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Ref Type Journal Article
PMID (32614698)
Authors Zhou C, Li X, Wang Q, Gao G, Zhang Y, Chen J, Shu Y, Hu Y, Fan Y, Fang J, Chen G, Zhao J, He J, Wu F, Zou J, Zhu X, Lin X
Title Pyrotinib in HER2-Mutant Advanced Lung Adenocarcinoma After Platinum-Based Chemotherapy: A Multicenter, Open-Label, Single-Arm, Phase II Study.
Journal Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Vol
Issue
Date 2020 Jul 02
URL
Abstract Text Targeted therapies against non-small-cell lung cancer (NSCLC) harboring HER2 mutations remain an unmet need. In this study, we assessed the efficacy and safety of pyrotinib in patients with HER2-mutant advanced NSCLC in a prospective, multicenter, open-label, single-arm, phase II study.Patients with stage IIIB or IV HER2-mutant lung adenocarcinoma who were previously treated with platinum-based chemotherapy were enrolled to receive pyrotinib at a dose of 400 mg/d for 21-day cycles. The primary end point was objective response rate per independent review committee (IRC).Between October 20, 2016, and December 10, 2018, 60 patients received pyrotinib monotherapy. At baseline, 58 (96.7%) were stage IV, and 25 (41.7%) received at least 2 lines of prior chemotherapy. As of data cutoff on June 20, 2019, IRC-assessed objective response rate was 30.0% (95% CI, 18.8% to 43.2%). All subgroups of patients with different HER2 mutation types showed a favorable objective response rate. The objective response rates were similar between patients with and without brain metastases (25.0% v 31.3%). The median duration of response was 6.9 months (95% CI, 4.9 to 11.1 months). The median progression-free survival was 6.9 months (95% CI, 5.5 to 8.3 months) per IRC. The median overall survival was 14.4 months (95% CI, 12.3 to 21.3 months). Treatment-related adverse events of grade 3 or 4 occurred in 28.3% of patients, with the most common being diarrhea (20.0%; all grade 3). No treatment-related deaths were reported.Pyrotinib showed promising antitumor activity and an acceptable safety profile in chemotherapy-treated patients with HER2-mutant NSCLC.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 V777L lung non-small cell carcinoma predicted - sensitive Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, a non-small cell lung cancer patient harboring ERBB2 (HER2) V777L who had received prior platinum-based chemotherapy demonstrated a partial response when treated with Pyrotinib (PMID: 32614698; NCT02834936). 32614698
ERBB2 L755P lung non-small cell carcinoma predicted - sensitive Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, Pyrotinib treatment resulted in an objective response rate of 25% (1/4) in non-small cell lung cancer patients harboring ERBB2 (HER2) L755P who had received prior platinum-based chemotherapy (PMID: 32614698; NCT02834936). 32614698
ERBB2 Y772_A775dup lung non-small cell carcinoma predicted - sensitive Pyrotinib Phase II Actionable In a Phase II trial, Pyrotinib treatment resulted in an objective response rate of 27.3% (12/44) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (also reported as A775_G776insYVMA or M774_A775insAYVM) who had received prior platinum-based chemotherapy (PMID: 32614698; NCT02834936). 32614698
ERBB2 G778_P780dup lung non-small cell carcinoma predicted - sensitive Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, Pyrotinib treatment resulted in an objective response rate of 60% (3/5) in non-small cell lung cancer patients harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) who had received prior platinum-based chemotherapy (PMID: 32614698; NCT02834936). 32614698
ERBB2 act mut lung non-small cell carcinoma predicted - sensitive Pyrotinib Phase II Actionable In a Phase II trial, Pyrotinib treatment resulted in an objective response rate of 30% (18/60), with 55% (33/60) demonstrating stable disease, median duration of response of 6.9 mo, and median progression-free survival of 6.9 mo, and median overall survival of 14.4 mo in non-small cell lung cancer patients harboring ERBB2 (HER2) activating mutations, including exon 20 insertions and mutations occurring at L755, G776, and V777, who had received prior platinum-based chemotherapy (PMID: 32614698; NCT02834936). 32614698