The contribution of cetuximab in the treatment of recurrent and/or metastatic head and neck cancer

Figures & data

Table 1 Phase II studies of cetuximab in disease progressing on prior therapy

Study	Treatment	Patients (n)	Response (%)	Disease control rate (%)	Median PFS (months)	Median OS (months)
Baselga et al^Citation76	Cetuximab/platinum	96	10	53	2.79	6.01
Herbst et al^Citation77	Cetuximab/platinum	155	11.5	NA	PD1 (3.0)	PD1 (6.1)
					PD2 (2.0)	PD2 (4.3)
					SD (4.9)	SD (11.7)
Vermorken et al^Citation78	Cetuximab monotherapy	103	13	46	2.29	5.84

Abbreviations: PFS, progression-free survival; OS, overall survival; NA, not applicable; PD1, patients who progressed on prior platinum therapy on protocol; PD2, patients who had prior platinum therapy off study; SD, stable disease.

Table 2 Studies of cetuximab in the first-line setting for recurrent/metastatic disease

Study	Treatment	Patients (n)	Response (%)	Median PFS (months)	Median OS (months)
Burtness et al^Citation69	CDDP	57	10	2.7	8
	CDDP/cetuximab	60	26 (P = 0.03)	4.2 (P = 0.09)	9.2 (NS)
Hitt et al^Citation72	Cetuximab/paclitaxel	46	71	5	NA
Vermorken et al^Citation71	CDDP/FU	220	20	3.3	7.4
	CDDP/FU/cetuximab	222	36 (P < 0.001)	5.6 (P < 0.001)	10.1 (P = 0.036)

Abbreviations: PFS, progression-free survival; OS, overall survival; CDDP, cisplatin; FU, fluorouracil; NA, not applicable.

Table 3 Ongoing studies combining cetuximab with novel agents for recurrent/metastatic disease (available on clinicaltrials.gov)

Title	Treatment	Phase	Sample size	Study drug target
A phase II trial of cetuximab and bevacizumab in patients with recurrent or metastatic head and neck cancer NCT00409565	cetuximab 400 mg/m^2 loading followed by 250 mg/m^2 weekly, bevacizumab 15 mg/kg q21 days	II	48	VEGF
Cetuximab with or without sorafenib tosylate in treating patients with refractory, recurrent and/or metastatic head and neck cancer NCT00939627	cetuximab weekly, placebo versus cetuximab weekly, sorafenib twice daily days 1–21	II	88	Raf; VEGFR 1, 2, 3; Flt-3; PDGFR β; c-kit, RET
Cilengitide in recurrent and/or metastatic squamous cell carcinoma of the head and neck NCT00705016	Cilengitide, cetuximab, cisplatin, 5FU vs cetuximab, cisplatin, 5FU	I/II	195	Integrins
Study of IMC-A12, alone or in combination with cetuximab, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck NCT00617734	IMC-A12 ± cetuximab	II	90	IGF-1R
BIBW 2992 in head and neck cancer NCT00514943	cetuximab vs BIBW2992	II	100	EGFR, Her-2/neu
Phase I study of cetuximab and RAD001	cetuximab and RAD001	I		mTOR
Cisplatin, cetuximab and temsirolimus in HNSCC NCT01015664	cisplatin, cetuximab, temsirolimus	I/II	56	mTOR
RAD001 in combination with cetuximab and cisplatin in recurrent/metastatic HNSCC NCT01009346	cisplatin, cetuximab, RAD001	I/II	98	mTOR
Safety study of cetuximab plus dasatinib (BMS-354825) NCT00388427	cetuximab and dasatinib	I	30	Src

BaselgaJTrigoJMBourhisJPhase II mulitcenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neckJ Clin Oncol2005235568557716009950

 PubMed Web of Science ®Google Scholar

HerbstRSArquetteMShinDMPhase II multicenter study of the epidermal growth factor receptor antibody cetuximab and cisplatin for recurrent and refractory squamous cell carcinoma of the head and neckJ Clin Oncol2005235568557716009950

 PubMed Web of Science ®Google Scholar

VermorkenJBTrigoJHittROpen-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapyJ Clin Oncol2007252171217717538161

 PubMed Web of Science ®Google Scholar

BurtnessBGoldwasserMAFloodWPhase II 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 Oncol20052386468865416314626

 PubMed Web of Science ®Google Scholar

HittRIrigoyenANunezJPhase II study of combination cetuximab and weekly paclitaxel in patients with metastatic/recurrent squamous cell carcinoma of head and neck: Spanish Head and Neck Cancer Group (TTCC)J Clin Oncol2007P I. Vol 25, No. 18S(June 20 suppl):abstr 6012.

 Google Scholar

VermorkenJBMesiaRRiveraFPlatinum based chemotherapy plus cetuximab in head and neck cancerN Engl J Med20083591116112718784101

 PubMed Web of Science ®Google Scholar