OBJECTIVE: To determine the feasibility of performing neoadjuvant chemotherapy (NCH) followed by radical surgery in patients with locally advanced squamous cell carcinoma of the vulva. METHODS: Prospective and multicenter trial. Thirty-five patients with a diagnosis of previously untreated locally advanced squamous cell carcinoma of the vulva were given 4 schemes of cisplatin-based NCH and 1 NCH regimen with single bleomycin. Then, they underwent radical surgery of the vulva if clinical response was 50% or more. Age, NCH schemes used, toxicity, response to treatment, type of radical surgery performed, and clinical outcome were evaluated. RESULTS: Thirty-three patients completed the proposed schemes, and 30 were assessed for radical surgery. Finally, 27 patients underwent radical surgery (radical vulvectomy or radical local excision plus bilateral inguinofemoral lymphadenectomy). In 2 cases of persistent rectal involvement, posterior pelvic exenteration was performed. Moreover, 24 of 27 patients remain with no evidence of disease to date. Toxicity was acceptable. Median age was 62 years (range, 54-72 years). Median follow-up was 49 months (range, 4-155 months). CONCLUSIONS: The use of NCH in selected groups may increase surgical feasibility in initially inoperable patients, thus favoring organ preservation and less extensive resections. Adverse reactions were acceptable, and vulvoperineal deleterious effects that may occur after radiotherapy were consequently avoided.
OBJECTIVE: To determine the feasibility of performing neoadjuvant chemotherapy (NCH) followed by radical surgery in patients with locally advanced squamous cell carcinoma of the vulva. METHODS: Prospective and multicenter trial. Thirty-five patients with a diagnosis of previously untreated locally advanced squamous cell carcinoma of the vulva were given 4 schemes of cisplatin-based NCH and 1 NCH regimen with single bleomycin. Then, they underwent radical surgery of the vulva if clinical response was 50% or more. Age, NCH schemes used, toxicity, response to treatment, type of radical surgery performed, and clinical outcome were evaluated. RESULTS: Thirty-three patients completed the proposed schemes, and 30 were assessed for radical surgery. Finally, 27 patients underwent radical surgery (radical vulvectomy or radical local excision plus bilateral inguinofemoral lymphadenectomy). In 2 cases of persistent rectal involvement, posterior pelvic exenteration was performed. Moreover, 24 of 27 patients remain with no evidence of disease to date. Toxicity was acceptable. Median age was 62 years (range, 54-72 years). Median follow-up was 49 months (range, 4-155 months). CONCLUSIONS: The use of NCH in selected groups may increase surgical feasibility in initially inoperable patients, thus favoring organ preservation and less extensive resections. Adverse reactions were acceptable, and vulvoperineal deleterious effects that may occur after radiotherapy were consequently avoided.