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Phase II study of definitive chemoradiation for locally advanced squamous cell cancer of the vulva
- Source :
- Gynecologic Oncology, 163(1), 117-124. Academic Press, Gynecologic oncology, 163(1), 117-124. Academic Press Inc., Gynecologic Oncology, 163, 1, pp. 117-124, Gynecologic Oncology, 163, 117-124, Gynecologic Oncology, 163(1), 117-124. ACADEMIC PRESS INC ELSEVIER SCIENCE
- Publication Year :
- 2021
-
Abstract
- Objective. 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. Methods. 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. Results. 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. Conclusions. 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. (c) 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
- Subjects :
- Adult
medicine.medical_specialty
CARCINOMA
Osteoradionecrosis
MODULATED RADIATION-THERAPY
medicine.medical_treatment
EUROPEAN-ORGANIZATION
Phases of clinical research
ORAL FLUOROPYRIMIDINE CARBAMATE
PREOPERATIVE CHEMORADIATION
Definitive chemoradiotherapy
Gastroenterology
Capecitabine
All institutes and research themes of the Radboud University Medical Center
SDG 3 - Good Health and Well-being
QUALITY-OF-LIFE
Internal medicine
medicine
Humans
Prospective Studies
Progression-free survival
Aged
Aged, 80 and over
Salvage Therapy
Chemotherapy
Toxicity
Vulvar cancer
Vulvar Neoplasms
business.industry
Obstetrics and Gynecology
Chemoradiotherapy
CHEMOTHERAPY
Middle Aged
medicine.disease
Women's cancers Radboud Institute for Health Sciences [Radboudumc 17]
Radiation therapy
TOXICITY CRITERIA
Oncology
Carcinoma, Squamous Cell
Locally advanced
Female
Organ-sparing
business
RADIOTHERAPY
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 00908258
- Volume :
- 163
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Gynecologic Oncology
- Accession number :
- edsair.doi.dedup.....6318faf3a3bda95644be767cdfe0c37e