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1. Biodynamic prediction of neoadjuvant chemotherapy response: Results from a prospective multicenter study of predictive accuracy among muscle-invasive bladder cancer patients

Author

Laviana, Aaron A., primary, Schiftan, Elizabeth G., additional, Mashni, Joseph W., additional, Large, Michael C., additional, Kaimakliotis, Hristos Z., additional, Nolte, David D., additional, Turek, John J., additional, An, Ran, additional, Morgan, Travis A., additional, and Chang, Sam S., additional

Published
2022
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3. Antiadenovirus Antibodies Predict Response Durability to Nadofaragene Firadenovec Therapy in BCG-unresponsive Non–muscle-invasive Bladder Cancer: Secondary Analysis of a Phase 3 Clinical Trial

Author

Mitra, Anirban P., primary, Narayan, Vikram M., additional, Mokkapati, Sharada, additional, Miest, Tanner, additional, Boorjian, Stephen A., additional, Alemozaffar, Mehrdad, additional, Konety, Badrinath R., additional, Shore, Neal D., additional, Gomella, Leonard G., additional, Kamat, Ashish M., additional, Bivalacqua, Trinity J., additional, Montgomery, Jeffrey S., additional, Lerner, Seth P., additional, Busby, J. Erik, additional, Poch, Michael, additional, Crispen, Paul L., additional, Steinberg, Gary D., additional, Schuckman, Anne K., additional, Downs, Tracy M., additional, Svatek, Robert S., additional, Mashni, Joseph, additional, Lane, Brian R., additional, Guzzo, Thomas J., additional, Bratslavsky, Gennady, additional, Karsh, Lawrence I., additional, Woods, Michael E., additional, Brown, Gordon A., additional, Canter, Daniel, additional, Luchey, Adam, additional, Lotan, Yair, additional, Krupski, Tracey, additional, Inman, Brant A., additional, Williams, Michael B., additional, Cookson, Michael S., additional, Keegan, Kirk A., additional, Andriole, Gerald L., additional, Sankin, Alexander I., additional, Boyd, Alan, additional, O'Donnell, Michael A., additional, Philipson, Richard, additional, Ylä-Herttuala, Seppo, additional, Sawutz, David, additional, Parker, Nigel R., additional, McConkey, David J., additional, and Dinney, Colin P.N., additional

Published
2021
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7. PD09-02 ANTI-ADENOVIRAL ANTIBODY LEVELS PREDICT NADOFARAGENE FIRADENOVEC RESPONSE IN BCG-UNRESPONSIVE NMIBC: RESULTS FROM A PHASE 3 TRIAL

Author

Mitra, Anirban P, primary, Narayan, Vikram M, additional, Boorjian, Stephen A, additional, Alemozaffar, Mehrdad, additional, Konety, Badrinath R, additional, Shore, Neal D, additional, Gomella, Leonard G, additional, Kamat, Ashish M, additional, Bivalacqua, Trinity J, additional, Montgomery, Jeffrey S, additional, Lerner, Seth P, additional, Busby, Joseph E, additional, Poch, Michael, additional, Crispen, Paul L, additional, Steinberg, Gary D, additional, Schuckman, Anne K, additional, Downs, Tracy M, additional, Svatek, Robert S, additional, Mashni, Joseph, additional, Lane, Brian R, additional, Guzzo, Thomas J, additional, Bratslavsky, Gennady, additional, Karsh, Lawrence I, additional, Woods, Michael E, additional, Brown, Gordon, additional, Canter, Daniel, additional, Luchey, Adam, additional, Lotan, Yair, additional, Krupski, Tracey, additional, Inman, Brant A, additional, Williams, Michael B, additional, Cookson, Michael S, additional, Keegan, Kirk A, additional, Andriole, Gerald L, additional, Sankin, Alexander I, additional, Boyd, Alan, additional, O'Donnell, Michael A, additional, Yang, Mindy, additional, Sawutz, David, additional, Philipson, Richard, additional, Ylä-Herttuala, Seppo, additional, Parker, Nigel R, additional, and Dinney, Colin P N, additional

Published
2021
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10. MULTI-INSTITUTIONAL QUALITY CARE INITIATIVE TO IMPROVE THE CARE OF PATIENTS WITH MUSCLE INVASIVE BLADDER CANCER: MP60-12

Author

Bochner, Bernard, Sperling, Dahlia, Feifer, Andrew, Mashni, Joseph, Jr., Bajorin, Dean, Dalbagni, Guido, Herr, Harry, Donat, Sherri M., Milowsky, Matthew, Shah, Jay, Kamat, Ashish, Grossman, Barton H., Grubb, Robert, III, Brandes, Stephen, Bullock, Arnold, Strope, Seth, Roth, Bruce, Kibel, Adam, Weigand, Louis, Steinberg, Gary, Stadler, Walter, Rutiaga, Natali, Schoenberg, Mark, Bivalacqua, Trinity, Rogers, Charlene, Black, Peter, So, Alan, Gleave, Martin, Kassouf, Wassim, Bachir, Bassel, Yafi, Faysal, Lerner, Seth, Godoy, Guilherme, Amiel, Gilead, Zlotta, Alexandre, Fleshner, Neil, Jewett, Michael, Kulkarni, Girish, Sridhar, Srikala, Tanock, Ian, Joshua, Anthony, Bostrom, Peter, Kuk, Cynthia, and Lotan, Yair

Published
2014
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13. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial

Author

Boorjian, Stephen A, primary, Alemozaffar, Mehrdad, additional, Konety, Badrinath R, additional, Shore, Neal D, additional, Gomella, Leonard G, additional, Kamat, Ashish M, additional, Bivalacqua, Trinity J, additional, Montgomery, Jeffrey S, additional, Lerner, Seth P, additional, Busby, Joseph E, additional, Poch, Michael, additional, Crispen, Paul L, additional, Steinberg, Gary D, additional, Schuckman, Anne K, additional, Downs, Tracy M, additional, Svatek, Robert S, additional, Mashni, Joseph, additional, Lane, Brian R, additional, Guzzo, Thomas J, additional, Bratslavsky, Gennady, additional, Karsh, Lawrence I, additional, Woods, Michael E, additional, Brown, Gordon, additional, Canter, Daniel, additional, Luchey, Adam, additional, Lotan, Yair, additional, Krupski, Tracey, additional, Inman, Brant A, additional, Williams, Michael B, additional, Cookson, Michael S, additional, Keegan, Kirk A, additional, Andriole, Gerald L, additional, Sankin, Alexander I, additional, Boyd, Alan, additional, O'Donnell, Michael A, additional, Sawutz, David, additional, Philipson, Richard, additional, Coll, Ruth, additional, Narayan, Vikram M, additional, Treasure, F Peter, additional, Yla-Herttuala, Seppo, additional, Parker, Nigel R, additional, and Dinney, Colin P N, additional

Published
2021
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25. MP30-18 PATHOLOGIC STAGE T3A SIGNIFICANTLY INCREASES DISEASE RECURRENCE ACROSS ALL TUMOR SIZES IN RENAL CELL CARCINOMA

Author

Chevinsky, Michael, primary, Imnadze, Mariam, additional, Sankin, Alexander, additional, Mano, Roy, additional, Jakubowski, Christopher, additional, Hakimi, A Ari, additional, Mashni, Joseph, additional, Sjoberg, Daniel D., additional, Chen, Yingbei, additional, Tickoo, Satish K., additional, Reuter, Victor E., additional, and Russo, Paul, additional

Published
2014
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26. MP60-12 MULTI-INSTITUTIONAL QUALITY CARE INITIATIVE TO IMPROVE THE CARE OF PATIENTS WITH MUSCLE INVASIVE BLADDER CANCER

Author

Bochner, Bernard, primary, Sperling, Dahlia, additional, Feifer, Andrew, additional, Mashni, Joseph, additional, Bajorin, Dean, additional, Dalbagni, Guido, additional, Herr, Harry, additional, Donat, Sherri M., additional, Milowsky, Matthew, additional, Shah, Jay, additional, Kamat, Ashish, additional, Grossman, H. Barton, additional, Grubb, Robert, additional, Brandes, Stephen, additional, Bullock, Arnold, additional, Strope, Seth, additional, Roth, Bruce, additional, Kibel, Adam, additional, Weigand, Louis, additional, Steinberg, Gary, additional, Stadler, Walter, additional, Rutiaga, Natali, additional, Schoenberg, Mark, additional, Bivalacqua, Trinity, additional, Rogers, Charlene, additional, Black, Peter, additional, So, Alan, additional, Gleave, Martin, additional, Kassouf, Wassim, additional, Bachir, Bassel, additional, Yafi, Faysal, additional, Lerner, Seth, additional, Godoy, Guilherme, additional, Amiel, Gilead, additional, Zlotta, Alexandre, additional, Fleshner, Neil, additional, Jewett, Michael, additional, Kulkarni, Girish, additional, Sridhar, Srikala, additional, Tanock, Ian, additional, Joshua, Anthony, additional, Bostrom, Peter, additional, Kuk, Cynthia, additional, and Lotan, Yair, additional

Published
2014
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28. Urine kidney injury molecule-1: a potential non-invasive biomarker for patients with renal cell carcinoma

Author

Zhang, Ping L., primary, Mashni, Joseph W., additional, Sabbisetti, Venkata S., additional, Schworer, Charles M., additional, Wilson, George D., additional, Wolforth, Stacy C., additional, Kernen, Kenneth M., additional, Seifman, Brian D., additional, Amin, Mitual B., additional, Geddes, Timothy J., additional, Lin, Fan, additional, Bonventre, Joseph V., additional, and Hafron, Jason M., additional

Published
2013
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34. Biodynamic prediction of neoadjuvant chemotherapy response: Results from a prospective multicenter study of predictive accuracy among muscle-invasive bladder cancer patients.

Author

Laviana, Aaron A., Schiftan, Elizabeth G., Mashni, Joseph W., Large, Michael C., Kaimakliotis, Hristos Z., Nolte, David D., Turek, John J., An, Ran, Morgan, Travis A., and Chang, Sam S.

Subjects
*CANCER invasiveness, *NEOADJUVANT chemotherapy, *CANCER patients, *LONGITUDINAL method, *BLADDER cancer, *CYTOTOXINS
Abstract

• Although neoadjuvant chemotherapy is currently standard of care for patients with muscle-invasive bladder cancer, its adoption remains far from universal, and we still lack predictive tools to better understand who may most benefit from chemotherapy, let alone from what type of therapy. • In this study, we utilized biodynamic analysis (also known as motility contrast tomography or biodynamic imaging) to help develop a classifier for predicting response to chemotherapy in muscle-invasive bladder cancer. • Biodynamic analysis provides a fast and simple quantitative analysis to help fill a large gap where targetable genetic biomarkers do not yet exist or still have unproven benefit. Biodynamic signatures (temporal patterns of microscopic motion within a 3-dimensional tumor explant) offer phenomic biomarkers that are highly predictive for therapeutic response. By utilizing motility contrast tomography, which provides a simple, fast assessment of motion patterns in living tissue, we evaluated the predictive accuracy of a biodynamic drug response classifier in muscle-invasive bladder cancer (MIBC) patients undergoing neoadjuvant chemotherapy (NAC). One hundred five consecutive bladder cancer patients suspected of having MIBC were screened in a multi-institutional prospective observational study (NCT03739177) from July 2018 to June 2020, of whom, 30 completed NAC and radical cystectomy. Biodynamic signatures from treatment-naïve fresh bladder tumor specimens obtained after transurethral resection were measured in living tumor fragments challenged by standard-of-care cytotoxins. Patients received gemcitabine and cisplatin or dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin per institutional guidelines and were followed through radical cystectomy. A 4-level classifier was developed to predict pathologic complete response (pCR) vs. incomplete response utilizing a one-left-out cross-validation protocol to minimize over-fitting. Area under the curve evaluated predictive utility. Thirty percent (9 of 30) achieved pCR. Utilizing the 4-level classifier, biodynamically "favored" (scoring ≥ 3) and "strongly favored" (scoring 4) regimens accurately predicted pCR at rates of 66.7% (4 of 6 patients) and 100% (4 of 4 patients), respectively. Biodynamically "favored" scores predicted pCR with 88% sensitivity and 95% negative predictive value, P < 0.0001. Only 5.0% (1 of 20 patients) achieved pCR from regimens scoring 1 or 2, indicating poor to no response from NAC. Area under the receiver operating curve was 96% (95% Confidence Interval: 79%–99%, P < 0.0001). Future direction involves validating this model prospectively. Biodynamic scoring accurately predicts response in MIBC patients receiving NAC and holds promise to substantially improve the scope of appropriate management intervention. [ABSTRACT FROM AUTHOR]

Published
2023
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35. Efficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin-Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial.

Author

Narayan VM, Boorjian SA, Alemozaffar M, Konety BR, Shore ND, Gomella LG, Kamat AM, Bivalacqua TJ, Montgomery JS, Lerner SP, Busby JE, Poch M, Crispen PL, Steinberg GD, Schuckman AK, Downs TM, Mashni J Jr, Lane BR, Guzzo TJ, Bratslavsky G, Karsh LI, Woods ME, Brown G, Canter D, Luchey A, Lotan Y, Inman BA, Williams MB, Cookson MS, Chang SS, Sankin AI, O'Donnell MA, Sawutz D, Philipson R, Parker NR, Yla-Herttuala S, Rehm D, Jakobsen JS, Juul K, and Dinney CPN

Subjects
Humans, Male, Female, Administration, Intravesical, Follow-Up Studies, Aged, Middle Aged, Carcinoma in Situ pathology, Carcinoma in Situ therapy, Carcinoma in Situ drug therapy, Neoplasm Invasiveness, Treatment Outcome, Adenoviridae genetics, Adjuvants, Immunologic administration & dosage, Adjuvants, Immunologic therapeutic use, Aged, 80 and over, Urinary Bladder Neoplasms pathology, Urinary Bladder Neoplasms drug therapy, Urinary Bladder Neoplasms therapy, Urinary Bladder Neoplasms mortality, BCG Vaccine administration & dosage, BCG Vaccine therapeutic use
Abstract

Purpose: Nadofaragene firadenovec-vncg is a nonreplicating adenoviral vector-based gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive carcinoma in situ (CIS) with/without high-grade Ta/T1. We report outcomes following 5 years of planned follow-up., Materials and Methods: This open-label phase 3 trial (NCT02773849) enrolled patients with BCG-unresponsive nonmuscle-invasive bladder cancer in 2 cohorts: CIS ± Ta/T1 (CIS; n = 107) and Ta/T1 without CIS (Ta/T1 cohort; n = 50). Patients received 75 mL (3 × 10 11 vp/mL) nadofaragene firadenovec intravesically once every 3 months with cystoscopy and cytology assessments, with continued treatment offered to those remaining high grade recurrence-free (HGRF)., Results: One hundred fifty-seven patients were enrolled from 33 US sites (n = 151 included in efficacy analyses). Median follow-up was 50.8 months (interquartile range 39.1-60.0), with 27% receiving ≥ 5 instillations and 7.6% receiving treatment for ≥ 57 months. Of patients with CIS 5.8% (95% CI 2.2-12.2) were HGRF at month 57, and 15% (95% CI 6.1-27.8) of patients with high-grade Ta/T1 were HGRF at month 57. Kaplan-Meier-estimated HGRF survival at 57 months was 13% (95% CI 6.9-21.5) and 33% (95% CI 19.5-46.6) in the CIS and Ta/T1 cohorts, respectively. Cystectomy-free survival at month 60 was 49% (95% CI 40.0-57.1): 43% (95% CI 32.2-53.7) in the CIS cohort and 59% (95% CI 43.1-71.4) in the Ta/T1 cohort. Overall survival at 60 months was 80% (71.0, 86.0): 76% (64.6-84.5) and 86% (70.9-93.5) in the CIS and Ta/T1 cohorts, respectively. Only 5 patients (4 with CIS and 1 with Ta/T1) experienced clinical progression to muscle-invasive disease., Conclusions: At 60 months, nadofaragene firadenovec-vncg allowed bladder preservation in nearly half of the patients and proved to be a safe option for BCG-unresponsive nonmuscle-invasive bladder cancer.

Published
2024
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36. Antiadenovirus Antibodies Predict Response Durability to Nadofaragene Firadenovec Therapy in BCG-unresponsive Non-muscle-invasive Bladder Cancer: Secondary Analysis of a Phase 3 Clinical Trial.

Author

Mitra AP, Narayan VM, Mokkapati S, Miest T, Boorjian SA, Alemozaffar M, Konety BR, Shore ND, Gomella LG, Kamat AM, Bivalacqua TJ, Montgomery JS, Lerner SP, Busby JE, Poch M, Crispen PL, Steinberg GD, Schuckman AK, Downs TM, Svatek RS, Mashni J, Lane BR, Guzzo TJ, Bratslavsky G, Karsh LI, Woods ME, Brown GA, Canter D, Luchey A, Lotan Y, Krupski T, Inman BA, Williams MB, Cookson MS, Keegan KA, Andriole GL, Sankin AI, Boyd A, O'Donnell MA, Philipson R, Ylä-Herttuala S, Sawutz D, Parker NR, McConkey DJ, and Dinney CPN

Subjects
Adjuvants, Immunologic therapeutic use, Administration, Intravesical, BCG Vaccine therapeutic use, Female, Humans, Male, Neoplasm Invasiveness, Neoplasm Recurrence, Local drug therapy, Prospective Studies, Antineoplastic Agents therapeutic use, Urinary Bladder Neoplasms drug therapy
Abstract

A recent phase 3 trial of intravesical nadofaragene firadenovec reported a promising complete response rate for patients with bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer. This study examined the ability of antiadenovirus antibody levels to predict the durability of therapeutic response to nadofaragene firadenovec. A standardized and validated quantitative assay was used to prospectively assess baseline and post-treatment serum antibody levels among 91 patients from the phase 3 trial, of whom 47 (52%) were high-grade recurrence free at 12 mo (responders). While baseline titers did not predict treatment response, 3-mo titer >800 was associated with a higher likelihood of durable response (p = 0.026). Peak post-treatment titers >800 were noted in 42 (89%) responders versus 26 (59%) nonresponders (p = 0.001; assay sensitivity, 89%; negative predictive value, 78%). Moreover, 22 (47%) responders compared with eight (18%) nonresponders had a combination of peak post-treatment titers >800 and peak antibody fold change >8 (p = 0.004; assay specificity, 82%; positive predictive value, 73%). A majority of responders continued to have post-treatment antibody titers >800 after the first 6 mo of therapy. In conclusion, serum antiadenovirus antibody quantification may serve as a novel predictive marker for nadofaragene firadenovec response durability. Future studies will focus on large-scale validation and clinical utility of the assay. PATIENT SUMMARY: This study reports on a planned secondary analysis of a phase 3 multicenter clinical trial that established the benefit of nadofaragene firadenovec, a novel intravesical gene therapeutic, for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer. Prospective assessment of serum anti-human adenovirus type-5 antibody levels of patients in this trial indicated that a combination of post-treatment titers and fold change from baseline can predict treatment efficacy. While this merits additional validation, our findings suggest that serum antiadenovirus antibody levels can serve as an important predictive marker for the durability of therapeutic response to nadofaragene firadenovec., (Copyright © 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Published
2022
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