529 NEOADJUVANT GEMCITABINE PLUS CARBOPLATIN FOLLOWED BY IMMEDIATE RADICAL CYSTECTOMY IN PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER: A PROPENSITY SCORE ANALYSIS

2012 ◽  
Vol 187 (4S) ◽  
Author(s):  
Takuya Koie ◽  
Akiko Okamoto ◽  
Hayato Yamamoto ◽  
Yuki Tobisawa ◽  
Tohru Yoneyama ◽  
...  
2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 276-276 ◽  
Author(s):  
Takuya Koie ◽  
Teppei Okamoto ◽  
Yuichiro Suzuki ◽  
Yuki Tobisawa ◽  
Tohru Yoneyama ◽  
...  

276 Background: Standard neoadjuvant chemotherapy has not yet been established for patients with muscle-invasive bladder cancer. Our pervious phase II trial demonstrated the efficacy and safety of neoadjuvant gemcitabine plus carboplatin (GCarb) chemotherapy followed by immediate radical cystectomy (RC) in patients with muscle-invasive bladder cancer. In the present study, we conducted a propensity score analysis to elucidate clinical significance of the present treatment protocol. Methods: The cohort of neoadjuvant group consists of 120 patients with muscle-invasive bladder cancer. They received 2 courses of GCarb therapy consisting of 800 mg/m2 gemcitabine on days 1, 8, and 15 and carboplatin with an AUC of 4 on day 2 between March 2005 and June 2011. After the chemotherapy, RC and bilateral pelvic lymph node dissection (PLND) were performed within an interval of 1 month. The cohort of surgery alone group includes 155 patients with muscle-invasive bladder cancer treated with RC and bilateral PLND between May 1994 and December 2004. Propensity score matching was used to adjust for potential selection biases associated with treatment type. The endpoints were overall (OS) and disease-free survival (DFS). Results: Of the 120 patients who received GCarb and RC, 28 (23.3%) RC specimens showed pT0. Grade 3/4 neutropenia occurred in 40 patients (33.9%) and thrombocytopenia in 23 patients (19.8%). Propensity score-matched analysis indicated 112 matched pairs from both groups. The 5-year OS rate was 91.5% for neoadjuvant GCarb versus 51.3% for surgery alone group (P < 0.0001). The DFS rate was 83.8% for neoadjuvant GCarb versus 53.1% for surgery alone (P < 0.0001). Multivariate analysis revealed that the neoadjuvant GCarb regimen was an extremely strong predictor of the improvement in OS and DFS. Conclusions: Although the present study is not randomized, neoadjuvant gemcitabine plus carboplatin therapy followed by immediate RC achieved significantly longer OS and DFS comparing to surgery alone. The clinical usefulness of the present treatment for the patient with muscle-invasive bladder cancer should be verified by further trials.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15565-e15565
Author(s):  
Takuya Koie ◽  
Yuichiro Suzuki ◽  
Yuki Tobisawa ◽  
Tohru Yoneyama ◽  
Kazuyuki Mori ◽  
...  

e15565 Background: Standard neoadjuvant chemotherapy has not yet been established for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin based chemotherapy. In the present study, we conducted a propensity score analysis to elucidate the clinical significance of neoadjuvant gemcitabine and carboplatin chemotherapy (GCarbo) for cisplatin-ineligible patients with MIBC. Methods: The cohort of the neoadjuvant group consisted of 51 patients with MIBC, treated between March 2005 and June 2011, who were ineligible for cisplatin. Patients received 2 courses of GCarbo consisting of 800 mg/m2gemcitabine on days 1, 8, and 15, and carboplatin with an AUC of 4 on day 2. After GCarbo, radical cystectomy (RC) and bilateral pelvic lymph node dissection (PLND) were performed at an interval of 1 month. The cohort of RC alone included 59 cisplatin-ineligible MIBC patients treated with RC and bilateral PLND between June 1998 and February 2010. Propensity score matching was used to adjust for potential selection biases associated with treatment type. The endpoints were overall (OS) and disease-free survival (DFS). Results: Of the 51 patients who received GCarbo and RC, 6 (11.8%) RC specimens were found to be cancer free. Grade 3/4 neutropenia occurred in 17 patients (33.3%) and thrombocytopenia in 11 patients (21.6%). There were no patients who experienced grade3/4 nephrotoxicity or nausea. Propensity score-matched analysis indicated 45 matched pairs from both groups. The median follow-up period was 35.3 months. The 3-year OS rate was 86.5% for neoadjuvant GCarbo vs. 50.6% for the RC alone group (P < 0.0001). The DFS rate was 78.8% for neoadjuvant GCarbo vs. 44.8% for RC alone (P= 0.001). Multivariate analysis revealed that the neoadjuvant GCarbo regimen was an extremely strong and independent predictor of the longer OS and DFS. Conclusions: Although the present study is non-randomized, neoadjuvant GCarbo chemotherapy followed by immediate RC achieved significantly longer OS and DFS than cystectomy alone. The clinical usefulness of the present treatment for cisplatin-ineligible patients with MIBC should be verified by further trials.


2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 392-392
Author(s):  
Fumitaka Shimizu ◽  
Satoru Muto ◽  
Masataka Taguri ◽  
Takeshi Ieda ◽  
Takatsugu Okegawa ◽  
...  

392 Background: The clinical evidence of adjuvant chemotherapy (AC ) is less robust than neoadjuvant chemotherapy (NAC). However, several surveys suggest that urologists prefer to use AC more frequently than NAC. We evaluate the clinical benefit of adjuvant platinum based chemotherapy following radical cystectomy (RC) for muscle-invasive bladder cancer (BCa) in routine clinical practice. Methods: This observational study was conducted to compare the effectiveness of AC versus observation postcystectomy in patients with clinicallymuscle-invasive BCa. Cancer-specific survival (CSS) and overall survival (OS) between the AC group and RC alone group were compared using Kaplan-Meiyer method and log-rank test. After adjusting for background factors using propensity score weighting, differences in CSS and OS between these two groups were compared. Subgroup analyses by the pathological characteristics were performed. Results: In total, 322 patients were included in this study. Of these, 23% received AC postcystectomy. Clinicopathological characteristics showed that patients in the AC group were pathologically more advanced and were at higher risk than the RC alone group. In the unadjusted population, although it is not significantly, the AC group had lower overall survival (3-years OS; 61.5% vs 73.6%, HR 1.44, p = 0.243, log-rank test, AC vs RC alone). In the weighted propensity score analysis, although it is not significantly, AC group were superior than RC alone groups (OS: HR 0.65, 95%CI 0.39-1.09, p = 0.099, log-rank test, AC vs RC alone). Subgroup analyses showed that AC significantly reduced the hazard ratio of OS and CSS in ≥ pT3, pN+, ly+, and v+ subgroups. Conclusions: The weighted propensity score analyses showed that platinum-based AC might be associated with increased CSS and OS in patients with high-risk invasive BCa.


2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 421-421
Author(s):  
Stephen Bentley Williams ◽  
Yong Shan ◽  
Usama Jazzar ◽  
Hemalkumar B Mehta ◽  
Jacques G. Baillargeon ◽  
...  

421 Background: Radical cystectomy is the guideline-recommended treatment for muscle-invasive bladder cancer. Recently there has been a resurgence in trimodal therapy with limited data on comparative outcomes, and especially attributable costs. Methods: A total of 3,200 patients aged 66 years or older diagnosed with clinical stage T2-4a bladder cancer from January 1, 2002- December 31, 2011 from the Surveillance, Epidemiology, and End Results (SEER)-Medicare data were analyzed. Cox regression analysis and propensity score matching methods were used to determine predictors for overall and cancer-specific survival. Results: A total of 3,200 patients met inclusion criteria. After propensity score matching, 687 patients underwent trimodal therapy and 687 patients underwent radical cystectomy. Patients who underwent trimodal therapy had significantly decreased overall (Hazard Ratio (HR) 1.49, 95% Confidence Interval (CI), 1.31-1.69, p < 0.001) and cancer-specific (HR 1.55, 95% CI 1.32-1.83, p < 0.001) survival, respectively. While there was no difference in costs at 30 days, median total costs were significantly higher with trimodal therapy than radical cystectomy at 90-d ($63,355 vs. $73,420, p < 0.001) and 180-d ($98,005 vs. $164,720, p < 0.001), respectively. Extrapolating these figures to the total US population results in excess spending of $179 million for trimodal therapy compared to less costly radical cystectomy for patients diagnosed in 2011. Conclusions: Trimodal therapy was associated with significantly decreased overall and cancer-specific survival resulting in excess national spending of $179 million in 2011 compared with radical cystectomy. These findings have important health policy implications regarding appropriate use of high-value based care among patients who are candidates for either treatment.


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