Platinum-based chemotherapy plus cetuximab in head and neck cancer.
Vermorken JB, Mesia R, Rivera F, et al. N Engl J Med. 2008;359(11):1116-1127.
Indication: 1st line for recurrent locoregional or metastatic SCCHN in combination with CT.
CT=platinum-based therapy with 5-FU; SCCHN=squamous cell carcinoma of the head and neck.
*Relative improvement in median overall survival from 7.4 to 10.1 months: ([10.1-7.4]/7.4) x 100% = 36%.
†Objective response=complete response + partial response; tumor size reduction ≥50% (modified WHO criteria).2-4
‡Relative improvement in median PFS from 3.3 to 5.5 months: ([5.5-3.3]/3.3) x 100% = 67%.
5-FU=5-fluorouracil; CI=confidence interval; CT=platinum-based therapy with 5-FU; HR=hazard ratio; OR=odds ratio; OS=overall survival; PFS=progression-free survival; SCCHN=squamous cell carcinoma of the head and neck; WHO=World Health Organization.
*Untreated 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 score (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 + cisplatin OR carboplatin + 5-FU. Patients received cisplatin (100 mg/m2 IV, day 1) OR carboplatin (area under the curve [AUC] 5 mg/mL/min IV, day 1) + 5-FU (1000 mg/m2 IV, days 1-4) in 3-week cycles. Patients with at least stable disease who received chemotherapy plus cetuximab after 6 chemotherapy cycles were to continue to receive cetuximab monotherapy until disease progression or unacceptable toxicity.
5-FU=5-fluorouracil; CT=platinum-based therapy with 5-FU; IV=intravenous; SCCHN=squamous cell carcinoma of the head and neck.
*Infusion reaction defined as any event of “anaphylactic reaction,” “hypersensitivity,” “fever and/or chills,” “dyspnea,” or “pyrexia” on the first day of dosing.
†Infection — this term excludes sepsis-related reactions which are presented separately.
5-FU=5-fluorouracil; CT=cisplatin + 5-fluorouracil or carboplatin + 5-fluorouracil; EU=European Union; SCCHN=squamous cell carcinoma of the head and neck.
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.
5-FU=5-fluorouracil; SCCHN=squamous cell carcinoma of the head and neck.
ERBITUX is approved for the treatment of certain patients who have colorectal cancer that has spread to other parts of the body. Only patients whose tumors are KRAS wild-type (which means they have a KRAS mutation-negative gene), and whose tumors have a protein called epidermal growth factor receptor (EGFR), should receive ERBITUX. FDA-approved tests are used to determine if tumors have these particular traits. Treatment with ERBITUX is given in the following three ways:
ERBITUX is not approved to treat colorectal cancer in patients whose tumors have mutations in genes called RAS (often called "RAS mutant"), or in patients for whom the mutational status of the genes is not known.
ERBITUX is available by prescription only.
In studies of ERBITUX:
In a study of ERBITUX and radiation therapy given to 208 patients versus radiation therapy alone given to 212 patients with head and neck cancer:
In a study of European cetuximab in combination with platinum-based chemotherapy with 5-fluorouracil given to 219 patients versus chemotherapy alone given to 215 patients with head and neck cancer:
In a study of European cetuximab in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) given to 317 patients versus FOLFIRI alone given to 350 patients with colorectal cancer that had spread to other parts of the body whose tumors were KRAS wild-type and whose tumors had a protein called Epidermal Growth Factor Receptor (EGFR):
In a study where ERBITUX and supportive care were given to 118 patients versus supportive care which was given to 124 patients with colorectal cancer that had spread to other parts of the body whose tumors were KRAS wild-type and whose tumors had a protein called Epidermal Growth Factor Receptor (EGFR):
In studies where ERBITUX and irinotecan were given to 354 patients with colorectal cancer that had spread to other parts of the body whose tumors had a protein called Epidermal Growth Factor Receptor (EGFR):
You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information for ERBITUX, including Boxed Warnings for allergic reactions and heart attack.
CE CON ISI_ALL 17JUN2015
ERBITUX is indicated for the treatment of KRAS wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use:
Limitation of Use: ERBITUX is not indicated for treatment of RAS-mutant colorectal cancer or when the results of the RAS mutation tests are unknown.
Please see full Prescribing Information for ERBITUX, including Boxed Warnings regarding infusion reactions and cardiopulmonary arrest.
CE HCP ISI_ALL 17JUN2015
The information contained in ERBITUX.com for healthcare professionals is technical in nature and intended for healthcare professionals in the United States only. If you are a US healthcare professional, click the “Continue” button below.
Yes, I am a US healthcare professional and would like to continue.
Click "Continue" to proceed or "Return" to return to ERBITUX.com