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Poster display session

3041 - Safety and efficacy of nimotuzumab with concurrent chemoradiotherapy in unresectable locally advanced squamous cell carcinoma of head and neck: Indian rural Hospital experience

Date

10 Sep 2017

Session

Poster display session

Topics

Clinical Research;  Cancers in Adolescents and Young Adults (AYA);  Surgical Oncology;  Radiation Oncology;  Head and Neck Cancers

Presenters

Shyamji Rawat

Citation

Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374

Authors

S. Rawat1, D. Pawar2, H. Tandon1, S. Patel1, S. Chaudhari2

Author affiliations

  • 1 Medical Oncology, N.S.C.B Medical College and Government Hospital, 482003 - Jabalpur/IN
  • 2 Medical Affairs, Biocon Limited, 560100 - Bangalore/IN
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Resources

Abstract 3041

Background

The aim of this study was to evaluate the safety and efficacy of nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor, in combination with chemoradiation for head and neck squamous cell cancer (HNC).

Methods

The hospital data of 42 patients with HNC who were treated with nimotuzumab from January 2012 to December 2016 were evaluated. Three patients who had undergone prior surgery were excluded and 39 patients diagnosed with locally advanced (stage III- IVb) unresectable HNC who were treated with concurrent chemoradiotherapy with weekly nimotuzumab were considered for final analysis. Tumour response was calculated as per RECIST criteria 1.1. Subgroup analysis was performed to assess association of tumour response with independent variables such as age, gender, histopathological grades and TNM stages using chi square or Fischer exact test. Overall survival (OS) and progression free survival (PFS) was calculated from date of diagnosis using Kaplan-Meier method. All patients were assessed for toxicity and adverse events (AE) were reported as per common terminology criteria for AE v 4.0. Statistical analysis was done using SPSS software (v19.0).

Results

At 24 weeks after completion of treatment, objective response rate (complete response [CR] + partial response [PR]) was 97.44% with 26 (66.67%) patients showing CR, 12 (30.77%) patients with PR and one patient (2.56%) had stable disease. Subgroup analysis did not show significant association of tumour response, although men, patients older than 65 years, laryngeal cancer, tumour grade III, TNM stage III showed more complete responses. OS at one year and two years was 100% and 72.9%, while PFS at one year and two years was 87% and 54.40%, respectively. Incidence of grade I, II, III and IV toxicity was 30%, 18.18%, 41.82%, 10%, respectively. No grade V toxicity was observed. Common AE observed were neutropenia (20.91%), mucositis (33.64%), vomiting (18.18%), diarrhea (2.73%), skin reaction (24.55%). Nimotuzumab was observed to be safe with no additional adverse events (hypersensitivity, allergic reaction and skin changes) were reported during the study period.

Conclusions

Nimotuzumab is an efficacious and safe option when added to concurrent chemoradiotherapy in patients with locally advanced Head and Neck cancer.

Clinical trial identification

125/12

Legal entity responsible for the study

Dr. Shyamji Rawat

Funding

None

Disclosure

D. Pawar: Works in a Pharmaceutical company. S. Chaudhari: works for Pharmaceutical company. All other authors have declared no conflicts of interest.

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