Effectiveness of adjuvant radiotherapy after radical cystectomy for locally advanced bladder cancer.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 484-484
Author(s):  
Benjamin Walker Fischer-Valuck ◽  
Jeff M. Michalski ◽  
John Paul Christodouleas ◽  
Eric Kim ◽  
Todd A. DeWees ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Radical Cystectomy ◽  
Adjuvant Radiotherapy ◽  
Univariate Analysis ◽  
Locally Advanced ◽  
Surgical Margin ◽  
High Morbidity ◽  
Matched Cohort ◽  
Positive Margins ◽  
Advanced Bladder Cancer

484 Background: Local-regional failure (LF) for locally advanced bladder cancer (LABC) after radical cystectomy (RC) is common even with chemo and is associated with high morbidity/mortality. Adjuvant radiotherapy (adjRT) can reduce LF and may enhance overall survival (OS) but has no defined role. We hypothesized that the addition of adjRT would improve OS in LABC in a large multi-institutional cohort. Methods: We identified ≥pT3 pN0-3, M0 LABC pts in the NCDB diagnosed in 2004 – 2013 who underwent RC +/- adjRT. AdjRT cohort included pts treated to ≥40Gy to the pelvis within 1 yr of diagnosis. Propensity matching was performed to match RC pts who received adjRT vs. those who did not. OS was calculated using Kaplan-Meier. Factors significant on univariate analysis were entered into Cox proportional hazards regression model to identify predictors of OS. Results: 15,246 RC pts were identified, with 450 (3.0%) receiving adjRT. Median OS was 23.0 mo (95% CI, 22.4-23.6) for RC vs. 19.7 mo (95% CI, 17.7-21.7) for adjRT [Log-rank P = 0.002; Wilcoxon P = 0.862]. Propensity score matching on demographic, clinical, & treatment variables yielded 742 pts (371 in each group). In the matched cohort, OS was 17.1 mo [95%CI, 14.5 - 19.6] for RC vs. 20.1 mo [95% CI, 17.8– 22.5] for adjRT [Log-rank P = 0.044]. On MVA in the matched cohort, factors predictive of OS were sex, pT stage, pN+ status, surgical margin status, number of nodes removed, adjRT, & chemo (p < 0.01 for all). On MVA of subgroups, adjRT was associated with significantly improved OS in pts with positive margins [HR 0.55 (95% CI, 0.43 – 0.71), P < 0.001], pN+ disease [HR 0.62 (95% CI, 0.49 – 0.79), P < 0.001], & pT4 disease [HR 0.68 (95% CI, 0.55 – 0.85), P = 0.001]. In MVA of pts with urothelial carcinoma (N = 578), adjRT remained associated with improved OS in pts with positive margins [HR 0.57 (95% CI, 0.43 – 0.76), P < 0.001], pN+ disease [HR 0.65 (95% CI, 0.50 – 0.86), P = 0.002], & pT4 disease [HR 0.68 (95% CI, 0.54 – 0.85), P = 0.001]. Conclusions: In this observational study, adjRT was associated with improved OS in LABC. While the data should be interpreted cautiously, these results lend support to the use of adjRT in selected pts with LABC, regardless of histology. Prospective trials of adjRT are warranted.

Adjuvant chemotherapy is associated with decreased mortality after radical cystectomy for locally advanced bladder cancer

2014 ◽  
Vol 32 (6) ◽  
pp. 1463-1468 ◽  
Author(s):  
Daniel A. Yelfimov ◽  
Igor Frank ◽  
Stephen A. Boorjian ◽  
Prabin Thapa ◽  
John C. Cheville ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Adjuvant Chemotherapy ◽  
Radical Cystectomy ◽  
Locally Advanced ◽  
Advanced Bladder Cancer

Randomized trial of adjuvant chemotherapy versus adjuvant radiation therapy for locally advanced bladder cancer after radical cystectomy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4507-4507 ◽  
Author(s):  
Mohamed S. Zaghloul ◽  
John Paul Christodouleas ◽  
Tarek Zaghloul ◽  
Andrew Smith ◽  
Ahmed Abdalla ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bladder Cancer ◽  
Adjuvant Chemotherapy ◽  
Radical Cystectomy ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Adjuvant Radiation ◽  
Advanced Bladder Cancer ◽  
Grade 3

4507 Background: Some chemotherapy-naïve patients with locally advanced bladder cancer (LABC) after radical cystectomy (RC) are sufficiently de-conditioned that they are not candidates for adjuvant chemotherapy or decline it, even though such treatment may be warranted. There is no clear alternative adjuvant therapy for these patients, who are usually observed. In this study, we compare post-op radiotherapy (PORT) vs. adjuvant chemotherapy in a randomized clinical trial. We hypothesized that PORT can achieve comparable disease-free survival (DFS). Methods: A randomized phase III trial was opened to compare PORT vs. sequential chemo+PORT after RC for LABC & accrued from 2002–2008 at the NCI in Cairo. In 2007, a third arm comparing adjuvant chemo was added. Herein, we report the results of PORT vs. adjuvant chemo. Patients ≤70 y/o with ≥1 of the following factors (≥pT3b/T4a, grade 3, or positive nodes) with negative margins after RC + pelvic node dissection were eligible. Routine follow-up & pelvic CT q6 months were performed. PORT included 3D conformal pelvic RT (45Gy/1.5Gy BID). Chemo included gemcitabine/cisplatin x 4. Post-hoc non-inferiority exploratory analysis was performed. Results: The PORT arm accrued 78; the chemo arm accrued 45. 51% had urothelial carcinoma; 49% had squamous cell carcinoma/other. The two arms were well-balanced except for gender (p = 0.06). Two-year outcomes & overall adjusted hazard ratios (HR) for PORT vs. chemo alone were 54% vs. 47% (HR 0.65(95%CI 0.35-1.19, p = 0.16) for DFS; 92% vs. 69% (HR 0.28(95%CI 0.10-0.82), p = 0.02 for LRFS; 75% vs. 79% (HR 2.39(95%CI 0.94-6.09), p = 0.07) for DMFS; 61% vs. 60% (HR 0.94(95%CI 0.52-1.69), p = 0.83) for OS. Late grade ≥3 GI toxicity was observed in 6 PORT patients (8%) & 1 chemo patient (2%). Based on our data, there is a greater than 90% probability that the true difference in 2 yr DFS is less than 10%, the pre-specified non-inferiority margin. Conclusions: This randomized study demonstrates superior local control with PORT vs. adjuvant chemo with no significant differences in DFS, DMFS or OS. Results suggest that PORT could be an option for patients with LABC after RC who are medically unfit for adjuvant chemo or who decline it. Clinical trial information: NCT01734798.

Prospective trial of adjuvant therapy after radical cystectomy for locally advanced bladder cancer: Analysis of the squamous cell carcinoma subgroup.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 524-524
Author(s):  
Mohamed S. Zaghloul ◽  
John Paul Christodouleas ◽  
Tarek Zaghloul ◽  
Ahmed Abdalla ◽  
Hany William ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Bladder Cancer ◽  
Adjuvant Therapy ◽  
Cell Carcinoma ◽  
Radical Cystectomy ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Limited Efficacy ◽  
Advanced Bladder Cancer ◽  
Post Hoc

524 Background: The role of adjuvant therapy after radical cystectomy (RC) is not well-defined for squamous cell carcinoma (SqCC) of the bladder. Several studies suggest limited efficacy for chemo while adjuvant RT improved disease-free survival (DFS) vs. observation in a previous trial. In this study, we report a post-hoc subgroup analysis of SqCC to compare adjuvant therapies. We hypothesized that adjuvant RT would improve DFS vs. chemo for locally advanced bladder cancer (LABC) (≥pT3N0-N+). Methods: A randomized phase III trial was opened to compare adjuvant RT vs. sandwich chemo+RT after RC for LABC at the NCI in Cairo. A 3rd arm, adjuvant chemo, was added later. Bladder cancer patients ≤70 y/o with ≥1 of the following (pT3b/pT4a, grade 3, or pN+) with negative margins after RC were eligible. RT was delivered to the pelvis with 3D conformal RT (45Gy in 1.5Gy BID). Chemo+RT included 2 cycles of gemcitabine/cisplatin before & after RT. Chemo alone included gem/cis x 4. Primary & secondary endpoints were DFS and overall survival (OS). Results: 198 patients were enrolled. 82 (41%) had SqCC & 77 had ≥pT3N0-N+ disease and were analyzed (34 RT, 27 chemo+RT, & 16 chemo). Median age was 53. Median F/U was 20 months (1-127 months). The RT vs chemo arms were well-balanced except for number of nodes removed (mean 12 vs. 9, p=0.05). On univariable analysis, RT was not significantly associated with DFS [HR 0.56 (95%CI 0.26-1.21), p=0.14]. On multivariable analysis, only pN+ was significant. 2-yr DFS was 60% for RT & 43% for chemo (log-rank p=0.13). OS was improved with RT (2-yr OS 71% vs. 43%, p=0.04). There was one death during treatment (chemo-related). There was no significant difference in DFS or OS for RT vs. chemo+RT with 2-yr DFS of 59% & 55% (p=0.65) & 2-yr OS of 67% & 74% (p=0.16). Conclusions: On post-hoc analysis, RT for locally advanced bladder SqCC was associated with significantly improved OS vs. adjuvant chemo. We hypothesize that the inferior OS with chemo was due to increased toxicity & limited efficacy. There was no difference in outcomes for RT vs. chemo+RT. Adjuvant RT should be a standard option for ≥pT3 SqCC of the bladder after RC. Alternative chemo agents for SqCC should be explored. Clinical trial information: NCT01734798.

scholarly journals Complications and Discharge after Radical Cystectomy for Older Patients with Muscle-Invasive Bladder Cancer: The ELCAPA-27 Cohort Study

Cancers ◽  
2021 ◽  
Vol 13 (23) ◽  
pp. 6010
Author(s):  
Romain Geiss ◽  
Lucrezia Sebaste ◽  
Rémi Valter ◽  
Johanne Poisson ◽  
Soraya Mebarki ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Radical Cystectomy ◽  
Geriatric Assessment ◽  
Complication Rate ◽  
Older Patients ◽  
Univariate Analysis ◽  
Invasive Bladder Cancer ◽  
High Morbidity ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive

Radical cystectomy is the standard of care for localized bladder cancer but is associated with high morbidity and mortality rates—especially among older patients with comorbidities. The association between geriatric assessment parameters on post-operative complications and discharge has not previously been investigated. The present analysis of the Elderly Cancer Patient (ELCAPA) prospective cohort included all patients aged ≥70 having undergone a geriatric assessment and then radical cystectomy for localized muscle-invasive bladder cancer between 2007 and 2018. The primary endpoint was the proportion of patients with one or more complications in the first 30 days after cystectomy. The secondary endpoints were the length of hospital stay (LOS), the 30-day mortality, and discharge rates. Sixty-two patients (median age: 81; range: 79–83.8) were included. The 30-day complication rate was 73%, and 49% of the patients had experienced a major complication, according to the Clavien-Dindo classification. The 30-day mortality rate was 4%. None of the geriatric, oncological, or laboratory parameters were significantly associated with the occurrence or severity of complications. The median (interquartile range) LOS was 18 days (15–23) overall and was longer in patients with complications (19 days vs. 15 days in those without complications; p = 0.013). Thirty days after cystectomy, 25 patients (53%) had been discharged to home and 22 (47%) were still in a rehabilitation unit. In a univariate analysis, a Geriatric-8 score ≤14, a loss of one point on the Activities of Daily Living Scale, anemia, at least one grade ≥3 comorbidity on the Cumulative Illness Rating Scale-Geriatric, and an inpatient geriatric assessment were associated with a risk of not being discharged to home. In older patients having undergone a geriatric assessment, radical cystectomy is associated with a high complication rate, a longer LOS, and functional decline at 30 days.

scholarly journals Comparison of Radical Cystectomy and Chemoradiotherapy in Patients with Locally Advanced Bladder Cancer

2014 ◽  
Vol 15 (16) ◽  
pp. 6519-6524 ◽  
Author(s):  
Masaomi Ikeda ◽  
Kazumasa Matsumoto ◽  
Morihiro Nishi ◽  
Ken-Ichi Tabata ◽  
Tetsuo Fujita ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Radical Cystectomy ◽  
Locally Advanced ◽  
Advanced Bladder Cancer
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