Background: The number of elderly patients with oesophageal cancer is expected to increase with the aging of the population and the rapidly increasing incidence of adenocarcinoma. Surgical resection is standard treatment for patients with localized disease considered fit for operation. However, elderly patients with oesophageal cancer are rarely referred for surgery. The aim of this prospective, single-arm, phase II study was to evaluate the feasibility and efficacy (tumour response) of chemoradiotherapy in the treatment of elderly patients with localized oesophageal cancer. Secondary endpoints were progression-free survival (PFS) and quality of life (QOL).
Methods: The main study inclusion criteria were: patients aged >or=75 years; oesophageal cancer disease stage II-III; Charlson co-morbidity index score <or=4; Eastern Cooperative Oncology Group (ECOG) performance status 0-2; and weight loss <15%. The radiotherapy regimen consisted of 50 Gy over 5 weeks. Cisplatin 75 mg/m2 was given on days 1 and 21 of radiotherapy. Complete response was defined as disappearance of the tumour at endoscopy and/or at oesophagography and CT scan. Written informed consent was obtained from all patients. A three-step Fleming design was used to calculate the sample size.
Results: Twenty-two patients were included in the study between March 2000 and June 2004; this sample size was sufficient to allow conclusions to be drawn from the study. The mean age of the patients was 79.4 years (range 75-89 years), 18 were male (81.8%), 15 had squamous cell carcinoma (68%) and 11 had stage IIA disease (50%). The mean Charlson co-morbidity index score was 1. All patients were compliant with the planned treatment, including doses and timing. During treatment, ECOG performance status remained stable during the first 3 weeks and worsened slightly over the last 2 weeks. Dysphagia remained stable. Five patients (22%) had transient grade 2 vomiting after the second cisplatin injection. No patient experienced nephrotoxic adverse effects and there were no toxicity-related deaths. Six weeks after treatment, 14 patients were in complete response (63.6%) and 8 patients (36.4%) had no treatment effect. The overall survival was 81.6% at 6 months and 62.4% at 1 year. The PFS at 1 year was 50%. Four patients (18.2%) were alive without disease from 2.6 to 5.5 years after treatment. In 14 evaluable patients, QOL 6 weeks after treatment was slightly altered by treatment.
Conclusions: The results of this prospective phase II study support the feasibility of chemoradiotherapy for oesophageal cancer in carefully selected elderly patients, with the potential for a curative effect.