Phase II study of sorafenib in combination with cisplatin and 5-fluorouracil to treat recurrent or metastatic nasopharyngeal carcinoma

We aimed to investigate the efficacy and tolerability of sorafenib combined with cisplatin and 5-fluorouracil (5-FU) in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). It was a Simon two-stage designed trial. Chemotherapy-naive patients with recurrent or metastatic disease were...

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Bibliographic Details
Published in:	Annals of oncology 2013-04, Vol.24 (4), p.1055-1061
Main Authors:	Xue, C., Huang, Y., Huang, P.Y., Yu, Q.T., Pan, J.J., Liu, L.Z., Song, X.Q., Lin, S.J., Wu, J.X., Zhang, J.W., Zhao, H.Y., Xu, F., Liu, J.L., Hu, Z.H., Zhao, L.P., Zhao, Y.Y., Wu, X., Zhang, J., Ma, Y.X., Zhang, L.
Format:	Article
Language:	eng
Subjects:	Adult Aged angiogenesis Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols Biological and medical sciences Carcinoma chemotherapy Cisplatin - administration & dosage Cisplatin - adverse effects Disease-Free Survival Drug-Related Side Effects and Adverse Reactions - chemically induced Drug-Related Side Effects and Adverse Reactions - pathology Female Fluorouracil - administration & dosage Fluorouracil - adverse effects Humans Liver Neoplasms - diagnostic imaging Liver Neoplasms - pathology Liver Neoplasms - secondary Male Medical sciences Middle Aged Nasopharyngeal Carcinoma Nasopharyngeal Neoplasms - drug therapy Neoplasm Metastasis - drug therapy Neoplasm Metastasis - pathology Neoplasm Recurrence, Local - pathology Niacinamide - administration & dosage Niacinamide - adverse effects Niacinamide - analogs & derivatives Otorhinolaryngology. Stomatology Pharmacology. Drug treatments Phenylurea Compounds - administration & dosage Phenylurea Compounds - adverse effects Sorafenib Tumors Ultrasonography Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology
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Summary:	We aimed to investigate the efficacy and tolerability of sorafenib combined with cisplatin and 5-fluorouracil (5-FU) in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). It was a Simon two-stage designed trial. Chemotherapy-naive patients with recurrent or metastatic disease were enrolled. The regimen was sorafenib 400 mg orally b.i.d., cisplatin 80 mg/m2 i.v. day 1, and 5-FU 1000 mg/m2/day CIV for 4 days, repeated every 21 days. After a maximum of six cycles of chemotherapy, patients received maintenance of sorafenib. In total, 54 patients were enrolled. The objective response rate reached 77.8%, including 1 complete response and 41 partial responses. The median progression-free survival was 7.2 months (95% CI 6.8–8.4 months), and the median overall survival was 11.8 months (95% CI 10.6–18.7 months). Major toxic effects included hand–foot skin reaction, myelosuppression, and gastrointestinal (GI) reaction. The incidence of hemorrhage was 22.2%, and one patient with liver metastases died of GI bleeding. Contrast-enhanced ultrasonography was carried out in a subset of patients with liver metastases. Combination of sorafenib, cisplatin (80 mg/m2) and 5-FU (3000 mg/m2) was tolerable and feasible in recurrent or metastatic NPC. Further randomized trials to compare sorafenib plus cisplatin and 5-FU with standard dose of cisplatin plus 5-FU in NPC are warranted.
ISSN:	0923-7534 1569-8041