[Phase II clinical trial of concurrent chemoradiotherapy (cisplatin plus 5-fluorouracil) for esophageal cancer].

Background & Objective: Concurrent chemoradiotherapy is a standard treatment for local advanced esophageal cancer in overseas countries; however, the treatment outcomes are various in China. This study was to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil (PF) regimen on esophageal cancer, and observe the adverse events.

Methods: Forty-four patients with esophageal squamous cell carcinoma (ESCC) were randomized into two groups. Twenty-two patients in concurrent chemoradiotherapy (CRT) group received conventional fractionated radiotherapy of 50 Gy during 5 weeks, with 5 daily fractions of 2.0 Gy per week. Chemotherapy was started on the first day of irradiation: cisplatin 52.5 mg/m2 at Day 1, 5-fluorouracil 700 mg/m2 at Days 1-5, repeated 4 times every 28 days. Twenty-two patients in late course accelerated hyperfractionated radiotherapy (LCAF) group received conventional fractionated radiotherapy of 30 Gy during 3 weeks (the same scheme as that of CRT group),followed by accelerated hyperfractionated radiotherapy of 30 Gy during 2 weeks: twice a day, 1.5 Gy per fraction, with a minimal interval of 6 h between fractions,10 fractions per week.

Results: The response rate was 95.5% in CRT group and 86.4% in LCAF group (P = 0.607). The 2-year local control rate and 2-year survival rate were 72.2% and 56.7% in CRT group, and 39.0% and 31.6% in LCAF group. Compared with LCAF group, CRT group obtained higher local control rate and survival rate, but only the difference of local control rate was significant (P = 0.014). Major acute adverse events in the two groups were radiation-induced esophagitis and radiation-induced pneumonia, while late adverse events were late injury in the esophagus and lung. Both acute and late adverse events in the two groups were mild.

Conclusions: Compared with LACF,CRT can significantly improve local control rate of ESCC, and may enhance survival rate. The adverse events are tolerable.