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Your search keyword '"Keefe, Stephen M"' showing total 34 results
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34 results on '"Keefe, Stephen M"'

1. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Lorusso, Domenica, Xiang, Yang, Hasegawa, Kosei, Scambia, Giovanni, Leiva, Manuel, Ramos-Elias, Pier, Acevedo, Alejandro, Cvek, Jakub, Randall, Leslie, Pereira de Santana Gomes, Andrea Juliana, Contreras Mejía, Fernando, Helpman, Limor, Akıllı, Hüseyin, Lee, Jung-Yun, Saevets, Valeriya, Zagouri, Flora, Gilbert, Lucy, Sehouli, Jalid, Tharavichitkul, Ekkasit, Lindemann, Kristina, Colombo, Nicoletta, Chang, Chih-Long, Bednarikova, Marketa, Zhu, Hong, Oaknin, Ana, Christiaens, Melissa, Petru, Edgar, Usami, Tomoka, Liu, Peng, Yamada, Karin, Toker, Sarper, Keefe, Stephen M, Pignata, Sandro, and Duska, Linda R

Published
2024
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2. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial

Author

Lorusso, Domenica, Xiang, Yang, Hasegawa, Kosei, Scambia, Giovanni, Leiva, Manuel, Ramos-Elias, Pier, Acevedo, Alejandro, Sukhin, Vladyslav, Cloven, Noelle, Pereira de Santana Gomes, Andrea J, Contreras Mejía, Fernando, Reiss, Ari, Ayhan, Ali, Lee, Jung-Yun, Saevets, Valeriya, Zagouri, Flora, Gilbert, Lucy, Sehouli, Jalid, Tharavichitkul, Ekkasit, Lindemann, Kristina, Lazzari, Roberta, Chang, Chih-Long, Lampé, Rudolf, Zhu, Hong, Oaknin, Ana, Christiaens, Melissa, Polterauer, Stephan, Usami, Tomoka, Li, Kan, Yamada, Karin, Toker, Sarper, Keefe, Stephen M, Pignata, Sandro, and Duska, Linda R

Published
2024
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3. Molecular determinants of clinical outcomes of pembrolizumab in recurrent ovarian cancer: Exploratory analysis of KEYNOTE-100

Author

Ledermann, Jonathan A., Shapira-Frommer, Ronnie, Santin, Alessandro D., Lisyanskaya, Alla S., Pignata, Sandro, Vergote, Ignace, Raspagliesi, Francesco, Sonke, Gabe S., Birrer, Michael, Provencher, Diane M., Sehouli, Jalid, Colombo, Nicoletta, González-Martín, Antonio, Oaknin, Ana, Ottevanger, P.B., Rudaitis, Vilius, Kobie, Julie, Nebozhyn, Michael, Edmondson, Mackenzie, Sun, Yuan, Cristescu, Razvan, Jelinic, Petar, Keefe, Stephen M., and Matulonis, Ursula A.

Published
2023
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5. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer

Author

Colombo, Nicoletta, Dubot, Coraline, Lorusso, Domenica, Caceres, M. Valeria, Hasegawa, Kosei, Shapira-Frommer, Ronnie, Tewari, Krishnansu S., Salman, Pamela, Usta, Edwin Hoyos, Yañez, Eduardo, Gümüş, Mahmut, Olivera Hurtado de Mendoza, Mivael, Samouëlian, Vanessa, Castonguay, Vincent, Arkhipov, Alexander, Toker, Sarper, Li, Kan, Keefe, Stephen M., and Monk, Bradley J.

Published
2022
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6. Pembrolizumab or Placebo Plus Chemotherapy With or Without Bevacizumab for Persistent, Recurrent, or Metastatic Cervical Cancer

Author

Tewari, Krishnansu S., primary, Colombo, Nicoletta, additional, Monk, Bradley J., additional, Dubot, Coraline, additional, Cáceres, M. Valeria, additional, Hasegawa, Kosei, additional, Shapira-Frommer, Ronnie, additional, Salman, Pamela, additional, Yañez, Eduardo, additional, Gümüş, Mahmut, additional, Olivera Hurtado de Mendoza, Mivael, additional, Samouëlian, Vanessa, additional, Castonguay, Vincent, additional, Arkhipov, Alexander, additional, Tekin, Cumhur, additional, Li, Kan, additional, Toker, Sarper, additional, Keefe, Stephen M., additional, and Lorusso, Domenica, additional

Published
2024
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9. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826.

Author

Monk, Bradley J., Colombo, Nicoletta, Tewari, Krishnansu S., Dubot, Coraline, Caceres, M. Valeria, Hasegawa, Kosei, Shapira-Frommer, Ronnie, Salman, Pamela, Yañez, Eduardo, Gümüş, Mahmut, Olivera Hurtado de Mendoza, Mivael, Samouëlian, Vanessa, Castonguay, Vincent, Arkhipov, Alexander, Tekin, Cumhur, Li, Kan, Keefe, Stephen M., and Lorusso, Domenica

Published
2023
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15. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer

Author

Colombo, Nicoletta, primary, Dubot, Coraline, additional, Lorusso, Domenica, additional, Caceres, M. Valeria, additional, Hasegawa, Kosei, additional, Shapira-Frommer, Ronnie, additional, Tewari, Krishnansu S., additional, Salman, Pamela, additional, Hoyos Usta, Edwin, additional, Yañez, Eduardo, additional, Gümüş, Mahmut, additional, Olivera Hurtado de Mendoza, Mivael, additional, Samouëlian, Vanessa, additional, Castonguay, Vincent, additional, Arkhipov, Alexander, additional, Toker, Sarper, additional, Li, Kan, additional, Keefe, Stephen M., additional, and Monk, Bradley J., additional

Published
2021
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18. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer

Author

Colombo, N, Dubot, C, Lorusso, D, Caceres, M, Hasegawa, K, Shapira-Frommer, R, Tewari, K, Salman, P, Hoyos Usta, E, Yañez, E, Gümüş, M, Olivera Hurtado de Mendoza, M, Samouëlian, V, Castonguay, V, Arkhipov, A, Toker, S, Li, K, Keefe, S, Monk, B, Colombo, Nicoletta, Dubot, Coraline, Lorusso, Domenica, Caceres, M Valeria, Hasegawa, Kosei, Shapira-Frommer, Ronnie, Tewari, Krishnansu S, Salman, Pamela, Hoyos Usta, Edwin, Yañez, Eduardo, Gümüş, Mahmut, Olivera Hurtado de Mendoza, Mivael, Samouëlian, Vanessa, Castonguay, Vincent, Arkhipov, Alexander, Toker, Sarper, Li, Kan, Keefe, Stephen M, Monk, Bradley J, Colombo, N, Dubot, C, Lorusso, D, Caceres, M, Hasegawa, K, Shapira-Frommer, R, Tewari, K, Salman, P, Hoyos Usta, E, Yañez, E, Gümüş, M, Olivera Hurtado de Mendoza, M, Samouëlian, V, Castonguay, V, Arkhipov, A, Toker, S, Li, K, Keefe, S, Monk, B, Colombo, Nicoletta, Dubot, Coraline, Lorusso, Domenica, Caceres, M Valeria, Hasegawa, Kosei, Shapira-Frommer, Ronnie, Tewari, Krishnansu S, Salman, Pamela, Hoyos Usta, Edwin, Yañez, Eduardo, Gümüş, Mahmut, Olivera Hurtado de Mendoza, Mivael, Samouëlian, Vanessa, Castonguay, Vincent, Arkhipov, Alexander, Toker, Sarper, Li, Kan, Keefe, Stephen M, and Monk, Bradley J

Abstract

BACKGROUND Pembrolizumab has efficacy in programmed death ligand 1 (PD-L1)–positive metastatic or unresectable cervical cancer that has progressed during chemotherapy. We assessed the relative benefit of adding pembrolizumab to chemotherapy with or without bevacizumab. METHODS In a double-blind, phase 3 trial, we randomly assigned patients with persistent, recurrent, or metastatic cervical cancer in a 1:1 ratio to receive pembrolizumab (200 mg) or placebo every 3 weeks for up to 35 cycles plus platinum-based chemotherapy and, per investigator discretion, bevacizumab. The dual primary end points were progression-free survival and overall survival, each tested sequentially in patients with a PD-L1 combined positive score of 1 or more, in the intention-to-treat population, and in patients with a PD-L1 combined positive score of 10 or more. The combined positive score is defined as the number of PD-L1–staining cells divided by the total number of viable tumor cells, multiplied by 100. All results are from the protocol-specified first interim analysis. RESULTS In 548 patients with a PD-L1 combined positive score of 1 or more, median progression-free survival was 10.4 months in the pembrolizumab group and 8.2 months in the placebo group (hazard ratio for disease progression or death, 0.62; 95% confidence interval [CI], 0.50 to 0.77; P<0.001). In 617 patients in the intention-to-treat population, progression-free survival was 10.4 months and 8.2 months, respectively (hazard ratio, 0.65; 95% CI, 0.53 to 0.79; P<0.001). In 317 patients with a PD-L1 combined positive score of 10 or more, progression-free survival was 10.4 months and 8.1 months, respectively (hazard ratio, 0.58; 95% CI, 0.44 to 0.77; P<0.001). Overall survival at 24 months was 53.0% in the pembrolizumab group and 41.7% in the placebo group (hazard ratio for death, 0.64; 95% CI, 0.50 to 0.81; P<0.001), 50.4% and 40.4% (hazard ratio, 0.67; 95% CI, 0.54 to 0.84; P<0.001), and 54.4% and 44.6% (hazar

Published
2021

20. Reaffirming and Clarifying the American Society of Clinical Oncology’s Policy Statement on the Critical Role of Phase I Trials in Cancer Research and Treatment

Author

Weber, Jeffrey S., primary, Levit, Laura A., additional, Adamson, Peter C., additional, Bruinooge, Suanna S., additional, Burris, Howard A., additional, Carducci, Michael A., additional, Dicker, Adam P., additional, Gönen, Mithat, additional, Keefe, Stephen M., additional, Postow, Michael A., additional, Thompson, Michael A., additional, Waterhouse, David M., additional, Weiner, Susan L., additional, and Schuchter, Lynn M., additional

Published
2017
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21. American Society of Clinical Oncology Policy Statement Update: The Critical Role of Phase I Trials in Cancer Research and Treatment

Author

Weber, Jeffrey S., primary, Levit, Laura A., additional, Adamson, Peter C., additional, Bruinooge, Suanna, additional, Burris, Howard A., additional, Carducci, Michael A., additional, Dicker, Adam P., additional, Gönen, Mithat, additional, Keefe, Stephen M., additional, Postow, Michael A., additional, Thompson, Michael A., additional, Waterhouse, David M., additional, Weiner, Susan L., additional, and Schuchter, Lynn M., additional

Published
2015
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23. Abstract CT340: Phase 1b/2a study of the nanopharmaceutical CRLX101 with bevacizumab (bev) in the treatment of patients (pts) with refractory metastatic renal cell carcinoma (mRCC): results from the planned interim analysis

Author

Keefe, Stephen M., primary, Hennessy, Meliessa, additional, Gunnarsson, Orvar, additional, Mamtani, Ronac, additional, Vaughn, David, additional, Hoffman-Censits, Jean, additional, Nathanson, Katherine, additional, Lal, Priti, additional, Pryma, Daniel, additional, Eliasof, Scott, additional, Garmey, Edward, additional, Cohen, Roger B., additional, and Haas, Naomi B., additional

Published
2014
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25. Occult Pelvic Lymph Node Involvement in Bladder Cancer: Implications for Definitive Radiation

Author

Goldsmith, Benjamin, primary, Baumann, Brian C., additional, He, Jiwei, additional, Tucker, Kai, additional, Bekelman, Justin, additional, Deville, Curtiland, additional, Vapiwala, Neha, additional, Vaughn, David, additional, Keefe, Stephen M., additional, Guzzo, Thomas, additional, Malkowicz, S. Bruce, additional, and Christodouleas, John P., additional

Published
2014
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26. Abstract PR09: Synergistic activity of CRLX101, a nanopharmaceutical in Phase II clinical trials, with antiangiogenic therapies mediated through HIF-1alpha inhibition: A translational research program.

Author

Eliasof, Scott, primary, Conley, Sarah, additional, Keefe, Stephen M., additional, Kerbel, Robert, additional, Krasner, Carolyn N., additional, Lazarus, Douglas, additional, Peters, Christian, additional, Pham, Elizabeth, additional, Wicha, Max S., additional, and Garmey, Edward G., additional

Published
2013
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28. Bladder Cancer Patterns of Pelvic Failure: Implications for Adjuvant Radiation Therapy

Author

Baumann, Brian C., primary, Guzzo, Thomas J., additional, He, Jiwei, additional, Vaughn, David J., additional, Keefe, Stephen M., additional, Vapiwala, Neha, additional, Deville, Curtiland, additional, Bekelman, Justin E., additional, Tucker, Kai, additional, Hwang, Wei-Ting, additional, Malkowicz, S. Bruce, additional, and Christodouleas, John P., additional

Published
2013
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33. Evaluating the safety and efficacy of axitinib in the treatment of advanced renal cell carcinoma.

Author

Gunnarsson, Orvar, Pfanzelter, Nicklas R., Cohen, Roger B., and Keefe, Stephen M.

Subjects
PROTEIN-tyrosine kinase inhibitors, DRUG efficacy, VASCULAR endothelial growth factors, CANCER treatment, RENAL cell carcinoma, CLINICAL trials, RENAL cancer, THERAPEUTICS
Abstract

Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor-α, and c-kit. Phase I studies demonstrated 5 mg twice daily as the recommended starting dose with notable effects seen in renal cell carcinoma, an observation confirmed in Phase II trials. The trial of comparative effectivess of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS) was an international randomized Phase III study designed for registration purposes, compared axitinib to sunitinib. This trial randomized 723 patients with metastatic kidney cancer to axitinib or sunitinib in the second-line setting and demonstrated a median progression-free survival of 6.7 months for axitinib versus 4.7 months for sorafenib (P,0.0001). Clinical benefit was detected regardless of prior therapy, but no overall survival benefit has been observed. Axitinib is well tolerated without a significant effect on quality of life. The most common grade 3 toxicities are hypertension (16%), diarrhea (11%), and fatigue (11%), with other notable side effects being anorexia, nausea, hand-foot syndrome, and rash. Patients who developed diastolic blood pressure >90 mmHg were noted to have significantly longer median overall survival and overall response rates when compared to normotensive patients. Therefore, the manufacturer recommends escalating the twice-daily dose to 7 mg and 10 mg, as tolerated, if there is no significant increase in blood pressure on treatment. Currently, axitinib is approved for use in the second-line setting for patients with metastatic renal cell carcinoma. Research is ongoing in other disease settings. [ABSTRACT FROM AUTHOR]

Published
2015
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34. MRI assessment of early tumor response in metastatic renal cell carcinoma patients treated with sorafenib.

Author

Kang HC, Tan KS, Keefe SM, Heitjan DF, Siegelman ES, Flaherty KT, O'Dwyer PJ, and Rosen MA

Subjects
Adult, Aged, Aged, 80 and over, Angiogenesis Inhibitors therapeutic use, Carcinoma, Renal Cell pathology, Contrast Media, Female, Gadolinium, Humans, Kidney Neoplasms drug therapy, Liver Neoplasms drug therapy, Liver Neoplasms secondary, Lymphatic Metastasis, Middle Aged, Niacinamide analogs & derivatives, Phenylurea Compounds, Sorafenib, Antineoplastic Agents therapeutic use, Benzenesulfonates therapeutic use, Carcinoma, Renal Cell drug therapy, Carcinoma, Renal Cell secondary, Kidney Neoplasms pathology, Magnetic Resonance Imaging, Pyridines therapeutic use
Abstract

Objective: The purpose of this study was to examine early MRI changes in renal cell carcinoma (RCC) treated with the antiangiogenic agent sorafenib and to identify MRI biomarkers of RCC response to sorafenib., Materials and Methods: Sixteen patients with RCC were evaluated by MRI before and 3-12 weeks after commencing treatment with sorafenib. Two experienced MR radiologists, blinded to treatment status, independently graded tumor appearance on T1-weighted, T2-weighted, and gadolinium-enhanced images. The proportional odds mixed model was used to compare qualitative appearance of tumors before and after therapy. Time-to-progression was correlated with Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 and MR-modified Choi criteria, incorporating changes in both tumor enhancement and size., Results: After sorafenib therapy, there was a significant increase in T1 signal intensity of tumors (p < 0.0001) and a significant decrease in degree of tumor enhancement (p < 0.0001). The sum of unidimensional tumor diameters decreased significantly after therapy (p = 0.005). However, the average decrease in size at early follow-up was 13%, and all patients except one had stable disease by RECIST 1.0. Early responders defined by MR-modified Choi criteria had increased time-to-progression compared with nonresponders, whereas early RECIST evaluation did not predict clinical outcome., Conclusion: Decreased enhancement and T1 shortening of tumors on MRI may be useful biomarkers of RCC response to angiogenesis inhibitors. Response criteria combining early changes in size and enhancement lead to better correlation with clinical outcome compared with size decrease alone.

Published
2013
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