A prospective randomized study concerning the point A dose in high-dose rate intracavitary therapy for carcinoma of the uterine cervix. The final results.

  • 1 November 1994
    • journal article
    • clinical trial
    • Vol. 170  (11) , 636-42
Abstract
High-dose rate (HDR) remote afterloading intracavitary therapy has been recognized as an effective and safe treatment modality for carcinoma of the uterine cervix. Since 1983, a prospective randomized study was started in order to investigate the more advantageous treatment schedule with keeping the local control rate. This paper reports the final results in terms of survival, local control and complications. Between January 1983 and February 1989, a total of 165 patients with carcinoma of the uterine cervix was entered in a prospective randomized study concerning the point A dose of HDR therapy (6 Gy/fraction vs 7.5 Gy/fraction) and external irradiation dose at Department of Radiation Therapy, The Center for Adult Diseases, Osaka. UICC [20] stage distribution of patients was as follows: stage IA = 4, stage IB = 33, stage IIA = 18, stage IIB = 38, stage III = 57, stage IV = 15. Overall 5-year cause specific survivals were as follows: stage IA = 100%, stage IB = 96%, stage IIA = 92%, stage IIB = 79%, stage III = 57%, stage IV = 27%. In each stage, 5-year survival rates in groups A and B were 100%, 93% in stage I, 82% and 85% in stage II, 62% and 52% in stage II and 22% and 31% in stage IV, respectively. There were no statistically significant differences among these survival curves in each stage. Five-year local failure rates were 16% in group A and 16% in group B (p = 0.9096), and corresponding distant failure rates were 23% in group A and 19% in group B (p = 0.2955). Moderate-to-severe complications requiring treatment (Kottmeier's grade 2 or more) were noted in 6 patients (7%) in group A and 6 patients (7%) in group B. All of the bladder and rectal complications needed medical treatment (Kottmeier's grade 2). Severe complications receiving surgery were noted in 4 patients (A: 1; B: 3), i.e., small intestine 3 and sigmoid colon 1 patient. Another 1 patient (A) was dead of ileus. There were no statistically significant differences between 2 treatment schedules in survival rates, failure patterns and complications rates. This fact suggests that small number of fractions (7.5 Gy/fraction) may be advantageous because of short duration and a low load of treatment.

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