Effect of pilocarpine during radiation therapy: Results of RTOG 97-09, a phase III randomized study in head and neck cancer patients

Charles W. Scarantino, Francis LeVeque, R. Suzanne Swann, Robert White, Alan Schulsinger, D. Ian Hodson, Ruby Meredith, Robert Foote, David Brachman, Nancy Lee

Research output: Contribution to journalArticle

60 Citations (Scopus)

Abstract

Radiation therapy is an important curative modality in the treatment of patients with head and neck cancer. However, radiation-induced changes in the oral cavity, such as xerostomia and mucositis, are among the most debilitating treatment sequelae experienced by patients undergoing radiation therapy, and attempts at ameliorating these side effects have been poor at best. Pilocarpine has been approved for post-radiation xerostomia, and the effect of its use during radiation therapy on salivary flow, xerostomia, mucositis, and quality of life (QOL) was assessed in a phase III study conducted by the Radiation Therapy Oncology Group (RTOG 97-09). In total, 245 evaluable patients were randomized to pilocarpine or placebo. Selected patients were required to have ≥ 50% of the volume of the major salivary glands receive ≥ 50Gy; to agree to provide stimulated and unstimulated samples of saliva (measured in g) before treatment, at the end of treatment, and 3 and 6 months after completion of radiation therapy; and to complete the University of Washington Head and Neck Symptom Scale. Following the completion of radiation therapy, the average unstimulated salivary flow was statistically greater in the pilocarpine group, whereas no difference was noted following parotid stimulation. There was no effect on the amelioration of mucositis. The results of the QOL scales did not reveal any significant difference between the pilocarpine and placebo groups with regard to xerostomia and mucositis. The significant difference in unstimulated salivary flow supports the concomitant use of oral pilocarpine to decrease radiation-associated xerostomia. However, the absent correlation between improved salivary flow and QOL scores is of some concern (though not a new finding) and may be related to the existence of comorbidities and the lack of effect on mucositis.

Original languageEnglish (US)
Pages (from-to)252-258
Number of pages7
JournalJournal of Supportive Oncology
Volume4
Issue number5
StatePublished - May 2006

Fingerprint

Pilocarpine
Xerostomia
Head and Neck Neoplasms
Mucositis
Radiotherapy
Quality of Life
Placebos
Radiation
Radiation Oncology
Radiation Effects
Therapeutics
Salivary Glands
Saliva
Mouth
Comorbidity
Neck
Head

ASJC Scopus subject areas

  • Oncology
  • Pharmacology (medical)

Cite this

Scarantino, C. W., LeVeque, F., Swann, R. S., White, R., Schulsinger, A., Hodson, D. I., ... Lee, N. (2006). Effect of pilocarpine during radiation therapy: Results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. Journal of Supportive Oncology, 4(5), 252-258.

Effect of pilocarpine during radiation therapy : Results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. / Scarantino, Charles W.; LeVeque, Francis; Swann, R. Suzanne; White, Robert; Schulsinger, Alan; Hodson, D. Ian; Meredith, Ruby; Foote, Robert; Brachman, David; Lee, Nancy.

In: Journal of Supportive Oncology, Vol. 4, No. 5, 05.2006, p. 252-258.

Research output: Contribution to journalArticle

Scarantino, CW, LeVeque, F, Swann, RS, White, R, Schulsinger, A, Hodson, DI, Meredith, R, Foote, R, Brachman, D & Lee, N 2006, 'Effect of pilocarpine during radiation therapy: Results of RTOG 97-09, a phase III randomized study in head and neck cancer patients', Journal of Supportive Oncology, vol. 4, no. 5, pp. 252-258.
Scarantino, Charles W. ; LeVeque, Francis ; Swann, R. Suzanne ; White, Robert ; Schulsinger, Alan ; Hodson, D. Ian ; Meredith, Ruby ; Foote, Robert ; Brachman, David ; Lee, Nancy. / Effect of pilocarpine during radiation therapy : Results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. In: Journal of Supportive Oncology. 2006 ; Vol. 4, No. 5. pp. 252-258.
@article{ee41bf8009294e17a6806e78f9da4981,
title = "Effect of pilocarpine during radiation therapy: Results of RTOG 97-09, a phase III randomized study in head and neck cancer patients",
abstract = "Radiation therapy is an important curative modality in the treatment of patients with head and neck cancer. However, radiation-induced changes in the oral cavity, such as xerostomia and mucositis, are among the most debilitating treatment sequelae experienced by patients undergoing radiation therapy, and attempts at ameliorating these side effects have been poor at best. Pilocarpine has been approved for post-radiation xerostomia, and the effect of its use during radiation therapy on salivary flow, xerostomia, mucositis, and quality of life (QOL) was assessed in a phase III study conducted by the Radiation Therapy Oncology Group (RTOG 97-09). In total, 245 evaluable patients were randomized to pilocarpine or placebo. Selected patients were required to have ≥ 50{\%} of the volume of the major salivary glands receive ≥ 50Gy; to agree to provide stimulated and unstimulated samples of saliva (measured in g) before treatment, at the end of treatment, and 3 and 6 months after completion of radiation therapy; and to complete the University of Washington Head and Neck Symptom Scale. Following the completion of radiation therapy, the average unstimulated salivary flow was statistically greater in the pilocarpine group, whereas no difference was noted following parotid stimulation. There was no effect on the amelioration of mucositis. The results of the QOL scales did not reveal any significant difference between the pilocarpine and placebo groups with regard to xerostomia and mucositis. The significant difference in unstimulated salivary flow supports the concomitant use of oral pilocarpine to decrease radiation-associated xerostomia. However, the absent correlation between improved salivary flow and QOL scores is of some concern (though not a new finding) and may be related to the existence of comorbidities and the lack of effect on mucositis.",
author = "Scarantino, {Charles W.} and Francis LeVeque and Swann, {R. Suzanne} and Robert White and Alan Schulsinger and Hodson, {D. Ian} and Ruby Meredith and Robert Foote and David Brachman and Nancy Lee",
year = "2006",
month = "5",
language = "English (US)",
volume = "4",
pages = "252--258",
journal = "Journal of Supportive Oncology",
issn = "1544-6794",
publisher = "Biolink Communications, Inc.",
number = "5",

}

TY - JOUR

T1 - Effect of pilocarpine during radiation therapy

T2 - Results of RTOG 97-09, a phase III randomized study in head and neck cancer patients

AU - Scarantino, Charles W.

AU - LeVeque, Francis

AU - Swann, R. Suzanne

AU - White, Robert

AU - Schulsinger, Alan

AU - Hodson, D. Ian

AU - Meredith, Ruby

AU - Foote, Robert

AU - Brachman, David

AU - Lee, Nancy

PY - 2006/5

Y1 - 2006/5

N2 - Radiation therapy is an important curative modality in the treatment of patients with head and neck cancer. However, radiation-induced changes in the oral cavity, such as xerostomia and mucositis, are among the most debilitating treatment sequelae experienced by patients undergoing radiation therapy, and attempts at ameliorating these side effects have been poor at best. Pilocarpine has been approved for post-radiation xerostomia, and the effect of its use during radiation therapy on salivary flow, xerostomia, mucositis, and quality of life (QOL) was assessed in a phase III study conducted by the Radiation Therapy Oncology Group (RTOG 97-09). In total, 245 evaluable patients were randomized to pilocarpine or placebo. Selected patients were required to have ≥ 50% of the volume of the major salivary glands receive ≥ 50Gy; to agree to provide stimulated and unstimulated samples of saliva (measured in g) before treatment, at the end of treatment, and 3 and 6 months after completion of radiation therapy; and to complete the University of Washington Head and Neck Symptom Scale. Following the completion of radiation therapy, the average unstimulated salivary flow was statistically greater in the pilocarpine group, whereas no difference was noted following parotid stimulation. There was no effect on the amelioration of mucositis. The results of the QOL scales did not reveal any significant difference between the pilocarpine and placebo groups with regard to xerostomia and mucositis. The significant difference in unstimulated salivary flow supports the concomitant use of oral pilocarpine to decrease radiation-associated xerostomia. However, the absent correlation between improved salivary flow and QOL scores is of some concern (though not a new finding) and may be related to the existence of comorbidities and the lack of effect on mucositis.

AB - Radiation therapy is an important curative modality in the treatment of patients with head and neck cancer. However, radiation-induced changes in the oral cavity, such as xerostomia and mucositis, are among the most debilitating treatment sequelae experienced by patients undergoing radiation therapy, and attempts at ameliorating these side effects have been poor at best. Pilocarpine has been approved for post-radiation xerostomia, and the effect of its use during radiation therapy on salivary flow, xerostomia, mucositis, and quality of life (QOL) was assessed in a phase III study conducted by the Radiation Therapy Oncology Group (RTOG 97-09). In total, 245 evaluable patients were randomized to pilocarpine or placebo. Selected patients were required to have ≥ 50% of the volume of the major salivary glands receive ≥ 50Gy; to agree to provide stimulated and unstimulated samples of saliva (measured in g) before treatment, at the end of treatment, and 3 and 6 months after completion of radiation therapy; and to complete the University of Washington Head and Neck Symptom Scale. Following the completion of radiation therapy, the average unstimulated salivary flow was statistically greater in the pilocarpine group, whereas no difference was noted following parotid stimulation. There was no effect on the amelioration of mucositis. The results of the QOL scales did not reveal any significant difference between the pilocarpine and placebo groups with regard to xerostomia and mucositis. The significant difference in unstimulated salivary flow supports the concomitant use of oral pilocarpine to decrease radiation-associated xerostomia. However, the absent correlation between improved salivary flow and QOL scores is of some concern (though not a new finding) and may be related to the existence of comorbidities and the lack of effect on mucositis.

UR - http://www.scopus.com/inward/record.url?scp=33646792561&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33646792561&partnerID=8YFLogxK

M3 - Article

C2 - 16724649

AN - SCOPUS:33646792561

VL - 4

SP - 252

EP - 258

JO - Journal of Supportive Oncology

JF - Journal of Supportive Oncology

SN - 1544-6794

IS - 5

ER -