Docetaxel and cisplatin concurrent with radiotherapy versus 5-fluorouracil and cisplatin concurrent with radiotherapy in treatment for locally advanced oesophageal squamous cell carcinoma: a randomized clinical study.

This randomized clinical study was to assess and compare the efficacy and safety of two chemoradiotherapy (cisplatin + 5-fluorouracil + radiotherapy and cisplatin + docetaxel + radiotherapy) regimens in patients with unresectable local advanced oesophageal squamous cell carcinoma. Previously untreated patients with histologically or cytologically confirmed squamous cell carcinoma were randomly assigned into two groups (each had 45 patients): cisplatin + 5-fluorouracil + radiotherapy (PF) group and cisplatin + docetaxel + radiotherapy (DP) group. All patients received radiotherapy of 50.4 Gy (28 fractions of 1.8 Gy) over 5 weeks (5 fractions a week). Chemotherapy for PF group comprises 5-fluorouracil at days 1-4 (250 mg/m(2)/day) and cisplatin (75 mg/m(2)) at day 1 of every 28-day cycle; full treatment course included 4 cycles. Chemotherapy for DP group comprises docetaxel (75 mg/m(2)) and cisplatin (75 mg/m(2)) at day 1 of every 28-day cycle; full treatment course included 4 cycles. Response, survival, progression and toxicity of both regimens were studied. Overall response rate (ORR) was 53.3 % for PF group and 73.3 % for DP group. Median overall survival (OS) time was 22.3 months for PF group and 43.2 group months for DP: Patients of DP group had a significant longer overall median survival time (P < 0.05). Toxicity was acceptable; patients of PF group and patients of DP group did not showed significant difference in serious haematological event incidence (24.4 vs. 35.6 %, P > 0.05). ORR and OS favour DP over PF in the treatment of patients with unresectable local advanced oesophageal squamous cell carcinoma.