Retrospective Study on the Efficacy and Safety of Pyrotinib-Based Therapy for HER2-Positive Nonbreast Advanced Solid
Jianzheng Wang1, Baiwen Zhang2, Xiaojiao Cheng2
1Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou Henan Province 450008, China.
Background:
Human epidermal growth factor receptor 2 (HER2) is a member of the large ErbB family and an important oncogene in many solid tumors. Pyrotinib has been approved for the treatment of HER2-positive, recurrent, or metastatic breast cancer. However, there are very few clinical studies on pyrotinib in other HER2-positive solid tumors. Therefore, more evidence of clinical research is impendently needed to shepherd pyrotinib-based therapy in HER2-positive nonbreast advanced solid tumors. Patients and Methods. We performed a retrospective analysis of HER2-positive nonbreast advanced solid tumors patients with HER2 amplification or mutations who were administered with pyrotinib-based therapy in Henan Cancer Hospital between July 1, 2019, and December 2, 2021. In our research, 25 eligible patients were included with 16 patients with lung cancer, 6 patients with gastric cancer, 2 patients with colorectal cancer, and 1 patient with cholangiocarcinoma. Progression-free survival (PFS) is our main research end point.
Results:
The median PFS was 188 days (95% CI: 83-not reached (NR)), and overall survival (OS) was 250 days (95% CI: 188-NR), respectively. 16 patients with lung cancer had a median PFS of 204 days (95% CI: 55-NR) and 6 patients with gastric cancer had PFS of 142 days (95% CI: 83-NR), respectively. The median OS was 366 days (95% CI: 248-NR) in patients with lung cancer and 179 days (95% CI: 90-NR) in patients with gastric cancer. The median PFS and OS of patients receiving >3 line treatment were lower than those receiving ≤3 line treatment (PFS: 188 days vs 204 days, p = 0.92; OS: 188 days vs 366 days, p = 0.43). All 25 patients can be evaluated. 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%. In addition, the ORR and DCR of patients receiving treatment ≤3 lines were higher than those receiving treatment >3 lines (ORR: 35.7% vs 9.1%, p = 0.18; DCR: 71.4% vs 63.6%, p > 0.99). The most common treatment-related adverse events (TRAEs) were diarrhea (84%), but only 3 patients (12%) reported grade 3 diarrhea with good control.
Conclusion:
These results show that in HER2-positive nonbreast advanced solid tumors, the treatment based on pyrotinib regimen has good antitumor activity and acceptable safety. This retrospective study aims to promote larger clinical studies to further clarify the efficacy and safety of pyrotinib in the treatment of nonbreast solid tumors.
Insights
Pyrotinib shows promising antitumor activity and acceptable safety in HER2-positive non-breast advanced solid tumors. Further clinical studies are warranted to confirm these findings for pyrotinib-based therapies.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Human epidermal growth factor receptor 2 (HER2) is a key oncogene in various solid tumors.
- Pyrotinib is approved for HER2-positive breast cancer but understudied in other HER2-positive solid tumors.
- Clinical evidence is needed for pyrotinib in HER2-positive advanced non-breast solid tumors.
Purpose of the Study:
- To evaluate the efficacy and safety of pyrotinib-based therapy in patients with HER2-positive non-breast advanced solid tumors.
- To assess progression-free survival (PFS) as the primary endpoint.
- To explore objective response rate (ORR) and disease control rate (DCR).
Main Methods:
- Retrospective analysis of 25 patients with HER2-positive non-breast advanced solid tumors treated with pyrotinib.
- Patients had HER2 amplification or mutations and received pyrotinib-based therapy between July 2019 and December 2021.
- Included lung, gastric, colorectal, and cholangiocarcinoma cases.
Main Results:
- Median PFS was 188 days and median OS was 250 days across all patients.
- Lung cancer patients showed a median PFS of 204 days and OS of 366 days.
- Objective response rate (ORR) was 24% and disease control rate (DCR) was 68%, with diarrhea as the most common adverse event.
Conclusions:
- Pyrotinib-based regimens demonstrate good antitumor activity and acceptable safety in HER2-positive non-breast advanced solid tumors.
- The findings support the need for larger clinical studies to further validate pyrotinib's efficacy and safety.
- This study provides preliminary evidence for pyrotinib's potential in treating non-breast HER2-positive solid tumors.
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