Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer

Jan B. Vermorken, E. Remenár, Carla Van Herpen, Thierry Gorlia, Ricard Mesia, Marian Degardin, John S. Stewart, Svetislav Jelic, Jan Betka, Joachim H. Preiss, Danielle Van Den Weyngaert, Ahmad Awada, Didier Cupissol, Heinz R. Kienzer, Augustin Rey, Isabelle Desaunois, Jacques Bernier, Jean Louis Lefebvre

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: Phase 2 studies suggest that the standard regimen of cisplatin and fluorouracil (PF) plus docetaxel (TPF) improves outcomes in squamous-cell carcinoma of the head and neck. We compared TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease. METHODS: We randomly assigned eligible patients between the ages of 18 and 70 years who had stage III or stage IV disease and no distant metastases to receive either TPF (docetaxel and cisplatin, day 1; fluorouracil by continuous infusion, days 1 to 5) or PF every 3 weeks for four cycles. Patients without progression of disease received radiotherapy within 4 to 7 weeks after completing chemotherapy. The primary end point was progression-free survival. RESULTS: A total of 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32.5 months, the median progression-free survival was 11.0 months in the TPF group and 8.2 months in the PF group (hazard ratio for disease progression or death in the TPF group, 0.72; P = 0.007). Treatment with TPF resulted in a reduction in the risk of death of 27% (P = 0.02), with a median overall survival of 18.8 months, as compared with 14.5 months in the PF group. There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group. The rates of death from toxic effects were 2.3% in the TPF group and 5.5% in the PF group. CONCLUSIONS: As compared with the standard regimen of cisplatin and fluorouracil, induction chemotherapy with the addition of docetaxel significantly improved progression-free and overall survival in patients with unresectable squamous-cell carcinoma of the head and neck. (ClinicalTrials.gov number, NCT00003888.)

Original languageEnglish
Pages (from-to)1695-1704
Number of pages10
JournalNew England Journal of Medicine
Volume357
Issue number17
DOIs
Publication statusPublished - Oct 25 2007

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docetaxel
Head and Neck Neoplasms
Fluorouracil
Cisplatin
Disease-Free Survival
Induction Chemotherapy
Disease Progression
Platelet Factor 3
Stomatitis
Poisons
Leukopenia
Risk Reduction Behavior
Random Allocation
Neutropenia
Hearing Loss
Nausea
Vomiting
Radiotherapy
Neoplasm Metastasis
Drug Therapy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Vermorken, J. B., Remenár, E., Van Herpen, C., Gorlia, T., Mesia, R., Degardin, M., ... Lefebvre, J. L. (2007). Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. New England Journal of Medicine, 357(17), 1695-1704. https://doi.org/10.1056/NEJMoa071028

Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. / Vermorken, Jan B.; Remenár, E.; Van Herpen, Carla; Gorlia, Thierry; Mesia, Ricard; Degardin, Marian; Stewart, John S.; Jelic, Svetislav; Betka, Jan; Preiss, Joachim H.; Van Den Weyngaert, Danielle; Awada, Ahmad; Cupissol, Didier; Kienzer, Heinz R.; Rey, Augustin; Desaunois, Isabelle; Bernier, Jacques; Lefebvre, Jean Louis.

In: New England Journal of Medicine, Vol. 357, No. 17, 25.10.2007, p. 1695-1704.

Research output: Contribution to journalArticle

Vermorken, JB, Remenár, E, Van Herpen, C, Gorlia, T, Mesia, R, Degardin, M, Stewart, JS, Jelic, S, Betka, J, Preiss, JH, Van Den Weyngaert, D, Awada, A, Cupissol, D, Kienzer, HR, Rey, A, Desaunois, I, Bernier, J & Lefebvre, JL 2007, 'Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer', New England Journal of Medicine, vol. 357, no. 17, pp. 1695-1704. https://doi.org/10.1056/NEJMoa071028
Vermorken, Jan B. ; Remenár, E. ; Van Herpen, Carla ; Gorlia, Thierry ; Mesia, Ricard ; Degardin, Marian ; Stewart, John S. ; Jelic, Svetislav ; Betka, Jan ; Preiss, Joachim H. ; Van Den Weyngaert, Danielle ; Awada, Ahmad ; Cupissol, Didier ; Kienzer, Heinz R. ; Rey, Augustin ; Desaunois, Isabelle ; Bernier, Jacques ; Lefebvre, Jean Louis. / Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. In: New England Journal of Medicine. 2007 ; Vol. 357, No. 17. pp. 1695-1704.
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abstract = "BACKGROUND: Phase 2 studies suggest that the standard regimen of cisplatin and fluorouracil (PF) plus docetaxel (TPF) improves outcomes in squamous-cell carcinoma of the head and neck. We compared TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease. METHODS: We randomly assigned eligible patients between the ages of 18 and 70 years who had stage III or stage IV disease and no distant metastases to receive either TPF (docetaxel and cisplatin, day 1; fluorouracil by continuous infusion, days 1 to 5) or PF every 3 weeks for four cycles. Patients without progression of disease received radiotherapy within 4 to 7 weeks after completing chemotherapy. The primary end point was progression-free survival. RESULTS: A total of 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32.5 months, the median progression-free survival was 11.0 months in the TPF group and 8.2 months in the PF group (hazard ratio for disease progression or death in the TPF group, 0.72; P = 0.007). Treatment with TPF resulted in a reduction in the risk of death of 27{\%} (P = 0.02), with a median overall survival of 18.8 months, as compared with 14.5 months in the PF group. There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group. The rates of death from toxic effects were 2.3{\%} in the TPF group and 5.5{\%} in the PF group. CONCLUSIONS: As compared with the standard regimen of cisplatin and fluorouracil, induction chemotherapy with the addition of docetaxel significantly improved progression-free and overall survival in patients with unresectable squamous-cell carcinoma of the head and neck. (ClinicalTrials.gov number, NCT00003888.)",
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T1 - Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer

AU - Vermorken, Jan B.

AU - Remenár, E.

AU - Van Herpen, Carla

AU - Gorlia, Thierry

AU - Mesia, Ricard

AU - Degardin, Marian

AU - Stewart, John S.

AU - Jelic, Svetislav

AU - Betka, Jan

AU - Preiss, Joachim H.

AU - Van Den Weyngaert, Danielle

AU - Awada, Ahmad

AU - Cupissol, Didier

AU - Kienzer, Heinz R.

AU - Rey, Augustin

AU - Desaunois, Isabelle

AU - Bernier, Jacques

AU - Lefebvre, Jean Louis

PY - 2007/10/25

Y1 - 2007/10/25

N2 - BACKGROUND: Phase 2 studies suggest that the standard regimen of cisplatin and fluorouracil (PF) plus docetaxel (TPF) improves outcomes in squamous-cell carcinoma of the head and neck. We compared TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease. METHODS: We randomly assigned eligible patients between the ages of 18 and 70 years who had stage III or stage IV disease and no distant metastases to receive either TPF (docetaxel and cisplatin, day 1; fluorouracil by continuous infusion, days 1 to 5) or PF every 3 weeks for four cycles. Patients without progression of disease received radiotherapy within 4 to 7 weeks after completing chemotherapy. The primary end point was progression-free survival. RESULTS: A total of 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32.5 months, the median progression-free survival was 11.0 months in the TPF group and 8.2 months in the PF group (hazard ratio for disease progression or death in the TPF group, 0.72; P = 0.007). Treatment with TPF resulted in a reduction in the risk of death of 27% (P = 0.02), with a median overall survival of 18.8 months, as compared with 14.5 months in the PF group. There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group. The rates of death from toxic effects were 2.3% in the TPF group and 5.5% in the PF group. CONCLUSIONS: As compared with the standard regimen of cisplatin and fluorouracil, induction chemotherapy with the addition of docetaxel significantly improved progression-free and overall survival in patients with unresectable squamous-cell carcinoma of the head and neck. (ClinicalTrials.gov number, NCT00003888.)

AB - BACKGROUND: Phase 2 studies suggest that the standard regimen of cisplatin and fluorouracil (PF) plus docetaxel (TPF) improves outcomes in squamous-cell carcinoma of the head and neck. We compared TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease. METHODS: We randomly assigned eligible patients between the ages of 18 and 70 years who had stage III or stage IV disease and no distant metastases to receive either TPF (docetaxel and cisplatin, day 1; fluorouracil by continuous infusion, days 1 to 5) or PF every 3 weeks for four cycles. Patients without progression of disease received radiotherapy within 4 to 7 weeks after completing chemotherapy. The primary end point was progression-free survival. RESULTS: A total of 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32.5 months, the median progression-free survival was 11.0 months in the TPF group and 8.2 months in the PF group (hazard ratio for disease progression or death in the TPF group, 0.72; P = 0.007). Treatment with TPF resulted in a reduction in the risk of death of 27% (P = 0.02), with a median overall survival of 18.8 months, as compared with 14.5 months in the PF group. There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group. The rates of death from toxic effects were 2.3% in the TPF group and 5.5% in the PF group. CONCLUSIONS: As compared with the standard regimen of cisplatin and fluorouracil, induction chemotherapy with the addition of docetaxel significantly improved progression-free and overall survival in patients with unresectable squamous-cell carcinoma of the head and neck. (ClinicalTrials.gov number, NCT00003888.)

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