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


CONCLUSIONS
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.
Grigsby
Perry
P
Department of Radiation Oncology, Washington University School of Medicine, 4939 Children's Place, Suite 5500, St. Louis, MO 63110, USA. grigsbyp@netscape.net
Winter
Kathryn
K
Komaki
Ritsuko
R
Marcial
Victor
V
Eifel
Patricia
P
Doncals
Desiree
D
Stevens
Randy
R
Rotman
Marvin
M
Gaffney
David
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011879:Radiotherapy Dosage; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000532:radiotherapy*