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

Ai Zheng. 2008 Oct;27(10):1077-81.
[Article in Chinese]

Abstract

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.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Carcinoma, Squamous Cell / drug therapy*
  • Carcinoma, Squamous Cell / pathology
  • Carcinoma, Squamous Cell / radiotherapy*
  • Cisplatin / administration & dosage
  • Combined Modality Therapy
  • Dose Fractionation, Radiation*
  • Esophageal Neoplasms / drug therapy*
  • Esophageal Neoplasms / pathology
  • Esophageal Neoplasms / radiotherapy*
  • Esophagitis / etiology
  • Female
  • Fluorouracil / administration & dosage
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Radiation Pneumonitis / etiology
  • Remission Induction
  • Survival Rate

Substances

  • Cisplatin
  • Fluorouracil