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Randomized Controlled Trial
. 2009 Sep;114(3):537-546.
doi: 10.1097/AOG.0b013e3181b12f99.

Radiation therapy compared with pelvic node resection for node-positive vulvar cancer: a randomized controlled trial

Charles Kunos  1 , Fiona Simpkins, Heidi Gibbons, Chunqiao Tian, Howard Homesley
Affiliations
Randomized Controlled Trial

Radiation therapy compared with pelvic node resection for node-positive vulvar cancer: a randomized controlled trial

Charles Kunos et al. Obstet Gynecol. 2009 Sep.

Abstract

Objectives: To report long-term survival and toxicity of radiation compared with pelvic node resection for patients with groin node-positive vulvar cancer.

Methods: A Gynecologic Oncology Group protocol enrolled 114 patients randomly allocated to postoperative pelvic and groin radiation (45-50 Gy, n=59) or to ipsilateral pelvic node resection (n=55) after radical vulvectomy and inguinal lymphadenectomy. Retrospective analyses for 114 enrolled patients included both risk of progression and death after treatment and assessment of toxicity.

Results: Median age was 70 years. Median survivor follow-up was 74 months. The relative risk of progression was 39% in radiation patients (95% confidence interval [CI] 0.17-0.88, P=.02). Fourteen intercurrent deaths occurred after radiation as compared with only two after pelvic node resection, narrowing 6-year overall survival (51% compared with 41%, hazard ratio 0.61 [95% CI 0.30-1.3], P=.18). However, the cancer-related death rate was significantly higher for pelvic node resection compared with radiation (51% compared with 29% at 6 years, hazard ratio 0.49 [95% CI 0.28-0.87], P=.015). Six-year overall survival benefit for radiation in patients with clinically suspected or fixed ulcerated groin nodes (P=.004) and two or more positive groin nodes (P<.001) persisted. A ratio of more than 20% positive ipsilateral groin nodes (number positive/number resected) was significantly associated with contralateral lymph node metastasis, relapse, and cancer-related death. Late chronic lymphedema (16% compared with 22%) and cutaneous desquamation (19% compared with 15%) were balanced after radiation and pelvic node resection.

Conclusion: Radiation after radical vulvectomy and inguinal lymphadenectomy significantly reduces local relapses and decreases cancer-related deaths. Late toxicities remained similar after radiation or pelvic node resection.

Level of evidence: I.

Trial registration: ClinicalTrials.gov NCT00898352.

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References

    1. Homesley H, Bundy B, Sedlis A, Adcock L. Radiation therapy versus pelvic node resection for carcinoma of the vulva with positive groin nodes. Obstet Gynecol 1986;68:733–40.
    1. Homesley H, Bundy B, Sedlis A, Yordan E, Berek JS, Jahshan A, et al. Assessment of current International Federation of Gynecology and Obstetrics staging of vulvar carcinoma relative to prognostic factors for survival (a Gynecologic Oncology Group Study). Am J Obstet Gynecol 1991;164:997–1003.
    1. Homesley H, Bundy B, Sedlis A, Yordan E, Berek JS, Jahshan A, et al. Prognostic factors for groin node metastasis in squamous cell carcinoma of the vulva (a Gynecological Oncology Group study). Gynecol Oncol 1993;49:279–83.
    1. Stehman FB, Bundy BN, Ball H, Clarke-Pearson DL. Sites of failure and times to failure in carcinoma of the vulva treated conservatively: a Gynecologic Oncology Group study. Am J Obstet Gynecol 1996;174:1128–32.
    1. Podratz K, Symmonds R, Taylor W, Williams T. Carcinoma of the vulva: analysis of treatment and survival. Obst Gynecol 1983;61:63–74.

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