Preoperative chemo-radiation for carcinoma of the vulva with N2/N3 nodes: A Gynecologic Oncology Group study

Purpose: To determine if patients with carcinoma of the vulva, with N2/N3 l ymph nodes, could undergo resection of the lymph nodes and primary tumor fo llowing preoperative chemo-radiation, Methods and Materials: Fifty-two patients were entered in the study, but si s patients did not meet the criteria of the protocol and were excluded. The remaining 46 patients are the subject of this report. Patients underwent a split course of radiation, 3760 cGy to the primary and lymph nodes,with co ncurrent chemotherapy, cisplatin/5-FU, followed by surgery, Results: Four patients did not complete the chemo-radiation, because three expired and one refused to complete the treatment. Four patients who comple ted chemo-radiation did not undergo surgery, because two of them died of no n-cancer-related causes, and in the other two patients, the nodes remained unresectable, Following chemo-radiation, the disease in the lymph nodes bec ame resectable in 38/40 patients. Two patients who completed the course of chemo-radiation did not undergo surgery as per protocol because of pulmonar y metastasis. One underwent radical vulvectomy and unilateral node dissecti on and the other radical vulvectomy only. The specimen of the lymph nodes w as histologically negative in 15/37 patients. Nineteen patients developed r ecurrent and/or metastatic disease. The sites of failure were as follows: p rimary area only, 9; lymph node area only, 1; primary area and distant meta stasis, 1; distant metastasis only, 8, Local control of the disease in the lymph nodes was achieved ed in 36/37 and in the primary area in 29/38 of th e patients. Twenty patients are alive and disease-free, and five have expir ed without evidence of recurrence or metastasis. Two patients died of treat ment-related complications, Conclusion: High resectability and local control rates of the lymph nodes m ere obtained in patients with carcinoma of the vulva with N2/N3 nodes treat ed preoperatively with chemo-radiation. (C) 2000 Elsevier Science Inc.