Docetaxel

An active drug for squamous cell carcinoma of the head and neck

A. I. Dreyfuss, J. R. Clark, C. M. Norris, R. M. Rossi, J. W. Lucarini, P. M. Busse, M. D. Poulin, L. Thornhill, R. Costello, M. R. Posner

Research output: Contribution to journalArticle

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Abstract

Purpose: We conducted a phase II study designed to evaluate the activity, safety, and tolerability of docetaxel (Taxotere: Rhone-Poulenc Rorer Pharmaceuticals Inc, Collageville, PA) in patients with advanced, incurable, or recurrent squamous cell carcinoma of the head and neck (SCCHN) who had not received prior palliative chemotherapy. Patients and Methods: Thirty-one patients with measurable, locoregional, or metastatic SCCHN were treated with docetaxel, administered at a dose of 100 mg/m2 as a 1-hour intravenous (IV) infusion once every 21 days on an outpatient basis. All patients were premedicated with dexamethasone, diphenhydramine, and cimetidine. Prophylactic administration of growth factors or antiemetics was not permitted. Results: Thirty-one patients were treated. Twenty-nine patients were assessable for response and 30 for toxicity. Four of 31 patients (13%) achieved complete response (CR), nine (29%) achieved partial response (PR), nine (29%) had stable disease (SD), and seven (23%) experienced progression of disease (PD). The major response rate was 42% (95% confidence interval [CI], 24% to 60%). The median duration of responses was 5 months (range, 2 to 14). The principal toxicity was leukopenia, which occurred with rapid onset and brief duration. Sixteen patients (53%) experienced nadir fever, and 13 required dose reduction. Hypersensitivity reactions occurred in four patients. Grade 3 peripheral neuropathy occurred in two patients; grade 2 or 3 fatigue occurred in six (20%) and 10 (33%), respectively. Minimal edema (grade 1) occurred in five patients (17%). Clinically significant mucositis, diarrhea, or dermatitis were not observed. Conclusion: Docetaxel has major activity against SCCHN. It appears to be well tolerated in this group of patients and can be safely administered on an outpatient basis. Premedication with dexamethasone, cimetidine, and diphenhydramine is associated with a reduced incidence of significant edema, hypersensitivity reactions, and dermatologic toxicities.

Original languageEnglish (US)
Pages (from-to)1672-1678
Number of pages7
JournalJournal of Clinical Oncology
Volume14
Issue number5
StatePublished - May 1996

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docetaxel
Pharmaceutical Preparations
Diphenhydramine
Cimetidine
Dexamethasone
Carcinoma, squamous cell of head and neck
Edema
Hypersensitivity
Outpatients

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Dreyfuss, A. I., Clark, J. R., Norris, C. M., Rossi, R. M., Lucarini, J. W., Busse, P. M., ... Posner, M. R. (1996). Docetaxel: An active drug for squamous cell carcinoma of the head and neck. Journal of Clinical Oncology, 14(5), 1672-1678.

Docetaxel : An active drug for squamous cell carcinoma of the head and neck. / Dreyfuss, A. I.; Clark, J. R.; Norris, C. M.; Rossi, R. M.; Lucarini, J. W.; Busse, P. M.; Poulin, M. D.; Thornhill, L.; Costello, R.; Posner, M. R.

In: Journal of Clinical Oncology, Vol. 14, No. 5, 05.1996, p. 1672-1678.

Research output: Contribution to journalArticle

Dreyfuss, AI, Clark, JR, Norris, CM, Rossi, RM, Lucarini, JW, Busse, PM, Poulin, MD, Thornhill, L, Costello, R & Posner, MR 1996, 'Docetaxel: An active drug for squamous cell carcinoma of the head and neck', Journal of Clinical Oncology, vol. 14, no. 5, pp. 1672-1678.
Dreyfuss AI, Clark JR, Norris CM, Rossi RM, Lucarini JW, Busse PM et al. Docetaxel: An active drug for squamous cell carcinoma of the head and neck. Journal of Clinical Oncology. 1996 May;14(5):1672-1678.
Dreyfuss, A. I. ; Clark, J. R. ; Norris, C. M. ; Rossi, R. M. ; Lucarini, J. W. ; Busse, P. M. ; Poulin, M. D. ; Thornhill, L. ; Costello, R. ; Posner, M. R. / Docetaxel : An active drug for squamous cell carcinoma of the head and neck. In: Journal of Clinical Oncology. 1996 ; Vol. 14, No. 5. pp. 1672-1678.
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abstract = "Purpose: We conducted a phase II study designed to evaluate the activity, safety, and tolerability of docetaxel (Taxotere: Rhone-Poulenc Rorer Pharmaceuticals Inc, Collageville, PA) in patients with advanced, incurable, or recurrent squamous cell carcinoma of the head and neck (SCCHN) who had not received prior palliative chemotherapy. Patients and Methods: Thirty-one patients with measurable, locoregional, or metastatic SCCHN were treated with docetaxel, administered at a dose of 100 mg/m2 as a 1-hour intravenous (IV) infusion once every 21 days on an outpatient basis. All patients were premedicated with dexamethasone, diphenhydramine, and cimetidine. Prophylactic administration of growth factors or antiemetics was not permitted. Results: Thirty-one patients were treated. Twenty-nine patients were assessable for response and 30 for toxicity. Four of 31 patients (13{\%}) achieved complete response (CR), nine (29{\%}) achieved partial response (PR), nine (29{\%}) had stable disease (SD), and seven (23{\%}) experienced progression of disease (PD). The major response rate was 42{\%} (95{\%} confidence interval [CI], 24{\%} to 60{\%}). The median duration of responses was 5 months (range, 2 to 14). The principal toxicity was leukopenia, which occurred with rapid onset and brief duration. Sixteen patients (53{\%}) experienced nadir fever, and 13 required dose reduction. Hypersensitivity reactions occurred in four patients. Grade 3 peripheral neuropathy occurred in two patients; grade 2 or 3 fatigue occurred in six (20{\%}) and 10 (33{\%}), respectively. Minimal edema (grade 1) occurred in five patients (17{\%}). Clinically significant mucositis, diarrhea, or dermatitis were not observed. Conclusion: Docetaxel has major activity against SCCHN. It appears to be well tolerated in this group of patients and can be safely administered on an outpatient basis. Premedication with dexamethasone, cimetidine, and diphenhydramine is associated with a reduced incidence of significant edema, hypersensitivity reactions, and dermatologic toxicities.",
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T1 - Docetaxel

T2 - An active drug for squamous cell carcinoma of the head and neck

AU - Dreyfuss, A. I.

AU - Clark, J. R.

AU - Norris, C. M.

AU - Rossi, R. M.

AU - Lucarini, J. W.

AU - Busse, P. M.

AU - Poulin, M. D.

AU - Thornhill, L.

AU - Costello, R.

AU - Posner, M. R.

PY - 1996/5

Y1 - 1996/5

N2 - Purpose: We conducted a phase II study designed to evaluate the activity, safety, and tolerability of docetaxel (Taxotere: Rhone-Poulenc Rorer Pharmaceuticals Inc, Collageville, PA) in patients with advanced, incurable, or recurrent squamous cell carcinoma of the head and neck (SCCHN) who had not received prior palliative chemotherapy. Patients and Methods: Thirty-one patients with measurable, locoregional, or metastatic SCCHN were treated with docetaxel, administered at a dose of 100 mg/m2 as a 1-hour intravenous (IV) infusion once every 21 days on an outpatient basis. All patients were premedicated with dexamethasone, diphenhydramine, and cimetidine. Prophylactic administration of growth factors or antiemetics was not permitted. Results: Thirty-one patients were treated. Twenty-nine patients were assessable for response and 30 for toxicity. Four of 31 patients (13%) achieved complete response (CR), nine (29%) achieved partial response (PR), nine (29%) had stable disease (SD), and seven (23%) experienced progression of disease (PD). The major response rate was 42% (95% confidence interval [CI], 24% to 60%). The median duration of responses was 5 months (range, 2 to 14). The principal toxicity was leukopenia, which occurred with rapid onset and brief duration. Sixteen patients (53%) experienced nadir fever, and 13 required dose reduction. Hypersensitivity reactions occurred in four patients. Grade 3 peripheral neuropathy occurred in two patients; grade 2 or 3 fatigue occurred in six (20%) and 10 (33%), respectively. Minimal edema (grade 1) occurred in five patients (17%). Clinically significant mucositis, diarrhea, or dermatitis were not observed. Conclusion: Docetaxel has major activity against SCCHN. It appears to be well tolerated in this group of patients and can be safely administered on an outpatient basis. Premedication with dexamethasone, cimetidine, and diphenhydramine is associated with a reduced incidence of significant edema, hypersensitivity reactions, and dermatologic toxicities.

AB - Purpose: We conducted a phase II study designed to evaluate the activity, safety, and tolerability of docetaxel (Taxotere: Rhone-Poulenc Rorer Pharmaceuticals Inc, Collageville, PA) in patients with advanced, incurable, or recurrent squamous cell carcinoma of the head and neck (SCCHN) who had not received prior palliative chemotherapy. Patients and Methods: Thirty-one patients with measurable, locoregional, or metastatic SCCHN were treated with docetaxel, administered at a dose of 100 mg/m2 as a 1-hour intravenous (IV) infusion once every 21 days on an outpatient basis. All patients were premedicated with dexamethasone, diphenhydramine, and cimetidine. Prophylactic administration of growth factors or antiemetics was not permitted. Results: Thirty-one patients were treated. Twenty-nine patients were assessable for response and 30 for toxicity. Four of 31 patients (13%) achieved complete response (CR), nine (29%) achieved partial response (PR), nine (29%) had stable disease (SD), and seven (23%) experienced progression of disease (PD). The major response rate was 42% (95% confidence interval [CI], 24% to 60%). The median duration of responses was 5 months (range, 2 to 14). The principal toxicity was leukopenia, which occurred with rapid onset and brief duration. Sixteen patients (53%) experienced nadir fever, and 13 required dose reduction. Hypersensitivity reactions occurred in four patients. Grade 3 peripheral neuropathy occurred in two patients; grade 2 or 3 fatigue occurred in six (20%) and 10 (33%), respectively. Minimal edema (grade 1) occurred in five patients (17%). Clinically significant mucositis, diarrhea, or dermatitis were not observed. Conclusion: Docetaxel has major activity against SCCHN. It appears to be well tolerated in this group of patients and can be safely administered on an outpatient basis. Premedication with dexamethasone, cimetidine, and diphenhydramine is associated with a reduced incidence of significant edema, hypersensitivity reactions, and dermatologic toxicities.

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