Top Line: What is the response rate for definitive chemoradiation for locally advanced vulvar cancer?
The Study: GOG 279 was a single arm, phase 2 trial of 52 patients with locally advanced vulvar squamous cell carcinoma (T2-3 N0-3) that was not amenable to radical vulvectomy. Before treatment, those with positive nodes had unilateral or bilateral inguinal lymphadenectomy. They were treated with IMRT and concurrent, weekly gemcitabine (50mg/m2) and cisplatin (40mg/m2). The total radiation dose to gross nodal and primary disease was 64 Gy in 34 fractions. Overall, 81% of patients completed all treatment. At 6-8 weeks after treatment, patients with a clinical complete response had biopsies to confirm response. The pathologic complete response rate was 73%, and the rate of PFS was 70% at 24 months. This is a significant improvement in response rate and treatment outcomes compared to older trials such as GOG 205. Though there were changes in the chemo regimen, the biggest improvements were from advances in radiation techniques that allowed tolerable dose escalation. 85% of patients had grade 3+ toxicity with the most frequent being heme toxicity, hypomagnesemia, and dermatitis.
TBL: GOG 279 made significant advances in the treatment of locally advanced vulvar cancer with a pathologic complete response rate of 73% from 64 Gy in 34 fractions and concurrent gemcitabine and cisplatin. | Horowitz, J Clin Oncol 2024
The Study: GOG 279 was a single arm, phase 2 trial of 52 patients with locally advanced vulvar squamous cell carcinoma (T2-3 N0-3) that was not amenable to radical vulvectomy. Before treatment, those with positive nodes had unilateral or bilateral inguinal lymphadenectomy. They were treated with IMRT and concurrent, weekly gemcitabine (50mg/m2) and cisplatin (40mg/m2). The total radiation dose to gross nodal and primary disease was 64 Gy in 34 fractions. Overall, 81% of patients completed all treatment. At 6-8 weeks after treatment, patients with a clinical complete response had biopsies to confirm response. The pathologic complete response rate was 73%, and the rate of PFS was 70% at 24 months. This is a significant improvement in response rate and treatment outcomes compared to older trials such as GOG 205. Though there were changes in the chemo regimen, the biggest improvements were from advances in radiation techniques that allowed tolerable dose escalation. 85% of patients had grade 3+ toxicity with the most frequent being heme toxicity, hypomagnesemia, and dermatitis.
TBL: GOG 279 made significant advances in the treatment of locally advanced vulvar cancer with a pathologic complete response rate of 73% from 64 Gy in 34 fractions and concurrent gemcitabine and cisplatin. | Horowitz, J Clin Oncol 2024