A randomized trial of pelvic radiation therapy versus no further therapy in selected patients with stage is carcinoma of the cervix after radical hysterectomy and pelvic lymphadenectomy: A gynecologic oncology group study

Objective. The objective of this study was to evaluate the benefits and ris k of adjuvant pelvic radiotherapy aimed at reducing recurrence in women wit h Stage IB cervical cancer treated by radical hysterectomy and pelvic lymph adenectomy. Methods. Two hundred seventy-seven eligible patients were entered with at l east two of the following risk factors: > 1/3 stromal invasion, capillary l ymphatic space involvement, and large clinical tumor diameter. Of 277 patie nts, 137 were randomized to pelvic radiotherapy (RT) and 140 to no further treatment (NFT). Results. Twenty-one (15%) in the RT group and 39 (28%) in the NFT group had a cancer recurrence, 18 of whom were vaginal/pelvic in the RT and 27 in th e NFT group. In the RT group, of 18 (13%) who died, 15 died of cancer. In t he NFT group, of the 30 (21%) who died, 25 died from cancer. Life table ana lysis indicated a statistically significant (47%) reduction in risk of recu rrence (relative risk = 0.53, P = 0.008, one-tail) among the RT group, with recurrence-free rates at 2 years of 88% versus 79% for the RT and NFT grou ps, respectively. Severe or life-threatening (Gynecologic Oncology Group gr ade 3 or 4) urologic adverse effects occurred in 4 (3.1%) in the RT group a nd 2 (1.4%) in the NFT group; 3 (2.3%) and 1 (0.7%) hematologic; 4 (3.1%) a nd 0 gastrointestinal (GI); and 1(0.8%) and 0 neurologic, respectively. One patient's death was attributable to grade 4 GI adverse effects, Conclusions. Adjuvant pelvic radiotherapy following radical surgery reduces the number of recurrences in women with Stage IB cervical cancer at the co st of 6% grade 3/4 adverse events versus 2.1% in the NFT group. (C) 1999 Ac ademic Press.