Abstract 1511P
Background
Pyrotinib have improved clinical outcomes in HER-2 positive breast cancer and are explored as potential treatments for HER-2 positive/mutations tumors other than breast cancer. We aimed to evaluate the efficacy and safety of pyrotinib for the treatment of the patients with HER-2 positive/mutations tumors other than breast cancer in clinical practice.
Methods
This is a multicentre, retrospective study. The clinical data of patients with HER-2 positive/mutations tumors excluding breast cancer were collected in 14 hospitals in Suzhou and Wuxi City from September 2018 to May 2019. Patients historically confirmed overexpression of HER-2 protein by ICH3+/ISH+ or HER-2 mutations on targeted NGS was included. All patients received any regimens based on pyrotinib.
Results
Total 25 pts with HER-2 positive/mutations were enrolled. The median age was 64 years (range 37-73 years). There were 10 lung cancer, 9 gastric cancer, 2 colorectal cancer, 2 thymic cancer, 1 ovarian cancer and 1 gallbladder cancer. Patients received pyrotinib as <3rd-line therapy, 3rd-line therapy, >3rd-line therapy accounted for 20% (5), 56% (14), and 24% (6), respectively. Seven pts received pyrotinib monotherapy, 18 pts received combination therapy, including 11 combined with capecitabine, 2 with albumin-bound paclitaxel, 1 with trastuzumab, 1 with osimertinib, 1 with bevacizumab,1 with pemetrexed, and 1 with irinotecan. 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 main AE was diarrhea in 23 (92%) cases, Grade 1-2 diarrhea were recored in 18 (72.0%) cases, and 5 (20%) cases reported grade 3 diarrhea.
Conclusions
The retrospective study showed that pyrotinib showed good efficacy and safety in patients with HER-2 positive/mutation solid tumors, not only in HER-2 positive breast cancer. Prospective studies are warranted to further confirm its efficacy and safety.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
JunQian.
Funding
Suzhou municipal health and family planning commission (GSWS2019019).
Disclosure
All authors have declared no conflicts of interest.