Combined preoperative chemoradiotherapy followed by radical surgery in locally advanced vulvar carcinoma. A pilot study

Cancer. 1996 Apr 15;77(8):1472-8. doi: 10.1002/(SICI)1097-0142(19960415)77:8<1472::AID-CNCR8>3.0.CO;2-E.


Background: Although for decades exenterative surgery has represented the standard treatment for patients with locally advanced vulvar cancer, combined approaches, including preoperative radiation with or without chemotherapy, are now considered the treatment of choice. We report the results of a pilot study on concurrent chemoradiotheraphy followed by radical surgery for patients with locally advanced squamous cell carcinomas of the vulva.

Methods: Thirty-one patients with squamous cell carcinoma of the vulva were treated with two courses of combination chemotherapy mitomycin C, 15 mg/m2 intravenously (i.v.) on Day 1, and 5-fluorouracil, 750 mg/m2 i.v., in continuous 24-hour infusion on Days 1 to 5. Inguinal and pelvic lymph node chains and the vulva were irradiated (starting on the same day as the chemotherapy) up to a total dose of 36 Gy. After a 2-week interval, a second course of chemoradiotherapy was given (18 Gy on the vulvar region only). After 2 weeks, patients underwent radical surgery.

Results: An objective response was observed in 22 of 24 primary cases (91.6%) and in 7 of 7 recurrent cases. All but two unresponsive patients underwent radical surgery. The postoperative morbidity rate was 65% (19 of 29 patients), and the mortality rate was 13.8% (4 of 29 patients). Five of nine patients (55%) with biopsy-proven inguinal lymph node metastases showed no residual lymph node disease in the surgical specimen. The recurrence rate was 31.8% and the medial follow-up time was 34 months.

Conclusions: Chemoradiotherapy seems to be effective for squamous cell carcinoma of the vulva. If treatment-related morbidity could be decreased, such a combined approach might offer a new perspectives for a conservative treatment of locally advanced vulvar cancer.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Squamous Cell / radiotherapy
  • Carcinoma, Squamous Cell / surgery
  • Carcinoma, Squamous Cell / therapy*
  • Combined Modality Therapy
  • Female
  • Fluorouracil / administration & dosage
  • Follow-Up Studies
  • Humans
  • Lymph Node Excision
  • Middle Aged
  • Mitomycin / administration & dosage
  • Neoplasm Recurrence, Local
  • Neoplasm Staging
  • Pilot Projects
  • Postoperative Care
  • Preoperative Care
  • Vulvar Neoplasms / radiotherapy
  • Vulvar Neoplasms / surgery
  • Vulvar Neoplasms / therapy*


  • Mitomycin
  • Fluorouracil