Phase II study of definitive chemoradiation for locally advanced squamous cell cancer of the vulva: An efficacy study

To evaluate feasibility of chemoradiation as alternative for extensive surgery in patients with locally advanced vulvar cancer and to report on locoregional control, toxicity and survival. In a multicenter, prospective phase II trial patients with locally advanced vulvar cancer were treated with loc...

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Published inGynecologic oncology Vol. 163; no. 1; pp. 117 - 124
Main Authors van Triest, Baukelien, Rasing, Marnix, van der Velden, Jacobus, de Hullu, Joanne, Witteveen, Petronella O., Beukema, Jannet C., van der Steen-Banasik, Elsbieta, Westerveld, Henrike, Snyers, An, Peters, Max, Creutzberg, Carien L., Nout, Remi A., Lutgens, Ludy, Jürgenliemk-Schulz, Ina
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.10.2021
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Summary:To evaluate feasibility of chemoradiation as alternative for extensive surgery in patients with locally advanced vulvar cancer and to report on locoregional control, toxicity and survival. In a multicenter, prospective phase II trial patients with locally advanced vulvar cancer were treated with locoregional radiotherapy combined with sensitizing chemotherapy (capecitabine). Treatment feasibility, percentage locoregional control, survival and toxicity were evaluated. 52 patients with mainly T2/T3 disease were treated according to the study protocol in 10 centers in the Netherlands from 2007 to 2019. Full dose radiotherapy (tumor dose of 64.8Gy) was delivered in 92% and full dose capecitabine in 69% of patients. Most prevalent acute ≥ grade 3 toxicities were regarding skin/mucosa and pain (54% and 37%). Late ≥grade 3 toxicity was reported for skin/mucosa (10%), fibrosis (4%), GI incontinence (4%) and stress fracture or osteoradionecrosis (4%). Twelve weeks after treatment, local clinical complete response (cCR) and regional control (RC) rates were 62% and 75%, respectively. After 2 years, local cCR persisted in 22 patients (42%) and RC was 58%. Thirty patients (58%) had no evidence of disease at end of follow-up (median 35 months). In 9 patients (17%) extensive surgery with stoma formation was needed. Progression free survival was 58%, 51% and 45% and overall survival was 76%, 66%, 52% at 1,2, and 5 years. Definitive capecitabine-based chemoradiation as alternative for extensive surgery is feasible in locally advanced vulvar cancer and results in considerable locoregional control with acceptable survival rates with manageable acute and late toxicity. •Surgery for locally advanced vulvar cancer is often extensive with stoma formation or need for reconstructive surgery.•Definitive capecitabine-based chemoradiation is feasible with acceptable acute and late toxicity.•Local clinical complete response of 62% after 12 weeks and persistent local control of 42% after 2 years•Need for subsequent stoma formation in only 17% of patients.•Definitive chemoradiation can serve as alternative for extensive surgery in locally advanced vulvar cancer.
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ISSN:0090-8258
1095-6859
DOI:10.1016/j.ygyno.2021.07.020