Administration of nimotuzumab combined with cisplatin plus 5-fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy: a multicenter randomized controlled study
Abstract Background Nimotuzumab (NTZ) is an anti-EGFR monoclonal antibody. However,the effect of targeted drugs combined with induction therapy in locally advanced nasopharyngeal carcinoma remains unclear. The aim of this study is to investigate the safety and efficacy of NTZ combined with cisplatin...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-12-01
|
| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12885-019-6459-6 |
| _version_ | 1818364028403056640 |
|---|---|
| author | Ying Lu Dagui Chen Jinhui Liang Jianquan Gao Zhanxiong Luo Rensheng Wang Wenqi Liu Changjie Huang Xuejian Ning Meilian Liu Haixin Huang |
| author_facet | Ying Lu Dagui Chen Jinhui Liang Jianquan Gao Zhanxiong Luo Rensheng Wang Wenqi Liu Changjie Huang Xuejian Ning Meilian Liu Haixin Huang |
| author_sort | Ying Lu |
| collection | DOAJ |
| description | Abstract Background Nimotuzumab (NTZ) is an anti-EGFR monoclonal antibody. However,the effect of targeted drugs combined with induction therapy in locally advanced nasopharyngeal carcinoma remains unclear. The aim of this study is to investigate the safety and efficacy of NTZ combined with cisplatin plus 5-fluorouracil (PF) as induction regimen in locally advanced nasopharyngeal carcinoma (NPC) patients receiving concurrent radiochemotherapy. Methods This was a multicenter randomized controlled study performed in eight Guangxi hospitals in 2015–2017. Eligible patients with NPC were randomized into nimotuzumab/PF (NPF group) and docetaxel/PF (DPF group) regimens, respectively, as induction therapy. After 2 cycles of induction therapy, all patients received cisplatin and concurrent intensity modulated radiation therapy (IMRT). Then, the two groups were compared for safety and efficacy. Results A total of 118 patients with stage III-IVa NPC were assessed, with 58 and 60 in the NPF and DPF groups, respectively. Compared with DPF treatment, NPF induction therapy showed a more pronounced effect on cervical lymph nodes (P = 0.036), with higher response rate (RR) (81% vs 60%). Compared with the DPF group, the NPF group showed significantly reduced leukopenia, neutropenia and gastrointestinal reactions (all P < 0.05); rash only appeared in the NPF group, but all cases were grade 1. During concurrent treatment with radiotherapy and chemotherapy, the NPF group showed better tolerance to radiotherapy and chemotherapy; neutropenia, anemia, gastrointestinal reactions, oral mucositis and radiation dermatitis in the NPF group were significantly reduced (P < 0.05). The expression rate of EGFR was 94.9% (112/118). Compared with the DPF group, patients with EGFR expression in the NPF group showed better response (77.8% vs 63.0%, P = 0.033). Conclusion For locally advanced NPC patients receiving follow-up cisplatin and IMRT, nimotuzumab/PF for induction therapy has better lymph node response rate and milder adverse reactions than the DPF regimen. In addition, the patients have better tolerance in subsequent concurrent radiotherapy and chemotherapy; however, long-term efficacy needs further follow-up evaluation. Trial registration The registration number of the clinical trial is ChiCTR-OIC-16008201 and retrospectively registered on March 31, 2016. |
| first_indexed | 2024-12-13T21:57:51Z |
| format | Article |
| id | doaj.art-c2a3bf67580e41009a14ab3e52f89988 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-13T21:57:51Z |
| publishDate | 2019-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-c2a3bf67580e41009a14ab3e52f899882022-12-21T23:30:05ZengBMCBMC Cancer1471-24072019-12-0119111010.1186/s12885-019-6459-6Administration of nimotuzumab combined with cisplatin plus 5-fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy: a multicenter randomized controlled studyYing Lu0Dagui Chen1Jinhui Liang2Jianquan Gao3Zhanxiong Luo4Rensheng Wang5Wenqi Liu6Changjie Huang7Xuejian Ning8Meilian Liu9Haixin Huang10Department of Oncology, the Fourth Affiliated Hospital of Guangxi Medical UniversityDepartment of Oncology, the Fourth Affiliated Hospital of Guangxi Medical UniversityDepartment of Radiotherapy, Wuzhou Red Cross HospitalDepartment of Radiotherapy, Wuzhou Red Cross HospitalDepartment of Radiotherapy, Liuzhou People’s HospitalDepartment of Radiotherapy, the First Affiliated Hospital of Guangxi Medical UniversityDepartment of Radiotherapy, the Second Affiliated Hospital of Guangxi Medical UniversityDepartment of Oncology, the Second People’s Hospital of NanningDepartment of Oncology, Liuzhou Traditional Chinese Medical HospitalDepartment of Radiotherapy, the Affiliated Hospital of Guilin Medical CollegeDepartment of Oncology, the Fourth Affiliated Hospital of Guangxi Medical UniversityAbstract Background Nimotuzumab (NTZ) is an anti-EGFR monoclonal antibody. However,the effect of targeted drugs combined with induction therapy in locally advanced nasopharyngeal carcinoma remains unclear. The aim of this study is to investigate the safety and efficacy of NTZ combined with cisplatin plus 5-fluorouracil (PF) as induction regimen in locally advanced nasopharyngeal carcinoma (NPC) patients receiving concurrent radiochemotherapy. Methods This was a multicenter randomized controlled study performed in eight Guangxi hospitals in 2015–2017. Eligible patients with NPC were randomized into nimotuzumab/PF (NPF group) and docetaxel/PF (DPF group) regimens, respectively, as induction therapy. After 2 cycles of induction therapy, all patients received cisplatin and concurrent intensity modulated radiation therapy (IMRT). Then, the two groups were compared for safety and efficacy. Results A total of 118 patients with stage III-IVa NPC were assessed, with 58 and 60 in the NPF and DPF groups, respectively. Compared with DPF treatment, NPF induction therapy showed a more pronounced effect on cervical lymph nodes (P = 0.036), with higher response rate (RR) (81% vs 60%). Compared with the DPF group, the NPF group showed significantly reduced leukopenia, neutropenia and gastrointestinal reactions (all P < 0.05); rash only appeared in the NPF group, but all cases were grade 1. During concurrent treatment with radiotherapy and chemotherapy, the NPF group showed better tolerance to radiotherapy and chemotherapy; neutropenia, anemia, gastrointestinal reactions, oral mucositis and radiation dermatitis in the NPF group were significantly reduced (P < 0.05). The expression rate of EGFR was 94.9% (112/118). Compared with the DPF group, patients with EGFR expression in the NPF group showed better response (77.8% vs 63.0%, P = 0.033). Conclusion For locally advanced NPC patients receiving follow-up cisplatin and IMRT, nimotuzumab/PF for induction therapy has better lymph node response rate and milder adverse reactions than the DPF regimen. In addition, the patients have better tolerance in subsequent concurrent radiotherapy and chemotherapy; however, long-term efficacy needs further follow-up evaluation. Trial registration The registration number of the clinical trial is ChiCTR-OIC-16008201 and retrospectively registered on March 31, 2016.https://doi.org/10.1186/s12885-019-6459-6Locally advanced nasopharyngeal carcinomaEGFR monoclonal antibodyInduction therapyCurative effectAdverse reaction |
| spellingShingle | Ying Lu Dagui Chen Jinhui Liang Jianquan Gao Zhanxiong Luo Rensheng Wang Wenqi Liu Changjie Huang Xuejian Ning Meilian Liu Haixin Huang Administration of nimotuzumab combined with cisplatin plus 5-fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy: a multicenter randomized controlled study BMC Cancer Locally advanced nasopharyngeal carcinoma EGFR monoclonal antibody Induction therapy Curative effect Adverse reaction |
| title | Administration of nimotuzumab combined with cisplatin plus 5-fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy: a multicenter randomized controlled study |
| title_full | Administration of nimotuzumab combined with cisplatin plus 5-fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy: a multicenter randomized controlled study |
| title_fullStr | Administration of nimotuzumab combined with cisplatin plus 5-fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy: a multicenter randomized controlled study |
| title_full_unstemmed | Administration of nimotuzumab combined with cisplatin plus 5-fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy: a multicenter randomized controlled study |
| title_short | Administration of nimotuzumab combined with cisplatin plus 5-fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy: a multicenter randomized controlled study |
| title_sort | administration of nimotuzumab combined with cisplatin plus 5 fluorouracil as induction therapy improves treatment response and tolerance in patients with locally advanced nasopharyngeal carcinoma receiving concurrent radiochemotherapy a multicenter randomized controlled study |
| topic | Locally advanced nasopharyngeal carcinoma EGFR monoclonal antibody Induction therapy Curative effect Adverse reaction |
| url | https://doi.org/10.1186/s12885-019-6459-6 |
| work_keys_str_mv | AT yinglu administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy AT daguichen administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy AT jinhuiliang administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy AT jianquangao administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy AT zhanxiongluo administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy AT renshengwang administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy AT wenqiliu administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy AT changjiehuang administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy AT xuejianning administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy AT meilianliu administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy AT haixinhuang administrationofnimotuzumabcombinedwithcisplatinplus5fluorouracilasinductiontherapyimprovestreatmentresponseandtoleranceinpatientswithlocallyadvancednasopharyngealcarcinomareceivingconcurrentradiochemotherapyamulticenterrandomizedcontrolledstudy |