Elderly patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with CDK4/6 inhibitors in a multicentre cohort.

INTRODUCTION: Cyclin-dependent kinases 4/6 inhibitors (CDK 4/6i) combined with endocrine therapy have become the gold standard in hormone receptor-positive (HR +) HER2-negative (HER2-) metastatic breast cancer (MBC). However, there is a significant lack of data regarding the efficacy and safety of these treatments in elderly patients. We present the results of a real-world data (RWD) cohort stratified by age at treatment initiation (≥ 70 years compared to patients < 70 years). METHODS: Clinico-pathological data of HR + HER2- MBC patients who were candidates for CDK4/6i therapy between January 2017 and December 2020 at the Institut Català d'Oncologia (Spain) were retrospectively collected. The primary goal was to assess Progression-Free Survival (PFS), Overall Survival (OS), and safety outcomes within this patient population. RESULTS: A total of 274 patients with MBC who received CDK4/6i treatment were included in the study. Among them, 84 patients (30.8%) were aged ≥ 70 years, with a mean age of 75, while 190 patients (69.2%) were under the age of 70, with a mean age of 55.7 years. The most frequently observed grade 3-4 toxicity was neutropenia, with similar rates in both the < 70 group (43.9%) and the ≥ 70 group (47.9%) (p = 0.728). The median Progression-Free Survival (mPFS) for the first-line CDK4/6i treatment was 22 months (95% CI, 15.4-39.8) in the < 70 group and 20.8 months (95% CI 11.2-NR) in the ≥ 70 group (p = 0.67). Similarly, the median PFS for the second-line CDK4/6i treatment was 10.4 months (95% CI, 7.4-15.1) and 7.1 months (95% CI 4.4-21.3) (p = 0.79), respectively. Median overall survival (mOS) was not reached either for the first- and second-line treatment. CONCLUSIONS: Our RWD suggests that elderly patients, when compared to those under 70, experience similar survival outcomes and exhibit comparable tolerance for CDK4/6i therapy.

Developing Cardio-Oncology Programs in the New Era: Beyond Ventricular Dysfunction Due to Cancer Treatments.

Cardiovascular disease is a common problem in cancer patients that is becoming more widely recognized. This may be a consequence of prior cardiovascular risk factors but could also be secondary to the anticancer treatments. With the goal of offering a multidisciplinary approach to guaranteeing optimal cancer therapy and the early detection of related cardiac diseases, and in light of the recent ESC Cardio-Oncology Guideline recommendations, we developed a Cardio-Oncology unit devoted to the prevention and management of these specific complications. This document brings together important aspects to consider for the development and organization of a Cardio-Oncology program through our own experience and the current evidence.

Venting percutaneous radiologic gastrostomy in malignant bowel obstruction: safety and effectiveness in a comprehensive cancer centre.

OBJECTIVE: Approximately 20% of established malignant bowel obstruction (MBO) patients do not respond to pharmacological treatment. In these cases, venting percutaneous radiologic gastrostomy (VPRG) may be useful. Existing evidence is based on retrospective studies with methodological limitations. The purpose of this study is to describe safety and effectiveness for symptom control after VPRG placement in a prospective cohort of MBO patients. METHODS: Complications of VPRG placement, symptom control, destination on discharge and survival were analysed. RESULTS: Twenty-one patients were included, 13 (61.9%) of whom were women. Mean age was 62.7 years (36-85). Local pain (n=8, 38.1%) and peristomal leakage (n=4, 19%) were the most frequent minor complications. No major complications occurred. Nausea and vomiting were relieved in most patients (n=20, 95.2%) after VPRG, and small quantities of liquid diet were introduced to these patients. Median time to death after VPRG was 13 days (IQR 8.6-17.4). Thirteen patients (61.9%) were discharged, with seven of them (33.3%) returning home. CONCLUSIONS: When pharmacological treatment fails, the use of VPRG in MBO patients may be feasible, safe and effective.

Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Autologous Transplantation Seems Less Efficacious in Poor Mobilizers with the Use of a Biosimilar of Filgrastim and Plerixafor: A Retrospective Comparative Analysis.

INTRODUCTION: Biosimilars of granulocyte colony-stimulating factors (G-CSF) have shown similar efficacy to originator filgrastim (Neupogen® [NEU]; Amgen Inc.) as prophylaxis in neutropenia and in the mobilization of stem cells in patients receiving combination chemotherapy with G-CSF. METHODS: This was a retrospective study in which the characteristics of stem cell mobilization treated with a G-CSF alone were compared in 216 patients and 56 donors. The two G-CSF compared were NEU and the biosimilar filgrastim Zarzio® (Sandoz GmbH) (referred to hereafter as BIO). Primary objectives were mobilization rate (minimum of 10 × 103/ml CD34+ on day 4 of treatment [day +4]) and use of the immunostimulant plerixafor (PLEX) in each group. RESULTS: The general characteristics of the patients receiving NEU (n = 138) and those receiving BIO (n = 78) did not differ significantly. PLEX was used in 24% of BIO patients and in 25.7% of NEU patients. The median CD34+ cell count on day +4 was significantly lower in BIO patients who needed PLEX than in those who did not (2.4 vs. 4.8 × 103/ml; p = 0.002), as was the final CD34+ cell count (2.5 vs. 3.3 × 106/kg; p 0.03). Mobilization failure rate was higher in the BIO group than in the NEU group (20 vs. 0%; p = 0.01). With respect to donors, more than one apheresis was needed in three BIO donors, one of them with PLEX. The use of BIO was the only risk factor for mobilization failure in patients who needed PLEX (hazard ratio 10.3; 95% confidence interval 1.3-77.8). CONCLUSION: The study revealed that BIO had a lower efficacy for stem cell mobilization when the only treatment was G-CSF, especially in poor mobilizers needing PLEX.

NUTRISCORE: A new nutritional screening tool for oncological outpatients.

OBJECTIVES: The aim of this study was to design a new nutritional screening tool (NUTRISCORE) to detect nutritional risk in outpatients with cancer. METHODS: A multicenter, cross-sectional study was conducted. We randomly selected outpatients receiving onco-specific, palliative, or symptomatic treatment for malignant neoplasms (including solid tumors and hematologic malignancies). These patients were assessed using the NUTRISCORE tool, the Malnutrition Screening Tool (MST), and the Patient-Generated Subjective Global Assessment (PG-SGA) to detect risk for malnutrition. The new tool included questions regarding the cancer site and active treatment. Sensitivity, specificity, and positive and negative predictive values were calculated for NUTRISCORE and MST using the PG-SGA as a reference method. RESULTS: We evaluated 394 patients. According to NUTRISCORE, 22.6% were at risk for malnutrition. The MST detected a risk in 28.2%, and the PG-SGA found that 19% were malnourished or at nutritional risk. Using the PG-SGA as a reference method, the MST had a sensitivity of 84% and a specificity of 85.6%, whereas NUTRISCORE exceeded these values, at 97.3% sensitivity and 95.9% specificity. The better performance of NUTRISCORE as compared with MST was confirmed by the receiver operating characteristic curve analysis, with area under the curve values of 0.95 (95% confidence interval, 0.92-0.98) for NUTRISCORE and 0.84 (95% confidence interval, 0.79-0.89) for the MST. CONCLUSIONS: NUTRISCORE has been found to be a novel, fast, and valid nutritional screening tool for outpatients with cancer. Its simplicity and high level of accuracy in detecting nutritional risk facilitates its applicability.

[1st National Meeting of Multidisciplinary Work in Oncogeriatrics: expert consensus document]. / 1.(a) Reunión Nacional de Trabajo Multidisciplinar en Oncogeriatría: documento de consenso.

On 2nd of June 2011 the Institut Català d' Oncologia l'Hospitalet--Hospital Duran i Reynals hosted the first Meeting of Multidisciplinary Work in Oncogeriatrics. The reason for the meeting, which follows on from an initiative of the Medical Societies of Radiotherapy, Oncology, Geriatrics and Gerontology and Palliative Care and Medical Oncology, was to initiate a joint line of work among the different specialties that generally take part in the handling of the elderly patient suffering from oncologic pathologies. This document summarises the different subjects covered during the Meeting.

Critical appraisal of temozolomide formulations in the treatment of primary brain tumors: patient considerations.

Chemotherapy is assuming an increasingly important role in the treatment of malignant gliomas, of which temozolomide (TMZ) is a key part. TMZ belongs to a class of second-generation imidazotetrazinone prodrugs that exhibit linear pharmacokinetics and do not require hepatic metabolism for activation to the active metabolite. New intravenous (iv) TMZ formulations have recently been approved based on studies of bioequivalence between iv and oral TMZ. The efficacy of TMZ was initially evaluated in patients with recurrent disease but phase II and III trials in newly diagnosed gliomas are available. The results of a large phase III trial that compared RT alone vs RT concomitant with oral TMZ created a new standard of adjuvant treatment. Efficacy data for iv TMZ on which its approval was based are those extrapolated from clinical trials with oral TMZ. No comparative data are available on the differences in tolerability and patient satisfaction between oral and iv formulations of TMZ, or for quality of life. New oral formulations could encourage the adherence of patients to treatment. Although patients presumably would prefer oral treatment, iv formulations may be an alternative in noncompliant patients or patients for whom good adherence could not be expected.