[Erbitux/Carboplatin versus Nasopharyngeal Carcinoma -- PII]
>>JCO Early Release, published online ahead of print Apr 4 2005
Journal of Clinical Oncology, 10.1200/JCO.2005.02.147
Received October 12, 2004
Accepted February 24, 2005
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 , and Alex Y. Chang
From the Cancer Therapeutics Research Group, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, China; Taiwan Cooperative Oncology Group, Departments of Otolaryngology and Oncology, National Taiwan University Hospital; Taiwan Cooperative Oncology Group, Division of Cancer Research, National Health Research Institute, Taipei, Taiwan; Cancer Therapeutics Research Group, Department of Clinical Oncology, National University Hospital; Cancer Therapeutics Research Group, Johns Hopkins-National University Hospital International Medical Center, Singapore; Cancer Therapeutics Research Group, Sydney Cancer Center, Sydney, Australia; and Merck KGaA, Darmstadt, Germany.
* To whom correspondence should be addressed. E-mail: anthonytcchan@cuhk.edu.hk
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.<<
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