Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial
Abstract 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 In this multicenter, open-label, phase 2 trial (ClinicalTrials.gov identifi...
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| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-05-01
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| Series: | BMC Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12916-025-04103-0 |
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| Summary: | Abstract 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 In this multicenter, open-label, phase 2 trial (ClinicalTrials.gov identifier: NCT03708822), patients with RM-NPC received intravenous nimotuzumab (200 mg on days 1, 8, and 15), docetaxel (75 mg/m2 on day 1), and cisplatin (75 mg/m2 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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| ISSN: | 1741-7015 |