Long-term results of a phase I/II trial of the addition of celecoxib to chemoradiotherapy for locally advanced or recurrent squamous cell carcinoma of the head-and-neck

Andrew M. McDonald, Roger Ove, James A. Bonner, Lisle M. Nabell, William R. Carroll, Nasser Said-Al-Naief, Margaret Brandwein-Gensler, Sharon A. Spencer

Research output: Contribution to journalArticle

Abstract

Purpose: We performed this open-label phase I/II trial to investigate concurrent celecoxib as a radiosensitizer during chemoradiotherapy. Methods and materials: Eligible patients included those with newly diagnosed, or recurrent, stage III or IVA locoregionally advanced squamous cell carcinoma of the head-and-neck (SCCHN), excluding nasopharyngeal tumors. The primary tumor was prescribed 70.2�Gy with concurrent weekly carboplatin and paclitaxel. Celecoxib was dosed at 400�mg twice daily, beginning 1�week prior to radiotherapy. Results: Thirty patients were enrolled between 2002 and 2007. The median age at enrollment was 57.6�years, and the median follow-up for surviving patients was 10.4�years (range 5.9–11.8�years). The complete clinical response rate was 87�%, nearly achieving the primary end point goal of 90�%. The 5-year actuarial disease-free survival (DFS) and overall survival (OS) were 40 and 53.3�%. Fourteen (47�%) patients experienced grade 3 or worse acute hematologic toxicity. Five (17�%) patients experienced grade 4 acute non-hematologic toxicity. Conclusion: Celecoxib appears to be a safe addition to cisplatin-based chemoradiotherapy for the primary treatment of locoregionally advanced SCCHN. Initial response rates were encouraging, and survival compared favorably with contemporary trials. Unfortunately, concern for cardiac toxicity of the drug led to early closure and limited statistical significance.

Original languageEnglish (US)
Pages (from-to)363-369
Number of pages7
JournalJournal of Radiation Oncology
Volume5
Issue number4
DOIs
StatePublished - Dec 1 2016

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Celecoxib
Chemoradiotherapy
Survival
Carboplatin
Paclitaxel
Cisplatin
Disease-Free Survival
Neoplasms
Radiotherapy
Carcinoma, squamous cell of head and neck

Keywords

  • Celecoxib
  • Chemoradiation
  • Chemotherapy
  • Head-and-neck cancer
  • Radiosensitization
  • Radiotherapy
  • Squamous cell carcinoma

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging

Cite this

Long-term results of a phase I/II trial of the addition of celecoxib to chemoradiotherapy for locally advanced or recurrent squamous cell carcinoma of the head-and-neck. / McDonald, Andrew M.; Ove, Roger; Bonner, James A.; Nabell, Lisle M.; Carroll, William R.; Said-Al-Naief, Nasser; Brandwein-Gensler, Margaret; Spencer, Sharon A.

In: Journal of Radiation Oncology, Vol. 5, No. 4, 01.12.2016, p. 363-369.

Research output: Contribution to journalArticle

McDonald, Andrew M. ; Ove, Roger ; Bonner, James A. ; Nabell, Lisle M. ; Carroll, William R. ; Said-Al-Naief, Nasser ; Brandwein-Gensler, Margaret ; Spencer, Sharon A. / Long-term results of a phase I/II trial of the addition of celecoxib to chemoradiotherapy for locally advanced or recurrent squamous cell carcinoma of the head-and-neck. In: Journal of Radiation Oncology. 2016 ; Vol. 5, No. 4. pp. 363-369.
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abstract = "Purpose: We performed this open-label phase I/II trial to investigate concurrent celecoxib as a radiosensitizer during chemoradiotherapy. Methods and materials: Eligible patients included those with newly diagnosed, or recurrent, stage III or IVA locoregionally advanced squamous cell carcinoma of the head-and-neck (SCCHN), excluding nasopharyngeal tumors. The primary tumor was prescribed 70.2{\"i}¿½Gy with concurrent weekly carboplatin and paclitaxel. Celecoxib was dosed at 400{\"i}¿½mg twice daily, beginning 1{\"i}¿½week prior to radiotherapy. Results: Thirty patients were enrolled between 2002 and 2007. The median age at enrollment was 57.6{\"i}¿½years, and the median follow-up for surviving patients was 10.4{\"i}¿½years (range 5.9–11.8{\"i}¿½years). The complete clinical response rate was 87{\"i}¿½{\%}, nearly achieving the primary end point goal of 90{\"i}¿½{\%}. The 5-year actuarial disease-free survival (DFS) and overall survival (OS) were 40 and 53.3{\"i}¿½{\%}. Fourteen (47{\"i}¿½{\%}) patients experienced grade 3 or worse acute hematologic toxicity. Five (17{\"i}¿½{\%}) patients experienced grade 4 acute non-hematologic toxicity. Conclusion: Celecoxib appears to be a safe addition to cisplatin-based chemoradiotherapy for the primary treatment of locoregionally advanced SCCHN. Initial response rates were encouraging, and survival compared favorably with contemporary trials. Unfortunately, concern for cardiac toxicity of the drug led to early closure and limited statistical significance.",
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T1 - Long-term results of a phase I/II trial of the addition of celecoxib to chemoradiotherapy for locally advanced or recurrent squamous cell carcinoma of the head-and-neck

AU - McDonald, Andrew M.

AU - Ove, Roger

AU - Bonner, James A.

AU - Nabell, Lisle M.

AU - Carroll, William R.

AU - Said-Al-Naief, Nasser

AU - Brandwein-Gensler, Margaret

AU - Spencer, Sharon A.

PY - 2016/12/1

Y1 - 2016/12/1

N2 - Purpose: We performed this open-label phase I/II trial to investigate concurrent celecoxib as a radiosensitizer during chemoradiotherapy. Methods and materials: Eligible patients included those with newly diagnosed, or recurrent, stage III or IVA locoregionally advanced squamous cell carcinoma of the head-and-neck (SCCHN), excluding nasopharyngeal tumors. The primary tumor was prescribed 70.2�Gy with concurrent weekly carboplatin and paclitaxel. Celecoxib was dosed at 400�mg twice daily, beginning 1�week prior to radiotherapy. Results: Thirty patients were enrolled between 2002 and 2007. The median age at enrollment was 57.6�years, and the median follow-up for surviving patients was 10.4�years (range 5.9–11.8�years). The complete clinical response rate was 87�%, nearly achieving the primary end point goal of 90�%. The 5-year actuarial disease-free survival (DFS) and overall survival (OS) were 40 and 53.3�%. Fourteen (47�%) patients experienced grade 3 or worse acute hematologic toxicity. Five (17�%) patients experienced grade 4 acute non-hematologic toxicity. Conclusion: Celecoxib appears to be a safe addition to cisplatin-based chemoradiotherapy for the primary treatment of locoregionally advanced SCCHN. Initial response rates were encouraging, and survival compared favorably with contemporary trials. Unfortunately, concern for cardiac toxicity of the drug led to early closure and limited statistical significance.

AB - Purpose: We performed this open-label phase I/II trial to investigate concurrent celecoxib as a radiosensitizer during chemoradiotherapy. Methods and materials: Eligible patients included those with newly diagnosed, or recurrent, stage III or IVA locoregionally advanced squamous cell carcinoma of the head-and-neck (SCCHN), excluding nasopharyngeal tumors. The primary tumor was prescribed 70.2�Gy with concurrent weekly carboplatin and paclitaxel. Celecoxib was dosed at 400�mg twice daily, beginning 1�week prior to radiotherapy. Results: Thirty patients were enrolled between 2002 and 2007. The median age at enrollment was 57.6�years, and the median follow-up for surviving patients was 10.4�years (range 5.9–11.8�years). The complete clinical response rate was 87�%, nearly achieving the primary end point goal of 90�%. The 5-year actuarial disease-free survival (DFS) and overall survival (OS) were 40 and 53.3�%. Fourteen (47�%) patients experienced grade 3 or worse acute hematologic toxicity. Five (17�%) patients experienced grade 4 acute non-hematologic toxicity. Conclusion: Celecoxib appears to be a safe addition to cisplatin-based chemoradiotherapy for the primary treatment of locoregionally advanced SCCHN. Initial response rates were encouraging, and survival compared favorably with contemporary trials. Unfortunately, concern for cardiac toxicity of the drug led to early closure and limited statistical significance.

KW - Celecoxib

KW - Chemoradiation

KW - Chemotherapy

KW - Head-and-neck cancer

KW - Radiosensitization

KW - Radiotherapy

KW - Squamous cell carcinoma

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