Outcomes of patients following dose-dense neoadjuvant chemotherapy for muscle-invasive bladder cancer: Implications for organ-sparing strategies.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 426-426
Author(s):  
Clement Dumont ◽  
Helene Gauthier ◽  
Pierre Mongiat-Artus ◽  
Alexandra Masson-Lecomte ◽  
Francois Desgrandchamps ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Complete Response ◽  
Median Number ◽  
Bladder Preservation ◽  
Intention To Treat ◽  
Number Of Patients ◽  
Dose Dense ◽  
Treat Population

426 Background: Locoregional management of muscle-infiltrating bladder cancer (MIBC) after neoadjuvant chemotherapy (NAC) is controversial, because of both the morbidity of radical cystectomy (RC). Bladder preservation may be feasible after complete tumor response. Methods: This single-center retrospective study included 120 MIBC patients (stages ypT2-4aN0-3M0) treated between 2011 and 2017 with up to 6 cycles of neoadjuvant dose-dense Methotrexate, Vinblastin, Doxorubicin and Cisplatin (DD-MVAC). The primary outcome was relapse-free survival (RFS) depending on pathological findings on RC specimens, classified as either pathological complete response (pCR: ypT0N0/x), residual organ-confined disease (yOCD: ypTa/is/1/2N0/x), residual non-organ-confined disease (yNOCD: ypT≥3Nany or ypTanyN1-3). Secondary objectives included the rate of pCR in RC patients, the rate of ypT0 in the intention-to-treat population, and RFS in ypT0 patients according to locoregional management. Results: After a median number of 5 cycles of NAC, RC was performed in 75% of the patients, concurrent radiochemotherapy (CRC) in 11% and cystoscopic surveillance (CS) in 8%. In the intention-to-treat population, the ypT0 rate was 47%. Among 90 patients who underwent RC, 49% achieved pCR, 16% had yOCD and 34% yNOCD. Median follow-up in RC patients alive at last follow-up was 40 months. Three-year RFS was 86% in RC patients with pCR, 69% in patients with yOCD and 21% in patients with yNOCD (p < 0.0001). Outcomes were similar between ypT0 patients treated with either RC or CRC/CS (3-year RFS: 81% vs 100%, p = 0.20). Limitations to this study included its restrospective design and the lower number of patients treated with CRC/CS. Conclusions: Patients reaching ypT0 after dose-dense NAC show improved prognosis regardless of locoregional treatment. Patients with yOCD are frequently cured by RC, as opposed to patients with yNOCD. Prospective trials are needed to compare upfront cystectomy and bladder-sparing management in patients with both pCR or yNOCD.

Selective organ preservation with neoadjuvant chemotherapy in the treatment of muscle invasive transitional cell carcinoma (TCC) of the bladder.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 310-310
Author(s):  
Shaista Hafeez ◽  
Robert Anthony Huddart
Keyword(s):  
Bladder Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Partial Response ◽  
Poor Response ◽  
Complete Response ◽  
Radical Radiotherapy ◽  
Bladder Preservation ◽  
Platinum Based Chemotherapy ◽  
Muscle Invasive

310 Background: Radiotherapy has been previously associated with high treatment failure for those with muscle invasive bladder cancer. Evidence suggests modern organ sparing approaches may have favourable outcome in appropriately selected patients. We investigate whether response to neo-adjuvant chemotherapy can guide selection for bladder preservation and identify those patients likely to have greater success with radical radiotherapy treatment. Methods: Retrospective analysis of 94 patients with T2-T4aN0M0 bladder TCC treated between January 2000 and June 2011. Patients received platinum based chemotherapy following transuretheral resection of bladder tumour, with repeat cystoscopy (+biopsy) performed to guide subsequent management. Poor responders were advised to proceed with surgery. We report on the outcome of 79 individuals who received radiotherapy. Results: 56 (60%) patients achieved complete response following chemotherapy (72% with stage T2). 15 (16%) patients achieved partial pathological response. 12 patients had radiological assessment of partial response made. 11 patients had poor response. All patients achieving complete response, 22 with partial response and 1 with poor response proceeded to radical radiotherapy. Median time to disease progression following radiotherapy was 17months (range 8-91). 5 patients developed invasive recurrence, 17 developed superficial recurrence, 4 developed local nodal disease and 7 developed metastasises. After median follow-up of 36 months (range 6-114), 50 patients were alive with no disease, 24 had died (14 from metastatic bladder cancer and 10 from other causes). 5 patients were alive with active disease (4 with localized and 1 with metastatic disease). 13 required cystectomy (9 for superficial disease, 3 for invasive recurrence, and 1 for treatment related toxicity). Of those alive and disease free 84% had an intact bladder. 82% had an intact bladder at last follow-up or death. Conclusions: Neoadjuvant chemotherapy followed by radical radiotherapy allows bladder preservation in over 80% of selected patients with survival rates comparable to contemporary surgical series.

Intra-Arterial Chemotherapy for Muscle-Invasive Bladder Cancer Following Transurethral Resection

2015 ◽  
Vol 94 (4) ◽  
pp. 406-411 ◽  
Author(s):  
Shengjie Liang ◽  
Qingsong Zou ◽  
Bangmin Han ◽  
Yifeng Jing ◽  
Di Cui ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Transurethral Resection ◽  
Clinical Stage ◽  
Complete Response ◽  
Intravesical Instillation ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Bladder Preservation ◽  
Muscle Invasive

Purpose: To assess the efficacy of intra-arterial chemotherapy as a bladder-preservation treatment in patients with muscle-invasive bladder cancer (MIBC) following transurethral resection of bladder tumors (TURBT). Materials and Methods: From 2005 June to 2012 November, 46 patients diagnosed with MIBC (clinical stage T2-T3N0M0) underwent three courses of cisplatin-based intra-arterial chemotherapy as a remedial approach for bladder preservation after TURBT. All patients also received intravesical instillation of chemotherapy as a maintenance strategy. Results: All 46 patients completed the treatment with minor complications. The median follow-up time was 34.5 months (range, 8-87 months). Thirty-two patients (69.6%) demonstrated complete response. The three-year and five-year overall survival was 70.65 and 61.23%, and the disease-specific survival over the same periods was 78.03 and 67.62%, respectively. During the entire follow-up period, more than 80% preserved their bladder. Conclusions: Intra-arterial chemotherapy can be performed as a remedial treatment for MIBC patient following TURBT. Combined with TURBT, it offers an option for bladder preservation therapy on patients who are unable or unwilling to undergo radical cystectomy.

Multicenter phase II trial of RRx-001 in previously treated SCLC.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20104-e20104
Author(s):  
Daniel Morgensztern ◽  
Michal G. Rose ◽  
John Charles Morris ◽  
Patrick C. Ma ◽  
Christina E. Brzezniak ◽  
...  
Keyword(s):  
Partial Response ◽  
Phase Ii ◽  
Complete Response ◽  
Median Number ◽  
Intention To Treat ◽  
Resistant Disease ◽  
Platinum Resistant ◽  
Primary Endpoints ◽  
Previously Treated ◽  
Treat Population

e20104 Background: This exploratory single arm phase II study evaluated the efficacy and safety of RRx-001 followed by reintroduction of platinum plus etoposide in patients with previously treated small cell lung cancer (SCLC). Methods: Patients with SCLC that was platinum-resistant or received at least 2 prior lines were treated with RRx-001 4 mg IV on day 1 of each week of a 21-day cycle followed at progression by re-challenge with etoposide and cisplatin or carboplatin. The primary endpoints were overall survival (OS) and overall response rate to platinum therapy. Results: Between December 2016 and March 2018, 26 patients were enrolled and received at least one dose of RRx-001. The median number of prior lines of therapy was 2 (range 1-9) and 19 (73.1%) patients had platinum-resistant disease. In the intention-to-treat population, 1 (3.8%) achieved partial response (PR) and 7 (26.9%) had stable disease (SD) during treatment with RRx-001, whereas 1 patient (3.8%) had complete response and 6 (23.1%) had partial response on platinum plus etoposide. The estimated median and 12-month OS from enrollment were 8.6 months and 44.1%, respectively. The most common treatment-emergent adverse events from RRx-001 was mild discomfort at the infusion site (23%) and decreased appetite (15.3%). Conclusions: RRx-001 followed by re-challenge with platinum plus etoposide chemotherapy is feasible and associated with promising results. Clinical trial information: NCT02489903.

Phase II trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer: SWOG S1605 (NCT #02844816).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5022-5022 ◽  
Author(s):  
Peter C. Black ◽  
Catherine Tangen ◽  
Parminder Singh ◽  
David James McConkey ◽  
Scott Lucia ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Phase Ii ◽  
Complete Response ◽  
Median Number ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Bladder Preservation ◽  
Bcg Therapy ◽  
Muscle Invasive

5022 Background: Radical cystectomy (RC) is the standard of care for patients with BCG-unresponsive high risk non-muscle invasive bladder cancer (NMIBC), but many patients are unfit for surgery or elect bladder preservation. Based on the reported efficacy of atezolizumab in metastatic urothelial carcinoma and the known expression of PD-L1 in NMIBC after BCG therapy, this trial was designed to evaluate the activity of atezolizumab in BCG-unresponsive high risk NMIBC. Methods: This single arm phase II registration trial testing systemic atezolizumab (1200 mg IV) every 3 weeks for one year aimed to enroll 135 (70 CIS and 65 non-CIS) eligible patients with histologically proven BCG-unresponsive high risk NMIBC who were unfit for or declined RC. Here we report on the subset with CIS (with or without concomitant Ta/T1) among patients who received at least one protocol treatment. The primary endpoint was pathological complete response (CR) rate at 6 months as defined by mandatory biopsy with a null hypothesis of 30% and alternative of 50% with a 1-sided alpha = 0.05 and 96% power. The 3 month CR rate, defined by cytology, cystoscopy and for-cause biopsy, is reported here as a secondary endpoint, in addition to safety. Results: Seventy-five eligible CIS patients were enrolled. Two received no treatment and are not evaluable. Of 73, median patient age was 73.4 years and median number of prior BCG doses was 12. Concomitant Ta/T1 tumor was found in 30 (41.1%) patients, including T1 disease in 16 (21.9%). A CR was observed in 30 (41.1%; 95% CI 29.7%, 53.2%) patients at 3 months and 19 (26.0%; 95% CI 16.5%, 37.6%) at 6 months. Any possibly or probably treatment-related adverse event (AE) was observed in 61 (83.6%) patients. The most frequent AEs were fatigue 36 (49.3%), pruritis 8 (11.0%), hypothyroidism 8 (11.0%), and nausea 8 (11.0%). Grade 3-5 AEs occurred in 9 (12.3%) patients and there was one treatment-related death (myasthenia gravis with respiratory failure and sepsis). Conclusion: The observed response to atezolizumab at 3 and 6 months in patients with BCG-unresponsive CIS was similar to that reported in recent similar trials and meets the benchmark for initial CR defined by the FDA guidance. This trial provided no new safety concerns. The duration of response will determine if this is a suitable treatment option for patients with BCG-unresponsive high risk CIS. Clinical trial information: 02844816 .

scholarly journals Background variables for the patients with invasive bladder cancer suitable for bladder-preserving therapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15610-15610
Author(s):  
N. Miyanaga ◽  
H. Akaza ◽  
S. Hinotsu ◽  
A. Joraku ◽  
T. Oikawa ◽  
...  
Keyword(s):  
Overall Survival ◽  
Bladder Cancer ◽  
Survival Rate ◽  
Tumor Size ◽  
Univariate Analysis ◽  
Complete Response ◽  
Overall Survival Rate ◽  
Bladder Preservation ◽  
Cause Specific Survival

15610 Background: The present study was undertaken to identify the patients suitable for bladder preservation by analysis of our previous studies. Methods: The subjects of this study were all 72 patients with T2–3N0M0 bladder cancer who underwent bladder- preserving therapy in our institute. The therapy involved intra-arterial chemotherapy with MTX and CDDP and concomitant radiotherapy. Results: Of the evaluable 70 cases, complete response was confirmed in 57 cases (81.4%). The median follow-up was 45.3 months. The 5-year cause-specific survival rate was 81 % and the 5-year overall survival rate was 66%. Based on the results of univariate analysis, variables contributing to complete response were selected. In T2 cases, tumor size of 3 cm or less was scored 0 and tumor larger than 3 cm was scored 1, while single tumor was scored 0 and multiple tumors were scored 1. In T3 cases, tumor size of 3 cm or less was scored 0 and tumor larger than 3 cm was scored 1, while G2 was scored 0 and G3 scored 1. The CR rates were 93.8% and 92.6% for total scores of 0 and 1, respectively, and 62.9% for a total score of 2 (P = 0.003; score 0 or 1 vs 2). The overall survival rate was significantly higher in the former group (P = 0.003). Conclusion: Bladder-preserving therapy can be acceptable for cases of single T2N0M0 tumor with a size of =3 cm and for T3N0M0 cases with a tumor size of =3 cm. No significant financial relationships to disclose.

A prospective observational study on oral administration of Ellagic Acid and Annona Muricata in patients affected by non-muscle invasive bladder cancer not undergoing maintenance after 6-week intravesical prophylaxis

2021 ◽  
pp. 039156032110222
Author(s):  
Vincenzo Serretta ◽  
Ettore De Berardinis ◽  
Alchiede Simonato ◽  
Alessio Guarneri ◽  
Nino Dispensa ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Oral Administration ◽  
Ellagic Acid ◽  
Invasive Bladder Cancer ◽  
Prophylactic Effect ◽  
Annona Muricata ◽  
Muscle Invasive Bladder Cancer ◽  
Number Of Patients ◽  
Muscle Invasive

Introduction: BCG and MMC shortage and Covid-19 pandemic, more recently, limit accessibility to maintenance regimen in intravesical prophylaxis against recurrence of non-muscle invasive bladder cancer (NMIBC). Ellagic acid (EA) and Annona muricata (AM) exert antitumor activity against different human tumours. An observational prospective study on the prophylactic effect of oral administration of EA+AM in patients avoiding maintenance regimen is presented. Materials and methods: Patients affected by NMIBC and not undergoing maintenance after a 6-week course of intravesical prophylaxis with MMC or BCG were entered. Tis and very high-risk tumours were excluded. After informed consent, the patients were subdivided in relation to the oral assumption or not of EA (100 mg) plus AM (100 mg), daily for 6 months. All patients were submitted to 3-month cytology and cystoscopy. Results: 162 (90%) of 180 entered patients are evaluable, 90 and 72 receiving or not EA+AM. No difference emerged in patients’ characteristics between the two groups. BCG was given in 86 (54%) and chemotherapy in 74 (46%) patients. The recurrence free rate at 3, 6 and 12 months in patients assuming or not EA was 96.5% versus 84.6% ( p = 0.003), 85.4% versus 64.8% ( p = 0.005) and 74.2% versus 60.6% ( p = 0.246), respectively. The recurrence free survival at 12 months in patients assuming or not EA was 63.0% versus 34.5% ( p < 0.0001). Discussion and conclusions: Our study suffers several limits: not randomized trial although prospective, limited number of patients and short follow-up, nevertheless it shows the prophylactic effect of oral EA+AM in absence of maintenance after intravesical chemotherapy or immunotherapy induction.

scholarly journals Natural history of pT3-4 or node positive bladder cancer treated with radical cystectomy and no neoadjuvant chemotherapy in a contemporary North-American multi-institutional cohort

2012 ◽  
Vol 6 (6) ◽  
pp. 217 ◽  
Author(s):  
Nicholas E. Power ◽  
Wassim Kassouf ◽  
David Bell ◽  
Armen Aprikian ◽  
Yves Fradet ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Natural History ◽  
Radical Cystectomy ◽  
Node Positive ◽  
Number Of Patients ◽  
History Of ◽  
Modern Era

Background: The present study documents the natural history and outcomes of high-risk bladder cancer after radical cystectomy (RC) in patients who did not receive neoadjuvant chemotherapy during a contemporary time period.Methods: We analyzed 1180 patients from 1993 to 2008 with >pT3N0 or pT0-4N+ bladder cancer who underwent RC ± standard (sLND) or extended (eLND) lymph node dissection from 8 Canadian centres.Results: Of the 1180 patients, 55% (n = 643) underwent sLND, 34% (n = 402) underwent ePLND and 11% did not undergo a formal LND. Of the total number of patients, 321 (27%) received adjuvant chemotherapy. The median follow-up was 2.1 years (range: 0.6 to 12.9). Overall 30-day mortality was 3.2%. Clinical and pathological stages T3-4 were present in 6.1% and 86.7% of the patients, respectively; this demonstrates a dramatic understaging. Overall survival (OS) at 2 and 5 years was 60% and 43%, respectively. Patients who received adjuvant chemotherapy hada 2- and 5-year disease-specific survival (DSS) of 72% and 57% versus 64% and 51% for those who did not (log-rank p = 0.0039). The 2- and 5-year OS for high-risk node-negative disease was 67%and 52%, respectively, whereas for node-positive patients, the OS was 52% and 32%, respectively (p < 0.001). The OS, DSS and RFS for patients with pN0 were significantly improved compared to those who did not undergo a LND (log-rank p = 0.0035, 0.0241 and 0.0383, respectively).Interpretation: This series suggests that bladder cancer outcomes inadvanced disease have improved in the modern era. The need for improved staging investigations, use of neoadjuvant chemotherapyand performance of complete LND is emphasized.

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