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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors

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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors

Excerpt:
...Patients with HER2 positive (defined as documented overexpression or amplification or mutation) metastatic breast cancer who have experienced disease progression following at least 2 prior anti-HER2 therapies for metastatic disease that contain trastuzumab with or without pertuzumab, prior T-DM1, or lapatinib therapy is required; 2....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer

Excerpt:
...- Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Retrospective study on the safety and efficacy of pyrotinib in the treatment of HER2-positive non-breast advanced solid tumors.

Published date:
05/26/2022
Excerpt:
16 patients with lung cancer and 6 patients with gastric cancer had a median PFS of 204 days (95% CI: 55–NA days) and 142 days (95% CI: 83–NA days), respectively. The median OS was 366 days (95% CI: 248–NA days) in patients with lung cancer and 179 days (95% CI: 90–NA days) in patients with gastric cancer....These results indicated that pyrotinib-based therapy exhibited good anti-tumor activity and acceptable safety profile in HER2-positive non-breast advanced solid tumors.
DOI:
10.1200/JCO.2022.40.16_suppl.e15064
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Retrospective Study on the Efficacy and Safety of Pyrotinib-Based Therapy for HER2-Positive Nonbreast Advanced Solid Tumors

Published date:
03/25/2022
Excerpt:
The objective response rate (ORR) was 24%, and the disease control rate (DCR) was 68%. Lung cancer ORR was 25%, and gastric cancer ORR was 16.7%. In addition, the DCR of lung cancer was 62.5% and that of gastric cancer was 66.7%....These results show that in HER2-positive nonbreast advanced solid tumors, the treatment based on pyrotinib regimen has good antitumor activity and acceptable safety.
DOI:
https://doi.org/10.1155/2022/4233782
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Studies on the Safety and Efficacy of Pyrotinib in the Treatment of HER2- Positive Advanced Solid Tumors Excluding Breast Cancer

Published date:
12/30/2020
Excerpt:
Twenty-five patients with HER2-positive advanced solid tumors excluding breast cancer were enrolled to receive pyrotinib-based therapy…The ORR for lung cancer was 44.4% and for gastric cancer was 50%...In addition, the DCR for lung cancer was 77.8% and for stomach cancer was 100%.
DOI:
10.2147/CMAR.S281765
Evidence Level:
Sensitive: C3 – Early Trials
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,...