MP65-02 A PHASE III SURGICAL TRIAL TO EVALUATE THE BENEFIT OF A STANDARD VERSUS AN EXTENDED PELVIC LYMPHADENECTOMY PERFORMED AT TIME OF RADICAL CYSTECTOMY FOR MUSCLE INVASIVE UROTHELIAL CANCER: SWOG S1011 (NCT #01224665)

2015 ◽  
Vol 193 (4S) ◽  
Author(s):  
Seth P. Lerner ◽  
Catherine M. Tangen ◽  
Robert S. Svatek ◽  
Theresa M. Koppie ◽  
Ajjai Alva ◽  
...  
Keyword(s):  
Radical Cystectomy ◽  
Urothelial Cancer ◽  
Pelvic Lymphadenectomy ◽  
Phase Iii ◽  
Surgical Trial ◽  
Muscle Invasive

Neoadjuvant or adjuvant immunotherapy in bladder cancer: biological opportunity or clinical utility?

2021 ◽  
pp. 030089162110616
Author(s):  
Fausto Petrelli ◽  
Gianluca Perego ◽  
Ivano Vavassori ◽  
Andrea Luciani
Keyword(s):  
Bladder Cancer ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Urothelial Cancer ◽  
Checkpoint Inhibitors ◽  
Phase Iii ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Cancer Of The Bladder ◽  
Muscle Invasive

In urothelial cancer of the bladder, the introduction of immunotherapy with immune checkpoint inhibitors represents progress in the management of the disease’s early and advanced stages. In particular, recent studies have implemented these drugs in the neoadjuvant and adjuvant phases to treat muscle-invasive bladder cancer. In some studies, patients received neoadjuvant immune checkpoint inhibitors alone (PURE and ABACUS) to treat muscle invasive bladder cancer, whereas other studies provided this therapy to cisplatin-ineligible patients. Furthermore, a large Phase III study (CheckMate 247) compared placebo with adjuvant nivolumab therapy in patients with high-risk urothelial cancer after neoadjuvant chemotherapy and surgery or surgery alone. Despite some uncertain niches (nonbladder, PD-L1-negative tumors, and node-negative resected cancers), certain biological opportunities (exploring new targets, evaluating in vivo pathologic response, focusing on biomarkers for response) and clinical uses (avoiding chemotherapy at all or in frail patients, attaining similar pathologic complete response rates as in cisplatin-based chemotherapy) are valid reasons for incorporating these agents into the therapeutic armamentarium of medical uro-oncologists.

Alliance A031501: Phase III randomized adjuvant study of MK-3475 (pembrolizumab) in muscle-invasive and locally advanced urothelial carcinoma (MIBC) (AMBASSADOR) versus observation.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. TPS504-TPS504 ◽  
Author(s):  
Andrea B. Apolo ◽  
Jonathan E. Rosenberg ◽  
William Y. Kim ◽  
Ronald C. Chen ◽  
Guru Sonpavde ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Urothelial Carcinoma ◽  
Radical Cystectomy ◽  
Locally Advanced ◽  
Phase Iii ◽  
Immune Gene ◽  
Significant Activity ◽  
Muscle Invasive

TPS504 Background: Patients with high-risk MIBC have a poor prognosis. Radical cystectomy remains the standard treatment. Yet despite substantial improvements in surgical techniques, mortality from metastatic recurrence remains high. A large number of MIBC patients are ineligible for cisplatin-based chemotherapy or have persistent muscle-invasive disease despite neoadjuvant chemotherapy (NAC). Pembrolizumab, a PD-1 inhibitor, has demonstrated significant activity and is FDA-approved for patients with advanced/chemotherapy-refractory metastatic urothelial carcinoma. We hypothesize that pembrolizumab given post-cystectomy will improve overall survival (OS) and disease-free survival (DFS) in patients with high-risk MIBC. Methods: Patients must have histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract, have received NAC and have ≥ pT2 and/or pN+ at surgery or be cisplatin-ineligible and have ≥ pT3 and/or pN+ at surgery or have declined adjuvant cisplatin-based therapy and have ≥ pT3 and/or pN+ at surgery. Surgery could be radical cystectomy, nephrectomy, or ureterectomy. Patients are stratified by pathologic stage, central PD-L1 status, and prior NAC. Patients are randomized to receive pembrolizumab 240 mg every 3 weeks for 1 year, or observation. The dual primary objectives are to determine DFS and OS. Secondary objectives are to determine DFS and OS in PD-L1-positive and -negative patients and assess safety. Correlative objectives are to determine whether 12 immune gene signatures, tumor molecular subtypes, diversity of T-cell receptor (TCR) clonotypes, persistence of TCR clonotypes, tumor and neoantigen burden, HLA subtypes, and plasma HGF and VEGF levels with IL-10 and IL-17 are associated with OS and DFS. Quality of Life Correlative objectives are to compare health-related quality of life as assessed by the EORTC QLQ-C30. Clinical trial information: NCT03244384.

scholarly journals CARCINOMA UROTELIAL DA BEXIGA: RELATO DE CASO

2020 ◽  
Vol 12 (3) ◽  
pp. 82-85
Author(s):  
Gabriel Bandeira Santos ◽  
Felipe Iankelevich Baracat ◽  
Oscar Rubini Ávila
Keyword(s):  
Bladder Cancer ◽  
Radical Cystectomy ◽  
Bladder Neoplasms ◽  
Kidney Injury ◽  
Disease Recurrence ◽  
Good Prognosis ◽  
Pelvic Lymphadenectomy ◽  
Common Symptom ◽  
Macroscopic Hematuria ◽  
Muscle Invasive

Among male patients, bladder cancer is the fourth most common and is rarely identified in young individuals. The most common symptom is macroscopic hematuria and the initial treatment is transurethral resection of the bladder, in which the stage and classification are identified. Smoking is known to be the main risk factor for bladder cancers. Radical cystectomy and bilateral pelvic lymphadenectomy are the “gold standard” treatment for muscle-invasive bladder cancer. Around 25% of bladder neoplasms are muscle-invasive at diagnosis, but the patients have a good prognosis with this kind of treatment. The Bricker technique is the most used for the reconstruction of the neobladder. In this paper we report the case of a male patient, 55 years old, with invasive high-grade bladder cancer, treated with a radical cystectomy, lymphadenectomy and neobladder using the Bricker technique. After the surgical procedure, the patient remained in the Intensive Care Unit for two days, presenting acute kidney injury and the need for three hemodialysis sessions. The recovery was adequate, with a good postoperative evolution. We emphasize the importance of reporting to the patient about the indispensable clinical follow-up, which must be done until medical discharge, to avoid disease recurrence and the need for more aggressive treatments, as we will see in this case.

scholarly journals The Adequacy of Pelvic Lymphadenectomy During Radical Cystectomy for Carcinoma Urinary Bladder: A Narrative Review of Literature

2021 ◽  
Vol 8 ◽  
Author(s):  
Rahul Jena ◽  
Nikita Shrivastava ◽  
Aditya Prakash Sharma ◽  
Gautam Ram Choudhary ◽  
Aneesh Srivastava
Keyword(s):  
Lymph Node ◽  
Radical Cystectomy ◽  
English Language ◽  
Controlled Trial ◽  
Pelvic Lymphadenectomy ◽  
The Other ◽  
Lymph Node Count ◽  
Definitive Evidence ◽  
Muscle Invasive ◽  
Uniform Nomenclature

An adequate pelvic lymph node dissection (PLND) is an essential part of radical cystectomy for muscle invasive bladder cancer. However, the definition of what constitutes an adequate PLND is often shrouded in controversy. Various authors have defined different anatomic templates of PLND based on levels of pelvic lymph nodes. Some have suggested other surrogate markers of the adequacy of PLND, namely lymph node count and lymph node density. While individual studies have shown the efficacy and reliability of some of the above markers, none of them have been recommended forthright due to the absence of robust prospective data. The use of non-standardized nomenclature while referring to the above variables has made this matter more complex. Most of older data seems to favor use of extended template of PLND over the standard template. On the other hand, one recent randomized controlled trial (RCT) did not show any benefit of one template over the other in terms of survival benefit, but the study design allowed for a large margin of bias. Therefore, we conducted a systematic search of literature using EMBASE, Medline, and PubMed using PRISMA-P checklist for articles in English Language published over last 20 years. Out of 132 relevant articles, 47 articles were included in the final review. We have reviewed existing literature and guidelines and have attempted to provide a few suggestions toward a uniform nomenclature for the various anatomical descriptions and the extent of PLND done while doing a radical cystectomy. The results of another large RCT (SWOG S1011) are awaited and until we have a definitive evidence, we should adhere to these suggestions as much as possible and deal with each patient on a case to case basis.

scholarly journals Radical cystectomy (bladder removal) against intravesical BCG immunotherapy for high-risk non-muscle invasive bladder cancer (BRAVO): a protocol for a randomised controlled feasibility study

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017913 ◽  
Author(s):  
Jamie B Oughton ◽  
Heather Poad ◽  
Maureen Twiddy ◽  
Michelle Collinson ◽  
Victoria Hiley ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Radical Cystectomy ◽  
Feasibility Study ◽  
Phase Iii ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Phase Iii Trial ◽  
Muscle Invasive ◽  
Randomised Controlled

IntroductionHigh-risk non-muscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease that can be difficult to predict. While around 25% of cancers progress to invasion and metastases, the remaining majority of tumours remain within the bladder. It is uncertain whether patients with HRNMIBC are better treated with intravesical maintenance BCG (mBCG) immunotherapy or primary radical cystectomy (RC). A definitive randomised controlled trial (RCT) is needed to compare these two different treatments but may be difficult to recruit to and has not been attempted to date. Before undertaking such an RCT, it is important to understand whether such a comparison is possible and how best to achieve it.Methods and analysisBRAVO is a multi-centre, parallel-group, mixed-methods, individually randomised, controlled, feasibility study for patients with HRNMIBC. Participants will be randomised to receive either mBCG immunotherapy or RC. The primary objective is to assess the feasibility and acceptability of performing the definitive phase III trial via estimation of eligibility and recruitment rates, assessing uptake of allocated treatment and compliance with mBCG, determining quality-of-life questionnaire completion rates and exploring reasons expressed by patients for declining recruitment into the study. We aim to recruit 60 participants from six centres in the UK. Surgical trials with disparate treatment options find recruitment challenging from both the patient and clinician perspective. By building on the experiences of other similar trials through implementing a comprehensive training package aimed at clinicians to address these challenges (qualitative substudy), we hope that we can demonstrate that a phase III trial is feasible.Ethics and disseminationThe study has ethical approval (16/YH/0268). Findings will be made available to patients, clinicians, the funders and the National Health Service through traditional publishing and social media.Trial registration numberISRCTN12509361; Pre results.

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