Intratumoral administration of hypoxic sensitizers in the radiotherapy of 494 uterine cancer patients: long-term results

Purpose: In Kazakh Institute of Oncology and Radiology we made clinical trials of direct interstitial of metronidazole (later, also Sanazole-AK 2123) in patients treated with radiotherapy for cancer of uterine cervix and endometrial. The indicated treatment was completed in 435 uterine cervix and 97 endometrial cancer patients, the respective numbers of controls being 263 and 36. We were only able to carry out a limited number of randomized studies, as news about a novel method of treatment with unprecedentedly good results had spread widely and patients in an increasing number were requesting treatment with the new regime. All the patients were followed for a minimum of 5 years after termination of treatment. The last examination we made in 2001 year.
Patients characteristics: To the clinical investigation were admitted patients with cervix tumors in stages IIB and III, and patients with endometrial cancer in stages IB, IIB and III. Distant metastasis, neuropathy and liver and kidney dysfunction cases, or patients over 70 years of age were excluded. Assessment of long-term cervix tumor results was based exclusively on squamous cell data as the most highly representative morphological sample (Table 1). As can be seen here, in both subject and control groups, 80% of the cervix occurred in the locally advanced stage III, out of these, 54.6% had both of the parametric involved in the process. Clinical staging was done according to the FIGO system. Pretreatment evaluation consisted of physical examination, routine laboratory studies and cystoscopy. Lymphographic test were included as required. Stage allocation and the degree of tumors morphology differentiation appear to be comparable in two arms (Table 2). This was found to apply also to small group of patients that underwent treatment therapy in a randomized fashion. In about one third of all cases, the degree of differentiation was established to have reached grades I and II (Tables 1-2).
Methods: RT was performed using combined external and intracavitary irradiations, with total dose varying between 65 and 72 Gy at Point A, and between 55 and 60 Gy at Point B. The treatment started with 5 fractions each of 3-4 Gy given every second day on the whole pelvic from two opposing fields 18 × 15 cm. Treatment continued with intracavitary irradiation per 5 Gy twice a week, and completed with 2 Gy boosters given at 48 intervals on two opposing narrow fields (5 × 15 cm). A 0.5%...


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