Induction docetaxel, cisplatin, and cetuximab followed by concurrent radiotherapy, cisplatin, and cetuximab and maintenance cetuximab in patients with locally advanced head and neck cancer

Athanassios Argiris, Dwight E. Heron, Ryan P. Smith, Seungwon Kim, Michael K. Gibson, Stephen Y. Lai, Barton F. Branstetter, Donna M. Posluszny, Lin Wang, Raja R. Seethala, Sanja Dacic, William Gooding, Jennifer R. Grandis, Jonas T. Johnson, Robert L. Ferris

Research output: Contribution to journalArticle

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Abstract

Purpose: We incorporated cetuximab, a chimeric monoclonal antibody against the epidermal growth factor receptor (EGFR), into the induction therapy and subsequent chemoradiotherapy of head and neck cancer (HNC). Patients and Methods: Patients with locally advanced HNC, including squamous and undifferentiated histologies, were treated with docetaxel 75 mg/m 2 day 1, cisplatin 75 mg/m 2 day 1, and cetuximab 250 mg/m 2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m 2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months. Quality of life (QOL) was assessed using Functional Assessment of Cancer Therapy - Head and Neck. In situ hybridization (ISH) for human papillomavirus (HPV), immunohistochemistry for p16, and fluorescence ISH for EGFR gene copy number were performed on tissue microarrays. Results: Of 39 enrolled patients, 36 had stage IV disease and 23 an oropharyngeal primary. Acute toxicities during TPE included neutropenic fever (10%) and during XPE, grade 3 or 4 oral mucositis (54%) and hypomagnesemia (39%). With a median follow-up of 36 months, 3-year progression-free survival and overall survival were 70% and 74%, respectively. Eight patients progressed in locoregional sites, three in distant, and one in both. HPV positivity was not associated with treatment efficacy. No progression-free patient remained G-tube dependent. The H&N subscale QOL scores showed a significant decrement at 3 months after XPE, which normalized at 1 year. Conclusion: This cetuximab-containing regimen resulted in excellent long-term survival and safety, and warrants further evaluation in both HPV-positive and -negative HNC.

Original languageEnglish (US)
Pages (from-to)5294-5300
Number of pages7
JournalJournal of Clinical Oncology
Volume28
Issue number36
DOIs
StatePublished - Dec 20 2010
Externally publishedYes

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docetaxel
Head and Neck Neoplasms
Cisplatin
Radiotherapy
Maintenance
Quality of Life
erbB-1 Genes
Stomatitis
Gene Dosage
Survival
Chemoradiotherapy
Fluorescence In Situ Hybridization
Epidermal Growth Factor Receptor
Disease-Free Survival
In Situ Hybridization
Histology
Fever
Immunohistochemistry
Monoclonal Antibodies
Cetuximab

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Induction docetaxel, cisplatin, and cetuximab followed by concurrent radiotherapy, cisplatin, and cetuximab and maintenance cetuximab in patients with locally advanced head and neck cancer. / Argiris, Athanassios; Heron, Dwight E.; Smith, Ryan P.; Kim, Seungwon; Gibson, Michael K.; Lai, Stephen Y.; Branstetter, Barton F.; Posluszny, Donna M.; Wang, Lin; Seethala, Raja R.; Dacic, Sanja; Gooding, William; Grandis, Jennifer R.; Johnson, Jonas T.; Ferris, Robert L.

In: Journal of Clinical Oncology, Vol. 28, No. 36, 20.12.2010, p. 5294-5300.

Research output: Contribution to journalArticle

Argiris, A, Heron, DE, Smith, RP, Kim, S, Gibson, MK, Lai, SY, Branstetter, BF, Posluszny, DM, Wang, L, Seethala, RR, Dacic, S, Gooding, W, Grandis, JR, Johnson, JT & Ferris, RL 2010, 'Induction docetaxel, cisplatin, and cetuximab followed by concurrent radiotherapy, cisplatin, and cetuximab and maintenance cetuximab in patients with locally advanced head and neck cancer', Journal of Clinical Oncology, vol. 28, no. 36, pp. 5294-5300. https://doi.org/10.1200/JCO.2010.30.6423
Argiris, Athanassios ; Heron, Dwight E. ; Smith, Ryan P. ; Kim, Seungwon ; Gibson, Michael K. ; Lai, Stephen Y. ; Branstetter, Barton F. ; Posluszny, Donna M. ; Wang, Lin ; Seethala, Raja R. ; Dacic, Sanja ; Gooding, William ; Grandis, Jennifer R. ; Johnson, Jonas T. ; Ferris, Robert L. / Induction docetaxel, cisplatin, and cetuximab followed by concurrent radiotherapy, cisplatin, and cetuximab and maintenance cetuximab in patients with locally advanced head and neck cancer. In: Journal of Clinical Oncology. 2010 ; Vol. 28, No. 36. pp. 5294-5300.
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abstract = "Purpose: We incorporated cetuximab, a chimeric monoclonal antibody against the epidermal growth factor receptor (EGFR), into the induction therapy and subsequent chemoradiotherapy of head and neck cancer (HNC). Patients and Methods: Patients with locally advanced HNC, including squamous and undifferentiated histologies, were treated with docetaxel 75 mg/m 2 day 1, cisplatin 75 mg/m 2 day 1, and cetuximab 250 mg/m 2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m 2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months. Quality of life (QOL) was assessed using Functional Assessment of Cancer Therapy - Head and Neck. In situ hybridization (ISH) for human papillomavirus (HPV), immunohistochemistry for p16, and fluorescence ISH for EGFR gene copy number were performed on tissue microarrays. Results: Of 39 enrolled patients, 36 had stage IV disease and 23 an oropharyngeal primary. Acute toxicities during TPE included neutropenic fever (10{\%}) and during XPE, grade 3 or 4 oral mucositis (54{\%}) and hypomagnesemia (39{\%}). With a median follow-up of 36 months, 3-year progression-free survival and overall survival were 70{\%} and 74{\%}, respectively. Eight patients progressed in locoregional sites, three in distant, and one in both. HPV positivity was not associated with treatment efficacy. No progression-free patient remained G-tube dependent. The H&N subscale QOL scores showed a significant decrement at 3 months after XPE, which normalized at 1 year. Conclusion: This cetuximab-containing regimen resulted in excellent long-term survival and safety, and warrants further evaluation in both HPV-positive and -negative HNC.",
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T1 - Induction docetaxel, cisplatin, and cetuximab followed by concurrent radiotherapy, cisplatin, and cetuximab and maintenance cetuximab in patients with locally advanced head and neck cancer

AU - Argiris, Athanassios

AU - Heron, Dwight E.

AU - Smith, Ryan P.

AU - Kim, Seungwon

AU - Gibson, Michael K.

AU - Lai, Stephen Y.

AU - Branstetter, Barton F.

AU - Posluszny, Donna M.

AU - Wang, Lin

AU - Seethala, Raja R.

AU - Dacic, Sanja

AU - Gooding, William

AU - Grandis, Jennifer R.

AU - Johnson, Jonas T.

AU - Ferris, Robert L.

PY - 2010/12/20

Y1 - 2010/12/20

N2 - Purpose: We incorporated cetuximab, a chimeric monoclonal antibody against the epidermal growth factor receptor (EGFR), into the induction therapy and subsequent chemoradiotherapy of head and neck cancer (HNC). Patients and Methods: Patients with locally advanced HNC, including squamous and undifferentiated histologies, were treated with docetaxel 75 mg/m 2 day 1, cisplatin 75 mg/m 2 day 1, and cetuximab 250 mg/m 2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m 2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months. Quality of life (QOL) was assessed using Functional Assessment of Cancer Therapy - Head and Neck. In situ hybridization (ISH) for human papillomavirus (HPV), immunohistochemistry for p16, and fluorescence ISH for EGFR gene copy number were performed on tissue microarrays. Results: Of 39 enrolled patients, 36 had stage IV disease and 23 an oropharyngeal primary. Acute toxicities during TPE included neutropenic fever (10%) and during XPE, grade 3 or 4 oral mucositis (54%) and hypomagnesemia (39%). With a median follow-up of 36 months, 3-year progression-free survival and overall survival were 70% and 74%, respectively. Eight patients progressed in locoregional sites, three in distant, and one in both. HPV positivity was not associated with treatment efficacy. No progression-free patient remained G-tube dependent. The H&N subscale QOL scores showed a significant decrement at 3 months after XPE, which normalized at 1 year. Conclusion: This cetuximab-containing regimen resulted in excellent long-term survival and safety, and warrants further evaluation in both HPV-positive and -negative HNC.

AB - Purpose: We incorporated cetuximab, a chimeric monoclonal antibody against the epidermal growth factor receptor (EGFR), into the induction therapy and subsequent chemoradiotherapy of head and neck cancer (HNC). Patients and Methods: Patients with locally advanced HNC, including squamous and undifferentiated histologies, were treated with docetaxel 75 mg/m 2 day 1, cisplatin 75 mg/m 2 day 1, and cetuximab 250 mg/m 2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m 2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months. Quality of life (QOL) was assessed using Functional Assessment of Cancer Therapy - Head and Neck. In situ hybridization (ISH) for human papillomavirus (HPV), immunohistochemistry for p16, and fluorescence ISH for EGFR gene copy number were performed on tissue microarrays. Results: Of 39 enrolled patients, 36 had stage IV disease and 23 an oropharyngeal primary. Acute toxicities during TPE included neutropenic fever (10%) and during XPE, grade 3 or 4 oral mucositis (54%) and hypomagnesemia (39%). With a median follow-up of 36 months, 3-year progression-free survival and overall survival were 70% and 74%, respectively. Eight patients progressed in locoregional sites, three in distant, and one in both. HPV positivity was not associated with treatment efficacy. No progression-free patient remained G-tube dependent. The H&N subscale QOL scores showed a significant decrement at 3 months after XPE, which normalized at 1 year. Conclusion: This cetuximab-containing regimen resulted in excellent long-term survival and safety, and warrants further evaluation in both HPV-positive and -negative HNC.

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