Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial
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Le résumé fourni par la source
BACKGROUND: To evaluate the efficacy and safety of nimotuzumab combined with docetaxel and cisplatin (TPN) as the first-line therapy in patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). METHODS: on day 1) every 3 weeks for 6 cycles. The primary endpoint was the objective response rate (ORR), and the secondary endpoints included the disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Between October 15, 2018, and July 20, 2022, 52 patients were enrolled. The ORR and DCR in the intention-to-treat population were 65.4% and 90.4%, respectively. With a median follow-up of 38.1 months, the median PFS and OS were 7.4 and 40.4 months, respectively. The majority of adverse events were grades 1-2. Grade 3/4 adverse events were neutropenia (42.3%), leukopenia (32.7%), febrile neutropenia (11.5%), nausea (7.7%), fatigue (5.8%), infection (5.8%), thrombocytopenia (1.9%), and anorexia (1.9%). There was no treatment-related death. Low baseline plasma Epstein-Barr virus (EBV) DNA level and the clearance of plasma EBV DNA after 2 cycles of treatment were associated with longer PFS. Additionally, patients who received ≥ 2400 mg of nimotuzumab and ≥ 4 cycles of docetaxel plus cisplatin had superior ORR and survival. CONCLUSIONS: First-line therapy with the TPN regimen showed promising efficacy with a well-tolerated safety profile in RM-NPC patients. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03708822.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial
- Date Crossref
- 06/05/2025
- 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
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Sun Yat-sen University Department of Medical Oncology pays non établi dans la noticeUniversité ou école supérieure
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Sun Yat-sen University Cancer Center pays non établi dans la noticeÉtablissement de santé
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Sun Yat-sen Memorial Hospital pays non établi dans la noticeÉtablissement de santé
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Huizhou Central People's Hospital pays non établi dans la noticeÉtablissement de santé
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Guangzhou Chest Hospital Department of Oncology pays non établi dans la noticeÉtablissement de santé
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First Affiliated Hospital of Guangdong Pharmaceutical University pays non établi dans la noticeÉtablissement de santé
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Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation pays non établi dans la noticeStructure de recherche
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Zhongshan School of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Huizhou Municipal Central Hospital Department of Medical Oncology pays non établi dans la noticeÉtablissement de santé
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The First Affiliated Hospital/The First Clinical Medicine School of Guangdong Pharmaceutical University Department of Oncology pays non établi dans la noticeUniversité ou école supérieure
Department of Medical Oncology — Sun Yat-sen University, Sun Yat-sen University Cancer Center et Sun Yat-sen Memorial Hospital, avec 7 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.