Hypofractionated Radiation with concurrent Cisplatin plus Erlotinib in locally advanced squamous cell carcinomas of head and neck: A Feasibility Phase II Study of a Single Institute
Journal Title: Journal of Medical Science And clinical Research - Year 2017, Vol 5, Issue 12
Abstract
Aim: To study the feasibility hypofractionated radiation along with standard concurrent Cisplatin plus Erlotinib in Locally advanced squamous cell carcinoma of head and neck (LASCCHN). Method and Materials: A prospective non-randomized phase II clinical study, undertaken in the Department of Radiotherapy, Regional Institute of Medical Sciences, Imphal, Manipur for a period of 24 months starting from September 2014.Thirty patients were recruited who fulfilled the inclusion criteria. Radiation was delivered using Theratron 780C Cobalt-60 teletherapy unit at a SSD of 80 cm using shrinking field technique. BED was calculated and spinal sparing done after 16 fractions. Gross tumor received 60 Gy over 24 fractions and 18 fractions was given as a prophylactic dose to low risk nodal areas. Patients also received concurrentcisplatin 30mg/m2 weekly for 5 doses and Tablet Erlotinib 100mg once a day started 1 week before radiotherapy and upto 4 weeks after completion of radiotherapy. Patients were assessed during radiation weekly and 6 weeks after completing radiotherapy for treatment response and acute radiation toxicity and also after 3 months for late radiation toxicity Results: The median age of patients was 58 years (range 45-70). A major deviation (three patients) minor deviation (five) in the treatment plan. Two patients out of 7 with oral cavity malignancy, 5 of six with laryngeal carcinoma, 3 of seven with hypo pharyngeal carcinoma and 2 of five in oropharynx carcinoma were attained complete response (CR). Out of 12 patients with the CR, five developed locoregional failure (LRF). The median time to LRF was 7 months (range 2-11) .One year survival attained by 9 (35%) patients. Most of them had no hematological toxicity. Grade 3 and 4 mucositis was experienced by 15 (60%) and 7 patients (27%) respectively. Grade 3 dysphagia was seen in 22 patients (85%) and grade 3 and 4 skin reactions were 9 and 2 patients respectively. More than 75% experienced grade 2 hoarseness and grade 3 acute salivary gland reaction found in 10 and 15 patients respectively. Most patients had manageable acute toxicities. Conclusion: Our study emphasizes that its feasible but no superior clinical benefit achieved by using this treatment design, so we recommend not to use except in clinical trials with slight modification
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Manirathinam Ramalingam
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