Paclitaxel or Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Cancer
In the Chinese phase III ESO-Shanghai 1 trial reported in the Journal of Clinical Oncology, Chen et al found that paclitaxel plus fluorouracil did not significantly prolong overall survival vs standard cisplatin plus fluorouracil in definitive concurrent chemoradiotherapy (dCRT) for locally advanced esophageal squamous cell carcinoma.
In the open-label multicenter trial, 436 patients were randomly assigned 1:1 between April 2012 and July 2015. They received either paclitaxel and fluorouracil, one cycle per week in definitive concurrent chemoradiotherapy for five cycles, followed by paclitaxel and fluorouracil, one cycle per month in consolidation chemotherapy for two cycles (n = 217); or cisplatin and fluorouracil, one cycle per month in definitive concurrent chemoradiotherapy for two cycles, followed by two cycles in consolidation chemotherapy (n = 219). Radiotherapy consisted of 61.2 Gy in 34 fractions.
Survival and Toxicity
The primary endpoint was 3-year overall survival. Median follow-up of surviving patients was 48.7 months.
Overall survival at 3 years was 55.4% in the paclitaxel/fluorouracil group vs 51.8% in the cisplatin/fluorouracil group (hazard ratio [HR] = 0.905, P = .448). Progression-free survival at 3 years was 43.7% vs 45.5% (HR = 0.973, P = .828).
The paclitaxel/fluorouracil group had significantly lower (all P < .05) rates of acute grade ≥ 3 anemia (2.8% vs 7.3%), thrombocytopenia (0.5% vs 15.1%), anorexia (1.4% vs 15.1%), nausea (1.4% vs 14.6%), vomiting (2.3% vs 18.7%), and fatigue (6.9% vs 21.0%); and significantly higher (all P < .05) rates of acute grade ≥ 3 leukopenia (31.3% vs 18.3%), radiation dermatitis (5.1% vs 1.4%), and radiation pneumonitis (8.8% vs 2.7%).
The investigators concluded, “The paclitaxel plus fluorouracil regimen did not significantly prolong the [overall survival] compared with the standard cisplatin plus fluorouracil regimen in [definitive concurrent chemoradiotherapy] in patients with locally advanced [esophageal squamous cell carcinoma].”
Kuaile Zhao, MD, of the Department of Radiation Oncology, Fudan University Shanghai Cancer Center, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by grants from the National Natural Science Foundation of China. The study authors’ full disclosures can be found at jco.ascopubs.org.
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