Alpelisib for treatment of patients with PIK3CA-related overgrowth spectrum (PROS)

Authors: Canaud, Guillaume, Lopez Gutierrez, Juan Carlos, Irvine, Alan D., Vabres, Pierre, Hansford, Jordan R., Ankrah, Nii, Branle, Fabrice, Papadimitriou, Athanasia, Ridolfi, Antonia, O’Connell, Paul, Turner, Stuart, Adams, Denise M.

Source: In Genetics in Medicine December 2023 25(12)

Case study using RWD in the context of a pivotal trial for regulatory approval in a rare disease.

Authors: O'Connell, Paul¹ (AUTHOR) Paul-1.oconnell@novartis.com, Ridolfi, Antonia² (AUTHOR), Fretault, Nathalie² (AUTHOR)

Source: Journal of Biopharmaceutical Statistics. 2023, Vol. 33 Issue 6, p812-819. 8p.

Subject Terms: *REGULATORY approval, *RARE diseases, *EXPERIMENTAL design

Effectiveness of Alpelisib + Fulvestrant Compared with Real‐World Standard Treatment Among Patients with HR+, HER2–, PIK3CA‐Mutated Breast Cancer

Authors: Turner, Stuart, Chia, Stephen, Kanakamedala, Hemanth, Hsu, Wei‐Chun, Park, Jinhee, Chandiwana, David, Ridolfi, Antonia, Yu, Chu‐Ling, Zarate, Juan Pablo, Rugo, Hope S.

Source: Oncologist. 26(7):e1133-e1142

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100122771797.0x000001&indx=1&recIds=ETOCvdc_100122771797.0x000001

Markers of Systemic Inflammation in Neuroendocrine Tumors

Authors: Chan, David L., Yao, James C., Carnaghi, Carlo, Buzzoni, Roberto, Herbst, Fabian, Ridolfi, Antonia, Strosberg, Jonathan, Kulke, Matthew H., Pavel, Marianne, Singh, Simron

Source: Pancreas. 50(2):130-137

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100182312295.0x000001&indx=1&recIds=ETOCvdc_100182312295.0x000001

Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension

Authors: Topouzis, Fotis, Goldberg, Ivan, Bell, Katharina, Tatham, Andrew J., Ridolfi, Antonia, Hubatsch, Douglas, Nicolela, Marcelo, Denis, Phillipe, Lerner, S. Fabian

Source: European journal of ophthalmology. 31(1):103-111

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN626927899&indx=1&recIds=ETOCRN626927899

Do You Want to Stay Single? Considerations on Single‐Arm Trials in Drug Development and the Postregulatory Space.

Authors: Dyachkova, Yulia, Dunger‐Baldauf, Cornelia, Barbier, Nathalie, Devenport, Jenny, Franzén, Stefan, Kazeem, Gbenga, Künzel, Thomas, Mancini, Pierre, Mordenti, Giacomo, Richert, Knut, Ridolfi, Antonia, Saure, Daniel

Source: Pharmaceutical Statistics; Nov2024, Vol. 23 Issue 6, p1206-1217, 12p

Subject Terms: DRUG development, RESEARCH questions, CAUSAL inference, RARE diseases, DECISION making

Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study

Authors: Fasching, Peter A., Beck, J. Thaddeus, Chan, Arlene, De Laurentiis, Michele, Esteva, Francisco J., Jerusalem, Guy, Neven, Patrick, Pivot, Xavier, Bianchi, Giulia V., Martin, Miguel, Chandiwana, David, Lanoue, Brad, Ridolfi, Antonia, Wang, Yingbo, Rodriguez Lorenc, Karen, Nusch, Arnd

Source: In The Breast December 2020 54:148-154

Adjunctive everolimus for children and adolescents with treatment-refractory seizures associated with tuberous sclerosis complex: post-hoc analysis of the phase 3 EXIST-3 trial

Authors: Curatolo, Paolo, Franz, David N, Lawson, John A, Yapici, Zuhal, Ikeda, Hiroko, Polster, Tilman, Nabbout, Rima, de Vries, Petrus J, Dlugos, Dennis J, Fan, Jenna, Ridolfi, Antonia, Pelov, Diana, Voi, Maurizio, French, Jacqueline A

Source: In The Lancet Child & Adolescent Health July 2018 2(7):495-504

RECORD-4 multicenter phase 2 trial of second-line everolimus in patients with metastatic renal cell carcinoma: Asian versus non-Asian population subanalysis

Authors: Yang, Lin, Alyasova, Anna, Ye, Dingwei, Ridolfi, Antonia, Dezzani, Luca, Motzer, Robert

Source: BMC cancer. 18(1):1-4

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100161429436.0x000001&indx=1&recIds=ETOCvdc_100161429436.0x000001

The effect of everolimus on renal angiomyolipoma in pediatric patients with tuberous sclerosis being treated for subependymal giant cell astrocytoma

Authors: Bissler, John J., Franz, David N., Frost, Michael D., Belousova, Elena, Bebin, E. Martina, Sparagana, Steven, Berkowitz, Noah, Ridolfi, Antonia, Kingswood, J. Christopher

Source: Pediatric nephrology. 33(1):101-109

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100125314976.0x000001&indx=1&recIds=ETOCvdc_100125314976.0x000001

Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1

Authors: Toi, Masakazu, Shao, Zhimin, Hurvitz, Sara, Tseng, Ling-Ming, Zhang, Qingyuan, Shen, Kunwei, Liu, Donggeng, Feng, Jifeng, Xu, Binghe, Wang, Xiaojia, Lee, Keun, Ng, Ting, Ridolfi, Antonia, Noel-baron, Florence, Ringeisen, Francois, Jiang, Zefei

Source: Breast cancer research. 19(1):1-13

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100125930242.0x000001&indx=1&recIds=ETOCvdc_100125930242.0x000001

Allele loss at 16q defines poorer prognosis Wilms tumour irrespective of treatment approach in the UKW1–3 clinical trials: A Children’s Cancer and Leukaemia Group (CCLG) study

Authors: Messahel, Boo, Williams, Richard, Ridolfi, Antonia, A’Hern, Roger, Warren, William, Tinworth, Lorna, Hobson, Rachel, Al-Saadi, Reem, Whyman, Gavin, Brundler, Marie-Anne, Kelsey, Anna, Sebire, Neil, Jones, Chris, Vujanic, Gordan, Pritchard-Jones, Kathy

Source: In European Journal of Cancer 2009 45(5):819-826

PIK3CA mutation status, progression and survival in advanced HR + /HER2- breast cancer: a meta-analysis of published clinical trials.

Authors: Fillbrunn, Mirko, Signorovitch, James, André, Fabrice, Wang, Iris, Lorenzo, Ines, Ridolfi, Antonia, Park, Jinhee, Dua, Akanksha, Rugo, Hope S.

Source: BMC Cancer; 9/21/2022, Vol. 22 Issue 1, p1-11, 11p

Subject Terms: HORMONE receptor positive breast cancer, CLINICAL trial registries, EPIDERMAL growth factor receptors, METASTATIC breast cancer, BREAST cancer, CLINICAL trials, PHOSPHATIDYLINOSITOL 3-kinases

Real-World Evidence Study on the Long-Term Safety of Everolimus in Patients With Tuberous Sclerosis Complex: Final Analysis Results.

Authors: Ruiz-Falcó Rojas, María Luz, Feucht, Martha, Macaya, Alfons, Wilken, Bernd, Hahn, Andreas, Maamari, Ricardo, Hirschberg, Yulia, Ridolfi, Antonia, Kingswood, John Chris

Source: Frontiers in Pharmacology; 4/8/2022, Vol. 13, p1-13, 13p

Subject Terms: TUBEROUS sclerosis, PATIENT safety, MENTAL illness, MALE infertility, CASTLEMAN'S disease, ATTENTION-deficit hyperactivity disorder, CANKER sores, MENSTRUAL cycle

Company/Entity: EUROPEAN Union

Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer.

Authors: Burris, Howard A., Chan, Arlene, Bardia, Aditya, Thaddeus Beck, J., Sohn, Joohyuk, Neven, Patrick, Tripathy, Debu, Im, Seock-Ah, Chia, Stephen, Esteva, Francisco J., Hart, Lowell, Zarate, Juan Pablo, Ridolfi, Antonia, Lorenc, Karen Rodriguez, Yardley, Denise A.

Source: British Journal of Cancer; Aug2021, Vol. 125 Issue 5, p679-686, 8p

Relationship between metabolic toxicity and efficacy of everolimus in patients with neuroendocrine tumors: A pooled analysis from the randomized, phase 3 RADIANT‐3 and RADIANT‐4 trials.

Authors: Fazio, Nicola, Carnaghi, Carlo, Buzzoni, Roberto, Valle, Juan W., Herbst, Fabian, Ridolfi, Antonia, Strosberg, Jonathan, Kulke, Matthew H., Pavel, Marianne E., Yao, James C.

Source: Cancer (0008543X); Aug2021, Vol. 127 Issue 15, p2674-2682, 9p

Subject Terms: NEUROENDOCRINE tumors, EVEROLIMUS, CLINICAL trials, LUNG tumors, PROGRESSION-free survival

Patient-Reported Outcomes in Patients With -Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1.

Authors: Ciruelos, Eva Maria, Rugo, Hope S, Mayer, Ingrid A, Levy, Christelle, Forget, Frédéric, Delgado Mingorance, Juan Ignacio, Safra, Tamar, Masuda, Norikazu, Park, Yeon Hee, Juric, Dejan, Conte, Pierfranco, Campone, Mario, Loibl, Sibylle, Iwata, Hiroji, Zhou, Xiaolei, Park, Jinhee, Ridolfi, Antonia, Lorenzo, Ines, André, Fabrice

Source: Journal of Clinical Oncology; 6/20/2021, Vol. 39 Issue 18, p2005-2015, 11p

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