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dc.contributor.authorHussain, SAen
dc.contributor.authorStocken, DDen
dc.contributor.authorPeake, DRen
dc.contributor.authorGlaholm, JGen
dc.contributor.authorZarkar, Aen
dc.contributor.authorWallace, DMAen
dc.contributor.authorJames, NDen

We conducted a phase I/II study investigating synchronous chemoradiotherapy with mitomycin C and infusional 5-fluorouracil (5-FU) in muscle invasive bladder cancer. Early dose escalation results were previously published. We report the long-term toxicity and efficacy results with the optimised regimen. Patients with muscle invasive bladder cancer with glomerular filtration rate >25 ml min(-1) were eligible. Mitomycin (12 mg m(-2) on day 1 only) and infusional 5-FU (500 mg m(-2) day(-1)) for 5 days were administered during weeks 1 and 4 of radiotherapy of 55 Gy in 20 fractions. A total of 41 patients were enrolled, median age was 68 years, 33 were male and eight female patients. Out of the 41 patients, 20 (49%) had hydronephrosis at presentation and 25 (62%) had T3b or T4 disease. Four patients experienced Grade III thrombocytopenia and three patients had Grade III neutropenia. There were no episodes of febrile neutropenia. Four patients experienced Grade III diarrhoea and 1 Grade III urgency and dysuria. Six patients did not undergo cystoscopic evaluation due to early metastatic spread although there was no clinical suggestion of bladder failure. In all, out of 35 evaluable patients, 25 (71%) had macroscopic complete response at 3-month cystoscopy, and biopsy confirmed in 24 out of 25. A total of 16 (39%) patients remain alive with a median follow-up of 50.7 (range 23.5-68.8) months, 14 with a functioning bladder with no reported long-term treatment-related bladder or bowel toxicity. Five out of 41 patients have undergone salvage cystectomy: two for persistent CIS, two T1 and one muscle invasive recurrence. Four patients have received intravesical chemotherapy, of whom two remain alive with a functioning bladder. Overall 12-, 24- and 60-month (m) survival rates were 68, 49 and 36%. Local and distant progression free rates were 82 and 86% at 12-m and 79 and 75% at 24-m. Organ preservation using multimodality therapy is feasible and safe, even in patients with poor renal reserve, and does not compromise salvage therapies. A national phase III trial BC2001 ( exploring the effects of synchronous chemoradiotherapy with this regimen is currently recruiting.

dc.format.extent2106 - 2111en
dc.subjectAntineoplastic Combined Chemotherapy Protocolsen
dc.subjectCarcinoma, Transitional Cellen
dc.subjectCombined Modality Therapyen
dc.subjectDose Fractionation, Radiationen
dc.subjectDrug Administration Scheduleen
dc.subjectInfusions, Intravenousen
dc.subjectMiddle Ageden
dc.subjectNeoplasm Invasivenessen
dc.subjectNeoplasm Recurrence, Localen
dc.subjectSurvival Analysisen
dc.subjectTreatment Outcomeen
dc.subjectUrinary Bladder Neoplasmsen
dc.titleLong-term results of a phase II study of synchronous chemoradiotherapy in advanced muscle invasive bladder cancer.en
dc.typeJournal Article
plymouth.journalBr J Canceren
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine/UoA01 Clinical Medicine
dc.rights.embargoperiodNot knownen
rioxxterms.typeJournal Article/Reviewen

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