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

PURPOSE: Alpelisib is newly-available breast cancer agent that targets PIK3 mutations and confers a somewhat unusual adverse event profile. This study focused on older patients (≥ 65 years of age) treated outside a clinical trial to gain further experience on how these under-studied patients do with this new agent. METHODS: This descriptive, multi-site study relied on medical record review. RESULTS: Fifty-one older breast cancer patients were started on alpelisib between May 2019 and September 2020. The median age and number of comorbidities at alpelisib initiation was 71 years and 4, respectively. Thirty-five patients had stopped alpelisib (median time on drug 2.6 months (range: < 1, 9.5 months)) for the following reasons: alpelisib adverse events (n = 15), cancer progression (n = 13), and other/unknown (n = 7). Alpelisib adverse events included hyperglycemia (n = 37), diarrhea (n = 23), rash (n = 19), fatigue (n = 12), and mouth sores (n = 7); (numbers in parentheses indicate the number of patients with at least one such event). Five patients were hospitalized for hyperglycemia. At the time of report, 14 patients were deceased, and median survival had not been reached. CONCLUSION: Older patients might derive further benefit from alpelisib if the adverse event profile of this agent, particularly the hyperglycemia, were able to be better managed.

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients.

ABSTRACT: Ketogenic diets appear promising for obesity, diabetes, cancer, and other illnesses. Because older patients are more likely to contend with such illnesses and because of a paucity of dietary outcomes among these patients, we examined ketogenic diets in older patients.This multisite study focused on patients (≥65 years of age) on a ketogenic diet. Medical records were identified with the keywords "keto," "ketogenic," and "Atkins." Records were reviewed in detail with extraction of direct quotations to substantiate observations.We report on 200 consecutive patients with a median age of 70 years. Reasons for diet included weight loss, diabetes, and cancer; the majority remained on the diet for >1 month. In 134 (67%: 95% confidence interval: 60, 73%), the ketogenic diet appeared beneficial: 93 of 117 (79%) who sought weight loss lost weight ("She has lost 15 pounds and plans to lose another 8"); 36 of 67 (54%) who sought glucose control appeared to achieve the latter ("He has gone on a ketogenic diet and has been able to bring his sugars down significantly"); and 5 of 8 (63%) who sought improved cancer outcomes appeared to derive them ("He attributes part of the control of his cancer and increased QOL to adopting the keto for cancer diet"). Adverse events occurred in 30 patients (15%): dyslipidemia (n = 14), constipation (n = 9), sub-therapeutic international normalized ratio (n = 3), pancreatitis (n = 2), diarrhea (n = 1), and fatigue (n = 1).Trials that test ketogenic diets for a variety of illnesses should enroll older adults.

Blenderized Tube Feeding Use in Adult Home Enteral Nutrition Patients: A Cross-Sectional Study.

BACKGROUND: Use of long-term enteral nutrition (EN) has increased dramatically in the United States. It has been the authors' experience that most home EN (HEN) patients use blenderized tube feeding (BTF) in addition to commercial EN. There are limited resources available for patients interested in BTF, and studies evaluating safety and effectiveness are limited. METHODS: The authors conducted a prospective cross-sectional study (n = 54). INCLUSION CRITERIA: age >18 years, follow-up in HEN clinic, prescribed commercial EN. Participants were provided the survey at HEN follow-up appointments after receiving HEN for at least 3 weeks. RESULTS: Median age (range) was 60.5 (22-87) years with 42.6% females (n = 23). BTF was used by 55.5% of patients (n = 30). Most (57%; n = 31) received HEN for >6 months. BTF use was a median of 4 (1-7) days per week. Most common reasons for using BTF were as follows: it is more natural (43%), like eating what their family does (33%), and tolerate BTF better (30%). In patients who use BTF, 80% reported maintaining goal body weight. BTF resulted in significantly less reported nausea, vomiting, bloating, diarrhea, and constipation compared with commercial EN. CONCLUSIONS: This is the first study to evaluate BTF use in an adult HEN population. More than 50% of our patients used and approximately 80% expressed a desire to use BTF if provided with adequate information. With new connection tube changes coming in the near future, adequate adapters for BTF need to be developed.