doi:10.1016/j.ijrobp.2004.05.046 CLINICAL INVESTIGATION Cervix LACK OF BENEFIT OF CONCURRENT CHEMOTHERAPY IN PATIENTS WITH CERVICAL CANCER AND NEGATIVE LYMPH NODES BY FDG-PET PERRY W. GRIGSBY, M.D.,* †‡ DAVID G. MUTCH, M.D., ‡§ JANET RADER, M.D., ‡§ THOMAS J. HERZOG, M.D., ‡§ IMRAN ZOBERI, M.D.,* ‡ BARRY A. SIEGEL, M.D., †‡ AND FARROKH DEHDASHTI, M.D. †‡ *Department of Radiation Oncology and † Division of Nuclear Medicine, Mallinckrodt Institute of Radiology; ‡ Alvin J. Siteman Cancer Center and § Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO Purpose: To compare the outcome of patients with cervical cancer and negative lymph nodes by fluorodeoxy- glucose-positron emission tomography (FDG-PET) treated with irradiation (RT) and concurrent chemotherapy or RT alone. Methods and Materials: This was a prospective data registry of 65 patients with cervical cancer and negative lymph nodes by whole-body FDG-PET. The tumor stage was IB2 in 11, IIB in 37, and IIIB in 17 patients. RT alone was administered to 15 and RT with concurrent weekly cisplatin to 50 patients. Results: The 5-year overall survival estimate was 85% with RT and 81% with RT and concurrent chemotherapy (p  0.91). The corresponding 5-year cause-specific survival estimates were 78% and 74% (p  0.98). The differences in the sites of recurrence (pelvis vs. distant metastasis) were not statistically significant between the two groups (p  0.77). A Cox proportional hazards model of survival outcome did not identify chemotherapy, overall treatment time, or radiation dose as statistically significant prognostic factors. Severe complications included one rectovaginal fistula, one rectal stricture requiring colostomy (both in the concurrent chemotherapy group), and one death from chemotherapy-related complications. Conclusion: Irradiation with concurrent cisplatin was not advantageous compared with RT alone in patients with negative lymph nodes on FDG-PET. © 2005 Elsevier Inc. Lymph nodes, Cervical Cancer, Concurrent chemotherapy, Cisplatin, Irradiation. INTRODUCTION It is currently recommended that patients with advanced cervical cancer should be treated with irradiation (RT) and concurrent chemotherapy (1). The purpose of this combined modality therapy is to improve survival by increasing con- trol of the primary cervical tumor and decreasing the rate of distant metastatic failure. However, the definition of ad- vanced disease has not been clearly elucidated and not all patients will benefit from adjuvant chemotherapy. Despite this, it is often assumed that all patients treated with RT should receive concurrent chemotherapy. In addition to such factors as patient age, obesity, comorbid conditions, and patient choice, some patients treated with RT will have early-stage disease and may not benefit from concurrent chemotherapy. Patients with early-stage cervical cancer may be treated with surgery or RT with equivalent survival outcomes (2). Many patients treated primarily with surgery do not benefit from adjuvant therapy. However, some do. Postoperatively, patients with pathologic risk factors indicative of a poor outcome, such as large tumor size, deep stromal tumor invasion, and lymphovascular space involvement are treated with pelvic RT to decrease the risk of pelvic recurrence (3). These patients do not undergo concurrent chemotherapy. If the risk factors that necessitated postoperative RT could have been known preoperatively, such patients would have been treated with RT rather than surgery. Postoperatively, the use of adjuvant RT and concurrent chemotherapy is reserved for those patients who have positive lymph nodes, positive parametrial invasion, or positive surgical margins and, therefore, are at risk of developing metastatic disease (4, 5). Hence, one may assume that a group of patients exists with early-stage cervical cancer, treated with RT (rather than surgery), in whom the lymph nodes are negative and for whom the use of additional concurrent chemotherapy will not be beneficial. The purpose of the current study was to evaluate the Reprint requests to: Perry W. Grigsby, M.D., Department of Radiation Oncology, Box 8224, Washington University School of Medicine, 4921 Parkview Pl., Lower Level, St. Louis, MO 63110. Tel: (314) 362-8502; Fax: (314) 362-8521; E-mail: pgrigsby@wustl.edu Received Dec 15, 2003, and in revised form Mar 18, 2004. Accepted for publication May 19, 2004. Int. J. Radiation Oncology Biol. Phys., Vol. 61, No. 2, pp. 444 – 449, 2005 Copyright © 2005 Elsevier Inc. Printed in the USA. All rights reserved 0360-3016/05/$–see front matter 444