...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)....

...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). ...

...Histologically proven adenocarcinoma of G/GEJ HER2 positivity (IHC3+ or ICH 2+ and HER2/CEP17 ratio greater than 2.0 on FISH) assessed before the first-line chemotherapy and refractory to fluoropyrimidine, platinum, and trastuzumab combination therapy. ...

...- Histologically or cytologic confirmed HER2 positive advanced gastric cancer (including adenocarcinoma of esophageal-gastric junction), with clinical phase III/IV....

...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....

There were five patients who had confirmed partial response (monotherapy: one each at 240, 400, and 480 mg dose cohort; combination therapy: two at 240 mg dose cohort), resulting in an objective response rate of 21% and 20%, respectively...Pyrotinib alone and combined with docetaxel showed acceptable toxicities in patients with pretreated HER2-positive GC.

There were five patients who had confirmed partial response (monotherapy: one each at 240, 400, and 480 mg dose cohort; combination therapy: two at 240 mg dose cohort), resulting in an objective response rate of 21% and 20%, respectively...Pyrotinib alone and combined with docetaxel showed acceptable toxicities in patients with pretreated HER2-positive GC.

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.

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.

In the subgroup analysis, ORR and DCR were 33.3% (5/15) and 66.7% (10/15) in CRC, 18.2% (2/11) and 54.5% (6/11) in GC, respectively. The median DOT was similar in CRC (6.3 months) and GC (5.8 months).,,,Pyrotinib-based therapy demonstrates promising effects in HER2-positive metastatic colorectal and gastric cancer and prospective clinical trial is warranted to confirm its activity in patients failed to first-line therapy.

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%.

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,...

13 patients with HER-2 positive advanced solid tumors were enrolled, including 11 patients with metastatic breast cancer, 3 patients with metastatic colon cancer, 3 patients with gastric cancer. Among them, 10 patients were evaluated for efficacy and(or) side effect, of which 3 patients were excluded because they were not taken pyrotinib according to the medical order... The total mPFS was 5.63 months (95%CI: 2.533-5.467), partial remission (PR) were 3 cases(30%), stead diease(SD) were 6 cases(60%), progress diease was 1 case(10%). The overall response rate (ORR) and the disease control rate (DCR) were 23.1%, 69.2%, respectively....The treatment of HER-2 positive advanced solid tumors with pyrotinib have good exact effect, and the toxicity could be controlled.

A 49-year-old female was diagnosed with stage IV GC with liver and lung metastasis in July 2017. She underwent gastrostomy, and the immunohistochemistry (IHC) result of postoperative tissue demonstrated HER2 (3+)….She started to receive third-line treatment of irinotecan (200 mg d1) and capecitabine (60 mg bid) plus pyrotinib (400 mg/day). After 2 months of treatment, the tumor is evaluated as partial response with PFS of 12 months.