Multicenter phase 2 trial of cisplatin plus gemcitabine and IMRT for locally advanced vulvar squamous cell carcinoma

The multicenter phase 2 NRG Oncology/GOG Study 279 evaluated cisplatin plus gemcitabine in combination with intensity-modulated radiation therapy in patients with locally advanced vulvar squamous cell carcinoma not amenable to surgery. The treatment resulted in complete pathologic response in 73% of evaluable patients (90% CI 61-83), with a 12-month progression-free survival rate of 74% (62,2-82,7) and a 24-month overall survival rate of70% (57-79). The most common grade 3 or 4 adverse events were hematologic toxicity and radiation dermatitis. The authors conclude that the combination of cisplatin with gemcitabine and IMRT had activity for locally advanced vulvar squamous cell carcinoma not amenable to surgical resection.