PREOPERATIVE CHEMORADIATION FOR ADVANCED VULVAR CANCER - A PHASE-II STUDY OF THE GYNECOLOGIC-ONCOLOGY-GROUP

Purpose: To determine the feasibility of using preoperative chemoradio therapy to avert the need for more radical surgery for patients with T -3 primary tumors, or the need for pelvic exenteration for patients wi th T-4 primary tumors, not amenable to resection by standard radical v ulvectomy, Methods and Materials: Seventy-three evaluable patients wit h clinical Stage III-IV squamous cell vulvar carcinoma were enrolled i n this prospective, multi-institutional trial. Treatment consisted of a planned split course of concurrent cisplatin/5-fluorouracil and radi ation therapy followed by surgical excision of the residual primary tu mor plus bilateral inguinal-femoral lymph node dissection. Radiation t herapy was delivered to the primary tumor volume via anterior-posterio r-posterior-anterior (AP-PA) fields in 170-cGy fractions to a dose of 4760 cGy. Patients with inoperable groin nodes received chemoradiation to the primary vulvar tumor, inguinal-femoral and lower pelvic lymph nodes, Results: Seven patients did not undergo a post-treatment surgic al procedure: deteriorating medical condition (2 patients); other medi cal condition (1 patient); unresectable residual tumor (2 patients); p atient refusal (2 patients). Following chemoradiotherapy, 33/71 (46.5% ) patients had no visible vulvar cancer at the time of planned surgery and 38/71 (53.5%) had gross residual cancer at the time of operation, Five of the latter 38 patients had positive resection margins and und erwent: further radiation therapy to the vulva (3 patients); wide loca l excision and vaginectomy necessitating colostomy (1 patient); no fur ther therapy (1 patient). Using this strategy of preoperative, split-c ourse, twice-daily radiation combined with cisplatin plus 5-fluorourac il chemotherapy, only 2/71 (2.8%) had residual unresectable disease. I n only three patients was it not possible to preserve urinary and/or g astrointestinal continence, Toxicity was acceptable, with acute cutane ous reactions to chemoradiotherapy and surgical wound complications be ing the most common adverse effects, Conclusion: Preoperative chemorad iotherapy in advanced squamous cell carcinoma of the vulva is feasible , and may reduce the need for more radical surgery including primary p elvic exenteration. (C) 1998 Elsevier Science Inc.