GOG 205

Background

Phase II single-arm GOG 205. N=58, T3–T4 squamous cell carcinoma of the vulva requiring primary exenterative surgery (unresectable without unacceptable morbidity). Neoadjuvant concurrent chemoradiation to convert unresectable disease to resectable and avoid exenteration.

Interventions and follow up

Treatment: Neoadjuvant concurrent cisplatin + 5-FU + radiation (57.6 Gy to primary site)
Primary endpoint: Pathologic complete response rate at surgery
mFollow up: Median ~37 month

Results

Complete clinical response: 37/58 (64%)
Underwent surgery: 40/58 (69%); pCR among these 33/40 (82.5%)
Overall pCR rate: 33/58 (57%) of all enrolled
3-year OS: ~56%

Adverse events

Hematologic: Grade 3–4 ~17%
GI: Grade 3 ~10%
Skin: Confluent moist desquamation common, manageable
Hospitalization: Treatment-related ~20%
Death: 1 treatment-related death

Conclusions

Neoadjuvant cisplatin-based chemoradiation achieves high pCR (57% of all patients; 82.5% of those resected) in locally advanced vulvar cancer, avoiding exenteration in the majority. Preferred approach for T3–T4 unresectable disease with definitive (non-exenterative) resection in responders.

Key Limitations

Single-arm phase II; no comparator. Small N=58. Limited data beyond 3 years. Optimal RT dose/chemo combination not definitively established. Not all patients can undergo post-CRT surgery. No quality-of-life data.

Clinical Context

Established neoadjuvant cisplatin-based chemoradiation followed by surgery as the preferred approach for locally advanced (T3–T4) unresectable vulvar cancer. ASCO/ESMO guidance supports definitive CRT followed by restaging and surgery for responders, a quality-of-life improvement over primary exenteration. The 57.6 Gy primary-site dose has influenced subsequent contouring guidelines.

References