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• W2769299951 abstract "Background: The aim of this study was to observe the long term safety of nimotuzumab in patients with head and neck cancer (HNC) in Sri Lanka for the first time. This study was conducted retrospectively in which all patients treated with nimotuzumab were assessed for toxicity and adverse events (AEs) Methods: The hospital data of 64 patients with HNC who were treated with nimotuzumab was evaluated from three major national hospitals of Sri Lanka. There were 59 were male and the mean age of the patients was 61.28 years, with the maximum age being 80. 20 (31.3%) patients were diagnosed with moderately differentiated squamous cell carcinoma, 9 (14.1%) with well differentiated squamous cell carcinoma and 3 (4.7%) with poorly differentiated squamous cell carcinoma. Majority of the patients (61%) were diagnosed with Oral Cavity tumor (table below). Out of these, 42 (65.7%) were treated with radiotherapy (RT), chemotherapy (CT) and nimotuzumab, 14(21.9%) patients were treated with RT and nimotuzumab and 8 (12.5%) patients were treated with CT and nimotuzumab. 56 (87.5%) patients received 200 mg of nimotuzumab and 2 (3.1%) patients received 400mg of nimotuzumab. The maximum dose used was 1600 mg. Most of the patients (57.8%) received 6 cycles of nimotuzumab. The number of cycles for the rest of the patients varied from 1 to 8 cycles.Table: 367P Percentage of patients diagnosed with specific anatomical subsite tumorAnatomical subsitesNo of PatientsPercent (%)Hypopharynx46.3Pyriform Fossa46.3Larynx11.6Epiglottis11.6Nasopharynx11.6Adenoid11.6Oral cavity3961Alveolus11.6Buccal Mucosa812.5Cheek1218.8Floor of the mouth11.6Hard Palate23.1Retromolar23.1Tongue1320.3Oropharynx1015.7Oropharynx23.2Soft Palate812.5 Open table in a new tab Results: AEs were reported as per common terminology criteria for adverse events v 4.0. Out of the total 64 patients only 11 patients (17.2%) reported AEs. Common AEs observed were Anaemia (3.1%), Mucositis (1.6%) and Neutropenia (1.6%) which are unlikely to be related to nimotuizumab. Other adverse events include oral pain (3.1%), trismus (3.2%), decreased creatinine (3.2%), allergic reaction (1.6%) and dysphagia (3.1%). No serious AEs or toxicity was related to treatment with nimotuzumab. Conclusions: Nimotuzumab is a safe option to be used in HNC in combination with CT/RT as no serious adverse events or toxicities were observed in the post marketing study conducted in Sri Lanka. Legal entity responsible for the study: Dr. Mahendra Perera Funding: None Disclosure: All authors have declared no conflicts of interest." @default.
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• W2769299951 date "2017-11-01" @default.
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• W2769299951 title "Nimotuzumab post marketing surveillance study: A Sri Lanka experience" @default.
• W2769299951 doi "https://doi.org/10.1093/annonc/mdx665.031" @default.
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