A phase II study of concurrent chemoradiotherapy with weekly docetaxel and cisplatin in advanced oesophageal cancer.

BACKGROUND

Concurrent chemoradiotherapy (CRT) is a main treatment option for patients with advanced oesophageal cancer. However, improvement of survival outcomes and toxicities according to the selected treatment is still needed. This phase II trial was conducted to assess the efficacy and safety of concurrent CRT with weekly docetaxel and cisplatin in advanced oesophageal cancer.

METHODS

Patients with unresectable oesophageal cancer due to advanced stage or patients medically unfit for surgery were enrolled. Patients received 20 mg/m(2) docetaxel and 25 mg/m(2) cisplatin in weeks 1, 2, 3, 5, 6, and 7 with concurrent 54-Gy radiotherapy at 200 cGy/day.

RESULTS

Thirty-six patients with oesophageal squamous cell carcinoma were enrolled from December 2007 to December 2009. Among them, the toxicity and response rate of 35 were evaluated. Thirty-five patients completed radiotherapy as planned, and 33 completed chemotherapy as planned. Grade 3 or 4 toxicity during CRT included leucopenia (5.7 %), febrile neutropenia (2.9 %), oesophagitis (22.9 %), and tracheo-oesophageal fistula (5.7 %). After CRT, 8 patients (22.9 %) had a complete response, 22 (62.9 %) had a partial response, 4 (11.4 %) had stable disease, and 1 (2.9 %) had progressive disease. Improvement of dysphagia was observed in 85.3 %. At a median follow-up of 26.7 months, the median time to progression was 13.5 months, and median overall survival was 26.9 months. The 3-year progression-free survival rate was 16.7 %, and survival rate was 27.8 %.

CONCLUSION

Concurrent CRT with weekly docetaxel and cisplatin was well tolerated and is a convenient combination with promising efficacy. This result indicated favourable activity in terms of both tumour and symptom control.