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Войти в исследования La Clinica terapeutica · 1998
Combined hyperfractionated radiotherapy and protracted infusion chemotherapy in bladder cancer for organ preservation.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Saracino B, Arcangeli G, Mecozzi A, Tirindelli Danesi D, Cruciani E, Altavista P, Giannarelli D
Аннотация
PURPOSE: To test an innovative schedule of concurrent protracted intravenous infusion (PVI) of cisplatin (CDDP) and 5-fluorouracil (5-FU) and hyperfractionated radiotherapy (HFRT) with organ-sparing intent in bladder cancer.
PATIENTS AND METHODS: Fifty-two patients (pts) were selected to receive an aggressive TURB followed by 2 MCV cycles, and HFRT with concomitant CDDP and 5-FU PVI (33 pts) or HFRT and concomitant CDDP and 5-FU PVI (20 pts). The 5-FU and CDDP doses ranged from 180 to 220 mg/sm/day and from 4 to 6 mg/sm/day, respectively. Radiotherapy was delivered as three 100 cGy fraction per day or two 150 cGy fraction per day to a total dose of 50 Gy to the pelvis and a 20 Gy boost to the bladder.
RESULTS: Grade III toxicity in pts who received or not MCV was: rectal tenesmus 12/33 and 0/20, dysuria 6/33 and 4/20, leukopenia 3/33 and 0/20, thrombocytopenia 7/33 and 1/20 pts, respectively. A Grade IV toxicity was observed in 2 pts. Of the 28 evaluable patients treated with MCV, CR were observed in 23 (82%) and PR in 5 cases. Of the 18 evaluable patients treated without MCV, CR were observed in 18 cases (100%). Actually, 65% and 14% of the CR pts treated with or without HCV are alive and free of tumor.
CONCLUSIONS: This bladder-sparing treatment shows an acceptable acute and late toxicity, similar to that observed with radiotherapy alone. The high CRs and bladder preservation rates observed deserve further clinical evaluation.
PATIENTS AND METHODS: Fifty-two patients (pts) were selected to receive an aggressive TURB followed by 2 MCV cycles, and HFRT with concomitant CDDP and 5-FU PVI (33 pts) or HFRT and concomitant CDDP and 5-FU PVI (20 pts). The 5-FU and CDDP doses ranged from 180 to 220 mg/sm/day and from 4 to 6 mg/sm/day, respectively. Radiotherapy was delivered as three 100 cGy fraction per day or two 150 cGy fraction per day to a total dose of 50 Gy to the pelvis and a 20 Gy boost to the bladder.
RESULTS: Grade III toxicity in pts who received or not MCV was: rectal tenesmus 12/33 and 0/20, dysuria 6/33 and 4/20, leukopenia 3/33 and 0/20, thrombocytopenia 7/33 and 1/20 pts, respectively. A Grade IV toxicity was observed in 2 pts. Of the 28 evaluable patients treated with MCV, CR were observed in 23 (82%) and PR in 5 cases. Of the 18 evaluable patients treated without MCV, CR were observed in 18 cases (100%). Actually, 65% and 14% of the CR pts treated with or without HCV are alive and free of tumor.
CONCLUSIONS: This bladder-sparing treatment shows an acceptable acute and late toxicity, similar to that observed with radiotherapy alone. The high CRs and bladder preservation rates observed deserve further clinical evaluation.