Double-blind, placebo-controlled, randomized trial of granulocyte-colony stimulating factor during postoperative radiotherapy for squamous head and neck cancer Journal Article


Authors: Su, Y. B.; Vickers, A. J.; Zelefsky, M. J.; Kraus, D. H.; Shaha, A. R.; Shah, J. P.; Serio, A. M.; Harrison, L. B.; Bosl, G. J.; Pfister, D. G.
Article Title: Double-blind, placebo-controlled, randomized trial of granulocyte-colony stimulating factor during postoperative radiotherapy for squamous head and neck cancer
Abstract: To evaluate the ability of granulocyte-stimulating factor to decrease mucositis during postoperative radiotherapy for stage II-IV squamous head and neck cancer in a randomized, double-blind, placebo-controlled trial. METHODS: After undergoing complete resection, patients were randomized to receive granulocyte-colony stimulating factor or placebo by daily subcutaneous injection during radiotherapy (63 Gy, 1.8 Gy/day). Patients undergoing prior radiotherapy or chemotherapy were excluded from the study. The primary outcome was the need for percutaneous endoscopic gastrostomy placement. Severity of mucositis was a secondary outcome. RESULTS: Forty-one patients were enrolled (132 planned). The study closed after slow accrual. Patient characteristics were as follows (granulocyte-colony stimulating factor vs placebo): median age, 59 versus 54 years; pT4, 16% versus 23%; pN2/3, 68% versus 59%; stage IV, 79% versus 68%. Forty patients were evaluable for planned outcomes. Patients in the granulocyte-colony stimulating factor arm showed trends toward lower rates of percutaneous endoscopic gastrostomy placement (0% vs 14%, P = 0.2) and severity of mucositis (P = 0.13), and had shorter mean radiotherapy duration (48.4 ± 4.32 days vs 51.6 ± 1.84 days, P = 0.005). Overall survival was significantly greater in the granulocyte-colony stimulating factor arm (hazard ratio, 0.37; P = 0.037). DISCUSSION: Granulocyte-colony stimulating factor during radiotherapy was feasible and led to significantly shorter radiotherapy duration and trends toward less percutaneous endoscopic gastrostomy placement and mucositis. The unanticipated improvement in survival outcomes warrants further hypothesis-driven investigation and validation. Copyright © 2006 Jones and Bartlett Publishers, Inc.
Keywords: adult; cancer survival; clinical article; controlled study; treatment outcome; aged; middle aged; clinical trial; fatigue; carcinoma, squamous cell; placebo; side effect; cancer radiotherapy; postoperative care; combined modality therapy; cancer staging; controlled clinical trial; skin defect; mucosa inflammation; randomized controlled trial; radiotherapy dosage; bone pain; coughing; rash; dysphagia; disease severity; head and neck cancer; head and neck neoplasms; endoscopic surgery; salivary gland disease; leukocyte count; double blind procedure; double-blind method; granulocyte colony stimulating factor; granulocyte colony-stimulating factor; mucositis; gastrostomy; desquamation; randomized clinical trial; symptom control; voice change
Journal Title: The Cancer Journal
Volume: 12
Issue: 3
ISSN: 1528-9117
Publisher: Lippincott Williams & Wilkins  
Date Published: 2006-05-01
Start Page: 182
End Page: 188
Language: English
DOI: 10.1097/00130404-200605000-00005
PUBMED: 16803675
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 11" - "Export Date: 4 June 2012" - "CODEN: CAJOC" - "Source: Scopus"
Altmetric Score
MSK Authors
  1. Yungpo Su
    16 Su
  2. Michael J Zelefsky
    619 Zelefsky
  3. Dennis Kraus
    259 Kraus
  4. Ashok R Shaha
    539 Shaha
  5. David G Pfister
    249 Pfister
  6. Andrew J Vickers
    560 Vickers
  7. Angel M Cronin
    145 Cronin
  8. Jatin P Shah
    543 Shah
  9. George Bosl
    262 Bosl