Article
Oncology
Preeti Narayan, Tatiana M. Prowell, Jennifer J. Gao, Laura L. Fernandes, Emily Li, Xiling Jiang, Junshan Qiu, Jianghong Fan, Pengfei Song, Jingyu Yu, Xinyuan Zhang, Bellinda L. King-Kallimanis, Wei Chen, Tiffany K. Ricks, Yutao Gong, Xing Wang, Katherine Windsor, Steve Y. Rhieu, Gerlie Geiser, Anamitro Banerjee, Xiaohong Chen, Francisca Reyes Turcu, Deb K. Chatterjee, Anand Pathak, Jeffrey Seidman, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Paul G. Kluetz, Shenghui Tang, Laleh Amiri-Kordestani, Marc R. Theoret, Richard Pazdur, Julia A. Beaver
Summary: The FDA granted regular approval to alpelisib in combination with fulvestrant for hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer patients. Results from the SOLAR-1 study showed a significant improvement in PFS with the combination therapy compared to the control group.
CLINICAL CANCER RESEARCH
(2021)
Article
Medicine, Research & Experimental
Bianca Lara Venancio de Godoy, Marina Gobbe Moschetta-Pinheiro, Luiz Gustavo de Almeida Chuffa, Noam Falbel Ponde, Russel J. Reiter, Jucimara Colombo, Debora Aparecida Pires de Campos Zuccari
Summary: This study evaluated the synergistic action of Alpelisib and Melatonin in breast cancer cell lines carrying the H1047R mutation in PIK3CA. The results showed that the combined use of Alpelisib and Melatonin may be more effective in inhibiting breast cancer than either treatment alone.
Article
Oncology
F. Andre, E. M. Ciruelos, D. Juric, S. Loibl, M. Campone, I. A. Mayer, G. Rubovszky, T. Yamashita, B. Kaufman, Y-S Lu, K. Inoue, Z. Papai, M. Takahashi, F. Ghaznawi, D. Mills, M. Kaper, M. Miller, P. F. Conte, H. Iwata, H. S. Rugo
Summary: The study confirmed a certain efficacy in overall survival when alpelisib was added to fulvestrant treatment in patients with PIK3CA-mutated hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer, prolonging the median survival time.
ANNALS OF ONCOLOGY
(2021)
Article
Biochemistry & Molecular Biology
Marion Bertho, Anne Patsouris, Paule Augereau, Marie Robert, Jean-Sebastien Frenel, Cyriac Blonz, Mario Campone
Summary: PIK3CA mutations are associated with endocrine resistance in breast cancer, and PI3K inhibitors offer new therapeutic options for HR+/HER2- PIK3CA-mutated breast cancer. Alpelisib, the first approved PI3K inhibitor in this context, showed improved progression-free survival in clinical trials, but the decision to use it should consider its side effects and benefits carefully. Identification of patients who will benefit the most from PI3K inhibitors remains a key focus in current research.
EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY
(2021)
Editorial Material
Oncology
Steven Tau, Todd W. Miller
Summary: The PI3K inhibitor alpelisib is approved for treating metastatic estrogen receptor-positive breast cancers with PIK3CA hotspot mutations. Clinical trials have shown the benefits of alpelisib in treating advanced ER+ breast cancers with PIK3CA hotspot mutations in exons 7, 9, and 20. However, a recent study demonstrates the efficacy of alpelisib in patients with non-hotspot PIK3CA mutations, which has important implications for clinical decision-making.
CLINICAL CANCER RESEARCH
(2023)
Article
Oncology
Stuart Turner, Stephen Chia, Hemanth Kanakamedala, Wei-Chun Hsu, Jinhee Park, David Chandiwana, Antonia Ridolfi, Chu-Ling Yu, Juan Pablo Zarate, Hope S. Rugo
Summary: The study compared the efficacy of alpelisib with fulvestrant in the BYLieve trial with standard treatments in a real-world setting for HR+, HER2-, PIK3CA-mutant advanced breast cancer. The results showed that treatment in BYLieve had better outcomes in terms of progression-free survival compared to standard treatments.
Article
Oncology
Sabah Alaklabi, Arya Mariam Roy, Kristopher Attwood, Anthony George, Tracey O'Connor, Amy Early, Ellis G. Levine, Shipra Gandhi
Summary: This study reviewed the clinical data of breast cancer patients treated with alpelisib, finding a low clinical response rate but a high incidence of adverse events, suggesting the need for caution in selecting this drug.
FRONTIERS IN ONCOLOGY
(2022)
Review
Oncology
Tsvetalina Tankova, Elzbieta Senkus, Maria Beloyartseva, Simona Borstnar, Doina Catrinoiu, Mona Frolova, Alinta Hegmane, Andrej Janez, Mladen Krnic, Zoltan Lengyel, Yiola Marcou, Laura Mazilu, Bela Mrinakova, Ruth Percik, Katarina Petrakova, Gabor Rubovszky, Margarita Tokar, Eduard Vrdoljak
Summary: Alpelisib is a drug used to treat a specific type of breast cancer. One of its side effects is an increase in blood glucose levels, which needs to be managed.
Article
Oncology
Maria Letizia Cataldo, Pietro De Placido, Daniela Esposito, Luigi Formisano, Grazia Arpino, Mario Giuliano, Roberto Bianco, Carmine De Angelis, Bianca Maria Veneziani
Summary: This study investigated the antitumor efficacy of the alpha-specific PI3K inhibitor alpelisib alone or in combination with anti-HER2 therapy in HER2-positive breast cancer. Models of acquired resistance to alpelisib were also generated to understand the mechanisms underlying resistance to alpha-specific PI3K inhibition.
FRONTIERS IN ONCOLOGY
(2023)
Article
Oncology
Peter Savas, Louisa L. Lo, Stephen J. Luen, Elizabeth F. Blackley, Jason Callahan, Kate Moodie, Courtney T. van Geelen, Yi-An Ko, Chen -Fang Weng, Lironne Wein, Maria Joao Silva, Andjelija Zivanovic Bujak, Miriam M. Yeung, Sarah Ftouni, Rodney J. Hicks, Prudence A. Francis, Chee Khoon Lee, Sarah -Jane Dawson, Sherene Loi
Summary: Alpelisib monotherapy demonstrated efficacy in heavily pretreated ER + breast cancer, and the dynamics of PIK3CA mutation and ESR1 mutation detected in plasma can serve as candidate biomarkers for predicting treatment response.
Article
Oncology
Sarah E. Burnette, Emily Poehlein, Hui-Jie Lee, Jeremy Force, Kelly Westbrook, Heather N. Moore
Summary: The study investigated the use of alpelisib-fulvestrant in patients with HR+/HER2-, PIK3CA-mutated advanced breast cancer and found a high incidence of hyperglycemia. As a result, a preventative protocol and identification of risk factors were implemented.
BREAST CANCER RESEARCH AND TREATMENT
(2023)
Article
Immunology
Gabriel Morin, Caroline Degrugillier-Chopinet, Marie Vincent, Antoine Fraissenon, Helene Aubert, Celia Chapelle, Clement Hoguin, Francois Dubos, Benoit Catteau, Florence Petit, Aurelie Mezel, Olivia Domanski, Guillaume Herbreteau, Marie Alesandrini, Nathalie Boddaert, Nathalie Boutry, Christine Broissand, Tianxiang Kevin Han, Fabrice Branle, Sabine Sarnacki, Thomas Blanc, Laurent Guibaud, Guillaume Canaud
Summary: This study reports the clinical outcomes of two infants with PIK3CA-related overgrowth spectrum treated with alpelisib. After 12 months of follow-up, alpelisib treatment was associated with improvements in symptoms, lesions, and anomalies in both patients.
JOURNAL OF EXPERIMENTAL MEDICINE
(2022)
Article
Genetics & Heredity
Guillaume Canaud, Juan Carlos Lopez Gutierrez, Alan D. Irvine, Pierre Vabres, Jordan R. Hansford, Nii Ankrah, Fabrice Branle, Athanasia Papadimitriou, Antonia Ridol, Paul O'Connell, Stuart Turner, Denise M. Adams
Summary: EPIK-P1 study provides real-world evidence supporting the effectiveness and safety of alpelisib in patients with PROS. The study shows that alpelisib can effectively reduce lesion volume and provide additional clinical benefits in PROS patients. Adverse events were observed in a significant proportion of patients, but no deaths occurred.
GENETICS IN MEDICINE
(2023)
Article
Oncology
Felipe Batalini, Niya Xiong, Nabihah Tayob, Madeline Polak, Julia Eismann, Lewis C. Cantley, Geoffrey Shapiro, Viktor Adalsteinsson, Eric P. Winer, Panagiotis A. Konstantinopoulos, Alan D'Andrea, Elizabeth M. Swisher, Ursula A. Matulonis, Gerburg M. Wulf, Erica L. Mayer
Summary: This study aimed to evaluate the safety and recommended dose of olaparib in combination with alpelisib in patients with breast cancer, and explore its effects on different subtypes. The results showed that this combination therapy was tolerable for pre-treated TNBC patients and demonstrated activity in non-BRCA mutant patients. Analysis of circulating-free DNA also provided important prognostic information.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Jose Alejandro Perez-Fidalgo, Carmen Criscitiello, Eva Carrasco, Meredith M. Regan, Angelo Di Leo, Karin Ribi, Virginie Adam, Philippe L. Bedard
Summary: ALPHABET is a phase III clinical trial that investigates the potential use of alpelisib in the treatment of certain subtypes of breast cancer. The trial aims to evaluate whether the combination of alpelisib and trastuzumab, with or without fulvestrant, is effective in treating previously treated HER2-positive PIK3CA-mutated advanced breast cancer. The study will compare this combination treatment with standard chemotherapy and trastuzumab. The primary outcome measure is investigator-assessed progression-free survival. The trial also includes additional analyses on side effects and quality of life.
Article
Oncology
Mutlay Sayan, Irina Vergalasova, Sachin Jhawar, Shicha Kumar, Mridula George, Maria Kowzun, Lindsay Potdevin, Deborah Toppmeyer, Bruce Haffty, Nisha Ohri
Summary: Although the utilization rate of Hypo-RT quadrupled in HER2-positive breast cancer patients, it was not significantly associated with overall survival. Factors such as age, income, and treatment facility can impact the selection of Hypo-RT.
CLINICAL BREAST CANCER
(2021)
Article
Oncology
Mansi R. Shah, Imraan Jan, Jeremy Johns, Kuldip Singh, Pallavi Kumar, Norma Belarmino, Kara J. Saggiomo, Carolyn Hayes, Kimyatta Washington, Deborah L. Toppmeyer, Bruce G. Haffty, Steven K. Libutti, Andrew M. Evens
Summary: Strict adherence to infection control protocols in outpatient and inpatient oncology units results in minimal environmental contamination with SARS-CoV-2.
Article
Oncology
Jennifer A. Ligibel, Luke Huebner, Hope S. Rugo, Harold J. Burstein, Debra L. Toppmeyer, Carey K. Anders, Cynthia Ma, William T. Barry, Vera Suman, Lisa A. Carey, Ann H. Partridge, Clifford A. Hudis, Eric P. Winer
Summary: In metastatic breast cancer patients, high rates of obesity and inactivity were observed, but they were not significantly associated with PFS and OS. Greater than 9 MET hours of PA per week may be marginally associated with improved PFS and OS outcomes.
JNCI CANCER SPECTRUM
(2021)
