NEW ORLEANS—In the treatment of locoregionally advanced cervical cancer, the addition of cisplatin(Drug information on cisplatin) (Platinol)-containing chemotherapy to a radiation therapy regimen significantly improves overall and disease-free survival, according to RTOG 90-01. Patricia J. Eifel, MD, of the Department of Radiation Oncology, M.D. Anderson Cancer Center, presented the data at the American Society for Therapeutic Radiology and Oncology plenary session (abstract plenary 1).
Preliminary findings from this study in 1999 "stimulated widespread evolution in the standard treatment of patients with high-risk cervical cancer," Dr. Eifel said. The updated analysis also included information about late complications.
The study was a randomized trial comparing extended-field radiotherapy with chemoradiation in 403 women enrolled between 1990 and 1997. Patients had stage IIB-IVA cervical cancer, stage IB2-IIA disease with a tumor diameter 5 cm or larger, or positive pelvic lymph nodes. Para-aortic lymph nodes were evaluated with either lymphangiogram or lymphadenectomy.
Patients were stratified by stage (IB-IIB and III-IVA) and by method of lymph node evaluation, Dr. Eifel said. Overall, 25% had positive pelvic lymph nodes and 30% had stage III-IVA disease. For patients with stage IB-IIB disease, median tumor diameter was 6 cm. In spite of disease stage, all patients were considered to have quite bulky and locally advanced disease.
One group (n = 195 evaluable) was randomized to receive extended-field radiation therapy, with 45 Gy to the pelvis and para-aortic nodes followed by low-dose-rate intracavitary radiation (brachy-therapy). The other group (n = 195 evaluable) received chemoradiation, with 45 Gy pelvic radiation therapy, intracavitary radiation therapy, and three cycles of concomitant chemotherapy with cisplatin 75 mg/m2 and fluorouracil(Drug information on fluorouracil) (5-FU) 4 g/m2 by continuous infusion over 96 hours.
More than two thirds of patients (68%) completed three cycles of chemotherapy, and 81% received at least two cycles. The median dose of radiation was 86 to 87 Gy, and median duration of treatment was 58 days. Median follow-up was 4.6 years altogether, and 6.6 years for surviving patients.
Study Results
