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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 RA, Hall E, Hussain SA, Jenkins P, Rawlings C, Tremlett J, Crundwell M, Adab FA, Sheehan D, Syndikus I, Hendron C, Lewis R, Waters R, James ND - Int. J. Radiat. Oncol. Biol. Phys. (2013)

Bottom Line: 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.In 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.

View Article: PubMed Central - PubMed

Affiliation: Institute of Cancer Research. robert.huddart@icr.ac.uk

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(a) 2Kaplan-Meier plot of time to locoregional recurrence. Cox model estimated absolute difference in locoregional recurrence-free rate (95% confidence interval) at 2 years: 6.4% (−7.3%, 16.8%). First locoregional recurrence (standard whole-bladder radiation therapy [sRT] vs reduced high-dose volume radiation therapy [RHDVRT]) was noninvasive for 21 (19.4%) vs 18 (16.2%), invasive for 15 (13.9%) vs 11 (9.9%), in the pelvic nodes for 5 (4.6%) vs 5 (4.5%), and unknown for one RHDVRT patient. (b) Kaplan-Meier plot of overall survival by randomized group. Cox model estimated absolute difference (95% confidence interval) at 2 years: 4.7% (−6.0%, 13.4%).
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fig4: (a) 2Kaplan-Meier plot of time to locoregional recurrence. Cox model estimated absolute difference in locoregional recurrence-free rate (95% confidence interval) at 2 years: 6.4% (−7.3%, 16.8%). First locoregional recurrence (standard whole-bladder radiation therapy [sRT] vs reduced high-dose volume radiation therapy [RHDVRT]) was noninvasive for 21 (19.4%) vs 18 (16.2%), invasive for 15 (13.9%) vs 11 (9.9%), in the pelvic nodes for 5 (4.6%) vs 5 (4.5%), and unknown for one RHDVRT patient. (b) Kaplan-Meier plot of overall survival by randomized group. Cox model estimated absolute difference (95% confidence interval) at 2 years: 4.7% (−6.0%, 13.4%).

Mentions: Two-year LRRF rate was, for sRT: 61% (95% CI 50%, 71%); for RHDVRT: 64% (52%, 73%) (Fig. 4a). The 95% CI for absolute difference in LRRF rate at 2 years excluded RHDVRT, being 10% worse in the ITT population (RHDVRT improvement 6.4% [−7.3%, 16.8%]) but not in the per-protocol population (RHDVRT improvement 2.6% [−12.8%, 14.6%]); therefore, noninferiority could not be formally concluded. Of 76 first locoregional recurrences reported, 39 were noninvasive bladder, 26 were invasive bladder, and 10 were in pelvic nodes (1 unknown). Twenty-six patients (11.9%) (13 sRT, 13 RHDVRT) have undergone cystectomy; time to cystectomy is comparable between treatment groups (log–rank: P=.78; 2-year rate, for sRT: 10.2% [95% CI 5.2%, 18.8%], for RHDVRT: 11.7% [6.6%, 20.1%]). Of 26 cystectomies, 23 (10 sRT, 13 RHDVRT) were for disease recurrence, 1 patient decided to have cystectomy before radiation therapy (sRT), and only 2 patients (both sRT) have had salvage cystectomy for radiation therapy side effects.


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 RA, Hall E, Hussain SA, Jenkins P, Rawlings C, Tremlett J, Crundwell M, Adab FA, Sheehan D, Syndikus I, Hendron C, Lewis R, Waters R, James ND - Int. J. Radiat. Oncol. Biol. Phys. (2013)

(a) 2Kaplan-Meier plot of time to locoregional recurrence. Cox model estimated absolute difference in locoregional recurrence-free rate (95% confidence interval) at 2 years: 6.4% (−7.3%, 16.8%). First locoregional recurrence (standard whole-bladder radiation therapy [sRT] vs reduced high-dose volume radiation therapy [RHDVRT]) was noninvasive for 21 (19.4%) vs 18 (16.2%), invasive for 15 (13.9%) vs 11 (9.9%), in the pelvic nodes for 5 (4.6%) vs 5 (4.5%), and unknown for one RHDVRT patient. (b) Kaplan-Meier plot of overall survival by randomized group. Cox model estimated absolute difference (95% confidence interval) at 2 years: 4.7% (−6.0%, 13.4%).
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fig4: (a) 2Kaplan-Meier plot of time to locoregional recurrence. Cox model estimated absolute difference in locoregional recurrence-free rate (95% confidence interval) at 2 years: 6.4% (−7.3%, 16.8%). First locoregional recurrence (standard whole-bladder radiation therapy [sRT] vs reduced high-dose volume radiation therapy [RHDVRT]) was noninvasive for 21 (19.4%) vs 18 (16.2%), invasive for 15 (13.9%) vs 11 (9.9%), in the pelvic nodes for 5 (4.6%) vs 5 (4.5%), and unknown for one RHDVRT patient. (b) Kaplan-Meier plot of overall survival by randomized group. Cox model estimated absolute difference (95% confidence interval) at 2 years: 4.7% (−6.0%, 13.4%).
Mentions: Two-year LRRF rate was, for sRT: 61% (95% CI 50%, 71%); for RHDVRT: 64% (52%, 73%) (Fig. 4a). The 95% CI for absolute difference in LRRF rate at 2 years excluded RHDVRT, being 10% worse in the ITT population (RHDVRT improvement 6.4% [−7.3%, 16.8%]) but not in the per-protocol population (RHDVRT improvement 2.6% [−12.8%, 14.6%]); therefore, noninferiority could not be formally concluded. Of 76 first locoregional recurrences reported, 39 were noninvasive bladder, 26 were invasive bladder, and 10 were in pelvic nodes (1 unknown). Twenty-six patients (11.9%) (13 sRT, 13 RHDVRT) have undergone cystectomy; time to cystectomy is comparable between treatment groups (log–rank: P=.78; 2-year rate, for sRT: 10.2% [95% CI 5.2%, 18.8%], for RHDVRT: 11.7% [6.6%, 20.1%]). Of 26 cystectomies, 23 (10 sRT, 13 RHDVRT) were for disease recurrence, 1 patient decided to have cystectomy before radiation therapy (sRT), and only 2 patients (both sRT) have had salvage cystectomy for radiation therapy side effects.

Bottom Line: 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.In 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.

View Article: PubMed Central - PubMed

Affiliation: Institute of Cancer Research. robert.huddart@icr.ac.uk

Show MeSH
Related in: MedlinePlus