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

Almodallal, Yahya; Le‐Rademacher, Jennifer; Cook, Kathryn; Yadav, Siddhartha; Singh, Amrit B.; Lee, Minji; Lammert, Lisa M.; Jatoi, Aminah

doi:10.1007/s10549-021-06277-6

Cited by 4 publications

(3 citation statements)

References 5 publications

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“…In the elderly population, this poses a serious challenge because patients have to self-monitor and take additional medications, in addition to dealing with symptoms including polyuria, dehydration, and dizziness that could increase the risk of falls and injuries ( 16 ). In a study by Almodallal and colleagues that examined the tolerance of alpelisib in a heavily pretreated elderly population (median age 71 years), 15/35 (43%) patients discontinued alpelisib due to AEs ( 14 ). This also supports the fact that alpelisib would be harder to tolerate for elderly patients.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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BackgroundIt is critically important to study the real-world data of FDA-approved medications to understand the response rates and toxicities observed in the real-world population not represented in the clinical trials.MethodsWe reviewed charts of patients diagnosed with metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 negative, PIK3CA-mutated breast cancer treated with alpelisib from May 2019 to January 2022. Clinical characteristics and treatment outcomes were collected. The association of clinical characteristics with responses and adverse events (AEs) was evaluated using the logistic regression model.Results27 patients were included. Median age at alpelisib initiation 67 years (range: 44, 77 years). Majority of patients had excellent performance status at time of alpelisib initiation. Most patients had chronic comorbidities, notably; 2 patients had controlled type 2 diabetes mellitus at time of alpelisib initiation. Majority had a median of three lines of therapy (range: 1, 7) before alpelisib. Clinical responses were determined using RECIST v1.1. 3/27 (11.11%) patients discontinued therapy before response assessment due to grade 3 AEs. Overall response rate was 12.5% (3/24), with all partial responses (PR). The median duration of response was 5.77 months (range: 5.54, 8.98). 14/27 (51.9%) of patients required dose interruption/reduction. Overall, 23/27 (85.19%) patients discontinued alpelisib of which 11 (47.83%) discontinued alpelisib due to AEs. Median duration of treatment was 2 months in patients who had grade 3 AEs (range: <1.00, 8.30) and 6.28 (1.15, 10.43) in those who did not. Any grade AEs were reported in 24/27 (88.9%) patients, namely, hyperglycemia 16/27 (59.3%), nausea 11/27 (40.7%), diarrhea 10/27 (37.0%), fatigue 7/27 (25.9%) and rash 6/27 (22.2%). Grade 3 AEs were reported in 13/27 patients (50%), namely, hyperglycemia in 7/27 (53.8%) patients followed by skin rash 4/27 (30.8%), GI side effects 3/27 (23.1%). Those with progressive disease as best response to alpelisib, had more non-metabolic comorbidities, higher number of liver metastases, PIK3CA E545K mutations, and shorter duration on therapy compared to those with PR and stable disease.ConclusionPatients should be counseled about the toxicity and modest benefit observed with alpelisib in real-world clinical practice when used in later lines of therapy.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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“…The second-line therapy should include a hormonal drug that has not been used yet in combination with a CDK 4/6 inhibitor (provided it has not been used before). The combination of hormone therapy with alpelisib is also recommended in older patients with PIK3CA mutations [53].…”

Section: Hormone-dependent Cancermentioning

confidence: 99%

Breast Cancer in the Elderly

Jagiełło-Gruszfeld¹,

Mlodzinska²

2023

Breast Cancer Updates

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Breast cancer is a serious health problem in the elderly female population. The approach to treating healthy women aged 65–70 years should be similar to treating younger patients with a similar stage and biological subtype of breast cancer. Greater individualization of treatment is necessary in the case of patients with worse parameters of functional efficiency and features of the frail syndrome. It should also be emphasized the need for closer cooperation with geriatricians, especially when defining the management plan and conducting systemic treatment in this group of patients. There is also a great need for research into the proper selection of treatment in elderly breast cancer patients. This is especially important in groups of patients with early and locally advanced breast cancer.

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“…Median age was 71 years and median time on drug was 2.6 months; 15 (29.4%) patients stopped alpilisib for adverse events, which included hyperglycemia, diarrhea, rash, fatigue and mucositis with 5 patients needed hospitalization for hyperglycemia. 123 …”

Section: Metastatic Diseasementioning

confidence: 99%

Breast Cancer in Geriatric Patients: Current Landscape and Future Prospects

Abdel‐Razeq¹,

Rous²,

Abuhijla³

et al. 2022

CIA

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Breast cancer is the most common cancer diagnosed among women worldwide and more than half are diagnosed above the age of 60 years. Life expectancy is increasing and the number of breast cancer cases diagnosed among older women are expected to increase. Undertreatment, mostly due to unjustifiable fears of advanced-age and associated comorbidities, is commonly practiced in this group of patients who are under-represented in clinical trials and their management is not properly addressed in clinical practice guidelines. With modern surgery and anesthesia, breast surgeries are considered safe and is usually associated with very low complication rates, regardless of extent of surgery. However, oncoplastic surgery and management of the axilla can be tailored based on patients'-and disease-related factors. Most of chemotherapeutic agents, along with targeted therapy and anti-Human epidermal growth factor receptor-2 (HER2) drugs can be safely given for older patients, however, dose adjustment and close monitoring of potential adverse events might be needed. The recently introduced cyclin-D kinase (CDK) 4/6-inhibitors in combination with aromatase inhibitors (AI) or fulvestrant, which changed the landscape of breast cancer therapy, are both safe and effective in older patients and had substituted more aggressive and potentially toxic interventions. Despite its proven efficacy, adjusting or even omitting adjuvant radiation therapy, at least in low-risk older patients, is safe and frequently practiced. In this paper, we review existing data related to breast cancer management among older patients across the continuum; from resection of the primary tumor through adjuvant chemotherapy, radiation and endocrine therapy up to the management of recurrent and advanced-stage disease.

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

Cited by 4 publications

References 5 publications

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

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

Breast Cancer in the Elderly

Breast Cancer in Geriatric Patients: Current Landscape and Future Prospects

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