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


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Department of Medical Oncology, Shan Dong Tumor Hospital, 440 Jiyan Road, Jinan, Shandong, People's Republic of China.
Jing
J
Tian
Department of Medical Oncology, Shan Dong Tumor Hospital, 440 Jiyan Road, Jinan, Shandong, People's Republic of China.
Ming
M
Shang
Department of Medical Oncology, Shan Dong Tumor Hospital, 440 Jiyan Road, Jinan, Shandong, People's Republic of China. sfmshishengbin@126.com.
Sheng-Bin
SB
Shi
Department of Medical Oncology, Shan Dong Tumor Hospital, 440 Jiyan Road, Jinan, Shandong, People's Republic of China.
Yong
Y
Han
Department of Medical Oncology, Shan Dong Tumor Hospital, 440 Jiyan Road, Jinan, Shandong, People's Republic of China.
Jun
J
Xu
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002294:Carcinoma, Squamous Cell / Q000097:blood / Q000188:drug therapy* / Q000556:secondary; D000068818:Cetuximab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000503:physiopathology; D019008:Drug Resistance, Neoplasm; D004938:Esophageal Neoplasms / Q000097:blood / Q000188:drug therapy*; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D035683:MicroRNAs / Q000097:blood; D008875:Middle Aged; D000068437:Pemetrexed / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016019:Survival Analysis
D015415:Biomarkers; C556347:MIRN335 microRNA, human; D035683:MicroRNAs; D000068437:Pemetrexed; D000068818:Cetuximab; D005472:Fluorouracil
Advanced esophageal cancer; Cetuximab; Pemetrexed; Second-line therapy