Objective To evaluate efficacy of weekly paclitaxel/carboplatin chemotherapy in patients with locally advanced, metastatic, or recurrent vulvar squamous cell carcinoma.

Method A prospective, single-arm, single-center pilot study was initiated to study response rate of 9 weekly courses of paclitaxel (60 mg/m²) and carboplatin (area under the curve, 2.7). We used this regimen in the neoadjuvant or metastatic setting when surgery would cause serious morbidity or was not an option owing to distant metastases. Primary outcome was response rate, measured according to Response Criteria in Solid Tumors criteria. Treatment toxicity, surgical morbidity, and type of surgery were also evaluated.

Results We treated 6 patients in the period between May 2009 and May 2011, of which 4 patients had a diagnosis of locally advanced disease and 2 patients had a diagnosis of recurrent disease. A median number of 7.5 cycles of paclitaxel/carboplatin weekly was administered (range, 3–9). No objective response was observed. Paclitaxel/carboplatin weekly was discontinued after a mean of 4.3 weekly cycles in 3 patients owing to local disease progression. After a median follow-up of 4.2 months (range, 1–29 months), 3 patients died owing to progressive disease and 1 patient died owing to intercurrent disease. The 2 remaining patients underwent radical vulvectomy + bilateral inguinofemoral lymphadenectomy after neoadjuvant chemotherapy. The main chemotherapy-related toxicity was anemia and could be managed conservatively with erythropoietin and intravenous iron therapy.

Conclusion Weekly administration of paclitaxel-carboplatin has limited clinical benefit in the treatment of vulvar squamous cell carcinoma.