RESUMEN
On the basis of previous experiences indicating that the anti-oxidant agent Cu/Zn superoxide dismutase (SOD) is an effective drug in reducing acute and late radiation-induced tissue injury, in the Center of Radiotherapy and Oncology of Catalonia, Barcelona, Spain in 1990 we implemented a randomized prospective study to analyze the incidence and grade of side effects in a group of bladder cancer patients. After surgery patients were randomly allocated to receive either: Option A: Radiotherapy or Option B: Radiotherapy + SOD 8 mgr/IM/day, after each radiotherapeutic application. Between January 1990 and January 1995 a total of 448 patients were included (226 A/ 222 B). Apart from cutaneous side effects, a highly significant incidence of radioinduced acute cystitis and rectitis was detected in patients not treated by SOD. Which was similar to the delayed side effects. From our data we can conclude that SOD is effective in decreasing acute radioinduced damage, and also in preventing the appearance of more delayed disorders.
Asunto(s)
Antioxidantes/uso terapéutico , Cistitis/prevención & control , Metaloproteínas/uso terapéutico , Traumatismos por Radiación/prevención & control , Radioterapia/efectos adversos , Superóxido Dismutasa/uso terapéutico , Neoplasias de la Vejiga Urinaria/radioterapia , Anciano , Análisis de Varianza , Antioxidantes/efectos adversos , Terapia Combinada , Cistitis/etiología , Femenino , Humanos , Masculino , Metaloproteínas/efectos adversos , Persona de Mediana Edad , Estadificación de Neoplasias , Estudios Prospectivos , Traumatismos por Radiación/etiología , Superóxido Dismutasa/efectos adversos , Neoplasias de la Vejiga Urinaria/patología , Neoplasias de la Vejiga Urinaria/cirugíaRESUMEN
From January 1978 to January 1988, 859 patients with T3-T4, NO-3, MO were randomly allocated to receive either: Group A--60Co 60, 60 Gy in 30 fractions; Group B--60Co, 70.4 Gy in 64 fractions; Group C--60Co, 60 Gy in 30 fractions plus chemotherapy (5 Fu, 250 mg/m2/IV every 2 days). Chemotherapy and radiotherapy were combined simultaneously. The average age was 56 years; the male/female ratio was 802/57. Median performance status (ECOG scale) was 1 (range 0-2). The TNM distribution as UICC criteria was T3 529 patients; T4 330 patients; No 217 patients; N1 52 patients; N2 319 patients; and N3 271 patients. The primary sites were nasopharynx 92, oral cavity 252, hypopharynx 119, larynx 310, and others (sinuses and unknown primary)86. Complete response was achieved in 188/277 patients in Group A (67.8%), 254/282 patients in Group B (90%), and 289/300 in Group C (96.3%). All patients were followed and statistical analysis shows a significant improvement in median duration of response, as well as survival for Groups B and C compared with Group A. No significant differences were seen between Group B and C. The acute toxicity was mucositis, skin toxicity, bone marrow depression. A mean temporary weight loss of 4.9 Kg was observed with a range of 2.3-10.5 Kg.