Pelvic node–positive disease

Patients with clinical stage I to stage IV primary squamous cell carcinoma of the vulva in whom groin node metastases were found at radical vulvectomy and bilateral groin lymph node dissection were randomly assigned (during the surgical procedure) to receive either ipsilateral pelvic node resection or pelvic radiation therapy (45 Gy–50 Gy at 1.8 Gy–2.0 Gy per fraction).[16] Because of a perceived emerging benefit of radiation therapy, the planned accrual of 152 patients was stopped after 114 patients were randomly assigned. However, the apparent benefit of radiation was subsequently attenuated with further follow-up.[16][Level of evidence A1]

Patients with clinical stage I to stage IV primary squamous cell carcinoma of the vulva in whom groin node metastases were found at radical vulvectomy and bilateral groin lymph node dissection were randomly assigned (during the surgical procedure) to receive either ipsilateral pelvic node resection or pelvic radiation therapy (45 Gy–50 Gy at 1.8 Gy–2.0 Gy per fraction).[16] Because of a perceived emerging benefit of radiation therapy, the planned accrual of 152 patients was stopped after 114 patients were randomly assigned. However, the apparent benefit of radiation was subsequently attenuated with further follow-up.[16][Level of evidence A1]

After a median follow-up of 74 months, the 6-year overall survival (OS) rate was 51% in the pelvic radiation therapy arm versus 41% in the pelvic node resection arm (hazard ratio [HR], 0.61; 95% CI, 0.3–1.3; P = .18).

Patients with clinical stage I to stage IV primary squamous cell carcinoma of the vulva in whom groin node metastases were found at radical vulvectomy and bilateral groin lymph node dissection were randomly assigned (during the surgical procedure) to receive either ipsilateral pelvic node resection or pelvic radiation therapy (45 Gy–50 Gy at 1.8 Gy–2.0 Gy per fraction).[16] Because of a perceived emerging benefit of radiation therapy, the planned accrual of 152 patients was stopped after 114 patients were randomly assigned. However, the apparent benefit of radiation was subsequently attenuated with further follow-up.[16][Level of evidence A1]

Vulvar cancer–specific mortality was statistically significantly lower in the pelvic radiation therapy arm (29% in the pelvic radiation therapy arm vs. 51% in the pelvic node resection arm) (HR, 0.49; 95% CI, 0.28–0.87; P = .015). However, there were 14 intercurrent deaths in the pelvic radiation therapy arm versus two deaths in the pelvic node resection arm.

Patients with clinical stage I to stage IV primary squamous cell carcinoma of the vulva in whom groin node metastases were found at radical vulvectomy and bilateral groin lymph node dissection were randomly assigned (during the surgical procedure) to receive either ipsilateral pelvic node resection or pelvic radiation therapy (45 Gy–50 Gy at 1.8 Gy–2.0 Gy per fraction).[16] Because of a perceived emerging benefit of radiation therapy, the planned accrual of 152 patients was stopped after 114 patients were randomly assigned. However, the apparent benefit of radiation was subsequently attenuated with further follow-up.[16][Level of evidence A1]

Late chronic lymphedema was similar in both trial arms with 16% in the pelvic radiation therapy arm and 22% in the pelvic node resection arm.