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Pyrotinib in Patients with HER2-Amplified Advanced Non-Small Cell Lung Cancer: A Prospective, Multicenter, Single-Arm
Zhengbo Song1, Dongqing Lv2, Shi-Qing Chen3
1Clinical Trials Center, Zhejiang Cancer Hospital, Hangzhou, China.
Purpose:
In this study, we aimed to evaluate the efficacy and safety of pyrotinib, a pan-HER inhibitor, in patients with HER2-amplified non-small cell lung cancer (NSCLC).
Patients And Methods:
In this prospective, multicenter, single-arm trial (ChiCTR1800020262), patients with advanced NSCLC with HER2 amplification, as determined by next-generation sequencing, were enrolled and administered pyrotinib orally at 400 mg per day. The primary endpoint was 6-month progression-free survival (PFS) rate. Other endpoints included objective response rate (ORR), disease control rate (DCR), PFS, overall survival (OS), and safety.
Results:
The enrolled cohort included 27 patients with HER2 amplification. The 6-month PFS rate was 51.9% [95% confidence interval (CI), 34.0-69.3]. The median PFS (mPFS) was 6.3 months (95% CI, 3.0-9.6 months), and median OS was 12.5 months (95% CI, 8.2-16.8 months). Pyrotinib elicited a confirmed ORR of 22.2% (95% CI, 10.6%-40.8%). Patients administered pyrotinib as first-line treatment achieved an mPFS of 12.4 months. Moreover, 30.8% of the patients who had progressed on EGFR tyrosine kinase inhibitor (TKI) responded to pyrotinib. Patients with brain metastases had an ORR of 40%. Treatment-related adverse events (TRAE) occurred in all patients (grade 3, 22.2%), but no grade 4 or higher TRAEs were documented. Diarrhea was the most frequent TRAE (all, 92.6%; grade 3, 7.4%). Loss of HER2 amplification was detected upon disease progression.
Conclusions:
Pyrotinib provided antitumor efficacy with a manageable safety profile in HER2-amplified patients with NSCLC.
Insights
Pyrotinib demonstrated antitumor efficacy in HER2-amplified non-small cell lung cancer (NSCLC) patients, with a 6-month progression-free survival rate of 51.9%. The treatment showed a manageable safety profile, with diarrhea as the most common side effect.
Area of Science:
- Oncology
- Pharmacology
Background:
- Non-small cell lung cancer (NSCLC) with HER2 amplification represents a distinct molecular subtype.
- Targeted therapies are crucial for improving outcomes in NSCLC patients with specific genetic alterations.
Purpose of the Study:
- To evaluate the efficacy and safety of pyrotinib, a pan-HER inhibitor, in patients with HER2-amplified NSCLC.
- To determine key efficacy endpoints including progression-free survival (PFS) and objective response rate (ORR).
Main Methods:
- A prospective, multicenter, single-arm trial involving patients with advanced NSCLC and HER2 amplification.
- Patients received oral pyrotinib at 400 mg daily.
- Primary endpoint was 6-month PFS rate; secondary endpoints included ORR, disease control rate (DCR), PFS, overall survival (OS), and safety.
Main Results:
- The study included 27 patients with HER2-amplified NSCLC.
- The 6-month PFS rate was 51.9% (95% CI, 34.0-69.3), with a median PFS of 6.3 months.
- Objective response rate (ORR) was 22.2%, and median OS was 12.5 months. Notably, patients with brain metastases had a 40% ORR.
Conclusions:
- Pyrotinib demonstrated significant antitumor efficacy in patients with HER2-amplified NSCLC.
- The pan-HER inhibitor exhibited a manageable safety profile, with manageable treatment-related adverse events.
- Pyrotinib represents a potential therapeutic option for this NSCLC patient population.
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