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Ten-Year Treatment Results of RTOG 79-20

Marvin Rotman, MD; Thomas F. Pajak, PhD; Kwang Choi, MD; Michelle Clery; Victor Marcial, MD; Perry W. Grigsby, MD; Jay Cooper, MD; Madhu John, MD

JAMA. 1995;274(5):387-393.

Abstract
Objective.
—To investigate whether irradiation to the standard pelvic field only improves the response rate and survival in comparison with pelvic plus para-aortic irradiation in patients with high-risk cervical carcinoma, and to investigate patterns of failure and treatment-related toxicity.

Design.
—Randomized controlled trial from November 1979 to October 1986, with stratification by histology, para-aortic nodal status, and International Federation of Gynecology and Obstetrics (FIGO) stage.

Setting.
—Radiation Therapy Oncology Group (RTOG) multicenter clinical trial.

Patients.
—A total of 367 patients with FIGO stage IB or IIA primary cervical cancers measuring 4 cm or greater in lateral diameter or with FIGO stage IIB cervical cancers were randomized to RTOG protocol 79-20 to receive either standard pelvic only irradiation or pelvic plus para-aortic irradiation.

Intervention.
—Pelvic only irradiation consisted of a midplane pelvic dose of 40 to 50 Gy in 4.5 to 6.5 weeks with daily fractions of 1.6 to 1.8 Gy for 5 d/wk. Pelvic plus para-aortic irradiation delivered 44 to 45 Gy in 4.5 to 6.5 weeks with daily fractions of 1.6 to 1.8 Gy for 5 d/wk. A total dose of 4000 to 5000 mg/h of radium equivalent or 30 to 40 Gy was provided by intracavitary brachytherapy to point A.

Main Outcome Measures.
—Response rate, overall and disease-free survival, patterns of failure, and treatment-related toxicities.

Results.
—Ten-year overall survival was 44% for the pelvic only irradiation arm and 55% for the pelvic plus para-aortic irradiation arm (P=.02). Cumulative incidence of death due to cervical cancer was estimated as significantly higher in the pelvic only arm at 10 years (P=.01). Disease-free survival was similar in both arms; 40% for the pelvic only arm and 42% for the pelvic plus para-aortic arm. Locoregional failures were similar at 10 years for both arms (pelvic only, 35%; pelvic plus para-aortic, 31%; P=.44). In complete responders, the patterns of locoregional failures were the same for both arms, but there was a lower cumulative incidence for first distant failure in the pelvic plus para-aortic irradiation arm (P=.053). Survival following first failure was significantly higher in the pelvic plus para-aortic arm (P=.007). A higher percentage of local failures were salvaged long-term on the pelvic plus para-aortic arm compared with the pelvic only arm (25% vs 8%). The cumulative incidence of grade 4 and 5 toxicities at 10 years in the pelvic plus para-aortic arm was 8%, compared with 4% in the pelvic only arm (P=.06). The death rate due to radiotherapy complications was higher in the pelvic plus para-aortic arm (four [2%] of 170) compared with the pelvic only arm (one [1%] of 167) (P=.38). The proportion of deaths due to radiotherapy complications in the pelvic plus para-aortic arm was higher than in the pelvic only arm (four [6%] of 67 vs one [1%] of 85; P=.24). If the patient had abdominal surgery prior to para-aortic irradiation, the estimated cumulative incidence of grade 4 and 5 complications was 11%, compared with 2% in the pelvic only arm.

Conclusions.
—The statistically significant difference in overall survival at 10 years for the pelvic plus para-aortic irradiation arm, without a difference in disease-free survival, can be explained by the following two factors: (1) a lower incidence of distant failure in complete responders and (2) a better salvage in the complete responders who later failed locally.

(JAMA. 1995;274:387-393)

Author Affiliations
From the Department of Radiation Oncology, State University of New York Health Science Center at Brooklyn (Drs Rotman and Choi); Radiation Therapy Oncology Group Headquarters, Philadelphia, Pa (Dr Pajak and Ms Clery); Radiation Oncology Center, San Juan, Puerto Rico (Dr Marcial); Mallinckrodt Institute of Radiology, St Louis, Mo (Dr Grigsby); New York University, Tisch Hospital, New York, NY (Dr Cooper); and Kaweah Delta Cancer Care Center, Visalia, Calif (Dr John).

Footnotes
Reprint requests to the Department of Radiation Oncology, State University of New York Health Science Center at Brooklyn, 450 Clarkson Ave, Box 1211, Brooklyn, NY 11203 (Dr Rotman).

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