Phase 2 study of concurrent cisplatin, capecitabine and celecoxib with radiotherapy in patients with carcinoma of the oesophagus.

Abstract

e16078 Background: Oesophageal cancer is the fourth common cause of cancer-related deaths in India. Definitive Chemoradiotherapy is standard for non-metastatic Squamous cell carcinoma of the oesophagus cancer. Chemoradiotherapy when given as definitive treatment is more effective than radiotherapy or chemotherapy alone. This treatment is usually offered to patients who are unsuitable for surgery. Unsuitability for surgery might be due to the extent of disease precluding the likelihood of a curative resection, or because the patient is physiologically not fit for surgery because of comorbidities or poor performance status. The aim of the present study was to analyse the effect of definitive concurrent chemo-radiotherapy in oesophageal cancer patients and assessment of toxicity profile and response. Methods: In the present Phase II study total 22 patients were recruited who had non-metastatic histologically confirmed carcinoma of the oesophagus selected for definitive chemoradiotherapy were enrolled. Chemotherapy consisted of three-weekly cycles of Inj. Cisplatin 60 mg/m2 given on D1, Tab. Capecitabine 625 mg/m2 given BD on D1-D21, and Tab. Celecoxib 200mg given BD on D1-D21. The planned protocol involved four cycles of concurrent chemotherapy. Radiotherapy in a dose of 50.4 Gy in 28 fractions was initiated on D1 of the second cycle of concurrent chemotherapy, or latest by D1 of the third cycle of concurrent chemotherapy. Results: In this Phase 2 study, 22 patients with a mean age of 55.68 ± 11.23 years, were treated. The tumor length averaged 6 ± 2.25 cm, with most common Stage III (52.17%), followed by Stage II (34.78%), Stage I (8.69%), and Stage IVA (4.34%). Grade 3 dysphagia was predominant (56.52%), followed by Grade 2 (34.78%), Grade 1 (4.35%), and Grade 4 (4.35%). During treatment, notable grade 1-2 toxicities included esophagitis(68%), fatigue(63%), nausea (54%), neutropenia (31%), anemia (22%), mucositis(18%), diarrhoea(13%), dermatitis(9%). There was gradual decline in the severity of dysphagia of all patients. Of the 8 patients evaluated for response with a median follow up of 12 months, the complete response rate was 25%, partial response rate was 25% and 37.5% showed stable disease whereas 12.5% developed progressive disease. The median overall survival is yet to be estimated. Conclusions: A notable clinical response, indicating a substantial treatment effect was observed. While some treatment-related toxicities were present, This approach shows potential in the treatment of oesophageal carcinoma. However, this study is still ongoing and it would be hasty to draw definitive conclusions.