Adjuvant oral 5-fluorouracil for cervical cancer: Japanese Gynecologic Oncology Group report.

Japanese women with low-stage cervical cancer receiving radical hysterectomy and radiotherapy have a good 5-year survival rate. However, women with risk factors such as nodal metastasis may benefit from adjuvant chemotherapy, which was studied in women having surgery alone or surgery plus radiotherapy. Patients having surgery alone (S) (n=623) or surgery and radiotherapy (SR) (n=919) were randomly assigned to receive or not receive oral 5-fluorouracil (5-FU) for 1 year. The effect of various factors on survival was studied by multivariate analysis. Patients who received S obtained no benefit from 5-FU, whereas 5-FU-treated SR patients had significantly better 5-year survival than those not receiving chemotherapy (P=0.043). The SR patients without nodal metastases had a better survival rate if they received 5-FU (P<0.001), whereas those with nodal metastases did not. Oral 5-FU after radical hysterectomy with radiotherapy appears useful for patients with low-stage cervical cancer who have some risk factors but not for those with pelvic lymph node metastases.