A phase I—II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer

Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2–T4a N0/NX M0 bladder cancer were ente...

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Veröffentlicht in:Annals of oncology 2001-07, Vol.12 (7), p.929-935
Hauptverfasser: Hussain, S. A., Moffitt, D. D., Glaholm, J. G., Peake, D., Wallace, D. M. A., James, N. D.
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container_end_page 935
container_issue 7
container_start_page 929
container_title Annals of oncology
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creator Hussain, S. A.
Moffitt, D. D.
Glaholm, J. G.
Peake, D.
Wallace, D. M. A.
James, N. D.
description Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2–T4a N0/NX M0 bladder cancer were entered into this single centre phase I—II study. Patients received radiotherapy to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was given with Mitomycin C 12 mg/m2 day 1 and 5-fluorouracil 500 mg/m2/24 hours weeks one and four of radiotherapy for five or seven days on each occasion. Results: Thirty-one patients entered the trial from March 1998 to December 1999 (22: 5-day; 9: 7-day schedule). Median age was 68 (range 58–79) years, 23 males and 8 females; T2: 9 (29%); T3a: 4 (12%); T3b: 9 (29%); 14: 9 (29%); TCC grade 2:8 (26%) and grade 3: 23 (74%); 14 of 31 had hydronephrosis. Ten of thirty-one had a GFR
doi_str_mv 10.1023/A:1011133820532
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A. ; Moffitt, D. D. ; Glaholm, J. G. ; Peake, D. ; Wallace, D. M. A. ; James, N. D.</creator><creatorcontrib>Hussain, S. A. ; Moffitt, D. D. ; Glaholm, J. G. ; Peake, D. ; Wallace, D. M. A. ; James, N. D.</creatorcontrib><description>Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2–T4a N0/NX M0 bladder cancer were entered into this single centre phase I—II study. Patients received radiotherapy to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was given with Mitomycin C 12 mg/m2 day 1 and 5-fluorouracil 500 mg/m2/24 hours weeks one and four of radiotherapy for five or seven days on each occasion. Results: Thirty-one patients entered the trial from March 1998 to December 1999 (22: 5-day; 9: 7-day schedule). Median age was 68 (range 58–79) years, 23 males and 8 females; T2: 9 (29%); T3a: 4 (12%); T3b: 9 (29%); 14: 9 (29%); TCC grade 2:8 (26%) and grade 3: 23 (74%); 14 of 31 had hydronephrosis. Ten of thirty-one had a GFR &lt;50 ml/min. Toxicity was mild to moderate with the five-day schedule. More severe toxicity was seen with the seven-day schedule: five of nine patients failed to complete planned therapy. Pathological complete response rate at three months was 74% (5-day regimen) and 50% (7-day regimen). Overall 12-month survival was 65%. Conclusion: Chemoradiotherapy with the five-day schedule is feasible with acceptable toxicity in poor prognosis patients. 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A.</creatorcontrib><creatorcontrib>Moffitt, D. D.</creatorcontrib><creatorcontrib>Glaholm, J. G.</creatorcontrib><creatorcontrib>Peake, D.</creatorcontrib><creatorcontrib>Wallace, D. M. A.</creatorcontrib><creatorcontrib>James, N. D.</creatorcontrib><title>A phase I—II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2–T4a N0/NX M0 bladder cancer were entered into this single centre phase I—II study. Patients received radiotherapy to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was given with Mitomycin C 12 mg/m2 day 1 and 5-fluorouracil 500 mg/m2/24 hours weeks one and four of radiotherapy for five or seven days on each occasion. Results: Thirty-one patients entered the trial from March 1998 to December 1999 (22: 5-day; 9: 7-day schedule). Median age was 68 (range 58–79) years, 23 males and 8 females; T2: 9 (29%); T3a: 4 (12%); T3b: 9 (29%); 14: 9 (29%); TCC grade 2:8 (26%) and grade 3: 23 (74%); 14 of 31 had hydronephrosis. Ten of thirty-one had a GFR &lt;50 ml/min. Toxicity was mild to moderate with the five-day schedule. More severe toxicity was seen with the seven-day schedule: five of nine patients failed to complete planned therapy. Pathological complete response rate at three months was 74% (5-day regimen) and 50% (7-day regimen). Overall 12-month survival was 65%. Conclusion: Chemoradiotherapy with the five-day schedule is feasible with acceptable toxicity in poor prognosis patients. 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subjects Aged
Antibiotics, Antineoplastic - administration & dosage
Antimetabolites, Antineoplastic - administration & dosage
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
bladder cancer
Carcinoma, Transitional Cell - diagnosis
Carcinoma, Transitional Cell - drug therapy
Carcinoma, Transitional Cell - physiopathology
Carcinoma, Transitional Cell - radiotherapy
chemoradiation
Chemotherapy, Adjuvant
Combined treatments (chemotherapy of immunotherapy associated with an other treatment)
Female
Fluorouracil - administration & dosage
Glomerular Filtration Rate
Humans
Male
Medical sciences
Middle Aged
Mitomycin - administration & dosage
Neoplasm Invasiveness
organ preservation
Pharmacology. Drug treatments
Prognosis
Radiotherapy, Adjuvant
Survival Analysis
Treatment Outcome
Urinary Bladder Neoplasms - diagnosis
Urinary Bladder Neoplasms - drug therapy
Urinary Bladder Neoplasms - physiopathology
Urinary Bladder Neoplasms - radiotherapy
title A phase I—II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer
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