Cetuximab: its unique place in head and neck cancer treatment

Figures & data

Table 1 Randomized Phase III trials with cetuximab in SCCHN

Author	Treatment	N	LRC (months)	OS (months)	PFS (months)	ORR
Locoregionally advanced disease
Bonner et al^Citation27,Citation28	RT	213	14.9*	29.3		64%
	RT + cetuximab	211	24.4*	49		74%
	P-value		0.005	0.018	0.006	0.02
Ang et al^Citation45	CRT	448		79.7‡	64.3*,†
	CRT + cetuximab	447		82.6‡	63.4*,†
	P-value			0.17	0.67
Recurrent/metastatic disease
Vermorken et al^Citation68	Platinum/5-FU	220		7.4*	3.3	20%
	Platinum/5-FU + cetuximab	222		10.7*	5.6	36%
	P-value			0.04	<0.001	<0.001
Burtness et al^Citation67	Cisplatin + placebo	60		8	2.7*	10%
	Cisplatin + cetuximab	57		9.2	4.2*	26%
	P-value			0.21	0.09	0.03

Notes:

* Primary endpoint;

† 2-year PFS rate;

‡ 2-year OS rate.

Platinum/5-FU: cisplatin (100 mg/m²) or carboplatin (AUC 5) on day 1, followed by 5-FU 1000 mg/m²/day as a continuous infusion day 1–4.

Abbreviations: RT, radiotherapy; CRT, chemoradiation; N, number of patients; LRC, locoregional control; OS, overall survival; PFS, progression-free survival; ORR, overall response rate.

Table 2 Adverse events with second line single agent cetuximab in squamous cell carcinoma of the head and neck

	All grades	Grade 3–4
Dermatological
Rash	49%	1%
Acne	26%	0%
Dry skin	14%	0%
Nail disorder	16%	0%
Other
Fever	14%	1%
Nausea	13%	1%
Vomiting	11%	2%
Dyspnea	5%	4%
Infusion-related reactions	6%	1%

Table 3 Adverse events occurring more frequently with the addition of cetuximab to radiotherapy

	All grades			Grade 3–5
	Radiotherapy	Radiotherapy + cetuximab	P-value	Radiotherapy	Radiotherapy + cetuximab	P-value
Acneiform rash	10%	87%	<0.001	1%	17%	<0.001
Weight loss	72%	84%	0.005
Nausea	37%	49%	0.02
Fever	13%	26%	0.001
Headache	8%	19%	0.001
Pruritus	4%	16%	<0.001
Infusion reaction	2%	15%	<0.001	0%	3%	0.01
Chills	5%	11%	0.03

Note:

BonnerJAHarariPMGiraltJRadiotherapy plus cetuximab for squamous-cell carcinoma of the head and neckN Engl J Med2006354656757816467544

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BonnerJAHarariPMGiraltJRadiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survivalLancet Oncol2010111212819897418

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AngKKZhangQRosenthalDIA randomized phase III trial (RTOG 0522) of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III-IV head and neck squamous cell carcinomas (HNC)J Clin Oncol201129Suppl Abstr 5500

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VermorkenJBMesiaRRiveraFPlatinum-based chemotherapy plus cetuximab in head and neck cancerN Engl J Med2008359111116112718784101

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BurtnessBGoldwasserMAFloodWMattarBForastiereAAEastern Cooperative Oncology GroupPhase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group studyJ Clin Oncol200523248646865416314626

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