Palbociclib in Older Patients with Advanced/Metastatic Breast Cancer: A Systematic Review.

BACKGROUND: Palbociclib in combination with endocrine therapy is approved for treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. In addition to clinical trials, several real-world studies have evaluated the effectiveness of palbociclib. With increased life expectancy in the general population, breast cancer in older women is also expected to increase. OBJECTIVE: The aim was to systematically review evidence from both clinical trials and real-world studies for palbociclib treatment outcomes in older patients with HR+/HER2- advanced/metastatic breast cancer (a/mBC). Older patients are often underrepresented in clinical trials, and real-world evidence (RWE) will enrich the analysis of palbociclib outcomes in this subgroup of patients. DESIGN: A systematic literature search in PubMed, EMBASE, and Cochrane Library through May 4, 2023, yielded 2355 unique articles. A total of 52 articles (13 and 39 articles reporting results from seven randomized controlled trials [RCTs] and 37 RWE studies, respectively) were included based on study eligibility criteria. RESULTS: All RCTs used age cutoffs of ≥ 65 years to define older population (n = 722; 437 received palbociclib); all RWE studies, except one with an age cutoff of > 60 years, had age cutoffs of ≥ 65 years or higher to define older population (n = 9840; 7408 received palbociclib). Overall, in studies that compared efficacy (progression-free survival [seven RCTs, 20 RWE studies], overall survival [four RCTs, 11 RWE studies], tumor response [three RWE studies], and clinical benefit rate [one RCT, two RWE studies]) and safety outcomes (three RCTs, three RWE studies) between older and younger patients, palbociclib showed similar benefits, regardless of age. Results from two RCTs and two RWE studies showed that global quality of life (QoL) was maintained in older patients receiving palbociclib. Overall, palbociclib dose modifications (two RWE studies), dose reductions (one RCT, seven RWE studies), and treatment discontinuation rates (three RCTs, three RWE studies) were higher in older patients compared with younger patients; however, these differences did not appear to adversely impact efficacy outcomes. CONCLUSIONS: In this systematic review, data from RCTs showed that palbociclib was effective, well tolerated, and maintained QoL in older patients with HR+/HER2- a/mBC. Palbociclib treatment in older patients in real-world settings was associated with similar clinical benefit as in RCTs. PROSPERO REGISTRATION: CRD42023444195.

Metabolic control and satisfaction in a diabetes education programme in flash glucose monitoring through telemedicine in type 1 diabetes.

OBJECTIVE: To evaluate metabolic control and satisfaction with a telemedicine diabetes education programme for the initiation of flash glucose monitoring (FGM) in type 1 diabetes. MATERIAL AND METHODS: Prospective study in 48 patients (52.1% women, 22.9% on insulin pump) who started FGM. They were analysed at baseline and 3 months after the beginning of the FGM. The results were compared with an on-site learning cohort matched by age, sex and HbA1c. RESULTS: At the beginning and 3 months after the MFG, HbA1c improvement was observed (7.9±1.4 vs 7.3±1.1%), p<0.01; with a decrease in time below range - TBR - (4.7±4.9 vs 3.5±3.5%), p<0.05 and number of hypoglycaemic events (9.4±8.7 vs 6.9±5.7/15 days), p<0.05, associated with a worsening in time above range - TAR - (33.5±19.9 vs 37.0±20.9%), p<0.05. No significant differences were observed in the TIR 70-180mg/dl (61.7±18.6 vs 59.4±20.0%), glycemic variability or the use of FGM. Patient satisfaction with telemedicine training was 4.8±0.3 out of 5. No significant differences were observed in the follow-up, either in HbA1c or other glucometer parameters between on-site and online training. In a multivariate analysis adopting the HbA1c at follow-up as the dependent variable, only the TIR (ß=-0.034; p<0.001) and the initial HbA1c (ß=0.303; p<0.001) maintained statistical significance, unrelated to the on-site or online training (ß=0.136; p=ns). CONCLUSIONS: A telemedicine programme is an adequate tool for training in FGM, with results similar to on-site training, and it was associated with a high degree of satisfaction.

Impact of flash glucose monitoring on quality of life and glycaemic control parameters in adults with type 1 diabetes mellitus⋆.

INTRODUCTION: Flash glucose monitoring (FGM) improves some glycaemic control variables and quality of life parameters. OBJECTIVE: Our aim was to evaluate the quality of life and glycaemic control parameters after initiating FGM in patients with type 1 diabetes (DM1) in clinical practice. MATERIAL AND METHODS: A prospective observational study in DM1 patients that started using FGM between June 2019 and April 2020. We analysed their scores on the Diabetes Quality of Life (DQOL) questionnaire, Diabetes Distress Scale (DDS), Diabetes Treatment Satisfaction Questionnaire (DTSQ) and glycaemic control parameters at baseline and 3 months after the FGM onset. RESULTS: We recruited 114 patients, 56% male, mean age 37.2 (standard deviation, SD 12.4), with 18.7 (SD 11.5) years of DM1, 24.6% of which used continuous subcutaneous insulin infusion. Differences were observed (baseline vs. 3 months) in the DTSQ score (22 [15.5-27] vs. 25 [22-28], P < 0.001) and in the DQOL score (88 [74-104] vs. 84 [70-101], P = 0.017) but not in the DDS score. HbA1c was 7.8% (SD 1.3) vs. 7.4% (SD 1.1) (P < 0.001), without improvement in other glycaemic control variables, except for the mean number of hypoglycaemic events/14 days: 14 (SD 9) at baseline vs. 11.5 (SD 7) at 3 months (P < 0.001). CONCLUSIONS: The initiation of FGM, combined with a structured educational programme, was associated with improvement in quality of life and patient satisfaction in DM1 patients. An improvement in HbA1c and a reduction in the number of hypoglycaemia events was observed, but not in the rest of glycaemic control parameters.