Long-term follow-up of RTOG 88-05: twice-daily external irradiation with brachytherapy for carcinoma of the cervix.

PURPOSE: To evaluate the efficacy and toxicity of twice-daily external irradiation to the pelvis with brachytherapy for carcinoma of the cervix in a long-term follow-up study. METHODS AND MATERIALS: This study was designed to administer twice-daily irradiation doses of 1.2 Gy to the pelvis, 5 d/wk. Radiotherapy also included one or two low-dose-rate intracavitary implants, to deliver a total minimal dose of 85 Gy to point A and 65 Gy to the lateral pelvic lymph nodes. RESULTS: Eighty-one patients with clinical Stage IB-IVA carcinoma of the cervix were enrolled in this prospective, single arm, Phase I/II study. Hyperfractionated irradiation was completed in 88%. Brachytherapy was given in two implants in 46% and in one implant in 54%. Six patients had acute Grade 3 toxicities. The cumulative rate of Grade 3 and 4 late effects for patients with Stage IB2, IIA, and IIB disease was 7% at 3 years, 7% at 5 years, and 10% at 8 years. For patients with Stage III and IVA disease, the rate of late toxicities (Grades 3 and 4) was 7% at 3 years and 12% at 5 years. The site of first failure was in the pelvis in 41%, para-aortic or supraclavicular lymph nodes in 6%, and other distant metastatic sites in 14%. The absolute survival rate was 61% at 3 years, 48% at 5 years, and 45% at 8 years. The disease-free survival rate was 43% at 3 years, 38% at 5 years, and 33% at 8 years. CONCLUSION: The results suggest that, combined with brachytherapy, hyperfractionated irradiation to total parametrial doses about 10% greater than doses administered with standard fractionation pelvic irradiation was tolerated and at least appears to be as effective as standard fractionation pelvic irradiation.