Introduction: The prognosis od R/M HNSCC patients is poor and the cisplatin-based chemotherapy is currently the standard care of those patients. Nimotuzumab is a humanized EGFR monoclonal antibody which has been proven to be effective in locally-advanced head and neck squamous cell carcinoma. However, its efficacy in recurrent/metastatic disease remains unclear.

Methods: R/M HNSCC patients (excluding nasopharyngeal carcinoma patients) who were not suitable for radical radiation therapy or operation were enrolled. No treatment after the diagnosis of recurrence and metastasis was allowed. Patients were given docetaxel(75mg/m2) +cisplatin (75mg/m2) (DP) or gemcitabine (1000mg/m2 d1,8) +cisplatin(75mg/m2) (GP) and nimotuzumab(200mg) every 3 weeks. Chemotherapy was given at most 6 cycles, and nimotuzumab was given until disease progression or intolerable adverse effects. The primary end point is progression free survival (PFS). Secondary endpoints were overall survival (OS), disease control rate (DCR),and objective response rate (ORR) according to RECIST v1.1,.

Results: 25 eligible patients were enrolled (17 M, 8 F;median age 57) between 2018.10-2019.10. Sinuses was most involved region followed by tongue, oral cavity and hypopharynx. At a median follow-up of 9.5 months, median PFS was 5.8 months and median OS was 11.2 months. At 12 weeks after completion of chemotherapy, objective response rate (complete response (CR) + partial response (PR)) was 40%. The DCR (complete response (CR) + partial response (PR)+ stable disease (SD)) was 88%. Grade 3 or worse all-cause adverse events occurred in 8 (32%) of 25 treated patients. Grade III neutropenia was seen in 16% of the patients, and grade IV neutropenia was seen in 4% of the patients. Grade III thrombocytopenia was seen in 8% of the patients, and no grade IV thrombocytopenia was seen. Grade III anemia was seen in 8% of the patients, and no grade IV anemia was seen. Grade III vomiting was seen in 4% of the patients. And no other grade III-IV side effect was seen.

Conclusion: Nimotuzumab + chemotherapy is a safe and effective regime for R/M HNSCC patients, which could be a considerable treatment choice worth further evaluation.

Table 1

Baseline Characteristics of the patients

Variable
Sex 
 Male 17(68%) 
 Female 8(32%) 
Age 
 Median 57 
 <65 22(88%) 
 ≥65 3(12%) 
ECOG 
 0 15(60%) 
 1 10(40%) 
Primary tumor site 
 Sinuses 7(28%) 
 tongue 6(24%) 
 Oral cavity 5(20%) 
 Hypopharynx 5(20%) 
 Larynx 2(8%) 
Extent of disease 
 Locoregional recurrence 12(48%) 
 Metastasis with or without locoregional recurrence 13(52%) 
Variable
Sex 
 Male 17(68%) 
 Female 8(32%) 
Age 
 Median 57 
 <65 22(88%) 
 ≥65 3(12%) 
ECOG 
 0 15(60%) 
 1 10(40%) 
Primary tumor site 
 Sinuses 7(28%) 
 tongue 6(24%) 
 Oral cavity 5(20%) 
 Hypopharynx 5(20%) 
 Larynx 2(8%) 
Extent of disease 
 Locoregional recurrence 12(48%) 
 Metastasis with or without locoregional recurrence 13(52%) 

Citation Format: Tao Hou, Min Lu, Xiayan Zhao, Yan He, Chunhong Hu, Ping Liu. Safety and efficacy of nimotuzumab in combination with chemotherapy in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): A phase II study [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr CT266.