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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Abstract

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.

Original languageEnglish
Pages (from-to)3568-3576
Number of pages9
JournalJournal of Clinical Oncology
Volume23
Issue number15
DOIs
Publication statusPublished - Dec 1 2005
Externally publishedYes

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Carboplatin
Platinum
Cetuximab
Nasopharyngeal carcinoma
Safety
Treatment Failure
Epidermal Growth Factor Receptor
Area Under Curve

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma. / Chan, Anthony T.C.; Hsu, Mow Ming; Goh, Boon C.; Hui, Edwin P.; Liu, Tsang Wu; Millward, Michael J.; Hong, Ruey Long; Whang-Peng, Jacqueline; Ma, Brigette B.Y.; To, Ka F.; Mueser, Matthias; Amellal, Nadia; Lin, Xiao; Chang, Alex Y.

In: Journal of Clinical Oncology, Vol. 23, No. 15, 01.12.2005, p. 3568-3576.

Research output: Contribution to journalArticle

Chan, ATC, Hsu, MM, Goh, BC, Hui, EP, Liu, TW, Millward, MJ, Hong, RL, Whang-Peng, J, Ma, BBY, To, KF, Mueser, M, Amellal, N, Lin, X & Chang, AY 2005, 'Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma', Journal of Clinical Oncology, vol. 23, no. 15, pp. 3568-3576. https://doi.org/10.1200/JCO.2005.02.147
Chan, Anthony T.C. ; Hsu, Mow Ming ; Goh, Boon C. ; Hui, Edwin P. ; Liu, Tsang Wu ; Millward, Michael J. ; Hong, Ruey Long ; Whang-Peng, Jacqueline ; Ma, Brigette B.Y. ; To, Ka F. ; Mueser, Matthias ; Amellal, Nadia ; Lin, Xiao ; Chang, Alex Y. / Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 15. pp. 3568-3576.
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abstract = "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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T1 - Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma

AU - Chan, Anthony T.C.

AU - Hsu, Mow Ming

AU - Goh, Boon C.

AU - Hui, Edwin P.

AU - Liu, Tsang Wu

AU - Millward, Michael J.

AU - Hong, Ruey Long

AU - Whang-Peng, Jacqueline

AU - Ma, Brigette B.Y.

AU - To, Ka F.

AU - Mueser, Matthias

AU - Amellal, Nadia

AU - Lin, Xiao

AU - Chang, Alex Y.

PY - 2005/12/1

Y1 - 2005/12/1

N2 - 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.

AB - 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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