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 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. (C) 2003 Elsevier Ireland Ltd. All rights reserved