Long&amp;ndash;Term Risk of Salvage Cystectomy after Radiotherapy for Muscle&amp;ndash;Invasive Bladder Cancer

Cooke, Peter; Dunn, Janet A.; Latief, T.; Bathers, Sarah; James, Nicholas D.; Wallace, D. M. A.

doi:10.1159/000020294

Cited by 29 publications

(19 citation statements)

References 20 publications

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“…Although cystectomy is frequently seen as standard treatment (4), bladder-sparing protocols utilizing radical radiation therapy are used as an alternative for those patients unsuitable for or unwilling to undergo radical surgery. Historically, drawbacks of this approach were twofold: ( i ) the rate of incomplete response or local recurrence (up to 50%) (5) with the need for subsequent salvage cystectomy; and ( ii ) the risk of late toxicity in the bladder, rectum, or bowel (severe toxicity rates of 8%-10%, 3%-4%, and 1%-2% reported for bladder, rectum, and bowel, respectively (6)). …”

Section: Introductionmentioning

confidence: 99%

Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004)

Huddart

Hall²,

Hussain

et al. 2013

International Journal of Radiation Oncology*Biology*Physics

123

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PurposeTo test whether reducing radiation dose to uninvolved bladder while maintaining dose to the tumor would reduce side effects without impairing local control in the treatment of muscle-invasive bladder cancer.Methods and MaterialsIn this phase III multicenter trial, 219 patients were randomized to standard whole-bladder radiation therapy (sRT) or reduced high-dose volume radiation therapy (RHDVRT) that aimed to deliver full radiation dose to the tumor and 80% of maximum dose to the uninvolved bladder. Participants were also randomly assigned to receive radiation therapy alone or radiation therapy plus chemotherapy in a partial 2 × 2 factorial design. The primary endpoints for the radiation therapy volume comparison were late toxicity and time to locoregional recurrence (with a noninferiority margin of 10% at 2 years).ResultsOverall incidence of late toxicity was less than predicted, with a cumulative 2-year Radiation Therapy Oncology Group grade 3/4 toxicity rate of 13% (95% confidence interval 8%, 20%) and no statistically significant differences between groups. The difference in 2-year locoregional recurrence free rate (RHDVRT − sRT) was 6.4% (95% confidence interval −7.3%, 16.8%) under an intention to treat analysis and 2.6% (−12.8%, 14.6%) in the “per-protocol” population.ConclusionsIn this study RHDVRT did not result in a statistically significant reduction in late side effects compared with sRT, and noninferiority of locoregional control could not be concluded formally. However, overall low rates of clinically significant toxicity combined with low rates of invasive bladder cancer relapse confirm that (chemo)radiation therapy is a valid option for the treatment of muscle-invasive bladder cancer.

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Section: Introductionmentioning

confidence: 99%

Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004)

Huddart

Hall²,

Hussain

et al. 2013

International Journal of Radiation Oncology*Biology*Physics

123

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“…For every patient undergoing surgery in the UK there are two patients receiving radiation treatment (BAUS 2000). This approach suffers from a relatively high rate of incomplete response or local recurrence (up to 50%) with salvage cystectomy being used for failures (Parker and Huddart, 1996;Cooke et al, 2000).…”

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confidence: 99%

Long-term results of a phase II study of synchronous chemoradiotherapy in advanced muscle invasive bladder cancer

et al. 2004

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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 425 ml min À1 were eligible. Mitomycin (12 mg m À2 on day 1 only) and infusional 5-FU (500 mg m À2 day À1 ) 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 (www.bc2001.org.uk) exploring the effects of synchronous chemoradiotherapy with this regimen is currently recruiting.

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“…In patients who fail this bladder conservation treatment locally, subsequent salvage cystectomy is then indicated. It has been reported that salvage cystectomy is necessary in up to one-quarter of patients after radiotherapy, and can be needed up to 10 years after treatment [11]. Organ-conWned disease before radiotherapy appears to be associated with better survival after salvage cystectomy, and salvage cystectomy should only be attempted if complete resection is probable [12].…”

Section: Discussionmentioning

confidence: 99%

Robotic salvage cystectomy in the nonagenarian

et al. 2009

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Radical cystectomy with pelvic lymphadenectomy remains the standard treatment for muscle-invasive bladder cancer. However, bladder preservation with radiotherapy, with or without chemotherapy, represents an alternative treatment strategy. In patients that fail this bladder conservation treatment, salvage cystectomy is then indicated to treat persistent or recurrent cancer. We report our experience with robotic-assisted laparoscopic salvage radical cystoprostatectomy with pelvic lymph node dissection in a 91-year-old man. This minimally invasive approach for treatment of persistent bladder cancer refractory to chemoradiation, even in the nonagenarian, is a safe and viable alternative to traditional open surgery.

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Long–Term Risk of Salvage Cystectomy after Radiotherapy for Muscle–Invasive Bladder Cancer

Cited by 29 publications

References 20 publications

Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004)

Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004)

Long-term results of a phase II study of synchronous chemoradiotherapy in advanced muscle invasive bladder cancer

Robotic salvage cystectomy in the nonagenarian

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