Prescribing preferences of U.S. oncologists for patients (Pts) with metastatic urothelial carcinoma (mUC) at first recurrence: Impact of novel agents.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 365-365
Author(s):  
Maria L. Lankford ◽  
Joanne P. Willey ◽  
Arden Buettner ◽  
Susan Lynne Britton ◽  
Mitch Scharf ◽  
...  
Keyword(s):  
Market Research ◽  
Locally Advanced ◽  
Audience Response ◽  
Muscle Invasive Bladder Cancer ◽  
Medical Need ◽  
Clinical Scenarios ◽  
Metastatic Urothelial Carcinoma ◽  
First Recurrence ◽  
Muscle Invasive ◽  
Audience Response Technology

365 Background: In May 2016 atezolizumab (A) was approved for the treatment of pts with locally advanced or mUC who have disease progression during or following platinum-containing chemotherapy (PCCT), or within 12 months (mos) of neoadjuvant or adjuvant treatment with PCCT. We evaluated prescribing preferences (PPrefs) of 248 U.S-based oncologists for 1strecurrence treatment across a range of clinical scenarios prior to and following A approval. Methods: PPrefs were assessed through a validated, case-based market research tool (Challenging Cases). Assessment dates were 3/5 and 4/30 (PRE-) and 8/6 (POST-approval). Data were acquired using blinded, audience-response technology. A core scenario (CS) and 5 variant scenarios (V1, 2, 3, 4, 5) were utilized. CS: 69-year-old pt with muscle invasive bladder cancer, with a CrCl 62 ml/min, Hgb 12.5, and PS 1, recurs in the liver and bone 18 months after receiving neoadjuvant gemcitabine/cisplatin and a radical cystectomy. V1: Same as CS but with reduced CrCl 48 ml/min. V2: Same as CS but recurrence at 6 months. V3: Same as V2 but multiple comorbidities and PS 2. V4: Same as CS but age 79. V5: Same as V4 but multiple comorbidities. The same query was posed in each setting: What therapy would you choose? Results: See Table. Conclusions: Following the approval of A, overall PPref of most regimens offered decreased across nearly all 1st recurrence scenarios in favor of A. This is particularly stark in platinum unfit (older, comorbid, poor PS) pts. This highlights the previously unmet medical need in the PCCT pre-treated mUC pts. [Table: see text]

Evaluating Patient-Defined Priorities for Female Patients with Bladder Cancer

2020 ◽  
pp. 1-8
Author(s):  
Amanda X. Vo ◽  
Mary Kate Keeter ◽  
Emily S. Tuchman ◽  
Joshua J. Meeks ◽  
Alicia K. Morgans
Keyword(s):  
Bladder Cancer ◽  
Locally Advanced ◽  
Invasive Bladder Cancer ◽  
Emotional Wellbeing ◽  
Structured Interviews ◽  
Muscle Invasive Bladder Cancer ◽  
Care Experience ◽  
Female Patients ◽  
Muscle Invasive ◽  
Optimal Approach

BACKGROUND: Although bladder cancer is much more common in men than in women, female patients with bladder cancer present with more locally advanced tumors and have worse disease-specific outcomes than male patients, even after controlling for biological differences. There is a paucity of research regarding the optimal approach to caring for female patients with bladder cancer in ways that maximize patient satisfaction, preferences, and values. OBJECTIVE: We sought to explore patient-defined priorities and areas in need of improvement for female patients with bladder cancer from the patient perspective. METHODS: We conducted focus group sessions and semi-structured interviews of women treated for bladder cancer to identify patient priorities and concerns until reaching topic saturation. Transcripts were analyzed thematically. RESULTS: Eight patients with muscle-invasive bladder cancer and six patients with non-muscle-invasive bladder cancer participated in two focus groups and seven interviews total. Three themes emerged as significantly affecting the care experience: physical impacts, mental health and emotional wellbeing, and the patient-provider interaction. Each theme included patient-defined specific recommendations on approaches to optimizing the care experience for women with bladder cancer. CONCLUSIONS: Although most participants were satisfied with the quality of care they received, they identified several opportunities for improvement. These concerns centered around enhancing support for patients’ physical and mental needs and strengthening the patient-provider interaction. Efforts to address these needs and reduce gender disparate outcomes via quality improvement initiatives are ongoing.

The effect of adjuvant chemotherapy for patients with adverse pathology after neoadjuvant chemotherapy for muscle invasive bladder cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 367-367
Author(s):  
William P. Parker ◽  
Elizabeth B. Habermann ◽  
Courtney N. Day ◽  
Harras B. Zaid ◽  
Igor Frank ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Locally Advanced ◽  
Multivariable Analysis ◽  
Invasive Bladder Cancer ◽  
Rank Test ◽  
Muscle Invasive Bladder Cancer ◽  
Pathologic Stage ◽  
Muscle Invasive

367 Background: While neoadjuvant chemotherapy (NAC) for muscle−invasive bladder cancer (MIBC) is recognized as the standard of care, the management of patients with locally advanced and/or nodal disease after NAC and radical cystectomy (RC) is not well defined. We sought to evaluate the association of adjuvant chemotherapy (AC) and overall survival (OS) among patients with adverse pathology after NAC and RC. Methods: The National Cancer Database was reviewed to identify patients with adverse pathology (pT3N0, pT4N0, or pTanyN1−3) at RC following NAC from 2006−2012. Patients were stratified by receipt of AC. Clinical and pathologic variables were abstracted. OS was the primary end−point and differences on the basis of AC were assessed by the Kaplan−Meier method and log−rank test. Multivariable Cox proportional hazards regression was used to assess the association of AC with OS controlling for age, sex, race, Charlson score, year of diagnosis, pathologic stage, and receipt of adjuvant radiotherapy. Results: Adverse pathology following NAC and RC was identified in 1,361 patients from 2006−2012, of whom 328 (24.1%) received AC. Staging was pT3N0 in 444 (32.6%), pT4N0 in 162 (11.9%), and pTanyN1−3 in 755 (55.5%). Median OS for the entire cohort was 22.9 months, which differed by pathologic stage: 34.6 months (pT3N0), 21.4 months (pT4N0), and 19.3 months (pTanyN1-3)(p < 0.01). No difference in OS was noted by receipt of AC in the overall cohort (median OS 24.6 months with AC vs 22.0 months without AC; p = 0.18), or when stratified by pathologic stage. On multivariable analysis, receipt of AC was not significantly associated with overall mortality (HR 0.86; 95%CI 0.74−1.01; p = 0.06) for all patients. When stratified by stage, AC was associated with a significantly decreased risk of mortality among patients with pT4N0 disease (HR 0.56; 95%CI 0.33−0.97; p = 0.04), but not pT3N0 or pTanyN1−3 (p > 0.05). Conclusions: Patients with adverse pathology at RC after NAC have a median OS of approximately 2 years. AC was not associated with improved survival, except in the subgroup with pT4N0 disease. Clinical trials with newer systemic therapies are warranted for patients in this setting.

scholarly journals Bladder cancer: what’s new in 2018–2019

2020 ◽  
Vol 15 (4) ◽  
pp. 126-134
Author(s):  
О. В. Karyakin
Keyword(s):  
Bladder Cancer ◽  
Adverse Reactions ◽  
Locally Advanced ◽  
Survival Rates ◽  
Epidemiological Studies ◽  
Muscle Invasive Bladder Cancer ◽  
Cancer Data ◽  
Large Populations ◽  
Muscle Invasive ◽  
Urological Diseases

The review presents the results of the most important and interesting studies on diagnosis, epidemiology and treatment of bladder cancer within 2018–2019. Some regulations are based on the recommendations of the European Association of Urology, while others – on the results of mutual studies. As for treating non-muscle-invasive bladder cancer, data of particular interest pertain to intravesical chemotherapy in case of to BCG resistance (Calmet–Guerin Bacillus) for therapeutic and prophylactic purposes. Response rate and number of adverse reactions are satisfactory and allow to hope for better results in future. The results of epidemiological studies on large populations showed that considering the disease pathogenesis it is necessary to take into account the presence of human hepatitis HBAb, as well as human papillomavirus type 6. As immunotherapeutic drugs are widely used in patients with oncological and urological diseases, their action is studied in patients with nonmuscleinvasive, locally advanced bladder cancer. The results showed the effectiveness of pembrolizumab when administered intravesically in BCG refractory cancer. The same drugs used in the neoadjuvant mode showed an increase of pT0 number after radical cystectomy. A comparative study of pembrolizumab and atesolizumab versus traditional chemotherapy showed their advantage in the frequency of complete regressions and survival rates to progression.

Pembrolizumab and concurrent radiation is an effective regimen for muscle invasive bladder cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17020-e17020
Author(s):  
Niraj K. Gupta ◽  
Chad A. Reichard ◽  
Michael Large ◽  
Christopher A. Leagre ◽  
Kenneth Ney ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Radical Cystectomy ◽  
Locally Advanced ◽  
Distant Metastases ◽  
Complete Response ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Female Ratio ◽  
Muscle Invasive ◽  
Radiation Treatments

e17020 Background: Neo-adjuvant chemotherapy with Gemcitabine and Cisplatin followed by radical cystectomy is the standard of care in muscle invasive bladder ca. Some patients, usually older patients or those with poor PS with bladder ca are either cisplatin in-eligble or medically unfit for radical cystectomy. We share our experience using a combination of Pembrozulimab and concurrent radiation in cisplatin in-eligible patients with muscle invasive bladder cancer. Methods: Patients with muscle invasive bladder ca underwent TURBT followed by treatment with Pembrolizumab 200 mg IV every three weeks for 4 cycles concurrent with radiation treatments. Radiation treatments were started 1 week after starting pembrolizumab. A total of 64-65 Gy was given to the bladder and pelvis. All patients underwent a cystoscopy to assess local response and imaging studies to rule out distant metastases. Results: Between June 2018 and October 2019, 9 patients with locally advanced, cT2-cT4 urothelial ca were treated. Male to female ratio 7 to 2. Median age was 76 years, range was 71-90. Reasons were not using cisplatin were, renal-insufficiency, 7 pts. and pt refusal in 2 pts. ECOG PS was 1 in 6 patients and 2 in 3 pts. All patients finished radiation treatments. All but one patient finished 4 cycles of pembrolizumab. One patient declined the last dose. Grade-3/4 I/O inhibitor AEs were seen in 2 patients, One had pneumonitis and other had elevation of LFTs. None of the patients was found to have distant mets on the scans done after 4 cycles of Pembrolizumab. A complete response, by cystoscopy (histology/cytology) was seen in 7/9 (77%) of the patients. The other 2 pts. with PR declined cystectomy and have continued on immunotherapy without any evidence of progression. Conclusions: A combination of Pembrolizumab concurrent with radiation treatments is an effective option and can be safely administered in cT2-T4 bladder cancer. It is an attractive option for cis-ineligible patients. The feasibility and efficacy of this combination needs to be further explored in larger studies

Durvalumab as neoadjuvant therapy for muscle-invasive bladder cancer: Preliminary results from the Bladder Cancer Signal Seeking Trial (BLASST)-2.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 507-507 ◽  
Author(s):  
Xiao X. Wei ◽  
Bradley Alexander McGregor ◽  
Richard J. Lee ◽  
Xin Gao ◽  
Kerry L. Kilbridge ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Neoadjuvant Therapy ◽  
Radical Cystectomy ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Predictive Biomarkers ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Platinum Based Chemotherapy ◽  
Muscle Invasive

507 Background: There is no established neoadjuvant therapy (NAT) for patients (pt) with muscle invasive bladder cancer (MIBC) ineligible for cisplatin-based chemotherapy preceding radical cystectomy. Encouraging prospective data indicate PD-1/PD-L1 inhibitors, including pembrolizumab and atezolizumab, are safe and active as NAT for MIBC. Durvalumab (D), a PD-L1 inhibitor, is FDA approved for treating locally advanced or metastatic urothelial carcinoma following platinum-based chemotherapy. The safety and activity of D as NAT in MIBC have not been reported. Methods: We are conducting a single-center sequential multicohort trial (NCT03773666) of D alone (Cohort 1, N=10) and D plus the CD73 inhibitor oleclumab (Cohort 2, N=10) in cT2-T4aN0M0 MIBC pts who are RC candidates and are ineligible for or declined cisplatin-based chemotherapy. The primary endpoint is feasibility, defined as ≥7 of 10 pts receiving at least 1 dose of D followed by radical cystectomy without dose limiting toxicity (DLT) up to 12 wks post-RC. In Cohort 1, D is administered at 750mg IV Q2W for 3 cycles followed by RC 2-4 weeks after the last dose. Baseline and RC tissue and baseline and on-study blood are collected for correlative studies, including immunohistochemistry, genomics, transcriptomics, and metabolomics. Results: Cohort 1 has completed enrollment; ten pts were enrolled between Feb 2019 to Sept 2019. Median age was 67 (Range: 53-85) and 8 (80%) were men. All 10 pts completed 3 durvalumab doses. Eight pts completed planned RC with at least 12wk follow-up post-op to date. No DLTs were observed. One Grade 3 treatment-related adverse event (trAE) was reported (anemia), with no Grade 4 or higher trAE. Pathologic response (<pT2N0) was seen in 2 of 8 (25%) pts with pathologic complete response (pT0) in 1 (12.5%) pts. Updated safety and efficacy data from Cohort 1 will be presented. Conclusions: D appears to be feasible as NAT in MIBC with preliminary evidence for antitumor activity. Toxicities are consistent with data from other PD-1/PD-L1 inhibitor trials. Future cohorts will examine D-containing combination NAT strategies. Analysis of tissue and blood-based predictive biomarkers are ongoing. Clinical trial information: NCT03773666.

Study EV-103: Preliminary durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 441-441 ◽  
Author(s):  
Jonathan E. Rosenberg ◽  
Thomas W. Flaig ◽  
Terence W. Friedlander ◽  
Matthew I. Milowsky ◽  
Sandy Srinivas ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Locally Advanced ◽  
Sensory Neuropathy ◽  
Multiple Organ ◽  
Antibody Drug Conjugate ◽  
Metastatic Urothelial Carcinoma ◽  
Previously Treated ◽  
Muscle Invasive ◽  
Platinum Chemotherapy ◽  
Peripheral Sensory

441 Background: Platinum chemotherapy is the standard for patients (pts) with metastatic urothelial carcinoma (mUC) in the first line (1L) setting. In cisplatin-ineligible pts, gem/carbo is a standard therapy, but is poorly tolerated with limited durability and survival. PD-1/PD-L1 inhibitors, such as pembrolizumab (P), have shown promising durability in this setting for PD-L1 high patients. Enfortumab vedotin (EV) is an antibody-drug conjugate that delivers the microtubule-disrupting agent MMAE to cells expressing Nectin-4, which is highly expressed in UC. EV has shown activity in previously treated mUC. Initial EV + P data were previously presented (Hoimes ESMO 2019); this provides first durability data and an update on safety/ORR. Methods: This multicohort study (NCT03288545) evaluated the safety/activity of EV + P. We report a cohort of 1L cis-ineligible patients treated with EV 1.25 mg/kg + P. In each 3-week cycle, EV was administered on Days 1 and 8 and P on Day 1. The primary endpoint was safety/tolerability; secondary objectives included determination of recommended EV dose, ORR, DCR, DOR/PFS per RECIST v1.1, and OS. Results: As of 8 Oct 2019, 45 mUC pts (median age 69 yr [51–90]) received a median of 9 (range 1-22) cycles of EV + P. The most common treatment-emergent adverse events (AE) were fatigue (58%, 11% ≥G3), alopecia (53%), and peripheral sensory neuropathy (53%, 4% ≥G3). One pt died due to an AE reported as related (multiple organ failure). With a median follow-up of 11.5 mo, confirmed investigator-assessed ORR was 73.3% (95% CI, 58.1, 85.4) including 15.6% CRs; DCR was 93.3%. The ORR in pts with liver metastasis was 53.3% (8/15). The ORR in pts with available PD-L1 status was 78.6% in PD-L1 high (11/14) and 63.2% in PD-L1 low (12/19). Of the 33 responders, 18 (55%) have ongoing responses including 11 responses beyond 10 months. The median DOR was not reached (range 1.2 to 12.9+ mo). The median PFS was 12.3 mo (95% CI, 7.98, -). Conclusions: In 1L cis-ineligible pts with mUC, EV + P, a potential platinum free option, demonstrates promising activity and durability, with a manageable safety profile. Further evaluation of EV + P in mUC and muscle-invasive UC is ongoing. Clinical trial information: NCT03288545.

scholarly journals Trends in the Use of Perioperative Chemotherapy for Localized and Locally Advanced Muscle-invasive Bladder Cancer: A Sign of Changing Tides

2015 ◽  
Vol 67 (1) ◽  
pp. 165-170 ◽  
Author(s):  
Zachary D. Reardon ◽  
Sanjay G. Patel ◽  
Harras B. Zaid ◽  
C.J. Stimson ◽  
Matthew J. Resnick ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Locally Advanced ◽  
Invasive Bladder Cancer ◽  
Perioperative Chemotherapy ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive
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