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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BMC
2025-05-01
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| Online Access: | https://doi.org/10.1186/s12916-025-04103-0 |
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| author | Qihua Zou Yi Cao Yulin Lai Yu Fang Yuchen Zhang Panpan Liu Lixia Lu Hao Wu Tianying Huang Ning Su Zhihua Li Xicheng Wang Xiaopeng Tian Lirong Li Yingxian Liu Qingqing Cai Yi Xia |
| author_facet | Qihua Zou Yi Cao Yulin Lai Yu Fang Yuchen Zhang Panpan Liu Lixia Lu Hao Wu Tianying Huang Ning Su Zhihua Li Xicheng Wang Xiaopeng Tian Lirong Li Yingxian Liu Qingqing Cai Yi Xia |
| author_sort | Qihua Zou |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a24b2cb9d791477fa520cca605d49f7b |
| institution | Kabale University |
| issn | 1741-7015 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
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| series | BMC Medicine |
| spelling | doaj-art-a24b2cb9d791477fa520cca605d49f7b2025-08-20T03:53:12ZengBMCBMC Medicine1741-70152025-05-0123111110.1186/s12916-025-04103-0Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trialQihua Zou0Yi Cao1Yulin Lai2Yu Fang3Yuchen Zhang4Panpan Liu5Lixia Lu6Hao Wu7Tianying Huang8Ning Su9Zhihua Li10Xicheng Wang11Xiaopeng Tian12Lirong Li13Yingxian Liu14Qingqing Cai15Yi Xia16State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterDepartment of Medical Oncology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterZhongshan School of Medicine, Sun Yat-Sen UniversityDepartment of Medical Oncology, Huizhou Municipal Central HospitalDepartment of Oncology, Guangzhou Chest HospitalDepartment of Medical Oncology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityDepartment of Oncology, The First Affiliated Hospital/The First Clinical Medicine School of Guangdong Pharmaceutical UniversityState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterAbstract 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.https://doi.org/10.1186/s12916-025-04103-0NimotuzumabDocetaxelCisplatinFirst-line therapyRecurrent or metastatic nasopharyngeal carcinoma |
| spellingShingle | Qihua Zou Yi Cao Yulin Lai Yu Fang Yuchen Zhang Panpan Liu Lixia Lu Hao Wu Tianying Huang Ning Su Zhihua Li Xicheng Wang Xiaopeng Tian Lirong Li Yingxian Liu Qingqing Cai Yi Xia Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial BMC Medicine Nimotuzumab Docetaxel Cisplatin First-line therapy Recurrent or metastatic nasopharyngeal carcinoma |
| title | Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial |
| title_full | Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial |
| title_fullStr | Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial |
| title_full_unstemmed | Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial |
| title_short | Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial |
| title_sort | nimotuzumab combined with docetaxel and cisplatin as first line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma a multicenter phase 2 trial |
| topic | Nimotuzumab Docetaxel Cisplatin First-line therapy Recurrent or metastatic nasopharyngeal carcinoma |
| url | https://doi.org/10.1186/s12916-025-04103-0 |
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