Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part)

J B Vermorken; F Peyrade; J Krauss; R Mesía; E Remenar; T C Gauler; U Keilholz; J P Delord; P Schafhausen; J Erfán; T H Brümmendorf; L Iglesias; U Bethe; C Hicking; P M Clement

doi:10.1093/annonc/mdu003

Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part)

Standard

Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part). / Vermorken, J B; Peyrade, F; Krauss, J; Mesía, R; Remenar, E; Gauler, T C; Keilholz, U; Delord, J P; Schafhausen, P; Erfán, J; Brümmendorf, T H; Iglesias, L; Bethe, U; Hicking, C; Clement, P M.

In: ANN ONCOL, Vol. 25, No. 3, 01.03.2014, p. 682-8.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Vermorken, JB, Peyrade, F, Krauss, J, Mesía, R, Remenar, E, Gauler, TC, Keilholz, U, Delord, JP, Schafhausen, P, Erfán, J, Brümmendorf, TH, Iglesias, L, Bethe, U, Hicking, C & Clement, PM 2014, 'Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part)', ANN ONCOL, vol. 25, no. 3, pp. 682-8. https://doi.org/10.1093/annonc/mdu003

APA

Vermorken, J. B., Peyrade, F., Krauss, J., Mesía, R., Remenar, E., Gauler, T. C., Keilholz, U., Delord, J. P., Schafhausen, P., Erfán, J., Brümmendorf, T. H., Iglesias, L., Bethe, U., Hicking, C., & Clement, P. M. (2014). Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part). ANN ONCOL, 25(3), 682-8. https://doi.org/10.1093/annonc/mdu003

Vancouver

Vermorken JB, Peyrade F, Krauss J, Mesía R, Remenar E, Gauler TC et al. Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part). ANN ONCOL. 2014 Mar 1;25(3):682-8. https://doi.org/10.1093/annonc/mdu003

Bibtex

@article{a4f8d2dd523e49a6afd271d35d9bb4b0,

title = "Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part)",

abstract = "BACKGROUND: Recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN) overexpresses αvβ5 integrin. Cilengitide selectively inhibits αvβ3 and αvβ5 integrins and is investigated as a treatment strategy.PATIENTS AND METHODS: The phase I/II study ADVANTAGE evaluated cilengitide combined with cisplatin, 5-fluorouracil, and cetuximab (PFE) in R/M-SCCHN. The phase II part reported here was an open-label, randomized, controlled trial investigating progression-free survival (PFS). Patients received up to six cycles of PFE alone or combined with cilengitide 2000 mg once (CIL1W) or twice (CIL2W) weekly. Thereafter, patients received maintenance therapy (cilengitide arms: cilengitide plus cetuximab; PFE-alone arm: cetuximab only) until disease progression or unacceptable toxicity.RESULTS: One hundred and eighty-two patients were treated. Median PFS per investigator read was similar for CIL1W + PFE, CIL2W + PFE, and PFE alone (6.4, 5.6, and 5.7 months, respectively). Accordingly, median overall survival and objective response rates were not improved with cilengitide (12.4 months/47%, 10.6 months/27%, and 11.6 months/36%, respectively). No clinically meaningful safety differences were observed between groups. None of the tested biomarkers (expression of integrins, CD31, Ki-67, vascular endothelial growth factor receptor 2, vascular endothelial-cadherin, type IV collagen, epidermal growth factor receptor, or p16 for human papillomavirus) were predictive of outcome.CONCLUSION: Neither of the cilengitide-containing regimens demonstrated a PFS benefit over PFE alone in R/M-SCCHN patients.",

keywords = "Adult, Aged, Antibodies, Monoclonal, Humanized, Antimetabolites, Antineoplastic, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Squamous Cell, Cisplatin, Disease Progression, Disease-Free Survival, Female, Fluorouracil, Head and Neck Neoplasms, Humans, Male, Middle Aged, Receptor, Epidermal Growth Factor, Snake Venoms, Treatment Outcome, Tumor Markers, Biological",

author = "Vermorken, {J B} and F Peyrade and J Krauss and R Mes{\'i}a and E Remenar and Gauler, {T C} and U Keilholz and Delord, {J P} and P Schafhausen and J Erf{\'a}n and Br{\"u}mmendorf, {T H} and L Iglesias and U Bethe and C Hicking and Clement, {P M}",

year = "2014",

month = mar,

day = "1",

doi = "10.1093/annonc/mdu003",

language = "English",

volume = "25",

pages = "682--8",

journal = "ANN ONCOL",

issn = "0923-7534",

publisher = "Oxford University Press",

number = "3",

}

RIS

TY - JOUR

T1 - Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part)

AU - Vermorken, J B

AU - Peyrade, F

AU - Krauss, J

AU - Mesía, R

AU - Remenar, E

AU - Gauler, T C

AU - Keilholz, U

AU - Delord, J P

AU - Schafhausen, P

AU - Erfán, J

AU - Brümmendorf, T H

AU - Iglesias, L

AU - Bethe, U

AU - Hicking, C

AU - Clement, P M

PY - 2014/3/1

Y1 - 2014/3/1

N2 - BACKGROUND: Recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN) overexpresses αvβ5 integrin. Cilengitide selectively inhibits αvβ3 and αvβ5 integrins and is investigated as a treatment strategy.PATIENTS AND METHODS: The phase I/II study ADVANTAGE evaluated cilengitide combined with cisplatin, 5-fluorouracil, and cetuximab (PFE) in R/M-SCCHN. The phase II part reported here was an open-label, randomized, controlled trial investigating progression-free survival (PFS). Patients received up to six cycles of PFE alone or combined with cilengitide 2000 mg once (CIL1W) or twice (CIL2W) weekly. Thereafter, patients received maintenance therapy (cilengitide arms: cilengitide plus cetuximab; PFE-alone arm: cetuximab only) until disease progression or unacceptable toxicity.RESULTS: One hundred and eighty-two patients were treated. Median PFS per investigator read was similar for CIL1W + PFE, CIL2W + PFE, and PFE alone (6.4, 5.6, and 5.7 months, respectively). Accordingly, median overall survival and objective response rates were not improved with cilengitide (12.4 months/47%, 10.6 months/27%, and 11.6 months/36%, respectively). No clinically meaningful safety differences were observed between groups. None of the tested biomarkers (expression of integrins, CD31, Ki-67, vascular endothelial growth factor receptor 2, vascular endothelial-cadherin, type IV collagen, epidermal growth factor receptor, or p16 for human papillomavirus) were predictive of outcome.CONCLUSION: Neither of the cilengitide-containing regimens demonstrated a PFS benefit over PFE alone in R/M-SCCHN patients.

AB - BACKGROUND: Recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN) overexpresses αvβ5 integrin. Cilengitide selectively inhibits αvβ3 and αvβ5 integrins and is investigated as a treatment strategy.PATIENTS AND METHODS: The phase I/II study ADVANTAGE evaluated cilengitide combined with cisplatin, 5-fluorouracil, and cetuximab (PFE) in R/M-SCCHN. The phase II part reported here was an open-label, randomized, controlled trial investigating progression-free survival (PFS). Patients received up to six cycles of PFE alone or combined with cilengitide 2000 mg once (CIL1W) or twice (CIL2W) weekly. Thereafter, patients received maintenance therapy (cilengitide arms: cilengitide plus cetuximab; PFE-alone arm: cetuximab only) until disease progression or unacceptable toxicity.RESULTS: One hundred and eighty-two patients were treated. Median PFS per investigator read was similar for CIL1W + PFE, CIL2W + PFE, and PFE alone (6.4, 5.6, and 5.7 months, respectively). Accordingly, median overall survival and objective response rates were not improved with cilengitide (12.4 months/47%, 10.6 months/27%, and 11.6 months/36%, respectively). No clinically meaningful safety differences were observed between groups. None of the tested biomarkers (expression of integrins, CD31, Ki-67, vascular endothelial growth factor receptor 2, vascular endothelial-cadherin, type IV collagen, epidermal growth factor receptor, or p16 for human papillomavirus) were predictive of outcome.CONCLUSION: Neither of the cilengitide-containing regimens demonstrated a PFS benefit over PFE alone in R/M-SCCHN patients.

KW - Adult

KW - Aged

KW - Antibodies, Monoclonal, Humanized

KW - Antimetabolites, Antineoplastic

KW - Antineoplastic Agents

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Carcinoma, Squamous Cell

KW - Cisplatin

KW - Disease Progression

KW - Disease-Free Survival

KW - Female

KW - Fluorouracil

KW - Head and Neck Neoplasms

KW - Humans

KW - Male

KW - Middle Aged

KW - Receptor, Epidermal Growth Factor

KW - Snake Venoms

KW - Treatment Outcome

KW - Tumor Markers, Biological

U2 - 10.1093/annonc/mdu003

DO - 10.1093/annonc/mdu003

M3 - SCORING: Journal article

C2 - 24567516

VL - 25

SP - 682

EP - 688

JO - ANN ONCOL

JF - ANN ONCOL

SN - 0923-7534

IS - 3

ER -