Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma

Anthony T.C. Chan, Mow Ming Hsu, Boon C. Goh, Edwin P. Hui, Tsang Wu Liu, Michael J. Millward, Ruey Long Hong, Jacqueline Whang-Peng, Brigette B.Y. Ma, Ka F. To, Matthias Mueser, Nadia Amellal, Xiao Lin, Alex Y. Chang

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229 引文 斯高帕斯(Scopus)

摘要

Purpose: To evaluate efficacy and toxicity of cetuximab plus carboplatin in recurrent or metastatic nasopharyngeal carcinoma (NPC) resistant to platinum treatment. Patients and Methods: A multicenter, open-label, single-arm, phase II study in patients with epidermal growth factor receptor-expressing NPC who progressed on or within 12 months after termination of platinum-based chemotherapy for recurrent or metastatic disease. Cetuximab was administered at an initial dose of 400 mg/m2 followed by weekly doses of 250 mg/m2. Carboplatin area under the curve 5 was administered every 3 weeks up to a maximum of eight cycles. Results: Sixty patients were enrolled (46 males, 14 females; median age, 44.5 years; range, 23 to 64 years), and all patients were included in the intent-to-treat and safety analyses. Of the 59 patients assessable for efficacy, there were seven partial responses (11.7%), 29 patients (48.3%) with stable disease, and 23 patients (38.3%) with progressive disease, giving an overall response rate of 11.7% (95% CI, 4.8% to 22.6%). The median time to progression was 81 days in all patients and was longest in the group of patients with a confirmed response (173 days). The median overall survival time was 233 days in all patients. Six patients (10%) experienced serious treatment-related adverse events. Grade 3 or 4 toxicities occurred in 31 patients (51.7%); of these patients, only 19 (31.7%) were considered to have toxicity related to cetuximab. Conclusion: Cetuximab in combination with carboplatin demonstrates clinical activity and an acceptable safety profile in heavily pretreated patients with recurrent or metastatic NPC who had previously experienced treatment failure with platinum-based therapy.
原文英語
頁(從 - 到)3568-3576
頁數9
期刊Journal of Clinical Oncology
23
發行號15
DOIs
出版狀態已發佈 - 十二月 1 2005
對外發佈

ASJC Scopus subject areas

  • 腫瘤科
  • 癌症研究

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