Poor efficacy of palbociclib in second-line treatment of metastatic lobular breast cancer in a case series: Use before or never more?

n/

The Impact of Locoregional Treatment on Response to Nivolumab in Advanced Platinum Refractory Head and Neck Cancer: The Need Trial

Background: Previous locoregional treatment could affect the response to nivolumab in platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The aim of this study is to evaluate the impact of the clinicopathological characteristics and previous treatment in predicting early progression to nivolumab in a real-world population. Methods: This is an observational, multicenter retrospective/prospective study including patients (pts) with platinum refractory R/M HNSCC who received nivolumab 240 mg every 2 weeks from October 2018 to October 2019. We analyzed the association between previous treatment, clinicopathological characteristics, and early progression (within 3 months). Results: Data from 61 pts were reviewed. Median age was 67 years (30–82). Forty-two pts (69%) received previous locoregional treatment. Early progression to nivolumab occurred in 36 pts (59%), while clinical benefit (stable disease and partial response) was achieved in 25 pts (41%). Early progression to nivolumab was significantly associated to previous locoregional treatment both at univariate and multivariate analysis (p = 0.005 and p = 0.048, respectively). Conclusion: nivolumab in R/M HNSCC is burdened with a high early progression rate. Previous wide neck dissection and high dose radiotherapy may compromise the efficacy of nivolumab, distorting the anatomy of the local lymphatic system and hindering the priming of immune response

Second victims in healthcare: the stages of recovery following an adverse event

A second victim has been defined as "a healthcare worker involved in an unanticipated adverse patient event, medical error and/or a patient related-injury who becomes victimized in the sense that the worker is traumatized by the event". The aim of the present research study was to assess the "second victim" phenomenon in Italy. Fifty interviews were conducted with different health care professionals previously involved in medical errors. All study participants clearly remembered the event. Support obtained by second victims was poor and inefficient. Healthcare workers become second victims every day and, considering that human resources are the most important resource of healthcare organizations, it is fundamental to implement valid programs to support and train these workers about the phenomenon

Evaluating the quality of care in nursing homes: comparison of three International models

The aim of this observational descriptive study was to identify the main international models evaluating the quality of nursing homes for non self-sufficient elderly persons, and to apply them in the Italian health system. Firstly, a bibliographic search of institutional websites and Pubmed-Medline was performed to identify the main international models. Secondly, three variables were chosen to evaluate the level of implementability of the models: (1) frequency of use of quality indicators in the international models; (2) degree of constructability of the models in two Italian nursing homes; (3) perceived relevance of the indicators used by the chosen models, by nursing home workers. Thirdly, the chosen models were evaluated. Three international models were identified, respectively used in USA, Canada and Australia. About 80% of the indicators used by the three models were constructable in the two Italian nursing homes that were evaluated. The two nursing homes were "promoted" according to the Canadian model, "better than sufficient" according to the Australian model, but "failed" when US model indicators were applied. The poorest performances in the two Italian nursing homes, with respect to international quality standards, were related to indicators of incontinence, physical restraints (1,1% for USA and 13% for Canada and Australia, versus 55% in one of the nursing homes and 30% in the second home), diagnosis of depressive symptoms, and antipneumococcical vaccination (0% in the two nursing homes, in comparison with the 93,8% in the USA). A low level of performance in prevention and safety matters was identified, while performance was higher for aspects warranted by law. The survey also revealed thatnursing home workers' perceptions of the utility of specific indicators were often based on habit rather than on the actual relevance of care indicators. The development of a model of quality of care that offers a multidimensional evaluation of the level of performance of Italian nursing homes is needed

Paradox CA 15-3 increase in metastatic breast cancer patients treated with everolimus: A change of paradigm in a case series

Everolimus and exemestane represent a standard treatment for metastatic hormone receptor-positive/HER2-negative advanced breast cancer resistant to aromatase inhibitors. CA 15-3 serum levels detect soluble forms of MUC-1, a transmembrane oncoprotein aberrantly overexpressed in breast cancers. In clinical practice, CA 15-3 may be used to indicate treatment failure in the absence of readily measurable disease during cytotoxic therapy. In the targeted therapy era, it is important to note that the C-terminal subunit of MUC-1 interacts with PI3K/AKT pathway, inducting cell growth. Vice versa, the block of this pathway may influence MUC-1 expression and CA 15-3 serum levels. In this report, we emphasize the equivocal role of CA 15-3 serum levels in monitoring treatment with everolimus, suggesting a potential and intriguing role of a CA 15-3 increase as paradox predictive biomarker of response to everolimus

[Evaluating quality and safety in long term care: results from the experimentation of the Smart Star model]

The Smart Star model is a rating system to evaluate the quality of care in nursing homes for the elderly; it uses a five star rating score. We tested the model in a sample of 16 nursing homes in Italy. The Smart Star model showed to be effective in the multidimensional evaluation of the performance of nursing homes. One of the major strengths of the model consisted in its flexibility of application, that suggested its possible adaptation for different areas of healthcare

Fractal-Based Radiomic Approach to Tailor the Chemotherapy Treatment in Rectal Cancer: A Generating Hypothesis Study

IntroductionThe aim of this study was to create a radiomic model able to calculate the probability of 5-year disease-free survival (5yDFS) when oxaliplatin (OXA) is or not administered in patients with locally advanced rectal cancer (LARC) and treated with neoadjuvant chemoradiotherapy (nCRT), allowing physicians to choose the best chemotherapy (CT) regimen. MethodsLARC patients with cT3-4 cN0 or cT1-4 cN1-2 were treated according to an nCRT protocol that included concomitant CT schedules with or without OXA and radiotherapy dose of 55 Gy in 25 fractions. Radiomic analysis was performed on the T2-weighted (T2-w) MR images acquired during the initial tumor staging. Statistical analysis was performed separately for the cohort of patients treated with and without OXA. The ability of every single radiomic feature in predicting 5yDFS as a univariate analysis was assessed using the Wilcoxon-Mann-Whitney (WMW) test or t-test. Two logistic models (one for each cohort) were calculated, and their performance was assessed using the area under the receiver operating characteristic (ROC) curve (AUC). ResultsA total of 176 image features belonging to four families (morphological, statistical, textural, and fractal) were calculated for each patient. At the univariate analysis, the only feature showing significance in predicting 5yDFS was the maximum fractal dimension of the subpopulation identified considering 30% and 50% as threshold levels (maxFD(30-50)). Once the models were developed using this feature, an AUC of 0.67 (0.57-0.77) and 0.75 (0.56-0.95) was obtained for patients treated with and without OXA, respectively. A maxFD(30-50) >1.6 was correlated to a higher 5yDFS probability in patients treated with OXA. ConclusionThis study suggests that radiomic analysis of MR T2-w images can be used to define the optimal concomitant CT regimen for stage III LARC cancer patients. In particular, by providing an indication of the gross tumor volume (GTV) spatial heterogeneity at initial staging, maxFD(30-50) seems to be able to predict the probability of 5yDFS. New studies including a larger cohort of patients and external validation sets are recommended to verify the results of this hypothesis-generating study

Is surgery mandatory in locally advanced gastrointestinal stromal tumors after imatinib? A case report and literature review.

Oesophageal gastrointestinal stromal tumors (GISTs) are rare neoplasms (about 2% ofall GISTs); radical surgery is the standard treatment of all GISTs but in case of locally advanced and unresectable disease no clear treatment guide lines are available. Studies including neoadjuvant imatinib mesylate (IM) are relatively recent, includes small sample size of heterogeneous patients and do not report a standardized duration of neoadjuvant treatment. The main question still remains whether surgery after neoadjuvant IM gives a survival benefit in locally advanced disease. A 46-year-old man with locally advanced unresectable oesophageal GIST harboring KIT exon 11 mutation was treated in our institution for 12 months with neoadjuvant IM; a reduction of 83% of tumor volume was obtained in 9-month of neoadjuvant IM, but in the last 3 months no further response was seen. After neoadjuvant therapy, patient underwent radical surgery and adjuvant IM, which is still ongoing. Since no definitive data are available about survival benefit of surgery after neoadjuvant IM in locally advanced GISTs, a careful balance between morbidity and mortality derived from surgery should be considered and more studies are needed to better define the utility and the optimal duration of neoadjuvant treatment

Palbociclib Plus Fulvestrant or Everolimus Plus Exemestane for Pretreated Advanced Breast Cancer with Lobular Histotype in ER+/HER2− Patients: A Propensity Score-Matched Analysis of a Multicenter Retrospective Patient Series

Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) in combination with endocrine therapy (ET) show meaningful efficacy and tolerability in patients with metastatic breast cancer (MBC), but the optimal sequence of ET has not been established. It is not clear if patients with lobular breast carcinomas (LBC) derive the same benefits when receiving second line CDK4/6i. This retrospective study compared the efficacy of palbociclib plus fulvestrant (PALBO–FUL) with everolimus plus exemestane (EVE–EXE) as second-line ET for hormone-resistant metastatic LBC. From 2013 to 2018, patients with metastatic LBC positivity for estrogen and/or progesterone receptors and HER2/neu negativity, who had relapsed during adjuvant hormonal therapy or first-line hormonal treatment, were enrolled from six centers in Italy in this retrospective study. A total of 74 out of 376 patients (48 treated with PALBO–FUL and 26 with EVE–EXE) with metastatic LBC were eligible for inclusion. Progression-free survival (PFS) was longer in patients receiving EVE–EXE compared with PALBO–FUL (6.1 vs. 4.5 months, univariate HR 0.58, 95% CI 0.35–0.96; p = 0.025). On the propensity score (PS) analysis, PFS was confirmed to be significantly longer for patients treated with EVE–EXE compared to PALBO–FUL (6.0 vs. 4.6 months, p = 0.04). This retrospective analysis suggests that EVE–EXE is more effective than PALBO–FUL for second line ET of metastatic LBC, allowing us to speculate on the optimal therapeutic sequence