Cetuximab plus pemetrexed as second-line therapy for fluorouracil-based pre-treated metastatic esophageal squamous cell carcinoma

The aim of this study was to evaluate the efficacy and toxicity of cetuximab and pemetrexed as the second-line treatment for advanced esophageal cancer patients, who had undergone treatment with the standard cisplatin and 5-FU regimens. A total of 29 patients accepted this treatment. Cetuximab was administered at an initial dose of 400 mg/m(2) IV followed by weekly doses of 250 mg/m(2) IV, whereas pemetrexed 500 mg/m(2) was administered on day 1 every 3 weeks. Twelve patients (41.4 %) presented PR, ten (34.5 %) had SD, and seven (24.1 %) had PD. The response rate was 41.4 %. The median PFS was 4.5 months (95 % CI 4.1-4.9), and the median OS was 9.4 months (95 % CI 8.4-10.5). The expression levels of serum miR-335 were determined, and the subsequent analysis suggested that PFS was significantly different between the patients with higher level of serum miR-335 and those with low level of serum miR-335. The former had a PFS of 4.9 months (95 % CI 4.2-5.7) and the latter 4.1 months (95 % CI 3.7-4.5) (log rank = 0.025). None of the patients experienced grade 4 toxicity. Twenty-four patients presented rash. A combination of cetuximab plus pemetrexed was marginally effective and well tolerated in patients with advanced esophageal squamous cell carcinoma as the second-line treatment.