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5. Rethinking Cancer Clinical Trial Conduct Induced by COVID-19: An Academic Center, Industry, Government, and Regulatory Agency Perspective

Author

Flaherty, Keith T, Doroshow, James H, Galbraith, Susan, Ribas, Antoni, Kluetz, Paul G, Pazdur, Richard, and Theoret, Marc R

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Good Health and Well Being, Academies and Institutes, COVID-19, Clinical Trials as Topic, Drug Industry, Government Agencies, Humans, Infection Control, National Cancer Institute (U.S.), Neoplasms, United States, United States Food and Drug Administration, Biochemistry and cell biology, Oncology and carcinogenesis
Abstract

The COVID-19 pandemic brought about major changes in cancer clinical trials. In its aftermath, the community has an opportunity to incorporate some of these changes as part of the future of trial conduct to make it more patient centered.

Published
2021

7. Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures

Author

Bui, Cat, Emechebe, Nnadozie, Kamalakar, Rajesh, Papadopoulos, Elektra, Sail, Kavita, Sen, Rohini, Turner, Sean C, Cocks, Kim, Reijneveld, Jaap, Gerlinger, Christoph, Keating, Karen, Su, Yun, Wolf, Birgit, Ge, Miaomiao, Ingelgaard, Anders, Peil, Barbara, Voorhaar, Maarten, Wong, Brendon, Dekanic Arbanas, Gracia, Kuljanic, Karin, Petranovic, Duska, Rede, Ivana, Arraras, Juan, Coons, Stephen Joel, Eremenco, Sonya, Murray, Lindsey, Reeve, Bryce, De Vries, Corinne, Herold, Ralf, Pignatti, Francesco, Machingura, Abigirl, Martinelli, Francesca, Musoro, Jammbe, Piccart, Martine, Barriuso, Jorge, Cherny, Nathan, Dafni, Ourania, De Vries, Elisabeth, Gyawali, Bishal, Kiesewetter, Barbara, Oosting, Sjoukje, Roitberg, Felipe, Rumpold, Gerhard, Schoepf, Felix, Tschuggnall, Michael, Black, Jennifer, Sasseville, Maxime, Soltys, Katherine, Ferrer, Montserrat, Garin, Olatz, Vilagut, Gemma, Schürmann, Christoph, Thomas, Stefanie, Wieseler, Beate, Snyder, Claire, Alonso Abad, Ariel, Bogaerts, Kris, Brackx, Febe, Molenberghs, Geert, Verbeke, Geert, Frigolett Catalan, Cristián, Choi, Jan, Thomassen, Doranne, Geissler, Jan, Sauerbrei, Willi, Gross, Franziska, Pilz, Micha Johannes, Barbachano, Yolanda, Campbell, Lisa, Rantell, Khadija, Desplanques, Gregoire, Regnault, Antoine, Morgan, Kate, Plate, Ananda, ten Seldam, Silene, Terada, Mitsumi, Mizusawa, Junki, Mitchell, Sandra, Wilder Smith, Ashley, Reksten, Tove Ragna, Schiel, Anja, Hansen Joseph, Kenth Louis, Campbell, Alicyn, Cappelleri, Joseph, de Besi, Patrizia, Russell-Smith, Alexander, Sandin, Rickard, Mamolo, Carla, Brundage, Michael, Tu, Dongsheng, Groenvold, Mogens, Petersen, Morten, Cleeland, Charlie, Williams, Lori, Shelley Wang, Xin, Ringash, Jolie, Calvert, Melanie, Cruz Rivera, Samantha, Aiyegbusi, Olalekan Lee, Goetghebeur, Els, Liu, Limin, Van Lancker, Kelly, Boele, Florien, Gilbert, Alexandra, Peacock, Rosemary, Basch, Ethan, King, Madeleine, Rutherford, Claudia, Bhatnagar, Vishal, Fiero, Mallorie, Horodniceanu, Erica, Johnson, Laura Lee, Kluetz, Paul, Rodriguez, Lisa, Pe, Madeline, Alanya, Ahu, Falk, Ragnhild Sorum, Amdal, Cecilie Delphin, Bjordal, Kristin, Chang, Jane, Cislo, Paul, Coens, Corneel, Dirven, Linda, Speck, Rebecca M, Fitzgerald, Kristina, Galinsky, Jayne, Giesinger, Johannes M, Holzner, Bernhard, Le Cessie, Saskia, O'Connor, Daniel, Oliver, Kathy, Pawar, Vivek, Quinten, Chantal, Schlichting, Michael, Ren, Jinma, Roychoudhury, Satrajit, Taphoorn, Martin J B, Velikova, Galina, Wintner, Lisa M, Griebsch, Ingolf, and Bottomley, Andrew

Published
2023
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8. Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice

Author

Aiyegbusi, Olalekan Lee, Alanya, Ahu, Barbachano, Yolanda, Basch, Ethan, Calvert, Melanie, Campbell, Alicyn, Cappelleri, Joseph, Choi, Jungyeon, Cruz Rivera, Samantha, Delphin Amdal, Cecilie, Fiero, Mallorie, Goetghebeur, Els, Kamalakar, Rajesh, Keating, Karen, Kluetz, Paul, le Cessie, Saskia, Liu, Limin, Molenberghs, Geert, Musoro, Jammbe, Ness, David, Rantell, Khadija, Regnault, Antoine, Reijneveld, Jaap, Roychoudhury, Satrajit, Rumpold, Gerhard, Russell-Smith, Alexander, Rutherford, Claudia, Sail, Kavita, Sandin, Rickard, Sasseville, Maxime, Sauerbrei, Willi, Schiel, Anja, Schlichting, Michael, Soltys, Kathy, Sorum Falk, Ragnhild, Su, Yun, ten Seldam, Silene, Thomassen, Doranne, Van Lancker, Kelly, Musoro, Jammbe Z, Amdal, Cecilie Delphin, Cappelleri, Joseph C, Falk, Ragnhild Sørum, Fiero, Mallorie H, and Reijneveld, Jaap C

Published
2023
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9. Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop.

Author

Weinstock, Chana, Suzman, Daniel, Kluetz, Paul, Baxley, John, Viviano, Charles, Ibrahim, Amna, Jarow, Jonathan, Sridhara, Raejshwari, Liu, Ke, Carroll, Peter, Eggener, Scott, Hu, Jim C, Hussain, Maha, King, Martin, Klein, Eric, Kungel, Terry, Makarov, Danil, Pinto, Peter A, Rini, Brian, Roach, Mack, Sandler, Howard, Schlegel, Peter N, Song, Daniel, Goldberg, Kirsten, Pazdur, Richard, and Beaver, Julia A

Subjects
Humans, Prostatic Neoplasms, Diagnostic Imaging, Endpoint Determination, Population Surveillance, Genomics, Research Design, United States Food and Drug Administration, Education, United States, Male, Clinical Trials as Topic, Watchful Waiting, drug development, equipment design, prostatic neoplasms, research design, Urologic Diseases, Cancer, Prostate Cancer, Aging, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, United States Food and Drug, Administration, Clinical Sciences, Urology & Nephrology
Abstract

PurposeThe following is a summary of discussion at a United States FDA (Food and Drug Administration) public workshop reviewing potential trial designs and end points to develop therapies to treat localized prostate cancer.Materials and methodsThe workshop focused on the challenge that drug and device development to treat localized prostate cancer has been limited by the large trial sizes and lengthy timelines required to demonstrate an improvement in overall or metastasis-free survival and by the lack of agreed on alternative end points. Additionally, evolving treatment paradigms in the management of localized prostate cancer include the widespread use of active surveillance of patients with low and some intermediate risk prostate cancer, and the availability of advances in imaging and genomics.ResultsThe workshop addressed issues related to trial design in this setting. Attendees discussed several potential novel end points such as a delay of morbidity due to radiation or prostatectomy and pathological end points such as Gleason Grade Group upgrade.ConclusionsThe workshop provided an open forum for multiple stakeholder engagement to advance the development of effective treatment options for men with localized prostate cancer.

Published
2020

10. Proceedings of the Comprehensive Oncology Network Evaluating Rare CNS Tumors (NCI-CONNECT) Oligodendroglioma Workshop.

Author

Penas-Prado, Marta, Wu, Jing, Cahill, Daniel P, Brat, Daniel J, Costello, Joseph F, Kluetz, Paul G, Cairncross, J Gregory, van den Bent, Martin, Verhaak, Roel GW, Aboud, Orwa, Burger, Peter, Chang, Susan M, Cordova, Christine, Huang, Raymond Y, Rowe, Lindsay S, Taphoorn, Martin JB, Gilbert, Mark R, Armstrong, Terri S, and NCI-CONNECT Oligodendroglioma Workshop

Subjects
NCI-CONNECT Oligodendroglioma Workshop, NCI-CONNECT, oligodendroglioma, rare CNS tumors, workshop, Rare Diseases, Neurosciences, Clinical Research, Cancer, Good Health and Well Being
Abstract

BackgroundOligodendroglioma is a rare primary central nervous system (CNS) tumor with highly variable outcome and for which therapy is usually not curative. At present, little is known regarding the pathways involved with progression of oligodendrogliomas or optimal biomarkers for stratifying risk. Developing new therapies for this rare cancer is especially challenging. To overcome these challenges, the neuro-oncology community must be particularly innovative, seeking multi-institutional and international collaborations, and establishing partnerships with patients and advocacy groups thereby ensuring that each patient enrolled in a study is as informative as possible.MethodsThe mission of the National Cancer Institute's NCI-CONNECT program is to address the challenges and unmet needs in rare CNS cancer research and treatment by connecting patients, health care providers, researchers, and advocacy organizations to work in partnership. On November 19, 2018, the program convened a workshop on oligodendroglioma, one of the 12 rare CNS cancers included in its initial portfolio. The purpose of this workshop was to discuss scientific progress and regulatory challenges in oligodendroglioma research and develop a call to action to advance research and treatment for this cancer.ResultsThe recommendations of the workshop include a multifaceted and interrelated approach covering: biology and preclinical models, data sharing and advanced molecular diagnosis and imaging; clinical trial design; and patient outreach and engagement.ConclusionsThe NCI-CONNECT program is well positioned to address challenges in oligodendroglioma care and research in collaboration with other stakeholders and is developing a list of action items for future initiatives.

Published
2020

11. Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group

Author

Piccinin, Claire, Basch, Ethan, Bhatnagar, Vishal, Calvert, Melanie, Campbell, Alicyn, Cella, David, Cleeland, Charles S, Coens, Corneel, Darlington, Anne-Sophie, Dueck, Amylou C, Groenvold, Mogens, Herold, Ralf, King-Kallimanis, Bellinda L, Kluetz, Paul G, Kuliś, Dagmara, O'Connor, Daniel, Oliver, Kathy, Pe, Madeline, Reeve, Bryce B, Reijneveld, Jaap C, Wang, Xin Shelley, and Bottomley, Andrew

Published
2023
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12. FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint inhibitors for the Treatment of Biliary Tract Cancer

Author

Casak, Sandra J., primary, Kumar, Vaibhav, additional, Song, Chi, additional, Yuan, Mengdie, additional, Amatya, Anup K., additional, Cheng, Joyce, additional, Mishra-Kalyani, Pallavi S., additional, Tang, Shenghui, additional, Lemery, Steven J., additional, Auth, Doris, additional, Davis, Gina, additional, Kluetz, Paul G., additional, Pazdur, Richard, additional, and Fashoyin-Aje, Lola A., additional

Published
2024
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14. Integrating 4 Methods (In4M) to evaluate physical function in patients with cancer: Results of a comprehensive digital health study.

Author

Thanarajasingam, Gita, primary, Dueck, Amylou C., additional, Bhatnagar, Vishal, additional, Brown, Abbie, additional, Cathcart-Rake, Elizabeth Jane, additional, Diamond, Matthew, additional, Faust, Louis, additional, Fiero, Mallorie, additional, Huntington, Scott F., additional, Jeffery, Molly, additional, Jones, Lee, additional, Paludo, Jonas, additional, Power, Bradford, additional, Ross, Joseph S., additional, Ruddy, Kathryn Jean, additional, Schellhorn, Sarah, additional, Tarver, Michelle, additional, Wood, William Allen, additional, Gross, Cary Philip, additional, and Kluetz, Paul Gustav, additional

Published
2024
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15. FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer

Author

Fusco, Michael J., primary, Casak, Sandra J., additional, Mushti, Sirisha L., additional, Cheng, Joyce, additional, Christmas, Brian J., additional, Thompson, Matthew D., additional, Fu, Wentao, additional, Wang, Hezhen, additional, Yoon, Miyoung, additional, Yang, Yuching, additional, Moore, Jason N., additional, Bi, Youwei, additional, Nan, Yang, additional, Long, Craig E., additional, Auth, Doris, additional, Rahman, Nam Atiqur., additional, Tang, Shenghui, additional, Pazdur, Richard, additional, Fashoyin-Aje, Lola A., additional, Kluetz, Paul G., additional, and Lemery, Steven J., additional

Published
2024
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16. Supplementary Table S2 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma

Author

Maguire, William F., primary, Lee, Daniel, primary, Weinstock, Chana, primary, Gao, Xin, primary, Bulik, Catharine C., primary, Agrawal, Sundeep, primary, Chang, Elaine, primary, Hamed, Salaheldin S., primary, Bloomquist, Erik W., primary, Tang, Shenghui, primary, Pazdur, Richard, primary, Kluetz, Paul G., primary, Amiri-Kordestani, Laleh, primary, and Suzman, Daniel L., primary

Published
2024
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17. Supplementary Figure S1 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma

Author

Maguire, William F., primary, Lee, Daniel, primary, Weinstock, Chana, primary, Gao, Xin, primary, Bulik, Catharine C., primary, Agrawal, Sundeep, primary, Chang, Elaine, primary, Hamed, Salaheldin S., primary, Bloomquist, Erik W., primary, Tang, Shenghui, primary, Pazdur, Richard, primary, Kluetz, Paul G., primary, Amiri-Kordestani, Laleh, primary, and Suzman, Daniel L., primary

Published
2024
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18. Data from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma

Author

Maguire, William F., primary, Lee, Daniel, primary, Weinstock, Chana, primary, Gao, Xin, primary, Bulik, Catharine C., primary, Agrawal, Sundeep, primary, Chang, Elaine, primary, Hamed, Salaheldin S., primary, Bloomquist, Erik W., primary, Tang, Shenghui, primary, Pazdur, Richard, primary, Kluetz, Paul G., primary, Amiri-Kordestani, Laleh, primary, and Suzman, Daniel L., primary

Published
2024
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19. Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies

Author

Thanarajasingam, Gita, Minasian, Lori M, Bhatnagar, Vishal, Cavalli, Franco, De Claro, R Angelo, Dueck, Amylou C, El-Galaly, Tarec C, Everest, Neil, Geissler, Jan, Gisselbrecht, Christian, Gormley, Nicole, Gribben, John, Horowitz, Mary, Ivy, S Percy, Jacobson, Caron A, Keating, Armand, Kluetz, Paul G, Kwong, Yok Lam, Little, Richard F, Matasar, Matthew J, Mateos, Maria-Victoria, McCullough, Kristen, Miller, Robert S, Mohty, Mohamad, Moreau, Philippe, Morton, Lindsay M, Nagai, Sumimasa, Nair, Abhilasha, Nastoupil, Loretta, Robertson, Kaye, Sidana, Surbhi, Smedby, Karin E, Sonneveld, Pieter, Tzogani, Kyriaki, van Leeuwen, Flora E, Velikova, Galina, Villa, Diego, Wingard, John R, Seymour, John F, and Habermann, Thomas M

Published
2022
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21. Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop

Author

Chang, Elaine, Apolo, Andrea B., Bangs, Rick, Chisolm, Stephanie, Duddalwar, Vinay, Efstathiou, Jason A., Goldberg, Kirsten B., Hansel, Donna E., Kamat, Ashish M., Kluetz, Paul G., Lerner, Seth P., Plimack, Elizabeth, Prowell, Tatiana, Singh, Harpreet, Suzman, Daniel, Yu, Evan Y., Zhang, Hui, Beaver, Julia A., Pazdur, Richard, Weinstock, Chana, and Galsky, Matthew D.

Published
2022
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23. US Food and Drug Administration Approval Summary: Eflornithine for High-Risk Neuroblastoma After Prior Multiagent, Multimodality Therapy.

Author

Duke, Elizabeth S., Bradford, Diana, Sinha, Arup K., Mishra-Kalyani, Pallavi S., Lerro, Catherine C., Rivera, Donna, Wearne, Emily, Miller, Claudia P., Leighton, John, Sabit, Hairat, Zhao, Hong, Lane, Ashley, Scepura, Barbara, Pazdur, Richard, Singh, Harpreet, Kluetz, Paul G., Donoghue, Martha, and Drezner, Nicole

Published
2024
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24. Evaluation of Real-World Tumor Response Derived From Electronic Health Record Data Sources: A Feasibility Analysis in Patients With Metastatic Non–Small Cell Lung Cancer Treated With Chemotherapy.

Author

McKelvey, Brittany A., Garrett-Mayer, Elizabeth, Rivera, Donna R., Alabaster, Amy, Andrews, Hillary S., Bond, Elizabeth G., Brown, Thomas D., Bruno, Amanda, Damato, Lauren, Espirito, Janet L., Fernandes, Laura L., Hansen, Eric, Kluetz, Paul, Ma, Xinran, McCracken, Andrea, Mishra-Kalyani, Pallavi S., Natanzon, Yanina, Potter, Danielle, Robert, Nicholas J., and Schwartz, Lawrence

Subjects
CANCER chemotherapy, ELECTRONIC health records, TERMINATION of treatment, DRUG efficacy, LUNG cancer
Abstract

PURPOSE: Real-world data (RWD) holds promise for ascribing a real-world (rw) outcome to a drug intervention; however, ascertaining rw-response to treatment from RWD can be challenging. Friends of Cancer Research formed a collaboration to assess available data attributes related to rw-response across RWD sources to inform methods for capturing, defining, and evaluating rw-response. MATERIALS AND METHODS: This retrospective noninterventional (observational) study included seven electronic health record data companies (data providers) providing summary-level deidentified data from 200 patients diagnosed with metastatic non–small cell lung cancer (mNSCLC) and treated with first-line platinum doublet chemotherapy following a common protocol. Data providers reviewed the availability and frequency of data components to assess rw-response (ie, images, radiology imaging reports, and clinician response assessments). A common protocol was used to assess and report rw-response end points, including rw-response rate (rwRR), rw-duration of response (rwDOR), and the association of rw-response with rw-overall survival (rwOS), rw-time to treatment discontinuation (rwTTD), and rw-time to next treatment (rwTTNT). RESULTS: The availability and timing of clinician assessments was relatively consistent across data sets in contrast to images and image reports. Real-world response was analyzed using clinician response assessments (median proportion of patients evaluable, 77.5%), which had the highest consistency in the timing of assessments. Relative consistency was observed across data sets for rwRR (median 46.5%), as well as the median and directionality of rwOS, rwTTD, and rwTTNT. There was variability in rwDOR across data sets. CONCLUSION: This collaborative effort demonstrated the feasibility of aligning disparate data sources to evaluate rw-response end points using clinician-documented responses in patients with mNSCLC. Heterogeneity exists in the availability of data components to assess response and related rw-end points, and further work is needed to inform drug effectiveness evaluation within RWD sources. Consistency of real-world response taken from EHR data in patients with mNSCLC treated with chemotherapy. [ABSTRACT FROM AUTHOR]

Published
2024
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25. FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations.

Author

Mehta, Gautam U, Vellanki, Paz J, Ren, Yi, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Pan, Lili, Zirkelbach, Jeanne F, Pan, Yuzhuo, Liu, Jiang, Aungst, Stephanie L, Miller, Claudia P, Shah, Mirat, Rahman, Nam Atiqur, Theoret, Marc, Kluetz, Paul, Pazdur, Richard, Beaver, Julia A, and Singh, Harpreet

Subjects
TRASTUZUMAB, PATIENT safety, FATIGUE (Physiology), BALDNESS, APPETITE, INTERSTITIAL lung diseases, DRUG approval, METASTASIS, ONCOGENES, LUNG cancer, GENETIC mutation, VOMITING, NAUSEA, CONSTIPATION
Abstract

On August 11, 2022, FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd, ENHERTU, Daiichi Sankyo) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. The approval was based on a prespecified interim analysis of DESTINY-Lung02 (Study U206), a multi-center, randomized, dose-optimization trial in patients with NSCLC harboring activating HER2 -mutations. At the approved dose of 5.4 mg/kg given intravenously every 3 weeks, the overall response rate (ORR) was 58% (95% confidence interval [CI]: 43, 71). The median duration of response was 8.7 months (95% CI: 7.1, not estimable). These results were consistent with response rates observed at the 6.4 mg/kg dose level. The most common (≥ 20%) adverse reactions were nausea, constipation, decreased appetite, vomiting, fatigue, and alopecia. The rate of interstitial lung disease (ILD) or pneumonitis was 6% at the 5.4 mg/kg dose level and 14% at the 6.4 mg/kg dose level. In the setting of similar efficacy and reduced toxicity, approval was granted for the 5.4 mg/kg dose level. The applicant conducted a randomized, dose-optimization study with guidance from the FDA Oncology Center of Excellence's Project Optimus. This is the first approval of a targeted therapy for HER2 -mutated NSCLC. [ABSTRACT FROM AUTHOR]

Published
2024
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26. Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a US Food and Drug Administration pooled analysis.

Author

Fallah, Jaleh, Gittleman, Haley, Weinstock, Chana, Chang, Elaine, Agrawal, Sundeep, Tang, Shenghui, Pazdur, Richard, Kluetz, Paul G, Suzman, Daniel L, and Amiri-Kordestani, Laleh

Subjects
IMMUNE checkpoint inhibitors, NEPHRECTOMY, PROPORTIONAL hazards models, RENAL cell carcinoma, OVERALL survival
Abstract

Background This pooled analysis of patient-level data from trials evaluated the clinical outcomes of patients with metastatic renal cell carcinoma with or without cytoreductive nephrectomy before a combination of immune checkpoint inhibitor and antiangiogenic therapy. Methods Data from 5 trials of immune checkpoint inhibitors plus antiangiogenic therapy were pooled. Only patients with stage 4 disease at initial diagnosis were included to ensure that nephrectomy was performed for cytoreductive purposes and not to previously treat an earlier stage of disease. The effect of cytoreductive nephrectomy before immune checkpoint inhibitor therapy on outcomes was evaluated using the Kaplan-Meier method and a Cox proportional hazards regression model, adjusted for age, sex, risk group, performance status, and the presence of sarcomatoid differentiation. Results A total of 981 patients were included. The estimated median progression-free survival with and without nephrectomy was 15 and 11 months, respectively; the adjusted hazard ratio was 0.71 (95% confidence interval = 0.59 to 0.85). The estimated median overall survival with and without nephrectomy was 46 and 28 months, respectively; the adjusted hazard ratio was 0.63 (95% confidence interval = 0.51 to 0.77). Objective response was 60% of patients with vs 46% of patients without cytoreductive nephrectomy. Conclusions Patients with metastatic renal cell carcinoma who undergo cytoreductive nephrectomy before immune checkpoint inhibitor plus antiangiogenic therapy had improved outcomes compared with patients without cytoreductive nephrectomy. Selection factors for cytoreductive nephrectomy may be prognostic and could not be fully controlled for in this retrospective analysis. Prospective determination of and stratification by prior cytoreductive nephrectomy may be considered when designing clinical trials to assess the impact of this factor on prognosis. [ABSTRACT FROM AUTHOR]

Published
2024
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28. FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma

Author

Maguire, William F., primary, Lee, Daniel, additional, Weinstock, Chana, additional, Gao, Xin, additional, Bulik, Catharine C., additional, Agrawal, Sundeep, additional, Chang, Elaine, additional, Hamed, Salaheldin S., additional, Bloomquist, Erik W., additional, Tang, Shenghui, additional, Pazdur, Richard, additional, Kluetz, Paul G., additional, Amiri-Kordestani, Laleh, additional, and Suzman, Daniel L., additional

Published
2024
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29. A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma

Author

Chang, Elaine, primary, Zhou, Jiaxi, additional, Song, Chi, additional, Gittleman, Haley, additional, Fernandes, Laura, additional, Weinstock, Chana, additional, Atkins, Michael B., additional, Agrawal, Sundeep, additional, Sridhara, Rajeshwari, additional, Gormley, Nicole, additional, Tang, Shenghui, additional, Suzman, Daniel L., additional, Amiri-Kordestani, Laleh, additional, Kluetz, Paul G., additional, Pazdur, Richard, additional, Rini, Brian I., additional, McDermott, David F., additional, and Regan, Meredith M., additional

Published
2024
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30. Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium

Author

Fangusaro, Jason, primary, Avery, Robert A., additional, Fisher, Michael J., additional, Packer, Roger J., additional, Walsh, Karin S., additional, Schouten-van Meeteren, Antoinette, additional, Karres, Dominik, additional, Bradford, Diana, additional, Bhatnagar, Vishal, additional, Singh, Harpreet, additional, Kluetz, Paul G., additional, Donoghue, Martha, additional, and Duke, Elizabeth S., additional

Published
2024
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31. Supplementary Table S1 from FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum

Author

Singh, Sonia, primary, Bradford, Diana, primary, Li, Xiaoxue, primary, Mishra-Kalyani, Pallavi S., primary, Shen, Yuan-Li, primary, Wang, Lingshan, primary, Zhao, Hong, primary, Xiong, Ye, primary, Liu, Jiang, primary, Charlab, Rosane, primary, Kraft, Jeffrey, primary, Khasar, Sachia, primary, Miller, Claudia P., primary, Rivera, Donna R., primary, Kluetz, Paul G., primary, Pazdur, Richard, primary, Beaver, Julia A., primary, Singh, Harpreet, primary, and Donoghue, Martha, primary

Published
2024
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32. Data from FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum

Author

Singh, Sonia, primary, Bradford, Diana, primary, Li, Xiaoxue, primary, Mishra-Kalyani, Pallavi S., primary, Shen, Yuan-Li, primary, Wang, Lingshan, primary, Zhao, Hong, primary, Xiong, Ye, primary, Liu, Jiang, primary, Charlab, Rosane, primary, Kraft, Jeffrey, primary, Khasar, Sachia, primary, Miller, Claudia P., primary, Rivera, Donna R., primary, Kluetz, Paul G., primary, Pazdur, Richard, primary, Beaver, Julia A., primary, Singh, Harpreet, primary, and Donoghue, Martha, primary

Published
2024
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34. Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study

Author

Thanarajasingam, Gita, primary, Kluetz, Paul, additional, Bhatnagar, Vishal, additional, Brown, Abbie, additional, Cathcart-Rake, Elizabeth, additional, Diamond, Matthew, additional, Faust, Louis, additional, Fiero, Mallorie H, additional, Huntington, Scott, additional, Jeffery, Molly Moore, additional, Jones, Lee, additional, Noble, Brie, additional, Paludo, Jonas, additional, Powers, Brad, additional, Ross, Joseph S, additional, Ritchie, Jessica D, additional, Ruddy, Kathryn, additional, Schellhorn, Sarah, additional, Tarver, Michelle, additional, Dueck, Amylou C, additional, and Gross, Cary, additional

Published
2024
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37. Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials

Author

Fallah, Jaleh, Zhang, Lijun, Amatya, Anup, Gong, Yutao, King-Kallimanis, Bellinda, Bhatnagar, Vishal, Weinstock, Chana, Suzman, Daniel L, Agrawal, Sundeep, Chang, Elaine, Anscher, Mitchell S, Chi, Dow-Chung, Xu, James X, Brewer, Jamie R, Brave, Michael H, Hadadi, Mehrnoosh, Theoret, Marc R, Kluetz, Paul G, Goldberg, Kirsten B, Ibrahim, Amna, Tang, Shenghui, Pazdur, Richard, Beaver, Julia A, Amiri-Kordestani, Laleh, and Singh, Harpreet

Published
2021
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43. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis

Author

Gao, Jennifer J, Cheng, Joyce, Bloomquist, Erik, Sanchez, Jacquelyn, Wedam, Suparna B, Singh, Harpreet, Amiri-Kordestani, Laleh, Ibrahim, Amna, Sridhara, Rajeshwari, Goldberg, Kirsten B, Theoret, Marc R, Kluetz, Paul G, Blumenthal, Gideon M, Pazdur, Richard, Beaver, Julia A, and Prowell, Tatiana M

Published
2020
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45. International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium

Author

Coens, Corneel, Pe, Madeline, Dueck, Amylou C, Sloan, Jeff, Basch, Ethan, Calvert, Melanie, Campbell, Alicyn, Cleeland, Charles, Cocks, Kim, Collette, Laurence, Devlin, Nancy, Dorme, Lien, Flechtner, Hans-Henning, Gotay, Carolyn, Griebsch, Ingolf, Groenvold, Mogens, King, Madeleine, Kluetz, Paul G, Koller, Michael, Malone, Daniel C, Martinelli, Francesca, Mitchell, Sandra A, Musoro, Jammbe Z, O'Connor, Daniel, Oliver, Kathy, Piault-Louis, Elisabeth, Piccart, Martine, Quinten, Chantal, Reijneveld, Jaap C, Schürmann, Christoph, Smith, Ashley Wilder, Soltys, Katherine M, Taphoorn, Martin J B, Velikova, Galina, and Bottomley, Andrew

Published
2020
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46. FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Author

Fallah, Jaleh, primary, Xu, Jianjin, additional, Weinstock, Chana, additional, Brave, Michael H., additional, Bloomquist, Erik, additional, Fiero, Mallorie H., additional, Schaefer, Timothy, additional, Pathak, Anand, additional, Abukhdeir, Abdelrahmman, additional, Bhatnagar, Vishal, additional, Chiu, Haw-Jyh, additional, Ricks, Tiffany, additional, John, Christy, additional, Hamed, Salaheldin, additional, Lee, Christal, additional, Pierce, William F., additional, Kalavar, Shyam, additional, Philip, Reena, additional, Tang, Shenghui, additional, Amiri-Kordestani, Laleh, additional, Pazdur, Richard, additional, Kluetz, Paul G., additional, and Suzman, Daniel, additional

Published
2023
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47. False-Positive Circulating Tumor DNA Results Do Not Explain Lack of Efficacy for PARP Inhibitors in Patients With Castration-Resistant Prostate Cancer Harboring ATM and CHEK2 Mutations.

Author

Fallah, Jaleh, Xu, Jianjin, Joeng, Hee-Koung, Weinstock, Chana, Heiss, Brian L., Maguire, William F., Gao, Xin, Cheng, Joyce, Chang, Elaine, Agrawal, Sundeep, Fiero, Mallorie H., Pazdur, Richard, Kluetz, Paul G., Amiri-Kordestani, Laleh, and Suzman, Daniel L.

Subjects
CIRCULATING tumor DNA, CASTRATION-resistant prostate cancer, PROSTATE cancer patients, CHECKPOINT kinase 2, POLY(ADP-ribose) polymerase
Abstract

False-positive ctDNA results do not explain lack of efficacy for PARPi in patients with ATMm and CHEK2m CRPC. [ABSTRACT FROM AUTHOR]

Published
2024
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