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.


METHODS
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.


CONCLUSIONS
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.
Uyl-De Groot
Carin A
CA
Department of Health Care Policy and Management, Institute for Medical Technology Assessment, Erasmus Medical Center, 3000 DR Rotterdam, The Netherlands. uyl@bmg.eur.nl
Hartog
Jolanda Gelderblom-Den
JG
Derksen
Jos G M
JG
Symons
Edith A
EA
Buijt
Ivonne
I
van der Velden
Jacobus
J
van Lindert
Arnold C M
AC
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000191:economics / Q000627:therapeutic use*; D013509:Gynecologic Surgical Procedures; D006801:Humans; D008197:Lymph Node Excision; D008875:Middle Aged; D009426:Netherlands; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins; D014846:Vulvar Neoplasms / Q000523:psychology* / Q000601:surgery*; D014945:Wound Healing
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim