INTRODUCTION: The phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib is the only approved agent for treating -PIK3CA-mutated, hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Trials have reported hyperglycemia, diarrhea, and rash as the main grade 3 side effects. METHODS: In a managed access program (ClinicalTrials.gov ID: NCT03706573; start: 06/2019), 8 HR+ HER2- ABC patients with a median 4.5 prior therapy lines were treated with alpelisib at the Breast Center of the Ludwig-Maximilian University (LMU) Hospital, Munich, based on the results of a new-generation sequencing (NGS) panel and PIK3CA mutation analysis by the Molecular Tumor Board of the Comprehensive Cancer Center, Munich. RESULTS: Median therapy duration was 3.42 months for patients who discontinued and 3.95 months for those still on alpelisib (4 pts). Five had hyperglycemia (1 with grade 3) with fasting glucose levels of up to 450 mg/dL that required hospitalization and insulin therapy. Two experienced rash (grades 1 and 3) and 2 reported grade 3 diarrhea. Supportive therapy as well as interruption and/or dose reduction were necessary to control treatment-associated side effects. CONCLUSION: Patient education and a well-trained, interdisciplinary team including diabetologists, from the initiation of alpelisib treatment onwards, are essential to safely treat ABC patients with this new drug and to maintain their quality of life and ensure their survival.
INTRODUCTION: The phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib is the only approved agent for treating -PIK3CA-mutated, hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Trials have reported hyperglycemia, diarrhea, and rash as the main grade 3 side effects. METHODS: In a managed access program (ClinicalTrials.gov ID: NCT03706573; start: 06/2019), 8 HR+ HER2- ABC patients with a median 4.5 prior therapy lines were treated with alpelisib at the Breast Center of the Ludwig-Maximilian University (LMU) Hospital, Munich, based on the results of a new-generation sequencing (NGS) panel and PIK3CA mutation analysis by the Molecular Tumor Board of the Comprehensive Cancer Center, Munich. RESULTS: Median therapy duration was 3.42 months for patients who discontinued and 3.95 months for those still on alpelisib (4 pts). Five had hyperglycemia (1 with grade 3) with fasting glucose levels of up to 450 mg/dL that required hospitalization and insulin therapy. Two experienced rash (grades 1 and 3) and 2 reported grade 3 diarrhea. Supportive therapy as well as interruption and/or dose reduction were necessary to control treatment-associated side effects. CONCLUSION: Patient education and a well-trained, interdisciplinary team including diabetologists, from the initiation of alpelisib treatment onwards, are essential to safely treat ABC patients with this new drug and to maintain their quality of life and ensure their survival.
Authors: Ana Bosch; Zhiqiang Li; Anna Bergamaschi; Haley Ellis; Eneda Toska; Aleix Prat; Jessica J Tao; Daniel E Spratt; Nerissa T Viola-Villegas; Pau Castel; Gerard Minuesa; Natasha Morse; Jordi Rodón; Yasir Ibrahim; Javier Cortes; Jose Perez-Garcia; Patricia Galvan; Judit Grueso; Marta Guzman; John A Katzenellenbogen; Michael Kharas; Jason S Lewis; Maura Dickler; Violeta Serra; Neal Rosen; Sarat Chandarlapaty; Maurizio Scaltriti; José Baselga Journal: Sci Transl Med Date: 2015-04-15 Impact factor: 17.956
Authors: G N Hortobagyi; S M Stemmer; H A Burris; Y S Yap; G S Sonke; S Paluch-Shimon; M Campone; K Petrakova; K L Blackwell; E P Winer; W Janni; S Verma; P Conte; C L Arteaga; D A Cameron; S Mondal; F Su; M Miller; M Elmeliegy; C Germa; J O'Shaughnessy Journal: Ann Oncol Date: 2018-07-01 Impact factor: 32.976
Authors: Rosa Giuliani; Josep Tabernero; Fatima Cardoso; Keith Hanson McGregor; Malvika Vyas; Elisabeth G E de Vries Journal: ESMO Open Date: 2019-03-06
Authors: George W Sledge; Masakazu Toi; Patrick Neven; Joohyuk Sohn; Kenichi Inoue; Xavier Pivot; Olga Burdaeva; Meena Okera; Norikazu Masuda; Peter A Kaufman; Han Koh; Eva-Maria Grischke; PierFranco Conte; Yi Lu; Susana Barriga; Karla Hurt; Martin Frenzel; Stephen Johnston; Antonio Llombart-Cussac Journal: JAMA Oncol Date: 2020-01-01 Impact factor: 31.777