed that pyrotinib showed good efficacy and safety in patients with HER-2 positive/mutation solid tumors,...
