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4. First-Line Lenvatinib Plus Pembrolizumab Versus Chemotherapy for Advanced Endometrial Cancer: A Randomized, Open-Label, Phase III Trial

Author

Marth, Christian, Moore, Richard G., Bidziński, Mariusz, Pignata, Sandro, Ayhan, Ali, Rubio, M. Jesús, Beiner, Mario, Hall, Marcia, Vulsteke, Christof, Braicu, Elena Ioana, Sonoda, Kenzo, Wu, Xiaohua, Frentzas, Sophia, Mattar, André, Lheureux, Stephanie, Chen, Xiaojun, Hasegawa, Kosei, Magallanes-Maciel, Manuel, Choi, Chel Hun, Shalkova, Mariia, Kaen, Diego, Wang, Peng-Hui, Berger, Regina, Okpara, Chinyere E., McKenzie, Jodi, Yao, Lili, Orlowski, Robert, Khemka, Vivek, Gilbert, Lucy, Makker, Vicky, Kaen, Diego Lucas, Gomez Abuin, Gonzalo, Zamora, Liliana Beatriz, Alfie, Margarita Sonia, Casarini, Ignacio Alfredo, Harrison, Michelle, Ananda, Sumitra, Shannon, Catherine Margaret, Frentzas, Sophia, Friedlander, Michael, Meniawy, Tarek, Gao, Bo, Baron-Hay, Sally, Diakos, Connie, Marth, Christian, Polterauer, Stephan, Petru, Edgar, De Bock, Marlies, Vulsteke, Christof, Baurain, Jean-Francois, Van Gorp, Toon, Altintas, Sevilay, Lima, Joao Paulo da Silveira Nogueira, Mattar, Andre, de Freitas Junior, Ruffo, Santana, Rosane O., de Melo, Andreia Cristina, Franke, Fabio Andre, Zibetti Dal Molin, Graziela, Damian, Fernanda Bronzon, Guedes, João Daniel Cardoso, Ellard, Susan, Tinker, Anna, Samouëlian, Vanessa, Fortin, Suzanne, Bessette, Paul, Kolinsky, Michael, Kumar Tyagi, Nidhi, Ethier, Josee-Lyne, Gilbert, Lucy, Lheureux, Stephanie, MacKay, Helen, Lim, Charles, Wu, Xiaohua, Pan, Lingya, An, Ruifang, Chen, Xiaojun, Zheng, Hong, Wu, Yumei, Zhu, Jianqing, Yao, Shuzhong, Jia, Xuemei, Huang, Yi, Lv, Weiguo, Zhang, Yu, Zhou, Qi, Ma, Cailing, Chekerov, Radoslav, Mach, Pawel, Witteler, Ralf, Marmè, Frederik, Cadoo, Karen, Korach, Jacob, Levy, Talia, Beiner, Mario, Amnon, Amit, Scollo, Paolo, Naglieri, Emanuele, Pignata, Sandro, Zamagni, Claudio, Salutari, Vanda, Usami, Tomoka, Nakamura, Kazuto, Matsumoto, Koji, Yamagami, Wataru, Kobayashi, Yoichi, Takano, Masashi, Kato, Hidenori, Sonoda, Kenzo, Kikuchi, Akira, Katsumata, Noriyuki, Kamiura, Shoji, Horie, Koji, Hasegawa, Kosei, Tsunoda, Takuya, Suzuki, Nao, Yunokawa, Mayu, Nishio, Shin, Kudaka, Wataru, Guerrero Cabrera, Fernando Felix, Gonzalez Mendoza, Rene Lazaro, Magallanes Maciel, Manuel Ernesto, Villalobos Valencia, Ricardo, Escobar Penagos, Jose, Lopez Chuken, Yamil Alonso, Mackowiak-Matejczyk, Beata, Tarnawski, Rafal, Kalinka, Ewa, Bidzinski, Mariusz, Bednarek, Wieslawa, Danska-Bidzinska, Anna, Koralewski, Piotr, Roszak, Andrzej, Kedrova, Anna, Musaeva, Natalia, Urmancheeva, Adiliya Fettekhovna, Vasiliev, Aleksandr Gennadievich, Safina, Sufia Zievna, Lisyanskaya, Alla Sergeevna, Rykov, Ivan V., Rumyantsev, Alexey Alexandrovich, Belonogov, Aleksandr, Makarycheva, Yulia, Kim, Yong Man, Choi, Chel Hun, Kim, Yong Beom, Kim, Hee Seung, Kim, Sang Wun, Quindos Varela, Maria, Casado Herraez, Antonio, Diaz Redondo, Tamara, Rubio Perez, Maria Jesus, Romeo Marin, Margarita, Romero Noguera, Ignacio, Taus Garcia, Alvaro, Lin, Wu-Chou, Chou, Hung-Hsueh, Cheng, Wen-Fang, Lu, Chien-Hsing, Wang, Peng-Hui, Simsek, Tayup, Kose, Fatih, Ayhan, Ali, Vardar, Mehmet Ali, Ozerkan, Kemal, Hughes, Andrew, Stillie, Alison, Eminowicz, Gemma, Khalique, Saira, Shalkova, Mariia, Sukhina, Olena, Piatnytska, Tetiana, Averina, Hanna, Kulyaba, Yaroslav, Kryzhanivska, Anna, Bondarenko, Igor, Svintsitsky, Valentyn, Krasnohrud, Yuliia, Voitko, Nataliia, Buscema, Joseph, Ghamande, Sharad, Lewin, Sharyn, Graham, Deena M., Makker, Vicky, Bell, Maria, Santin, Alessandro, Lee, Christine, Blank, Stephanie, Konecny, Gottfried E., Corr, Bradley, Van Le, Linda, Moore, Richard G., Scalici, Jennifer, Anderson, Charles, Braly, Patricia, Fehniger, Julia, Westhoff, Gina, and Bollinger, Lauren

Published
2024
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6. Autoantibodies, antigen-autoantibody complexes and antigens complement CA125 for early detection of ovarian cancer

Author

Young Han, Chae, Bedia, Jacob S., Yang, Wei-Lei, Hawley, Sarah J., Bergan, Lindsay, Hopper, Marika, Celestino, Joseph, Guo, Jing, Gornet, Terrie G., Soosaipillai, Antoninus, Yang, Hailing, Doskocil, Samantha D., Lokshin, Anna E., Handy, Beverly C., Diamandis, Eleftherios P., Moore, Richard G., Lu, Karen H., Lu, Zhen, Anderson, Karen S., Drescher, Charles W., Skates, Steven J., and Bast, Jr, Robert C.

Published
2024
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7. Cediranib and Olaparib Combination Compared With Cediranib or Olaparib Alone, or Chemotherapy in Platinum-Resistant or Primary Platinum-Refractory Ovarian Cancer: NRG-GY005

Author

Lee, Jung-Min, Brady, Mark F., Miller, Austin, Moore, Richard G., MacKay, Helen, McNally, Leah, Lea, Jayanthi, Street, Daron, Lheureux, Stephanie, McDonald, Megan E., Duska, Linda R., Cantuaria, Guilherme, Kavecansky, Juraj, Leath, Charles A., III, Powell, Matthew, Cadungog, Mark G., Rose, Peter G., Kim, Yong-Man, Huang, Helen Q., Provencher, Michèle, Wenzel, Lari B., Bookman, Michael A., Kohn, Elise C., and Secord, Angeles Alvarez

Published
2024
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8. Cediranib in combination with olaparib in patients without a germline BRCA1/2 mutation and with recurrent platinum-resistant ovarian cancer: Phase IIb CONCERTO trial

Author

Lee, Jung-Min, Moore, Richard G, Ghamande, Sharad, Park, Min S, Diaz, John P, Chapman, Julia, Kendrick, James, Slomovitz, Brian M, Tewari, Krishnansu S, Lowe, Elizabeth S, Milenkova, Tsveta, Kumar, Sanjeev, Dymond, Mike, Brown, Jessica, and Liu, Joyce F

Subjects
Ovarian Cancer, Rare Diseases, Clinical Trials and Supportive Activities, Orphan Drug, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Adolescent, Adult, BRCA1 Protein, Bevacizumab, Carcinoma, Ovarian Epithelial, Female, Germ Cells, Germ-Line Mutation, Humans, Indoles, Mutation, Neoplasm Recurrence, Local, Ovarian Neoplasms, Phthalazines, Piperazines, Poly(ADP-ribose) Polymerase Inhibitors, Quinazolines, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe efficacy, safety, and tolerability of cediranib plus olaparib (cedi/ola) were investigated in patients with nongermline-BRCA-mutated (non-gBRCAm) platinum-resistant recurrent ovarian cancer.Patients and methodsPARP inhibitor-naïve women aged ≥18 years with platinum-resistant non-gBRCAm ovarian cancer, ECOG performance status of 0-2, and ≥3 prior lines of therapy received cediranib 30 mg once daily plus olaparib 200 mg twice daily in this single-arm, multicenter, phase IIb trial. The primary endpoint was objective response rate (ORR) by independent central review (ICR) using RECIST 1.1. Progression-free survival (PFS), overall survival (OS), and safety and tolerability were also examined.ResultsSixty patients received cedi/ola, all of whom had confirmed non-gBRCAm status. Patients had received a median of four lines of chemotherapy; most (88.3%) had received prior bevacizumab. ORR by ICR was 15.3%, median PFS was 5.1 months, and median OS was 13.2 months. Forty-four (73.3%) patients reported a grade ≥3 adverse event (AE), with one patient experiencing a grade 5 AE (sepsis), considered unrelated to the study treatment. Dose interruptions, reductions, and discontinuations due to AEs occurred in 55.0%, 18.3%, and 18.3% of patients, respectively. Patients with high global loss of heterozygosity (gLOH) had ORR of 26.7% [4/15; 95% confidence interval (CI), 7.8-55.1], while ORR was 12.5% (4/32; 95% CI, 3.5-29.0) in the low gLOH group.ConclusionsClinical activity was shown for the cedi/ola combination in heavily pretreated, non-gBRCAm, platinum-resistant patients with ovarian cancer despite failing to meet the target ORR of 20%, highlighting a need for further biomarker studies.

Published
2022

9. Efficacy and safety of niraparib in patients aged 65 years and older with advanced ovarian cancer: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Valabrega, Giorgio, Pothuri, Bhavana, Oaknin, Ana, Graybill, Whitney S., Sánchez, Ana Beatriz, McCormick, Colleen, Baurain, Jean-François, Tinker, Anna V., Denys, Hannelore, O’Cearbhaill, Roisin E., Hietanen, Sakari, Moore, Richard G., Knudsen, Anja Ør, de La Motte Rouge, Thibault, Heitz, Florian, Levy, Tally, York, Whitney, Gupta, Divya, Monk, Bradley J., and González-Martín, Antonio

Published
2024
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10. Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study

Author

Graybill, Whitney S, Pardo Búrdalo, Beatriz, O’Malley, David M, Vergote, Ignace, Monk, Bradley J, Auranen, Annika, Copeland, Larry J, Sabbatini, Roberto, Herzog, Thomas J, Follana, Philippe, Pothuri, Bhavana, Braicu, Elena Ioana, McCormick, Colleen, Yubero, Alfonso, Moore, Richard G, Vuylsteke, Peter, Raaschou-Jensen, Nicoline, York, Whitney, Hartman, John, González-Martín, Antonio, and Stockman, Liz

Published
2024
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11. Progression-free survival and safety at 3.5 years of follow-up: results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer

Author

González-Martín, Antonio, Pothuri, Bhavana, Vergote, Ignace, Graybill, Whitney, Lorusso, Domenica, McCormick, Colleen C., Freyer, Gilles, Backes, Floor, Heitz, Florian, Redondo, Andrés, Moore, Richard G., Vulsteke, Christof, O'Cearbhaill, Roisin E., Malinowska, Izabela A., Shtessel, Luda, Compton, Natalie, Mirza, Mansoor R., and Monk, Bradley J.

Published
2023
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13. Efficacy of niraparib by time of surgery and postoperative residual disease status: A post hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study

Author

O'Cearbhaill, Roisin E., Pérez-Fidalgo, Jose-Alejandro, Monk, Bradley J., Tusquets, Ignacio, McCormick, Colleen, Fuentes, Jose, Moore, Richard G., Vulsteke, Christof, Shahin, Mark S., Forget, Frédéric, Bradley, William H., Hietanen, Sakari, O'Malley, David M., Dørum, Anne, Slomovitz, Brian M., Baumann, Klaus, Selle, Frédéric, Calvert, Paula M., Artioli, Grazia, Levy, Tally, Kumar, Aalok, Malinowska, Izabela A., Li, Yong, Gupta, Divya, and González-Martín, Antonio

Published
2022
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14. The NF-κB-HE4 axis: A novel regulator of HE4 secretion in ovarian cancer.

Author

Kim, Kyukwang, Khazan, Negar, McDowell, Jamie L., Snyder, Cameron W. A., Miller, John P., Singh, Rakesh K., Whittum, Michelle E., Turner, Rachael, and Moore, Richard G.

Subjects
TUMOR necrosis factors, OVARIAN cancer, CELL migration, OVARIAN tumors, METASTASIS, CELL adhesion
Abstract

Ovarian cancer is the leading cause of death among gynecologic malignancies. Despite recent advancements in targeted therapies such as PARP inhibitors, recurrence is common and frequently resistant to existing therapies. A powerful diagnostic tool, coupled with a comprehensive understanding of its implications, is crucial. HE4, a clinical serum biomarker for ovarian cancer, has shown efficacy in monitoring malignant phenotypes, yet little is known about its biological role and regulatory mechanisms. Our research demonstrates that HE4 expression in ovarian cancer can be regulated by the NF-κB signaling pathway. We found that the activation of NF-κB signaling by tumor necrosis factor (TNF)-α, a cytokine found in ovarian cancer tumors and ascites, enhanced the secretion of HE4 while its inhibition suppressed HE4 levels. Nuclear translocation of the NF-κB component p65 was found to be critical for HE4 expression; induced NF-κB activation through p65 expression or constitutive IKK2 activity elevated HE4 expression, while p65 knockdown had the opposite effect. Furthermore, we observed that NF-κB mediated HE4 expression at the transcriptional level. Our data also suggests that there is a regulatory role for HE4 in the expression of α5-Integrin, a crucial adhesion molecule in ovarian cancer metastasis; HE4 knockdown corresponded with reduced α5-Integrin expression, cell migration and cell adhesion to fibronectin. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Antitumor Activity of 3-Indolylmethanamines 31B and PS121912.

Author

Guthrie, Margaret L, Sidhu, Preetpal S, Hill, Emily K, Horan, Timothy C, Nandhikonda, Premchendar, Teske, Kelly A, Yuan, Nina Y, Sidorko, Marina, Rodali, Revathi, Cook, James M, Han, Lanlan, Silvaggi, Nicholas R, Bikle, Daniel D, Moore, Richard G, Singh, Rakesh K, and Arnold, Leggy A

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Orphan Drug, Ovarian Cancer, Rare Diseases, Biotechnology, Cancer, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Amines, Aniline Compounds, Animals, Antineoplastic Agents, Apoptosis, Blotting, Western, Cell Proliferation, Female, Flow Cytometry, Humans, Hydrocarbons, Aromatic, Indoles, Magnetic Resonance Spectroscopy, Mice, Mice, Nude, Ovarian Neoplasms, Tumor Cells, Cultured, Xenograft Model Antitumor Assays, 3-Indolylmethanamine, leukemia, ovarian cancer, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

AimTo investigate the in vivo effects of 3-indolylmethanamines 31B and PS121912 in treating ovarian cancer and leukemia, respectively.Materials and methodsTerminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL) and western blotting were applied to demonstrate the induction of apoptosis. Xenografted mice were investigated to show the antitumor effects of 3-indolylmethanamines. (13)C-Nuclear magnetic resource (NMR) and western blotting were used to demonstrate inhibition of glucose metabolism.Results31B inhibited ovarian cancer cell proliferation and activated caspase-3, cleaved poly (ADP-ribose) polymerase 1 (PARP1), and phosphorylated mitogen-activated protein kinases (MAPK), JUN N-terminal kinase/stress-activated protein kinase (JNK/SAPK) and p38. 31B reduced ovarian cancer xenograft tumor growth and PS121912 inhibited the growth of HL-60-derived xenografts without any sign of toxicity. Compound 31B inhibited de novo glycolysis and lipogenesis mediated by the reduction of fatty acid synthase and lactate dehydrogenase-A expression.Conclusion3-Indolylmethanamines represent a new class of antitumor agents. We have shown for the first time the in vivo anticancer effects of 3-indolylmethanamines 31B and PS121912.

Published
2015

19. Normal Risk Ovarian Screening Study: 21-Year Update

Author

Han, Chae Young, primary, Lu, Karen H., additional, Corrigan, Gwen, additional, Perez, Alexandra, additional, Kohring, Sharlene D., additional, Celestino, Joseph, additional, Bedi, Deepak, additional, Bedia, Enrique, additional, Bevers, Therese, additional, Boruta, David, additional, Carlson, Matthew, additional, Holman, Laura, additional, Leeds, Leroy, additional, Mathews, Cara, additional, McCann, Georgia, additional, Moore, Richard G., additional, Schlumbrecht, Matthew, additional, Slomovitz, Brian, additional, Tobias, Dan, additional, Williams-Brown, Yvette, additional, Bevers, Michael W., additional, Liu, Jinsong, additional, Gornet, Terrie G., additional, Handy, Beverly C., additional, Lu, Zhen, additional, Bedia, Jacob S., additional, Skates, Steven J., additional, and Bast, Robert C., additional

Published
2024
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20. Identification of circulating tumor cells captured by the FDA-cleared Parsortix® PC1 system from the peripheral blood of metastatic breast cancer patients using immunofluorescence and cytopathological evaluations.

Author

Ciccioli, Mariacristina, Kim, Kyukwang, Khazan, Negar, Khoury, Joseph D, Cooke, Martin J, Miller, M Craig, O'Shannessy, Daniel J, Pailhes-Jimenez, Anne-Sophie, and Moore, Richard G

Subjects
METASTATIC breast cancer, BREAST biopsy, CANCER cells, CELL size, CANCER patients
Abstract

Circulating Tumor Cells (CTCs) may serve as a non-invasive source of tumor material to investigate an individual's disease in real-time. The Parsortix® PC1 System, the first FDA-cleared medical device for the capture and harvest of CTCs from peripheral blood of metastatic breast cancer (MBC) patients for use in subsequent user-validated downstream analyses, enables the epitope-independent capture of CTCs with diverse phenotypes based on cell size and deformability. The aim of this study was to determine the proportion of MBC patients and self-declared female healthy volunteers (HVs) that had CTCs identified using immunofluorescence (IF) or Wright-Giemsa (WG) staining. Peripheral blood from 76 HVs and 76 MBC patients was processed on Parsortix® PC1 Systems. Harvested cells were cytospun onto a charged slide and immunofluorescently stained for identification of CTCs expressing epithelial markers. The IF slides were subsequently WG-stained and analyzed for CTC identification based on morphological features of malignant cells. All testing was performed by operators blinded to the clinical status of each subject. CTCs were identified on the IF slides in 45.3% (≥ 1) / 24.0% (≥ 5) of the MBC patients (range = 0 – 125, mean = 7) and in 6.9% (≥ 1) / 2.8% (≥ 5) of the HVs (range = 0 – 28, mean = 1). Among the MBC patients with ≥ 1 CTC, 70.6% had only CK + /EpCAM- CTCs, with none having EpCAM + /CK- CTCs. CTC clusters were identified in 56.0% of the CTC-positive patients. On the WG-stained slides, CTCs were identified in 42.9% (≥ 1) / 21.4% (≥ 5) of the MBC patients (range = 0 – 41, mean = 4) and 4.3% (≥ 1) / 2.9% (≥ 5) of the HVs (range = 0 – 14, mean = 0). This study demonstrated the ability of the Parsortix® PC1 System to capture and harvest CTCs from a significantly larger proportion of MBC patients compared to HVs when coupled with both IF and WG cytomorphological assessment. The presence of epithelial cells in subjects without diagnosed disease has been previously described, with their significance being unclear. Interestingly, a high proportion of the identified CTCs did not express EpCAM, highlighting the limitations of using EpCAM-based approaches. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Progression-free survival and safety at 3.5 years of follow-up: results from the randomized phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer – a plain language summary.

Author

González-Martín, Antonio, Pothuri, Bhavana, Vergote, Ignace, Graybill, Whitney, Lorusso, Domenica, McCormick, Colleen C, Freyer, Gilles, Backes, Floor, Heitz, Florian, Redondo, Andrés, Moore, Richard G, Vulsteke, Christof, O'Cearbhaill, Roisin E, Malinowska, Izabela A, Shtessel, Luda, Compton, Natalie, Mirza, Mansoor R, and Monk, Bradley J

Abstract

Plain Language Summary What is this summary about? This PLSP provides a short summary of an original scientific article that presented results from the PRIMA study after 3.5 years of follow-up time. The original article was published in the European Journal of Cancer in 2023. The PRIMA study included adult patients with newly diagnosed advanced high-risk ovarian cancer whose tumors shrunk or became undetectable after treatment with chemotherapy with or without surgery. The PRIMA study evaluated how well the drug niraparib, also known as Zejula, worked at delaying or preventing ovarian cancer from coming back (recurring) or getting worse (progressing) compared with placebo (a substance with no effects that a doctor gives to a patient instead of a drug). The first results from the PRIMA study were published in 2019, when patients had participated in the PRIMA study for about 1.2 years. The article this PLSP is based on reports longer-term data from the PRIMA study, when patients had participated in the PRIMA study for about 3.5 years. Patients were monitored (or followed) for a longer time to understand how well niraparib continued to work and to evaluate whether the safety of niraparib changed with additional time being monitored. What were the results? Patients who took niraparib had more time before their cancer came back or got worse than patients who took placebo. In terms of safety, no new types of side effects with niraparib treatment were observed with additional time being monitored as part of the PRIMA study. What do the results mean? These results support that niraparib remains an important treatment option to help delay the cancer from coming back or getting worse in patients with newly diagnosed advanced ovarian cancer that responded to initial treatment. Clinical Trial Registration:NCT02655016 (PRIMA study) (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

Published
2024
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22. A Whole-Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Weight, Cardiometabolic, and Hormonal Outcome

Author

Campbell, Thomas M, primary, Campbell, Erin K, additional, Culakova, Eva, additional, Blanchard, Lisa, additional, Wixom, Nellie, additional, Guido, Joseph, additional, Fetten, James, additional, Huston, Alissa, additional, Shayne, Michelle, additional, Janelsins, Michelle C, additional, Mustian, Karen M, additional, Moore, Richard G, additional, and Peppone, Luke J, additional

Published
2023
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24. Pembrolizumab Plus Chemotherapy in Advanced Endometrial Cancer

Author

Eskander, Ramez N., primary, Sill, Michael W., additional, Beffa, Lindsey, additional, Moore, Richard G., additional, Hope, Joanie M., additional, Musa, Fernanda B., additional, Mannel, Robert, additional, Shahin, Mark S., additional, Cantuaria, Guilherme H., additional, Girda, Eugenia, additional, Mathews, Cara, additional, Kavecansky, Juraj, additional, Leath, Charles A., additional, Gien, Lilian T., additional, Hinchcliff, Emily M., additional, Lele, Shashikant B., additional, Landrum, Lisa M., additional, Backes, Floor, additional, O'Cearbhaill, Roisin E., additional, Al Baghdadi, Tareq, additional, Hill, Emily K., additional, Thaker, Premal H., additional, John, Veena S., additional, Welch, Stephen, additional, Fader, Amanda N., additional, Powell, Matthew A., additional, and Aghajanian, Carol, additional

Published
2023
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26. Cost-analysis comparison of clinical risk assessment with and without ROMA for the management of women with pelvic masses

Author

Underkofler Kaylee A, Morell Alexandra J, Esquivel Rianne, DeSimone Francesca I, Miller M Craig, and Moore Richard G

Subjects
General Medicine
Abstract

Objective: Pelvic masses can be classified as low risk (likely benign) and high risk (likely malignant) based on an initial clinical risk assessment, which involves a detailed history, physical exam, basic laboratory tests, and imaging. In recent years, the Risk of Ovarian Malignancy Algorithm (ROMA), which combines CA125, HE4 and menopausal status, has emerged as a powerful tool in the classification of pelvic masses and triage of patients to either a generalist gynecologist or a gynecologic oncologist for management. The objective of this study was to evaluate whether the use of ROMA, alone or in combination with Initial Clinical Risk Assessment (ICRA), provides cost savings compared to triage based on ICRA alone. Methods: A health-economic decision model was developed to assess clinical and cost differences associated with three different clinical pathways of risk assessment for a pelvic mass: ICRA alone, ROMA alone, or ICRA + ROMA in combination. Using previously reported accuracy rates and patient characteristics from a prospective, multicenter, blinded clinical trial, total healthcare costs were modeled for each clinical pathway using the Medicare 2020 reimbursement rates. Results: A total of 461 patients with pelvic masses were included with 10.4% ultimately diagnosed with epithelial ovarian cancer. Total healthcare costs for patients with benign disease, EOC, or low malignant potential tumors (LMP) (n = 441) triaged using ROMA alone were 3.3% lower than when triaged using ICRA alone. While lab costs increased 55% using ROMA, the use of ROMA alone resulted in a 4% decrease in laparoscopy costs and a 3.1% decrease in laparotomy costs compared with ICRA alone. Similarly, total costs associated with a combination of ICRA + ROMA were 3.9% lower than total costs associated with ICRA alone. The model also predicted a 63% reduction in repeat surgeries resulting from false negative ICRA when using ROMA to triage patients. Conclusion: Triage of women with pelvic masses using the more sensitive ROMA score lowers overall healthcare costs compared to ICRA alone. With fewer false negative results than ICRA alone, the ROMA score improves initial detection of malignancy and reduces second surgical treatments in women with pelvic masses.

Published
2022
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27. Patient, disease and surgeon predictors of successful bilateral sentinel lymph node mapping for endometrial cancer: A retrospective, multicenter analysis

Author

Towner Mary, Underkoffler Kaylee, Urh Anze, Robison Katina, and Moore Richard G

Subjects
General Medicine
Abstract

Objective: Sentinel lymph node mapping is an acceptable standard for lymph node evaluation in patients with endometrial cancer. The purpose of this study was to evaluate the adoption of this technique at two academic institutions, including which patient and disease features are associated with rates of successfully identifying sentinel lymph nodes with fluorescent mapping. In addition, we sought to characterize if and how surgeons experience the technique related to successful bilateral sentinel lymph node mapping. Methods: A retrospective chart review was performed of patients at two academic institutions who underwent sentinel lymph node mapping prior to a minimally invasive hysterectomy for endometrial cancer over the first 30 months during which the technique was adopted at each institution. A modified Poisson regression model was used to determine the relationships between patient, disease, and surgeon factors on outcomes of sentinel lymph node mapping. Results: A total of 460 charts were reviewed. The mean age was 64 and the median body mass index was 34.2. The most disease was stage I (83%), endometrioid (89%), and Grade I (64%). The bilateral sentinel lymph node mapping success rate was 65%, while unilateral or bilateral success occurred in 91% of cases. Sentinel lymph node mapping was significantly more likely to be successful in premenopausal women (RR 1.25; 95% CI 1.07 - 1.46; p = 0.005) and Asian women (RR 1.48; 95% CI 1.3-1.68; p < 0.001). BMI was not significantly predictive of mapping success (RR 1.03; 95% CI 1.00 - 1.07; p = 0.05). Increasing surgeon experience with the technique did predict successful bilateral sentinel lymph node mapping (RR 1.02; 95% CI 1.00 - 1.03; p = 0.02). Conclusion: Premenopausal status and surgeon experience with the technique increases the likelihood of bilateral sentinel lymph node detection for endometrial cancer.

Published
2022
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28. Niraparib in Patients With Newly Diagnosed Advanced Ovarian Cancer

Author

González-Martín, Antonio, Pothuri, Bhavana, Vergote, Ignace, Christensen, René DePont, Graybill, Whitney, Mirza, Mansoor R., McCormick, Colleen, Lorusso, Domenica, Hoskins, Paul, Freyer, Gilles, Baumann, Klaus, Jardon, Kris, Redondo, Andrés, Moore, Richard G., Vulsteke, Christof, OʼCearbhaill, Roisin E., Lund, Bente, Backes, Floor, Barretina-Ginesta, Pilar, Haggerty, Ashley F., Rubio-Pérez, Maria J., Shahin, Mark S., Mangili, Giorgia, Bradley, William H., Bruchim, Ilan, Sun, Kaiming, Malinowska, Izabela A., Li, Yong, Gupta, Divya, and Monk, Bradley J.

Published
2020
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30. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775

Author

Makker, V, Colombo, N, Herráez, A, Monk, B, Mackay, H, Santin, A, Miller, D, Moore, R, Baron-Hay, S, Ray-Coquard, I, Ushijima, K, Yonemori, K, Kim, Y, Guerra Alia, E, Sanli, U, Bird, S, Orlowski, R, Mckenzie, J, Okpara, C, Barresi, G, Lorusso, D, Makker, Vicky, Colombo, Nicoletta, Herráez, Antonio Casado, Monk, Bradley J, Mackay, Helen, Santin, Alessandro D, Miller, David S, Moore, Richard G, Baron-Hay, Sally, Ray-Coquard, Isabelle, Ushijima, Kimio, Yonemori, Kan, Kim, Yong Man, Guerra Alia, Eva M, Sanli, Ulus A, Bird, Steven, Orlowski, Robert, McKenzie, Jodi, Okpara, Chinyere, Barresi, Gianmaria, Lorusso, Domenica, Makker, V, Colombo, N, Herráez, A, Monk, B, Mackay, H, Santin, A, Miller, D, Moore, R, Baron-Hay, S, Ray-Coquard, I, Ushijima, K, Yonemori, K, Kim, Y, Guerra Alia, E, Sanli, U, Bird, S, Orlowski, R, Mckenzie, J, Okpara, C, Barresi, G, Lorusso, D, Makker, Vicky, Colombo, Nicoletta, Herráez, Antonio Casado, Monk, Bradley J, Mackay, Helen, Santin, Alessandro D, Miller, David S, Moore, Richard G, Baron-Hay, Sally, Ray-Coquard, Isabelle, Ushijima, Kimio, Yonemori, Kan, Kim, Yong Man, Guerra Alia, Eva M, Sanli, Ulus A, Bird, Steven, Orlowski, Robert, McKenzie, Jodi, Okpara, Chinyere, Barresi, Gianmaria, and Lorusso, Domenica

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We report the final prespecified analysis for overall survival (OS), along with updated progression-free survival (PFS) and objective response rate (ORR), and safety from the open-label, randomized, phase III Study 309/KEYNOTE-775. In total, 827 patients with advanced, recurrent, or metastatic endometrial cancer (EC) were randomly assigned to receive lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously once every 3 weeks (n = 411) or chemotherapy of the treating physician's choice (doxorubicin 60 mg/m2 intravenously once every 3 weeks or paclitaxel 80 mg/m2 intravenously once weekly [3 weeks on; 1 week off] [n = 416]). Efficacy was reported for patients with mismatch repair proficient (pMMR) tumors and all-comers, and by subgroups (histology, prior therapy, MMR status). Updated safety was also reported.Lenvatinib plus pembrolizumab showed benefits in OS (pMMR HR, 0.70; 95% CI, 0.58 to 0.83; all-comer HR, 0.65; 95% CI, 0.55 to 0.77), PFS (pMMR HR, 0.60; 95% CI, 0.50 to 0.72; all-comer HR, 0.56; 95% CI, 0.48 to 0.66), and ORR (pMMR patients, 32.4% v 15.1%; all-comers, 33.8% v 14.7%) versus chemotherapy. OS, PFS, and ORR favored lenvatinib plus pembrolizumab in all subgroups of interest. No new safety signals were observed. Lenvatinib plus pembrolizumab continued to show improved efficacy versus chemotherapy and manageable safety in patients with previously treated advanced EC.

Published
2023

31. Vitamin D Receptor Antagonist MeTC7 Inhibits PD-L1

Author

Khazan, Negar, primary, Quarato, Emily R., additional, Singh, Niloy A., additional, Snyder, Cameron W. A., additional, Moore, Taylor, additional, Miller, John P., additional, Yasui, Masato, additional, Teramoto, Yuki, additional, Goto, Takuro, additional, Reshi, Sabeeha, additional, Hong, Jennifer, additional, Zhang, Naixin, additional, Pandey, Diya, additional, Srivastava, Priyanka, additional, Morell, Alexandra, additional, Kawano, Hiroki, additional, Kawano, Yuko, additional, Conley, Thomas, additional, Sahasrabudhe, Deepak M., additional, Yano, Naohiro, additional, Miyamoto, Hiroshi, additional, Aljitawi, Omar, additional, Liesveld, Jane, additional, Becker, Michael W., additional, Calvi, Laura M., additional, Zhovmer, Alexander S., additional, Tabdanov, Erdem D., additional, Dokholyan, Nikolay V., additional, Linehan, David C., additional, Hansen, Jeanne N., additional, Gerber, Scott A., additional, Sharon, Ashoke, additional, Khera, Manoj K., additional, Jurutka, Peter W., additional, Rochel, Natacha, additional, Kim, Kyu Kwang, additional, Rowswell-Turner, Rachael B., additional, Singh, Rakesh K., additional, and Moore, Richard G., additional

Published
2023
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32. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775

Author

Makker, Vicky, primary, Colombo, Nicoletta, additional, Herráez, Antonio Casado, additional, Monk, Bradley J., additional, Mackay, Helen, additional, Santin, Alessandro D., additional, Miller, David S., additional, Moore, Richard G., additional, Baron-Hay, Sally, additional, Ray-Coquard, Isabelle, additional, Ushijima, Kimio, additional, Yonemori, Kan, additional, Kim, Yong Man, additional, Guerra Alia, Eva M., additional, Sanli, Ulus A., additional, Bird, Steven, additional, Orlowski, Robert, additional, McKenzie, Jodi, additional, Okpara, Chinyere, additional, Barresi, Gianmaria, additional, and Lorusso, Domenica, additional

Published
2023
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33. In silico predicted compound targeting the IQGAP1-GRD domain selectively inhibits growth of human acute myeloid leukemia

Author

Sahasrabudhe, Deepak M., primary, Liesveld, Jane L., additional, Minhajuddin, Mohammad, additional, Singh, Niloy A., additional, Nath, Subhangi, additional, Kumar, Vishuwes M., additional, Balys, Marlene, additional, Evans, Andrew G., additional, Azadniv, Mitra, additional, Hansen, Jeanne N., additional, Becker, Michael W., additional, Sharon, Ashoke, additional, Thomas, V Kaye, additional, Moore, Richard G., additional, Khera, Manoj K., additional, Jordan, Craig T., additional, and Singh, Rakesh K., additional

Published
2023
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37. Supplementary Table from Cediranib in Combination with Olaparib in Patients without a Germline BRCA1/2 Mutation and with Recurrent Platinum-Resistant Ovarian Cancer: Phase IIb CONCERTO Trial

Author

Lee, Jung-Min, primary, Moore, Richard G., primary, Ghamande, Sharad, primary, Park, Min S., primary, Diaz, John P., primary, Chapman, Julia, primary, Kendrick, James, primary, Slomovitz, Brian M., primary, Tewari, Krishnansu S., primary, Lowe, Elizabeth S., primary, Milenkova, Tsveta, primary, Kumar, Sanjeev, primary, Dymond, Mike, primary, Brown, Jessica, primary, and Liu, Joyce F., primary

Published
2023
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38. Supplementary Data from Cediranib in Combination with Olaparib in Patients without a Germline BRCA1/2 Mutation and with Recurrent Platinum-Resistant Ovarian Cancer: Phase IIb CONCERTO Trial

Author

Lee, Jung-Min, primary, Moore, Richard G., primary, Ghamande, Sharad, primary, Park, Min S., primary, Diaz, John P., primary, Chapman, Julia, primary, Kendrick, James, primary, Slomovitz, Brian M., primary, Tewari, Krishnansu S., primary, Lowe, Elizabeth S., primary, Milenkova, Tsveta, primary, Kumar, Sanjeev, primary, Dymond, Mike, primary, Brown, Jessica, primary, and Liu, Joyce F., primary

Published
2023
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39. Supplementary Figure from Cediranib in Combination with Olaparib in Patients without a Germline BRCA1/2 Mutation and with Recurrent Platinum-Resistant Ovarian Cancer: Phase IIb CONCERTO Trial

Author

Lee, Jung-Min, primary, Moore, Richard G., primary, Ghamande, Sharad, primary, Park, Min S., primary, Diaz, John P., primary, Chapman, Julia, primary, Kendrick, James, primary, Slomovitz, Brian M., primary, Tewari, Krishnansu S., primary, Lowe, Elizabeth S., primary, Milenkova, Tsveta, primary, Kumar, Sanjeev, primary, Dymond, Mike, primary, Brown, Jessica, primary, and Liu, Joyce F., primary

Published
2023
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42. A Multi-Center Clinical Study to Harvest and Characterize Circulating Tumor Cells from Patients with Metastatic Breast Cancer Using the Parsortix® PC1 System

Author

Cohen, Evan N., primary, Jayachandran, Gitanjali, additional, Moore, Richard G., additional, Cristofanilli, Massimo, additional, Lang, Julie E., additional, Khoury, Joseph D., additional, Press, Michael F., additional, Kim, Kyu Kwang, additional, Khazan, Negar, additional, Zhang, Qiang, additional, Zhang, Youbin, additional, Kaur, Pushpinder, additional, Guzman, Roberta, additional, Miller, Michael C., additional, Reuben, James M., additional, and Ueno, Naoto T., additional

Published
2022
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45. Receipt of adjuvant endometrial cancer treatment according to race: an NRG Oncology/Gynecologic Oncology Group 210 Study

Author

Felix, Ashley S., Cohn, David E., Brasky, Theodore M., Zaino, Richard, Park, Kay, Mutch, David G., Creasman, William T., Thaker, Premal H., Walker, Joan L., Moore, Richard G., Lele, Shashikant B., Guntupalli, Saketh R., Downs, Levi S., Nagel, Christa I., Boggess, John F., Pearl, Michael L., Ioffe, Olga B., Randall, Marcus E., and Brinton, Louise A.

Published
2018
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49. Olaparib With or Without Cediranib Versus Platinum-Based Chemotherapy in Recurrent Platinum-Sensitive Ovarian Cancer (NRG-GY004): A Randomized, Open-Label, Phase III Trial

Author

Liu, Joyce F., primary, Brady, Mark F., additional, Matulonis, Ursula A., additional, Miller, Austin, additional, Kohn, Elise C., additional, Swisher, Elizabeth M., additional, Cella, David, additional, Tew, William P., additional, Cloven, Noelle G., additional, Muller, Carolyn Y., additional, Bender, David P., additional, Moore, Richard G., additional, Michelin, David P., additional, Waggoner, Steven E., additional, Geller, Melissa A., additional, Fujiwara, Keiichi, additional, D'Andre, Stacy D., additional, Carney, Michael, additional, Alvarez Secord, Angeles, additional, Moxley, Katherine M., additional, and Bookman, Michael A., additional

Published
2022
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