TriangleHEALTH PROFESSIONAL · SOURCE READING
Localized node-negative disease
Source: Vulvar Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 14, 2025 · Captured 2026-09-09.
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Context: Treatment Option Overview for Vulvar Cancer / Radiation Therapy
A randomized trial to address the efficacy of radiation therapy in patients with clinically localized vulvar cancer has been reported.[14,15] In that study, women with disease clinically confined to the vulva, who did not have clinically suspicious groin lymph node metastases, underwent radical vulvectomy followed by either groin radiation (50 Gy at 2 Gy per fraction) or groin dissection (plus groin radiation if nodes were pathologically involved). Although the planned accrual was 300 patients, the study was stopped after 58 women were randomly assigned because of worse outcomes in the radiation therapy arm.
Five of 27 (18.5%) women in the radiation therapy arm and 0 of 25 women in the groin dissection arm had a groin recurrence, but this difference was not statistically significant (relative risk [RR], 10.21; 95% CI, 0.59–175.78).
There were ten deaths in the radiation therapy arm and three deaths in the groin dissection arm (RR, 4.31; 95% CI, 1.03–18.15).
Disease-specific mortality was not statistically significantly different between the two arms. However, there were eight vulvar cancer–related deaths in the radiation therapy arm versus two vulvar cancer–related deaths in the groin dissection arm (including one related to the groin dissection surgery) (RR, 3.70; 95% CI, 0.87–15.80).[14,15][Level of evidence A1]
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There were fewer cases of lymphedema (none in the radiation therapy arm vs. seven in the groin dissection arm) and shorter hospital stays in the radiation therapy arm. The dose penetration of the radiation (3 cm for full dose) has been criticized as inadequate.[14]
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In summary, the trial was stopped prematurely, and little can be said about the relative efficacy of the two treatment approaches.[14]
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Preserved source evidence · Not medical advice