A phase I/II study of CHARTWEL with concurrent chemotherapy in locally advanced, inoperable carcinoma of the oesophagus.

AIM: To evaluate the feasibility, efficacy and toxicity of concurrent chemotherapy and continuous, hyperfractionated, accelerated radiotherapy weekend less (CHARTWEL) in the treatment of locally advanced, inoperable oesophageal cancer.

METHODS: A prospective study of 19 patients with histologically confirmed, locally advanced, inoperable carcinoma of the oesophagus. CHARTWEL was prescribed from day 1 to doses of 40.5 Gy (three patients), 42 Gy (five patients), 45 Gy (four patients), 46.5 Gy (three patients) and 49.5 Gy (four patients). Cisplatin 75 mg/m2 was administered on day 1 of radiotherapy, followed by 5-fluorouracil (5-FU) 1000 mg daily for 4 days.

RESULTS: All patients completed radiotherapy, with two requiring modification of their chemotherapy dose. Acute toxicity was acceptable, with no interruptions to treatment. The median dysphagia free time was 9.6 months with 38% of patients being dysphagia free at 42 months. The median time to locoregional relapse was 13.2 months with 50% being free at 1 year and 35% at 3.5 years. There was a trend towards greater control when the higher doses (45-49.5 Gy) were compared with the lower doses (40.5-42 Gy), P = 0.07. The median survival time was 10.7 months with 1- and 2-year survival rates of 50 and 26%, respectively. Strictures developed in seven out of 18 patients (38%), but five were found on biopsy to be due to recurrent disease. There was no other long-term toxicity and no treatment-related death occurred.

CONCLUSIONS: CHARTWEL with concomitant cisplatin/5-FU chemotherapy is a feasible treatment option in these patients. It is well tolerated, achieves a high rate of local control and effectively palliates the symptoms of dysphagia, all with relatively rapid resolution of treatment-related toxicity. The results warrant continued dose escalation to 51 Gy.