Larotinib in patients with advanced and previously treated esophageal squamous cell carcinoma with epidermal growth factor receptor overexpression or amplification: an open-label, multicenter phase 1b study
Rattachement africain : cn. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: Larotinib is a new first-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. This open-label, phase 1b study is aimed to evaluate the efficacy, safety of larotinib in patients with advanced esophageal squamous cell carcinoma (ESCC) with EGFR overexpression or amplification pretreated with one or more system regimens, and to recommend an appropriate dose for its further study. METHODS: Patients received larotinib orally at 3 doses (250, 300, 350 mg), once daily. Clinical response was evaluated every 8 weeks according to RECIST v1.1 criteria by both investigators and independent radiology review (IRC). RESULTS: 81 patients were enrolled. The investigator-assessed overall response rate (ORR) was 13.7% (10/73), all responses were observed in the 350 mg group of which ORR up to 20.0% (10/50), with 10 of them having EGFR overexpression and 4 having EGFR amplification. Per IRC assessment, ORR for all patients and 350 mg group were 13.9% (10/72) and 16.3% (8/50). In the 350 mg group, median overall survival (OS) and progression-free survival (PFS) were 8.0 (95% CI 4.9-10.2) months and 3.4 (95% CI 2.4-3.7) months, respectively. The most common treatment-related adverse events (TRAEs) were diarrhea, rash, and palmar-plantar erythrodysesthesia syndrome, elevated AST/ALT, vomiting, similarly with other EGFR TKIs. CONCLUSIONS: Larotinib demonstrated promising antitumor activity and manageable safety profiles in patients with pre-treated advanced ESCC with EGFR overexpression or amplification, especially at the dose of 350 mg, which showed better efficacy and acceptable safety. A phase 3 study is underway on 350 mg larotinib in ESCC patients with EGFR overexpression. TRIAL REGISTRATION: This trial was retrospectively registered on 25/03/2019, NCT03888092. https://clinicaltrials.gov/ct2/show/NCT03888092 .
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Larotinib in patients with advanced and previously treated esophageal squamous cell carcinoma with epidermal growth factor receptor overexpression or amplification: an open-label, multicenter phase 1b study
- Date Crossref
- 23/10/2021
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
-
Chinese PLA General Hospital Department of Oncology pays non établi dans la noticeÉtablissement de santé
-
Jiangsu Province Hospital Department of Oncology pays non établi dans la noticeÉtablissement de santé
-
Academy of Military Medical Sciences pays non établi dans la noticeStructure de recherche
-
Harbin Medical University Department of Internal Medicine pays non établi dans la noticeUniversité ou école supérieure
-
Third Affiliated Hospital of Harbin Medical University pays non établi dans la noticeÉtablissement de santé
-
First Affiliated Hospital Zhejiang University pays non établi dans la noticeÉtablissement de santé
-
Shandong Tumor Hospital pays non établi dans la noticeÉtablissement de santé
-
Shandong First Medical University pays non établi dans la noticeUniversité ou école supérieure
-
Henan Cancer Hospital Department of Medical Oncology pays non établi dans la noticeÉtablissement de santé
-
Fujian Provincial Cancer Hospital Department of Medical Oncology pays non établi dans la noticeÉtablissement de santé
-
First Affiliated Hospital of Zhengzhou University Department of Oncology pays non établi dans la noticeÉtablissement de santé
-
Qilu Hospital of Shandong University Department of Chemotherapy pays non établi dans la noticeÉtablissement de santé
Department of Oncology — Chinese PLA General Hospital, Department of Oncology — Jiangsu Province Hospital et Academy of Military Medical Sciences, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.