NCCN Guidelines Insights: Bladder Cancer, Version 5.2018

Flaig, Thomas W.; Spiess, Philippe E.; Agarwal, Neeraj; Bangs, Rick; Boorjian, Stephen A.; Buyyounouski, Mark K.; Downs, Tracy M.; Efstathiou, Jason A.; Friedlander, Terence W.; Greenberg, Richard E.; Guru, Khurshid A.; Hahn, Noah M.; Herr, Harry W.; Hoimes, Christopher J.; Inman, Brant A.; Jimbo, Masahito; Kader, A. Karim; Lele, Subodh M.; Meeks, Joshua J.; Michalski, Jeff M.; Montgomery, Jeffrey S.; Pagliaro, Lance C.; Pal, Sumanta K.; Patterson, Anthony; Petrylak, Daniel P.; Plimack, Elizabeth R.; Pohar, Kamal S.; Porter, Michael P.; Preston, Mark A.; Sexton, Wade J.; Siefker-Radtke, Arlene; Tward, Jonathan D.; Wile, Geoffrey; Johnson-Chilla, Alyse; Dwyer, Mary A.; Gurski, Lisa A.

doi:10.6004/jnccn.2018.0072

Cited by 191 publications

(178 citation statements)

References 35 publications

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“…2 However, despite these challenges, clinical staging of bladder cancer is defined by the American Joint Committee on Cancer staging system and is incorporated into practice guidelines. [16][17][18] We have demonstrated the impact of pDS on OS in 2 highly complementary data sets representing the full spectrum of real-world clinical practice environments and have highlighted the utility of this endpoint despite the aforementioned complexities. Furthermore, notwithstanding the potential difficulties of clinical staging applicable to all patients with MIBC, we have demonstrated a significantly higher likelihood of achieving pDS with NAC in comparison with cystectomy alone.…”

Section: Discussionmentioning

confidence: 99%

Tumor downstaging as an intermediate endpoint to assess the activity of neoadjuvant systemic therapy in patients with muscle‐invasive bladder cancer

Martini

Jia

Ferket

et al. 2019

Cancer

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BACKGROUND: Achieving a pathologic complete response (pCR) with neoadjuvant chemotherapy (NAC) in patients with muscle-invasive bladder cancer (MIBC) has been associated with improved overall survival (OS). This study was aimed at evaluating the impact of pathologic downstaging (pDS; ie, a pT stage at least 1 stage lower than the pre-NAC cT stage) on the OS of patients with MIBC treated with NAC. METHODS: The Retrospective International Study of Cancers of the Urothelial Tract (RISC) and the National Cancer Database (NCDB) were queried for cT2-4N0M0 patients treated with NAC. A multivariable Cox model including either pDS or pCR was generated. A nested model was built to evaluate the added value of pDS (excluding patients achieving a pCR) to a model including pCR alone. C indices were computed to assess discrimination. NCDB was used for validation. The treatment effect of NAC versus cystectomy alone in achieving pDS was estimated through an inverse probability-weighted regression adjustment. RESULTS: Overall, 189 and 2010 patients from the RISC and NCDB cohorts, respectively, were included; pDS and pCR were achieved by 33% and 35% and by 20% and 15% in RISC and NCDB, respectively. In both data sets, pDS and pCR were associated with better OS and C indices. Adding pDS excluding pCR to the model with pCR fit the data better (likelihood ratio, P = .019 for RISC and P < .001 for NCDB), and it yielded better discrimination (incremental C index, 4.2 for RISC and 1.6 for NCDB). The treatment effect of NAC in achieving pDS was 2.07-fold (P < .001) in comparison with cystectomy alone. CONCLUSIONS: A decrease of at least 1 stage from the cT stage to the pT stage is associated with improved OS in patients with MIBC treated with NAC.

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Section: Discussionmentioning

confidence: 99%

Tumor downstaging as an intermediate endpoint to assess the activity of neoadjuvant systemic therapy in patients with muscle‐invasive bladder cancer

Martini

Jia

Ferket

et al. 2019

Cancer

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“…According to previous studies on BCG refractory and BCG relapsing, patients with BCG‐unresponsive disease are extremely unlikely to benefit from further conservative therapy, including repeated BCG therapy . In this category, the National Comprehensive Cancer Network and European Association of Urology guidelines presented therapeutic options for RC, another intravesical immunotherapy, intravesical chemotherapy, device‐assisted therapy, combination chemoimmunotherapy, gene therapy and participation in a clinical trial; however, further investigations and validation are warranted for these alternative conservative therapies . Although early RC is regarded as the preferred option for patients with BCG‐unresponsive disease, a notable subset of patients want to preserve their bladders or are not suitable candidates for radical surgery.…”

Section: Subclassification Of Bcg Failure and The Definition Of Bcg‐umentioning

confidence: 99%

“…27 In this category, the National Comprehensive Cancer Network and European Association of Urology guidelines presented therapeutic options for RC, another intravesical immunotherapy, intravesical chemotherapy, device-assisted therapy, combination chemoimmunotherapy, gene therapy and participation in a clinical trial; however, further investigations and validation are warranted for these alternative conservative therapies. 1,28 Although early RC is regarded as the preferred option for patients with BCG-unresponsive disease, a notable subset of patients want to preserve their bladders or are not suitable candidates for radical surgery. Therefore, patients in this category are now regarded as good candidates for a single-arm clinical trial, because an appropriate control does not exist, and several trials are now ongoing worldwide, as discussed later.…”

Section: Concept For "Bcg Unresponsive"mentioning

confidence: 99%

Bacillus Calmette–Guérin‐unresponsive non‐muscle‐invasive bladder cancer: Its definition and future therapeutic strategies

et al. 2019

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Bacillus Calmette–Guérin induction with or without maintenance is the gold standard therapy for intermediate‐/high‐risk non‐muscle‐invasive bladder cancer; however, one‐third of patients treated with adequate bacillus Calmette–Guérin therapy do not achieve sufficient responses, and this is referred to as “bacillus Calmette–Guérin failure.” The term, bacillus Calmette–Guérin failure, is ambiguous and includes a very heterogeneous population of patients. By strictly focusing on patients who are unlikely to benefit from additional bacillus Calmette–Guérin therapy and who need to be treated with radical cystectomy, the new concept of “bacillus Calmette–Guérin unresponsive” was recently proposed, and might accelerate the development of novel therapeutic options for bacillus Calmette–Guérin‐unresponsive disease. A promising therapeutic strategy for bacillus Calmette–Guérin‐unresponsive disease is the blockade of the programmed cell death‐1/programmed cell death‐ligand 1 pathway, which is considered to be activated by bacillus Calmette–Guérin therapy. Several large clinical trials have been carried out to assess the potential of programmed cell death‐1/programmed cell death‐ligand 1 blockade in bacillus Calmette–Guérin‐naïve high‐risk non‐muscle‐invasive bladder cancer and bacillus Calmette–Guérin‐unresponsive disease. Furthermore, clinical trials that are targeting bacillus Calmette–Guérin‐unresponsive disease with other strategies, such as vaccines, gene therapy, and targeted and cytotoxic therapies, are ongoing. The findings of these trials are awaited in order to establish appropriate bladder‐sparing approaches for patients with bacillus Calmette–Guérin‐unresponsive disease.

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“…RC entails high risk of re‐operations, long hospital‐stays, long‐term sequelae, and even postoperative mortality . A contemporary bladder‐sparing treatment alternative to RC is chemoradiotherapy . There is no evidence from randomized controlled trials to support superiority of RC over radiotherapy with respect to survival.…”

Section: Introductionmentioning

confidence: 99%

“…3,4 A contemporary bladder-sparing treatment alternative to RC is chemoradiotherapy. [5][6][7][8] There is no evidence from randomized controlled trials to support superiority of RC over radiotherapy with respect to survival. The largest trial to date was closed due to poor accrual, 9 and a recent review concluded that observational studies comparing outcomes of RC to bladder-sparing therapies had serious methodological shortcomings and inconsistent findings.…”

Section: Introductionmentioning

confidence: 99%

Survival after radiotherapy versus radical cystectomy for primary muscle‐invasive bladder cancer: A Swedish nationwide population‐based cohort study

et al. 2019

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Background Studies of survival comparing radical cystectomy (RC) and radiotherapy for muscle‐invasive bladder cancer have provided inconsistent results and have methodological limitations. The aim of the study was to investigate risk of death after radiotherapy as compared to RC. Methods We selected patients with muscle‐invasive urothelial carcinoma without distant metastases, treated with radiotherapy or RC from 1997 to 2014 in the Bladder Cancer Data Base Sweden (BladderBaSe) and estimated absolute and relative risk of bladder cancer death and all‐cause death. In a group of patients, theoretically eligible for a trial comparing radiotherapy and RC, we calculated risk difference in an instrumental variable analysis. We have not investigated chemoradiotherapy as this treatment was not used in the study time period. Results The study included 3 309 patients, of those 17% were treated with radiotherapy and 83% with RC. Patients treated with radiotherapy were older, had more advanced comorbidity, and had a higher risk of death as compared to patients treated with RC (relative risks of 1.5‐1.6). In the “trial population,” all‐cause death risk difference was 6 per 100 patients lower after radiotherapy at 5 years of follow‐up, 95% confidence interval −41 to 29. Conclusion(s) Patient selection between the treatments make it difficult to evaluate results from conventionally adjusted and propensity‐score matched survival analysis. When taking into account unmeasured confounding by instrumental variable analysis, no differences in survival was found between the treatments for a selected group of patients. Further clinical studies are needed to characterize this group of patients, which can serve as a basis for future comparison studies for treatment recommendations.

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NCCN Guidelines Insights: Bladder Cancer, Version 5.2018

Cited by 191 publications

References 35 publications

Tumor downstaging as an intermediate endpoint to assess the activity of neoadjuvant systemic therapy in patients with muscle‐invasive bladder cancer

Tumor downstaging as an intermediate endpoint to assess the activity of neoadjuvant systemic therapy in patients with muscle‐invasive bladder cancer

Bacillus Calmette–Guérin‐unresponsive non‐muscle‐invasive bladder cancer: Its definition and future therapeutic strategies

Survival after radiotherapy versus radical cystectomy for primary muscle‐invasive bladder cancer: A Swedish nationwide population‐based cohort study

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