Clinical and pathological outcomes for patients with T1HG bladder cancer managed with upfront cystectomy with or without neoadjuvant chemotherapy and the impact of the MDACC high-risk features.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 366-366
Author(s):  
Michael J. Metcalfe ◽  
James Edward Ferguson ◽  
Roger Li ◽  
Lianchun Xiao ◽  
Colin P.N. Dinney ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Systemic Disease ◽  
Survival Outcomes ◽  
Increased Risk ◽  
Node Positive Disease ◽  
Variant Histology ◽  
Muscle Invasive ◽  
The Impact

366 Background: In muscle invasive bladder cancer there is an increased risk for systemic disease identified for patients with certain high risk features (HRF): pre-operative hydronephrosis (POH), lymphovascular invasion (LVI), abnormal exam under anesthesia (AbnEUA), and the presence of variant histology (VH). We sought to identify the effect of these high risk features in the T1HG population. Methods: With IRB approval, a single center retrospective review was performed on all patients at MDACC from 1995-2013 who underwent radical cystectomy (RC) for T1HG urothelial cancer. Patients were stratified according to the presence or absence of HRF defined by the presence of LVI, POH, VH, AbnEUA, prostatic ductal involvement (PDI), and the delivery of neoadjuvant chemotherapy (NAC). Primary outcome included pathologic T (pT) upstage and presence of lymph node positive disease (LN+) at time of RC, as well as survival outcomes. Results: 372 T1HG patients underwent RC, of these 196 (53%) have HRF including: VH (n=98, 25%), LVI (n=44, 12%), PDI (n=31, 8%), POH (n=38, 10%) and/or AbnEUA (n=34, 9%). pT upstage occurred in 43/176 (24.4%) of patients without HRF, in 45/151 (30%) of patients with 1 HRF, and in 38% (17/45) of patients with > 2 HRF (p=0.088). LN+ occurred in 18/176 (10.2%) of patients without HRF, 7.8% (15/151) of patients with 1 HRF and in 17.8% (8/45) of patients with > 2 HRF (p=0.0403). Presence of HRF were not significant for a decreased OS (p=0.076), DSS (0.425), and RFS (p=0.103). No patients without HRF got NAC, and 41/196 (21%) of patients with HRF received NAC. There was no effect of NAC on pT upstage (OR 1.184, 95% CI 0.355-3.954, p=0.7834) or rate of LN+ disease (OR 1.758, 95% CI 0.669-5.606, p=0.2525) on multivariate analysis. There was no effect of NAC on OS (p=0.122), DSS (0.437), or RFS (0.7483). Conclusions: Presence of certain high risk features in the T1HG setting does have increased risk of pT upstage and LN+ disease in patients treated with cystectomy. However, there is no effect seen on survival outcomes. Use of NAC did not significantly alter outcome in our cohort and should be reserved for the muscle invasive setting.

scholarly journals The increased risk for thromboembolism pre-cystectomy in patients undergoing neoadjuvant chemotherapy for muscle-invasive urinary bladder cancer is mainly due to central venous access: a multicenter evaluation

2019 ◽  
Vol 52 (4) ◽  
pp. 661-669 ◽  
Author(s):  
Kristoffer Ottosson ◽  
Sofia Pelander ◽  
Markus Johansson ◽  
Ylva Huge ◽  
Firas Aljabery ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Central Venous Access ◽  
Urinary Bladder Cancer ◽  
Venous Access ◽  
Central Venous ◽  
Chemotherapy Administration ◽  
Increased Risk ◽  
Chi Squared ◽  
Muscle Invasive

Abstract Purpose To investigate if patients receiving neoadjuvant chemotherapy (NAC) for muscle-invasive bladder cancer (MIBC) had an increased risk of thromboembolic events (TEE) and to evaluate when these events occur on a timeline starting from 6 months pre-cystectomy, during NAC-administration and 60 months post-cystectomy. Methods Two hundred and fifty five patients undergoing radical cystectomy during 2009–2014 at three Swedish cystectomy centers (Umeå, Linköping and Sundsvall) were in-detail reviewed retrospectively, using individual medical records. One hundred and twenty nine patients were ineligible for analysis. NAC patients (n = 67) were compared to NAC-naïve NAC-eligible patients (n = 59). The occurrence of TEE was divided into different periods pre-cystectomy and post-cystectomy. Statistical analyses included Chi-squared and logistical regression tests. Results Significant associations were found between receiving NAC and acquiring a TEE during NAC therapy pre-cystectomy. All but one pre-cystectomy event was venous and all but one of the patients received NAC. 31% (14/45) of TEEs occurred pre-cystectomy. The incidence of TEEs pre-cystectomy in NAC-naive NAC-eligible patients was only 10% (2/20), whereas the incidence of TEEs in NAC patients occurred pre-cystectomy in 48% (12/25) and 11/12 incidents were detected during NAC therapy—this including 7/11 (64%) incidents affecting veins in anatomical conjunction with the placement of central venous access for chemotherapy administration. Conclusions There is a significantly increased risk for TEE pre-cystectomy during chemotherapy administration in MIBC patients receiving NAC, compared to the risk in NAC-naïve NAC-eligible MIBC patients. In 64% of the pre-RC TEEs in NAC patients, there was a clinical connection to placement of central venous access.

scholarly journals High-risk bladder cancer: improving outcomes with perioperative chemotherapy

2011 ◽  
pp. 4-8
Author(s):  
Daniel Y.C. Heng ◽  
Jorge A. Garcia
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Meta Analysis ◽  
Standard Of Care ◽  
Muscle Invasive Bladder Cancer ◽  
Advantages And Disadvantages ◽  
High Risk Disease ◽  
Muscle Invasive

Despite treatment with radical cystectomy and pelvic lymph node dissection, muscle invasive bladder cancer has a relapse rate of 50%. Patients can develop regionally advanced or metastatic disease that ultimately leads to death. The addition of neoadjuvant or adjuvant chemotherapy to reduce the risk of relapse and death has been extensively studied over the past two decades. Two contemporary trials coupled with a recent meta-analysis evaluating neoadjuvant chemotherapy demonstrated a modest but real improvement in overall survival. This has made neoadjuvant chemotherapy a standard of care. Clinical trials evaluating adjuvant chemotherapy in patients with high-risk disease have been plagued with statistical flaws and have, therefore, been unable to define the survival impact of this approach. It is hoped that ongoing adjuvant trials that are powered to detect small but meaningful clinical differences will clarify the benefit of chemotherapy after cystectomy. Since there are theoretical advantages and disadvantages to each of these approaches, both are widely used in North America. The evidence behind each approach and potential future developments in this field will be described.

scholarly journals Systematic Review and Meta-Analysis of Cisplatin Based Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer

2021 ◽  
pp. 1-13
Author(s):  
Raed Benkhadra ◽  
Tarek Nayfeh ◽  
Sai Krishna Patibandla ◽  
Chelsea Peterson ◽  
Larry Prokop ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Meta Analysis ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Invasive Bladder Cancer ◽  
Efficacy And Safety ◽  
Muscle Invasive Bladder Cancer ◽  
Increased Risk ◽  
Muscle Invasive

BACKGROUND: Cisplatin-based neoadjuvant chemotherapy is the standard of care for muscle invasive bladder cancer (MIBC). OBJECTIVE: To compare the efficacy and safety of the two most commonly used cisplatin-based regimens; gemcitabine, and cisplatin (GC) vs. accelerated (dose-dense: dd) or conventional methotrexate, vinblastine, adriamycin, and cisplatin (MVAC). METHODS: We searched MEDLINE, Embase, Scopus and other sources. Outcomes of interest included overall survival, downstaging to pT≤1, pathologic complete response (pCR), recurrence, and toxicity. Meta-analysis was conducted using the random-effects model. RESULTS: We identified 24 studies. Efficacy outcomes were comparable between MVAC and GC for MIBC. dd-MVAC was associated with favorable efficacy compared to GC in terms of downstaging (OR 1.45; 95%CI 1.15–1.82) and all-cause mortality at longest follow-up (OR 0.63; 95%CI 0.44–0.81). However, GC was associated with a better safety profile in terms of febrile neutropenia (OR 0.32; 95%CI 0.13–0.80), anemia (OR 0.32; 95%CI 0.18–0.54), nausea and vomiting (OR 0.27; 95%CI 0.12–0.65) compared to dd-MVAC. Compared to MVAC, patients receiving GC had an increased risk of developing grade 3–4 thrombocytopenia (OR 4.70; 95%CI 1.59–13.89) and a lower risk of nausea and vomiting (OR 0.05; 95%CI 0.01–0.31). Certainty in the estimates was very low for most outcomes. CONCLUSIONS: Efficacy and safety outcomes were comparable between MVAC and GC for MIBC. Including non-peer-reviewed studies showed higher efficacy with dd-MVAC. A phase III randomized trial comparing the two regimens is needed to guide clinical practice.

Does “low risk” muscle invasive bladder cancer actually exist?

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 308-308
Author(s):  
Eugene J. Pietzak ◽  
S. Bruce Malkowicz ◽  
Thomas J. Guzzo
Keyword(s):  
Risk Factors ◽  
Bladder Cancer ◽  
High Risk ◽  
Low Risk ◽  
Risk Patients ◽  
Variant Histology ◽  
Mixed Histology ◽  
Muscle Invasive ◽  
Tumor Upstaging ◽  
Mixed Variant

308 Background: Despite level one evidence demonstrating improved survival with neoadjuvant chemotherapy (NAC), studies suggest that many eligible patients with muscle invasive bladder cancer (MIBC) never receive it prior to radical cystectomy (RC). Our objective was to determine if the absence of known pre-operative risk factors can indeed stratify for low risk of extravesical disease with RC alone. Methods: We identified consecutive NAC-naive patients with clinical stage cT2N0M0 urothelial type bladder cancer treated with RC at our center. cT2 patients with either hydronephrosis, transurethral resection (TUR) specimens containing lymphovascular invasion (LVI), or mixed variant histology were grouped as high risk. Clinicopathologic and survival outcomes were compared to cT2 patients without these adverse features, who were grouped as low risk. Results: Of 251 cT2 patients, 119 (47.4%) were high risk [LVI=31, hydronephrosis=69, mixed histology=54; ≥2 risk factors=70]. High and low risk cohorts did not differ in age, gender, race, BMI, smoking, co-morbidities, prior intravescial therapy, or treatment delay. At time of RC, high risk patients more often had lymph node metastasis (38.6% v. 26.7% p=0.04) & tumor upstaging to pT3/4 (53.7% v. 40.2 p<0.001), with significantly less achieving pT0 (2.5% v. 12.1% p=0.004). There was no difference in adjuvant chemotherapy rates (26.4% v. 25% p=0.8). Two and five year cancer-specific survival (CSS) was 84.8% and 62.3% for low risk patients, but only 59.5% and 42% for high risk patients (p=0.008), with competing risk analysis revealing worse bladder cancer specific mortality (BCSM) (sub HR=2.08 [95%CI=1.36 – 3.2]). Odds Ratio for BCSM was 1.29 (95%CI=0.68-2.5) if one risk factor was present, & 3.2 (95%CI=1.7-5.8) if two risk factors. Only hydronephrosis (2.2 [95%CI=1.2-4.2]) and mixed histology (2.4 [95%CI=1.2-4.8]) were independently associated with worse BCSM on multi-variable analysis. Conclusions: Good cancer control is provided by RC alone to many patients with cT2 MIBC without adverse risk factors, particularly if hydronephrosis & mixed variant histology is absent. However, tumor upstaging and lymph node involvement is not trivial even in low risk patients, which must be included in informed decision making on NAC.

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