Multi-institutional review of sequential intravesical gemcitabine and mitomycin C chemotherapy for non-muscle-invasive bladder cancer.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 294-294
Author(s):  
Andrew J. Lightfoot ◽  
Benjamin N. Breyer ◽  
Henry M. Rosevear ◽  
Badrinath Konety ◽  
Michael A. O'Donnell

294 Background: Combination chemotherapy is the standard of care for neoadjuvant, adjuvant, and metastatic bladder cancer due to increased efficacy when compared to monotherapy. We report our experience with sequential intravesical combination chemotherapy using gemcitabine and mitomycin C (MMC) for non-muscle invasive bladder cancer (NMIBC). Methods: We performed a multi-institutional retrospective review of 47 consecutive patients who received 6 weekly treatments with sequential gemcitabine (1g) and mitomycin C (40mg) chemotherapy for NMIBC. Thirty patients received treatment at University of Iowa, 14 at UCSF and 3 at University of Minnesota. Results: A total 47 patients (median age 70, range 32-85; 36 males, 11 females) previously failing a median of 2 intravesical treatments were reviewed. The complete response (CR), 1-year recurrence-free survival (1-RFS) and 2-year recurrence-free survival (2-RFS) for all patients was 68%, 48% and 38%, respectively. In all, 14 of 47 patients (30%) remain free of recurrence with a median time to followup of 26 months (range 6-80 months). The median time to recurrence for all patients who recurred was 4 months (range 1-33 months). Ten patients required cystectomy. Conclusions: Sequential intravesical combination chemotherapy using gemcitabine and MMC appears to be a useful treatment for patients with a history of NMIC which has failed BCG or other intravesical therapy, in addition to patients with intermediate and high-risk disease.

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Won Sik Ham ◽  
Jee Soo Park ◽  
Won Sik Jang ◽  
Young Deuk Choi ◽  
Jongchan Kim

AbstractThere is evidence that a history of benign prostatic hyperplasia increases the incidence of bladder cancer, and treatment with 5-alpha reductase inhibitor or androgen deprivation therapy reduces recurrence of non-muscle invasive bladder cancer. We aimed to evaluate whether prostate volume affects its prognosis. We reviewed medical records of men who underwent transurethral resection of bladder tumor due to non-muscle invasive bladder cancer from January 2012 to December 2017. Patients were divided into two groups based on prostate volume measured by computed tomography (group 1: 264 patients with ≤ 30 mL, group 2: 124 patients with > 30 mL). Propensity score matching analysis was used for adjust selection bias, and then assessed recurrence-free survival and progression-free survival. With a median follow up duration of 52 months, group 1 showed higher 5-year recurrence-free and progression-free survival (69.3% vs 47.0%, p = 0.001; 96.7% vs 87.7%, p = 0.002). Further, cox-regression analysis showed that tumor size (HR = 1.292 p < 0.001), multifocal tumor (HR = 1.993, p < 0.001), adjuvant intravesical therapy (chemotherapy: HR = 0.580, p = 0.037 and bacillus Calmette–Guérin: HR = 0.542, p = 0.004) and prostate volume (HR = 2.326, p < 0.001) were significant predictors of recurrence-free survival. Prostate volume (HR = 2.886, p = 0.014) was also associated with PFS with age (HR = 1.043, p = 0.044) and tumor grade (HR = 3.822, p = 0.013). We conclude higher prostate volume is associated with worse recurrence and progression-free survival in non-muscle invasive bladder cancer.


2021 ◽  
Author(s):  
Won Sik Ham ◽  
Jee Soo Park ◽  
Won Sik Jang ◽  
Young Deuk Choi ◽  
Jongchan Kim

Abstract There is evidence that a history of benign prostatic hyperplasia increases the incidence of bladder cancer, and treatment with 5-alpha reductase inhibitor or androgen deprivation therapy reduces recurrence of non-muscle invasive bladder cancer. We aimed to evaluate whether prostate volume affects its prognosis. We reviewed medical records of men who underwent transurethral resection of bladder tumor due to non-muscle invasive bladder cancer from January 2012 to December 2017. Patients were divided into two groups based on prostate volume measured by computed tomography (group 1: 264 patients with ≤30 mL, group 2: 124 patients with >30 mL), and assessed recurrence-free survival and progression-free survival. With a median follow up duration of 52 months, group 1 showed higher 5-year recurrence-free and progression-free survival (69.3% vs 47.0%, p=0.001; 96.7% vs 87.7%, p=0.002). Further, cox-regression analysis showed that tumor size (HR=1.292 p<0.001), multifocal tumor (HR=1.993, p<0.001), adjuvant intravesical therapy (chemotherapy: HR=0.580, p=0.037 and bacillus Calmette-Guérin: HR=0.542, p=0.004) and prostate volume (HR=2.326, p<0.001) were significant predictors of recurrence-free survival. Prostate volume (HR=2.886, p=0.014) was also associated with PFS with age (HR=1.043, p=0.044) and tumor grade (HR=3.822, p=0.013). We conclude higher prostate volume is associated with worse recurrence and progression-free survival in non-muscle invasive bladder cancer.


2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 373-373
Author(s):  
Jessica Gough ◽  
Mathini Sridharan ◽  
Ruochen Li ◽  
Rakesh Raman ◽  
Albert Edwards ◽  
...  

373 Background: The BC2001 trial in 2012 showed concurrent chemoradiotherapy to be the new standard of care for bladder preserving treatment of muscle invasive bladder cancer. Addition of concurrent MMC and infusional 5FU showed a relative risk reduction of 33% in locoregional recurrence (James ND, Hussain S, Hall E et al. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med. 2012;366(16):1477–88.). This audit evaluates the experience across Kent in six hospitals adopting this protocol. Methods: 116 patients treated with radical radiotherapy for bladder cancer between January 2013 and December 2015 were retrospectively reviewed. 64 patients received radiotherapy alone due to contraindications to chemotherapy, performance status and patient choice. 52 patients received concurrent chemotherapy, the majority with 5FU/MMC and a subset with oral Capecitabine in place of infusional 5FU. Kaplan Meier and Log-Rank analysis of overall survival, local recurrence free survival and metastasis free survival were performed using SPSS. Results: Local recurrence free survival in the chemoradiotherapy group was 73% (95% CI 59-87%) compared to the radiotherapy group 61% (45-77) (p=0.27). There was a trend for greater metastasis free survival at 2 years, 63% (47-79) in the chemoradiotherapy group compared to 52% (38-66) in the radiotherapy group (p=0.21). Similarly, overall 2 year survival was 74% (60-88) and 59% (43-75) respectively (p=0.21). Conclusions: Our results showed a trend towards improved local control, distant control and increased overall survival in patients treated with concurrent chemoradiotherapy compared to radiotherapy alone. The differences did not meet statistical significance; however this was a small retrospective series with a relatively short median followup of 17.5 months. Treatment was well tolerated in our patient group. Overall, our data is in keeping with the results of the BC2001 trial (James ND, Hussain S, Hall E et al. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med. 2012;366(16):1477–88.)


2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 491-491
Author(s):  
Nicholas D. James ◽  
Sarah Pirrie ◽  
Wenyu Liu ◽  
Daniel Ford ◽  
Anjali Zarkar ◽  
...  

491 Background: Chemoradiotherapy (cRT) with 5FU and Mitomycin C (5FU/MMC) is an accepted standard of care for muscle invasive bladder cancer. Cetuximab is an approved radio-sensitiser in head and neck cancer and EGFR is over-expressed in bladder cancer. We report a phase 1/2 trial of the addition of cetuximab to standard cRT. Methods: Phase 1/2 single-arm, multicentre, open-label study conducted in 5 UK centres. Treatment: RT: 64 Gy/32 fractions, 5FU 2.5g/m2 over days 1-5 & 22-26, MMC 12g/m2 day 1, cetuximab 400mg/m2 day -8, 200mg/m2 day 1 and weekly x7. Main inclusion criteria: T2-4aN0M0 urothelial cancer, PS 0-1; prior neoadjuvant therapy permitted. Endpoints: Phase 1; feasibility and safety of cRT with cetuximab + 5FU/MMC in combination. Phase 2; local control (LC) at 3 months. Secondary outcomes: invasive loco-regional progression free survival (LPFS), noninvasive LPFS, metastasis free survival (MFS), overall survival (OS) & patient reported outcomes (PROMs). Sample size; phase 1 between 6 and 18, phase 2 up to 45 including those recruited in phase 1. Results: Between Sept 2012 and Oct 2016, 33 patients were recruited; 7 in phase 1 26 in phase 2. Median age 70.1 (IQR 65.4-80.2) yrs, 60.6% WHO Performance Status 0; 81.8% male, 26/33 neoAd chemotherapy. 3 patients ineligible post registration. 30 evaluable pts started RT, 1 patient didn’t complete RT due to serious adverse event (interstitial pneumonitis), 3 with delays. Phase 1, 6/7 pts completed Cetux therapy, 1 omitted 1 dose for grade 3 rash. LC was 77% (95% CI 58, 90). Overall median dose intensities Cetux 100%, MMC 99% 5FU 99.8%. 8 pts developed recurrence; 2 MIBC. The 6 & 12 month muscle-invasive LPFS was 93 &; non-invasive LPFS 97% & 85%, MFS 90% & 90%, OS 97% & 87%. PROMs showed a transient dip at 1 mo, back to baseline at 3 mo. Conclusions: Phase 1 data demonstrate it’s feasible and safe to add cetuximab to cRT with 5FU/MMC with high delivered dose intensities. Although recruitment failed to reach the pre-specified target for phase 2 exploratory analysis indicate the 3 month bladder control rates and recurrence rates are above those reported in BC2001 with good PROMs provides evidence to consider further evaluation of cetuximab. Clinical trial information: 80733590.


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