In a Chinese phase II trial reported in the Journal of Clinical Oncology, Zhou et al found that pyrotinib produced durable responses in patients with HER2-mutated advanced non–small cell lung cancer (NSCLC) who had received prior platinum-based chemotherapy.
Study Details
The multicenter study enrolled 60 patients with stage IIIB or IV disease between October 2016 and December 2018. Patients were treated with oral pyrotinib at 400 mg/d in 21-day cycles. Overall, 97% of patients had stage IV disease and 42% had received at least two prior lines of chemotherapy. No patients had received immunotherapy.
KEY POINTS
- Objective response was observed in 30% of patients.
- Treatment-related grade 3 diarrhea occurred in 20% of patients.
Responses
At data cutoff in June 2019, median follow-up was 11.7 months. Objective response on independent review committee assessment was observed in 18 patients (30%; all partial responses), with an additional 33 patients (55%) having stable disease. Response rates were 25% among 12 patients with brain metastases and 31.3% among 48 patients without brain metastases. Responses were observed irrespective of HER2 mutation subtype. Median duration of response was 6.9 months (95% confidence interval [CI] = 4.9–11.1 months). Median progression-free survival was 6.9 months (95% CI = 5.5–8.3 months) and median overall survival was 14.4 months (95% CI = 12.3–21.3 months).
Adverse Events
Patients received a median of 10 cycles of treatment. Treatment-related diarrhea occurred in 91.7% of patients (predominantly grade 1 or 2). Treatment-related grade 3 or 4 adverse events were observed in 28.3% of patients, with the most common being diarrhea (20%; all grade 3). Serious treatment-related adverse events occurred in two patients (3.3) and consisted of increased amylase and abnormal hepatic function. No treatment-related deaths were reported.
The investigators concluded, “Pyrotinib showed promising antitumor activity and an acceptable safety profile in chemotherapy-treated patients with HER2-mutant NSCLC.”
Caicun Zhou, MD, PhD, of Shanghai Pulmonary Hospital, Tongji University School of Medicine, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Jiangsu Hengrui Medicine Co, Ltd. For full disclosures of the study authors, visit ascopubs.org.
