GOG 205

A phase II trial of radiation therapy and weekly cisplatin chemotherapy for the treatment of locally-advanced squamous cell carcinoma of the vulva: a gynecologic oncology group study
Date of Publication:

November 9, 2011

Pubmed Link:
Does weekly cisplatin improve resectability of locally advanced vulvar cancer treated initially with EBRT?
Control Arm(s):
NA as this was a phase II trial
Experimental Arm(s):
EBRT 32 fractions of 1.8 Gy/fx with weekly Cisplatin 40mg/m2 x 5-7 weeks
Primary End Point:
Complete pathologic response
Inclusion Criteria:
Locally-advanced, previously untreated SCC of the vulva w/T3/T4 primary tumors not amenable to surgical resection by standard radical vulvectomy - PS 0-3 - Adequate bone marrow, renal, hepatic fxn - Judged "capable of tolerating a radical course of chemoradiation"
Exclusion Criteria:
- Vulvar melanomas or sarcomas - Septicemia or severe infection - GI bleeding or severe GI sx - Prior radiation or cytotoxic chemotherapy - Concurrent invasive malignancy (exception non-melanoma skin cancer) - Any evidence of cancer in the last 5 years
40/58 (70%) completed study treatment (>97% of radiation + at least 5 cycles of chemotherapy) - 37/58 (64%) with complete clinical response - 29/58 (50%) with complete pathological response

Patients with an inoperable tumor or lymph nodes benefit from chemoradiatoin if an operation of lesser scope can ultimately be performed.

Laurel K Berry