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 European Union (EU)-approved cetuximab as the clinical trial material*
- This trial compared EU-approved cetuximab + platinum-based therapy (cisplatin or carboplatin) with 5-fluorouracil (CT) vs CT alone; choice of cisplatin or carboplatin was at the discretion of the treating physician
- ERBITUX provides approximately 22% higher exposure relative to the EU-approved cetuximab. 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 squamous cell carcinoma of the head and neck (SCCHN)
- Sixty-four percent 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 primary endpoint was overall survival
- Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety
EXTREME study: Most common adverse reactions1
- EXTREME trial: Observed toxicities were consistent with individual agent safety profiles
- For cardiac disorders, approximately 9% of subjects in both the EU-approved cetuximab plus chemotherapy and chemotherapy-only treatment arms in study 2 experienced a cardiac event. The majority of these events occurred in patients who received cisplatin/5-FU, with or without cetuximab as follows: 11% and 12% in patients who received cisplatin/5-FU, with or without cetuximab, respectively, and 6% or 4% in patients who received carboplatin/5-FU, with or without cetuximab, respectively. In both arms, the incidence of cardiovascular events was higher in the cisplatin with 5-FU containing subgroup. Death at tribute to cardiovascular event or sudden death was reported in 3% of the patients in the cetuximab plus platinum-based therapy with 5-FU arm and 2% in the platinum-based chemotherapy with 5-FU alone arm
- Since US-licensed ERBITUX® (cetuximab) provides approximately 22% higher exposure relative to the EU-approved cetuximab, the data provided may underestimate the incidence and severity of adverse reactions anticipated with ERBITUX for this indication. However, the tolerability of the recommended dose is supported by safety data from additional studies of ERBITUX
*Infusion reaction defined as any event of “anaphylactic reaction,” “hypersensitivity,” “fever and/or chills,” “dyspnea,” or “pyrexia” on the first day of dosing.
Cetuximab (ERBITUX®) + chemotherapy— A nationally recognized option1,5,6 in the first-line treatment of people with recurrent locoregional disease or metastatic SCCHN
National Comprehensive Cancer Network® (NCCN®) recommendation6
ERBITUX (cetuximab) FDA-approved Indication1
ERBITUX is indicated in combination with platinum-based therapy with 5-FU for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck (SCCHN).
- ERBITUX (cetuximab) [package insert]. Indianapolis, IN: Eli Lilly and Company, its subsidiaries or affiliates.
- Vermorken JB, et al. N Engl J Med. 2008;359(11):1116-1127.
- Miller AB, et al. Cancer. 1981;47(1):207-214.
- Data on file, Eli Lilly and Company. ONC20150527B.
- Wong SJ, Heron DE, Stenson K, et al. Locoregional Recurrent or Second Primary Head and Neck Cancer: Management Strategies and Challenges. American Society of Clinical Oncology 2016 Educational Book. http://meetinglibrary.asco.org/content/157804-176. Accessed March 29, 2017.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Head and Neck Cancers V.2.2017. © National Comprehensive Cancer Network, Inc. 2017. All rights reserved. Accessed May 9, 2017. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.