Cost-effectiveness and quality of life of granulocyte-colony stimulating factor (filgrastim) after radical vulvectomy and bilateral inguino-femoral lymphadenectomy: results of a randomized clinical trial

Objective: To examine the effect of filgrastim on the incidence of wound infection, quality of life and costs after a radical vulvectomy and bilateral inguino-femoral lymphadenectomy. Study design: In a prospective, randomized clinical trial 40 patients were treated with either filgrastim or placebo...

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Published in:European journal of obstetrics & gynecology and reproductive biology 2004-05, Vol.114 (1), p.77-82
Main Authors: Uyl-de Groot, Carin A., Hartog, Jolanda Gelderblom-den, Derksen, Jos G.M., Symons, Edith A., Buijt, Ivonne, van der Velden, Jacobus, van Lindert, Arnold C.M.
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Biological and medical sciences
Cost-Benefit Analysis
Costs
Double-Blind Method
Female
Filgrastim
Granulocyte Colony-Stimulating Factor - economics
Granulocyte Colony-Stimulating Factor - therapeutic use
Gynecologic Surgical Procedures
Gynecology. Andrology. Obstetrics
Humans
Lymph Node Excision
Medical sciences
Middle Aged
Netherlands
Postoperative Complications - prevention & control
Prospective Studies
Quality of Life
Radical vulvectomy
Recombinant Proteins
Vulva carcinoma
Vulvar Neoplasms - psychology
Vulvar Neoplasms - surgery
Wound Healing
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Summary:Objective: To examine the effect of filgrastim on the incidence of wound infection, quality of life and costs after a radical vulvectomy and bilateral inguino-femoral lymphadenectomy. Study design: In a prospective, randomized clinical trial 40 patients were treated with either filgrastim or placebo for 9 consecutive days starting at the day before surgery. Data on wound healing was scored up to 56 days postoperatively. Quality of life was measured and cost data were collected. Statistical analyses used were the Mann–Whitney test and the Student’s t-test. Results: The clinical results showed no differences in wound infection between both groups. The average score on the EuroQol showed that patients felt worst in the week after surgery. Treatment costs were higher in the filgrastim group versus the placebo group. Conclusion: Filgrastim does not improve wound healing after radical vulvectomy, does not improve quality of life and is not cost-effective. However, the postoperative stay after radical vulvectomy is relatively long due to wound healing problems and has a major impact on the patient’s quality of life.
ISSN:0301-2115
1872-7654
DOI:10.1016/j.ejogrb.2003.09.018