Table 6.
Studies (Original research studies) on nimotuzumab in nasopharyngeal carcinoma advanced patients.
| Reference | Study Type | n | Treatment schedule | Survival benefits | Toxicity |
|---|---|---|---|---|---|
| Huang XD, et al. 2007 35 |
Phase II | N=137 | Nimotuzumab in combination with RT or RT alone. | 3-year OS rate (84.29% nimotuzumab group vs 77.61% non nimotuzumab group, p<0.05) | Most common nimo-related AEs were fever (4.28%), hypotension (2.86%), nausea (1.43%), dizziness (2.86%), rash (1.43%). No worse radiation-related AEs. |
| Rui-ping Zhai et al. 2015. 29 |
Prospective open | N=38 | Nimotuzumab in combination with IMRT. | 3-year LRFS 92.8%, DMFS 89.5%, PFFS 78.7%, and OS 87.5%. | Grade 3 radiation-induced mucositis (36.8%). No skin rash and infusion reaction. |
| Li et al. 2016. 36, |
Matched pair retrospective |
N=104 | TPF neoadjuvant chemotherapy, followed by IMRT plus concurrent nimotuzumab or cisplatin. |
5-year OS and PFS for the nimo/RT vs. CDDP/RT groups were 63.9% vs. 81.4% (p = 0.024) and 58.0% vs. 80.6% (p = 0.028). No significant difference for OS in patients with stage II AJCC (p =0.571) or for patients aged 60 years or older (p =0.236). | Nimotuzumab/RT patients experienced less leukopenia and milder nausea and vomiting with p values of 0.048 and 0.000, respectively. |
| Jianfeng Huang, et al. 2017 37 |
Phase II | N=23 | Induction chemotherapy followed by IMRT plus, weekly nimotuzumab and CCT. |
2-year PFSand OS were 83.5% and 95.0%. | Grade 3-4 oral mucositis dermatitis and neutropenia occurred in 7(36.8%), 1(5.3%) and 5(26.3%) patients, respectively. 1 patient suffered anaphylaxis, no acne-like rash was reported. |
| Zhi-gang Liu. 2017. 28 |
Retrospective | N=42 | Nimotuzumab combined with CCRT. | 2-year LRFS: 96.4%, DMFS: 93.1% and OS: 96.6% | Most common AEs were mucositis (19 patients), hematology toxicity (14 patients) with 6 and 3 cases of grade 3/4 toxicity respectively. Non skin rash. |
| Fangzheng Wang, et al. 2017. 38 |
Retrospective | N=210 | Nimotuzumab plus neoadjuvant chemotherapy followed by CCRT. |
5-year LRFS: 95.6%, DMFS: 91.7%, PFS: 84.0%, and OS: 88.7%, respectively. | Grade 3/4 leukocytopenia 24 patients (11.4%), and 6 patients (2.9%) with mild liver damage during neoadjuvant chemotherapy. Grade 3/4 acute mucositis 13 patients (6.2%), and 12 patients (5.7%)with grade 3/4 leukocytopenia during the CCRT. |
OS: Overall Survival; LRFS: Local Recurrence-Free Survival; DMFS: Distant Metastasis-Free Survival; PFFS: Progression Failure-Free Survival; PFS: Progression-Free Survival; TPF: docetaxel + DDP 25 mg/m2 + 5-fu.