Chemotherapy versus radiotherapy versus observation for high-risk cervicalcarcinoma after radical hysterectomy: A randomized, prospective, multicenter trial

Background. Adjuvant treatment modalities after radical hysterectomy have l ong been used in an attempt to eradicate microscopic tumor residuals in pat ients at high risk for recurrence. However, it has not been clearly demonst rated that adjuvant radiation, adjuvant chemotherapy, or both improve the o utcome. To evaluate the effect of adjuvant treatment in patients with high- risk cervical cancer after radical hysterectomy, the Austrian Gynecologic O ncology Group conducted a prospective, randomized, multicenter clinical tri al between 1989 and 1995. Material and Methods. Seventy-six patients with stage IB-IIB cervical cance r treated with radical hysterectomy with pelvic lymph node metastases and/o r vascular invasion randomly received adjuvant chemotherapy (400 mg/m(2) ca rboplatin, and 30 mg bleomycin), standardized external pelvic radiation the rapy, or no further treatment. Results. After a median follow-up of 4.1 years (range, 2-7) there were no s tatistically significant differences (P = 0.9530) in disease-free survival among the three treatment arms. Conclusion. The data suggest that adjuvant chemotherapy or radiation do not improve survival or recurrence rates in high-risk cervical cancer patients after radical hysterectomy. The most important treatment for these patient s seems to be radical abdominal hysterectomy with systematic pelvic lymphad enectomy. (C) 1999 Academic Press.