The EXTREME trial: A landmark, multicenter, phase III trial1,2
- EXTREME was an open-label, randomized (1:1), multicenter, controlled clinical trial conducted outside the United States using a cetuximab product as the clinical trial materialǁ
- This trial compared a cetuximab product with CT vs CT alone; choice of cisplatin or carboplatin was at the discretion of the treating physician

IV=intravenous.
- ERBITUX provides approximately 22% higher exposure relative to the cetuximab product used in the study. These pharmacokinetic data, together with the results of the EXTREME trial and other clinical study data, establish the efficacy of ERBITUX at the recommended dose in the first-line treatment of recurrent locoregional or metastatic SCCHN
- 64% of patients received cisplatin therapy and 34% received carboplatin as initial therapy
- Approximately 15% of the patients in the cisplatin-alone arm switched to carboplatin during the treatment period
- The main outcome measure was OS
- Secondary endpoints included PFS, objective response rate (ORR), and safety
ǁUntreated patients met the following eligibility requirements: histologically or cytologically confirmed recurrent locoregional or metastatic SCCHN, no prior therapy for recurrent locoregional or metastatic SCCHN, no surgery or irradiation within the previous 4 weeks, and Karnofsky performance status (KPS) of ≥70%. Patients were stratified according to KPS (<80% vs ≥80%) and previous chemotherapy (receipt vs nonreceipt). Cetuximab was administered as a 400 mg/m2 IV initial dose, then 250 mg/m2 IV weekly with cisplatin OR carboplatin and fluorouracil. Patients received cisplatin (100 mg/m2 IV, day 1) OR carboplatin (area under the curve [AUC] 5 mg/mL*min IV, day 1) and fluorouracil (1000 mg/m2 IV, days 1-4) in 3-week cycles. In the absence of disease progression or unacceptable toxicity after completion of 6 planned courses of platinum-based therapy, weekly cetuximab as monotherapy could be continued until disease progression or unacceptable toxicity.