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GOG 74

Early Stage I Carcinoma of the Vulva treated With Ipsilateral Superficial Inguinal Lymphadenectomy and Modified Radical Hemivulvectomy: A Prospective Study of the Gynecologic Oncology Group
Date of Publication:

April 1, 1992

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/1553164/
Hypothesis:

Modified radical hemivulvectomy with ipsilateral superficial ingu9inal lymphadenectomy is an alternative to radical operation for select patients with stage I carcinoma of the vulva.

Control Arm(s):

Historical comparison group from GOG 36 (588 patients who underwent radical vulvectomy and bilateral inguinofemoral lymphadenectomy): 96 patients with stage I disease, 5mm or less invasion, no LVSI, and negative inguinal and femoral nodes

Experimental Arm(s):

Modified radical hemivulvectomy + superficial inguinal lymphadenectomy
-Depth at least 1cm below the lesion
-2cm margin of normal skin around the lesion
-Superficial inguinal lymphadenectomy w/preservation of cribriform fascia

Primary End Point:

OS, Recurrence free interval, Site of Recurrence

Inclusion Criteria:

-Primary, previously untreated, invasive carcinoma of the vulva, Stage I (FIGO 1971)
-Vulvar lesion 2cm or less in greatest dimension (T1)
-Lymph nodes if palpable had to be nonsuspicious (N0, N1)

Exclusion Criteria:

-Patients medically unsuited for an operation
-Prior radiation therapy or chemotherapy
-Prior malignancy other than non-melanoma skin cancer
-Intraop exclusion criteria: positive frozen section of superficial inguinal nodes
-Postop exclusion criteria: + LVSI, Max thickness > 5mm, + margins

Results:

Experimental (121) vs Controls (98)

Recurrence free interval at 5 years: 15.6% experimental vs. 7.2% historical control (SS)
Recurrence locations:
--Vulva 8.2% vs 6.2% (NS)
--Groin 7.3% (6 ipsilateral, 3 contralateral) vs 0
--"Pelvic": 1 in control

OS at 5 years: 87.6% vs 82.6% (NS)
Experimental: 7 deaths (47%) due to non-disease related reasons

Conclusions:

Modified radical hemivulvectomy and ipsilateral inguinal lymphadenectomy is an alternative to traditional radical operation for these selected patients with stage I carcinoma of the vulva. The number of patients who experienced recurrence in the operated groin is of concern and may be attributable to the decision to leave the femoral nodes intact.

Reviewer:
Laurel K Berry