Real world outcomes with alpelisib in metastatic hormone receptor-positive breast cancer patients: A single institution experience

Article Oncology

Factors leading to alpelisib discontinuation in patients with hormone receptor positive, human epidermal growth factor receptor-2 negative breast cancer

Yee-Ming M. Cheung et al.

Summary: This study evaluates real-world experience with alpelisib and examines the association between treatment duration and cancer progression.

BREAST CANCER RESEARCH AND TREATMENT (2022)

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Article Pharmacology & Pharmacy

Adverse events of alpelisib: A postmarketing study of the World Health Organization pharmacovigilance database

Xiao Chen et al.

Summary: This study explored and described the adverse reaction signals in safety reporting for alpelisib by performing a disproportionality analysis on the World Health Organization's VigiBase database, identifying a comprehensive list of potentially associated adverse events.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2022)

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Article Oncology

The efficacy and safety of alpelisib in breast cancer: A real-world analysis

Jenn Miller et al.

Summary: The real-world effectiveness of alpelisib + fulvestrant in heavily pretreated patients with metastatic breast cancer is worse compared to its efficacy as a first-line treatment. Adverse effects such as hyperglycemia, rash, and diarrhea are frequent and require hospitalization and pharmacological treatment.

JOURNAL OF ONCOLOGY PHARMACY PRACTICE (2022)

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Editorial Material Oncology

Biased Evaluation in Cancer Drug Trials-How Use of Progression-Free Survival as the Primary End Point Can Mislead

Ian F. Tannock et al.

JAMA ONCOLOGY (2022)

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Article Oncology

Primary results from TROPiCS-02: A randomized phase 3 study of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) in patients (Pts) with hormone receptor–positive/HER2-negative (HR+/HER2-) advanced breast cancer.

Hope S. Rugo et al.

JOURNAL OF CLINICAL ONCOLOGY (2022)

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Article Medicine, General & Internal

Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer

Shanu Modi et al.

Summary: Trastuzumab deruxtecan demonstrated significantly longer progression-free and overall survival compared to physician's choice chemotherapy in patients with HER2-low metastatic breast cancer.

NEW ENGLAND JOURNAL OF MEDICINE (2022)

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Article Oncology

Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2enegative advanced breast cancer: final overall survival results from SOLAR-1

F. Andre et al.

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)

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Article Oncology

Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1

Eva Maria Ciruelos et al.

Summary: In the SOLAR-1 trial, treatment with alpelisib did not show a statistical difference in deterioration of Global Health Status/QoL between arms, while symptom subscales favored placebo for diarrhea, appetite loss, nausea or vomiting, and fatigue.

JOURNAL OF CLINICAL ONCOLOGY (2021)

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Article Oncology

Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study

Hope S. Rugo et al.

Summary: The study demonstrated that in patients with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer who progressed on treatment with CDK4/6 inhibitors plus aromatase inhibitors, the combination therapy of Alpelisib and Fulvestrant showed activity with manageable toxicity.

LANCET ONCOLOGY (2021)

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Article Oncology

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

Stuart Turner et al.

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.

ONCOLOGIST (2021)

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Article Oncology

Alpelisib-induced hyperglycemia in older patients with breast Cancer: Qualitative findings

Kathryn Cook et al.

Summary: This study examined older female patients (aged 65 and above) who developed hyperglycemia while taking alpelisib, revealing that patients faced a significant burden in terms of self-monitoring glucose levels, taking extra medications, and frequent adjustments in insulin and alpelisib dosages, which required greater engagement with the healthcare system. The study also focused on symptomatology and how patients suffered from hyperglycemia.

JOURNAL OF GERIATRIC ONCOLOGY (2021)

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Review Oncology

Observations with alpelisib in older patients (≥ 65 year of age) with breast cancer in a non-clinical trial setting

Yahya Almodallal et al.

Summary: This study focused on older breast cancer patients aged 65 and above who were treated with Alpelisib outside of a clinical trial. The study found that the main reasons for treatment discontinuation were Alpelisib adverse events and cancer progression. Adverse events included hyperglycemia, diarrhea, rash, fatigue, and mouth sores.

BREAST CANCER RESEARCH AND TREATMENT (2021)

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Article Medicine, General & Internal

Alpelisib-Induced Diabetic Ketoacidosis in a Non-diabetic Patient

Tyler Fugere et al.

Summary: Alpelisib, a PIK3CA inhibitor used in breast cancer patients with mutations, can cause hyperglycemia with rare cases of diabetic ketoacidosis. A patient with no diabetes history developed DKA after using alpelisib, but returned to normal blood sugar levels three days after discontinuation of the drug.

CUREUS JOURNAL OF MEDICAL SCIENCE (2021)

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Article Oncology

First Experiences with Alpelisib in Clinical Routine: Case Reports from a German Breast Center

Anna Hester et al.

Summary: The study observed that common side effects in advanced breast cancer patients treated with alpelisib include hyperglycemia, diarrhea, and rash, requiring a multidisciplinary team, including diabetologists, for supportive therapy and dose adjustments to control these side effects.

BREAST CARE (2021)

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Article Oncology