Premium
Phase II study of nimotuzumab ( TheraCim‐hR3 ) concurrent with cisplatin/radiotherapy in patients with locally advanced head and neck squamous cell carcinoma
Author(s) -
Ang MeiKim,
Montoya Jose Enrique,
Tharavichitkul Ekkasit,
Lim Cindy,
Tan Terence,
Wang Lan Ying,
Wee Joseph,
Soong YokeLim,
Fong KamWeng,
Ng Quan Sing,
Tan Daniel ShaoWeng,
Toh CheeKeong,
Tan EngHuat,
Lim WanTeck
Publication year - 2021
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.26635
Subject(s) - nimotuzumab , medicine , head and neck squamous cell carcinoma , oncology , clinical endpoint , phases of clinical research , radiation therapy , cisplatin , mucositis , adverse effect , epidermal growth factor receptor , head and neck cancer , toxicity , chemotherapy , clinical trial , cancer
Background The efficacy of a combination of nimotuzumab, a humanized monoclonal antibody to the epidermal growth factor receptor, with chemoradiation in locally advanced head and neck squamous cell carcinoma (HNSCC) was evaluated in a phase II study. Methods Patients with stage III/IV HNSCC received 3‐weekly cisplatin 100 mg/m 2 for three cycles and weekly nimotuzumab 200 mg for 8 weeks concurrently with radiotherapy. Primary endpoint was best overall response (BOR) and secondary endpoint was progression‐free survival (PFS). Results Thirty‐seven patients were included; the majority were Chinese (76%), male (89%), and had stage IVA/IVB HNSCC (92%). BOR of complete and partial response was seen in 22/37 (59%) and 10/37 (27%) patients, respectively. Median PFS was 17.5 months (95% CI: 11.1–54.5) and 3‐year PFS was 40.4% (95% CI: 24.3–55.9). The frequency and type of adverse events observed were similar to standard chemoradiation. Conclusion The combination of nimotuzumab with cisplatin and radiotherapy was safe and achieved high response rates in HNSCC.