Radical hysterectomy followed by tailored postoperative therapy in the treatment of stage IB2 cervical cancer: feasibility and indications for adjuvant therapy

Objective. To determine the outcome, complications and likelihood of requiring adjuvant therapy of patients with stage IB2 cervical cancer treated with primary radical hysterectomy and lymph node dissection. Methods. Clinical and pathologic data between 1985 and 1999 were reviewed. Associations between clinical and pathologic variables were tested using the Fisher's exact test. Survival was estimated using the Kaplan-Meier method with significance being calculated using the Log Rank test. Results. Six hundred radical hysterectomies were performed during the study period. Fifty-eight of these women (9.6% of all radical hysterectomies) were diagnosed with FIGO stage IB2 cancers. Sixteen patients (28%) had positive pelvic lymph nodes. Forty-six patients (79%) had invasion involving the outer 1/3 of the cervical stroma, six had positive vaginal margins while five had occult parametrial extension. After retrospective review of the histopathologic data from this case series, criteria from two recently published prospective multicenter Gynecologic Oncology Group (GOG) trials were applied to this data set. According to criteria established by GOG protocol 92, 30 (52%) patients should have theoretically received adjuvant pelvic radiation while 21 (36%) would have qualified for adjuvant chemotherapy and radiation according to the results of GOG protocol 109. In actual fact, only 35 patients (60%) received adjuvant radiotherapy and one received adjuvant chemo-radiation. Severe toxicity was unusual with two developing urinary fistulae and one having a pulmonary embolism. Despite the lack of adjuvant therapy in most cases, only 21 women (38%) recurred of whom 11 failed on the pelvic wall, with an estimated 5-year survival of 62.1%. Conclusions. Radical hysterectomy and tailored adjuvant radiation therapy in stage 1132 cervical cancer is feasible. Even without the liberal use of adjuvant therapy, survival in this high-risk group compares favorably to primary chemotherapy and radiation. According to recently published randomized clinical trials, most patients should receive adjuvant postoperative therapy. The benefits of this multimodality approach require randomized study. (C) 2004 Elsevier Inc. All rights reserved.