| General information |
| Database: | DB00282 |
| Objective: | To assess the efficacy and safety of cetuximab in combination with cisplatin and 5fluorouracil for firstline treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. |
| Authors: | Yoshino T, et al |
| Title: | Platinumbased chemotherapy plus cetuximab for the firstline treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: results of a phase II trial. |
| Journal: | Jpn J Clin Oncol. |
| Year: | 2013 |
| PMID: | 23479384 |
| Trial Design |
| Clinical Trial Id: | NCT00971932 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | platinumbased chemotherapy + cetuximab |
| Study Type: | an openlabel, singlearm, multicenter, phase II trial |
| Key Patients Feature: | Japanese adults with histologically or cytologically confirmed R/M SCCHN, unsuitable for local therapy, with at least one bidimensionally measurable [CT scan or MRI] lesion and confirmed expression of EGFR by immunohistochemistry were eligible for entry to the trial. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received weekly cetuximab (week 1, 400 mg/m(2); subsequent weeks, 250 mg/m(2)) plus a maximum of six threeweekly cycles of cisplatin (100 mg/m(2), day 1) and 5fluorouracil (1000 mg/m(2)/day, 24h infusion, days 14) |
| Primary End Point: | antitumor activity; |
| Secondary End Point: | safety, pharmacokinetic (PK) parameters, biomarkers, pharmacogenomics and the immunogenicity |
| Patients Number: | 33 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The best overall response rate as assessed by the independent review committee was 36% (95% confidence interval: 20, 55) and was significantly greater (P = 0.002) than the protocolspecified threshold of 15% at the onesided 5% level. |
| Disease Control Rate: | 0.88 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.1 months |
| Median OS A vs. C: | 14.1 months |
| Adverse Event(agent arm): | There were no unexpected safety concerns. Grade 3 or 4 adverse events were experienced by nearly all patients (32, 97%). No adverse events were fatal. |
| Conclusions: | The demonstrated efficacy and safety of cetuximab in combination with cisplatin and 5fluorouracil for the firstline treatment of Japanese patients with recurrent andor metastatic squamous cell carcinoma of the head and neck justify the further use of this combination treatment in this patient population . |