Efficacy and safety of concurrent radiotherapy and chemotherapy for locally advanced esophageal squamous cell carcinoma: a randomized controlled trial.

BACKGROUND

Neoadjuvant concurrent chemoradiotherapy (CCRT) has become the preferred modality for patients with inoperable locally advanced esophageal squamous cell carcinoma (ESCC). To investigate whether the CCRT regimen of paclitaxel plus 5-fluorouracil (TF) increases the efficacy when compared with a regimen of cisplatin plus 5-fluorouracil (PF) in the locally advanced ESCC patient treatment.

METHODS

A total of 103 ESCC patients were randomly divided into study group (TF, n=52) and control group (PF, n=51), treated in Affiliated Hospital of Jiangnan University from July 2014 to June 2016. These patients were followed up for 2 years in our department by performing certain examinations to evaluate their survival state. The primary endpoint was overall survival (OS). Local control (LC), progression-free survival (PFS) and adverse effects were secondary endpoints.

RESULTS

A total of 103 patients were enrolled. The 1-, 2-year OS for TF group was 76.9%, 59.6% versus 74.5% (χ=0.134, P=0.72), 56.9% (χ=0.151, P=0.70) for PF group. The 1-, 2-year LPS for TF group and PF group were 71.2%, 61.5% and 66.7% (χ=0.065, P=0.80), 58.8% (χ=0.079, P=0.78) respectively. The serious leukopenia (grade 3-4) incidence rate for TF group was 36.5% versus 17.6% for PF group (χ=4.642, P<0.05).

CONCLUSIONS

When compared with the PF regimen, the TF regimen shows no survival benefit but exhibited a trend to a better control rate and a decreased distant metastasis rate. Both regimens showed tolerable toxicity.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2500100712.