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

...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. ...

...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). ...

...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....

...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)....

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.