Weekly Chemotherapy of 5-Fluorouracil plus Cisplatin Concurrent with Radiotherapy for Esophageal Squamous Cell Carcinoma Patients with Postoperative Locoregional Recurrence: Results from a Phase II Study

Abstract

Lessons learned: Weekly treatment with 5-fluorouracil and cisplatin, concurrent with radiotherapy, achieved promising response rates in patients with postoperative recurrent esophageal squamous cell carcinoma. Superior toxicity results were also found.

Background: Concurrent chemoradiotherapy (CCRT) is one of the treatment strategies for patients with esophageal squamous cell carcinoma (ESCC) with postoperative locoregional recurrence. However, the once every 3 weeks chemotherapy regimen causes a high incidence of toxicity. The aim of this study was to evaluate the efficacy and toxicity of weekly 5-fluorouracil (5-FU) and cisplatin concurrent with radiotherapy in postoperative locoregional recurrent ESCC.

Materials and methods: Patients received four weekly chemotherapy cycles of cisplatin (25 mg/m2 , day 1) plus 5-FU (1,176 mg/m2 , day 1-3), and concurrent with radiotherapy (50.4-60 Gy). The primary endpoint was objective response rate (ORR). Secondary objectives were toxicity, disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

Results: Between January 2013 and December 2015, 48 patients were enrolled. The ORR was 68.8% (12 patients with complete response, 21 patients with partial response), with DCR 68.8%. No treatment-related grade 4 adverse events occurred. Grade 3 hematologic toxicities were observed in eight (17%) patients. Grade 3 vomiting or esophagitis occurred in four (8%) patients each. The median PFS and OS were 13.94 months (95% confidence interval [CI], 0.75-51.05) and 27.43 months (95% CI, 5.278-49.58; Fig. 1).

Conclusion: Weekly 5-FU and cisplatin concurrent with radiotherapy achieved a promising response rate and improved toxicity in patients with postoperative locoregional recurrent ESCC.

© AlphaMed Press; the data published online to support this summary are the property of the authors.

Figures

Figure 1

Overall survival (right) and progression‐free survival (left) of the whole cohort. As shown in the Kaplan‐Meier curves, the 1‐, 2‐, and 3‐year PFS rates for all patients were 56.9%, 29.8%, and 27%, respectively. The 1‐, 2‐, and 3‐year OS rates were 78.5%, 59.7%, and 49.7%, respectively. The median PFS was 13.94 months (95% confidence interval [CI], 0.75–51.05), and the median OS was 27.43 months (95% CI, 5.278–49.58).Abbreviations: OS, overall survival; PFS, progression‐free survival.

Figure 2

A total dose of 50.4–60 Gy radiation was daily administered at 2.0 Gy for 5 days per week. Concomitant chemotherapy is the continuous infusion of DDP 25 mg/m2/2 hours on day 1 and 5‐FU 1176/m2/72 hours on day 1–3 by repeated weekly for 4 weeks.Abbreviations: DDP, cisplatin; 5‐FU, 5‐fluorouracil.