ABSTRACT
Background: Estrogen receptors (ER) are predictive of endocrine responsiveness. However, 30% of ER+ BC patients will relapse despite adjuvant ET and 10 to 20% of metastatic lesions loose the expression of ER. The early identification of endocrine resistant patients may help to improve treatment strategies, especially in the light of innovative drugs recently approved. In the ET-FES trial we evaluated 18F-FES CT/PET as a prediction tool for endocrine responsiveness in ER+ MBC. The ET-FES study was funded by the ERANET-Transcan project. Methods: MBC patients with ER+/HER2- disease, were eligible for the ET/FES study. All patients underwent a baseline [18]F-FES PET/CT in addition to conventional procedures. Patients were classified as endocrine sensitive if overall Standardized Uptake Value (SUV) ≥ 2 and received ET;patients with SUV <2 were randomized to receive ET or chemotherapy (CT). The prognostic role of [18]F-FES PET/CT was assessed for PFS and OS by univariate and multivariate analyses. The primary endpoint was disease progression rate (DPR) at 6 months. Results: From April 2015 to October 2020 146 patients, from 7 EU centers were enrolled: of them, 115 with a mean SUV >2 received ET and 30 with SUV <2 were included in the randomized study. Median follow up was 18.4 months (range 8.0 to 38.3 months) in endocrine sensitive patients (SUV > 2) versus 10.1 months (range 8.0 to 36.8) in patients with SUV <2. Overall, at the time of this analysis 67 patients (45.9%) had disease progression and 37 (25.3%) died. DPR at 6 months was 57% in patients with SUV >2 vs 50% in SUV <2 randomized to ET and 57% in case of CT. DPR at 12 months was 35% vs 17% and 14%, respectively. Median PFS was 7.3 months (IQR 3.8 – 17.3) vs 5.2 (IQR 3.1 – 9.4) vs 7.7 months (IQR 3.0 – 14.0), respectively. OS rate at 12 months was 31% versus 17% versus 14%. Conclusions: The ET-FES clinical trial was prematurely interrupted, due to COVID-19 pandemic. The discriminating ability of this assay was high, leading to a personalized endocrine approach;a considerable proportion of patients with a mean SUV >2 is still on ET. Clinical trial identification: EudraCT 2013-000287-29. Legal entity responsible for the study: Alessandra Gennari - Università del Piemonte Orientale. Funding: AIRC. Disclosure: All authors have declared no conflicts of interest.
ABSTRACT
Background: SARS-CoV-2 pandemic changed oncology clinical practice. Health care workers (HCW) in oncology experienced double concerns as they had to guarantee patients global care while protecting them from the infection. We performed a longitudinal survey during this year to evaluate how daily practice and life of cancer HCW has changed. Methods: Three online surveys were sent to Italian Association of Medical Oncology (AIOM) members of Piedmont and Valle d'Aosta during the first wave, just before the second wave and at the end of the second wave. The 5 main topics were: population characteristics, changes in working practice, SARS-CoV-2 swab management, the influence of the pandemic on diagnostic, and on therapeutic paths. Results: 201, 186 and 136 HCW responded to the 3 surveys, respectively. 45% were oncologists, 28% nurses, 5% palliative doctors, and 9% interns. 75% did not received adequate training and 50% adequate personal protective equipment during the 1st wave. Screening by molecular swabs increased during time (from 6% in the 1st wave to 93.7% at the end of the 2nd wave). HCW main concerns were on beloved ones, lack of COVID-19 guidelines and practical skills (1st survey), the fear of a 2nd wave and its consequences (2nd survey), the persistence of emergency despite vaccines (3rd survey). Most HCW intended to be vaccinated (94%). Pandemic changed HCW-patient relationship due to the lack of physical contact and hampered non-verbal communication. A moderate to significant reduction of first oncological consultations occurred. Most follow-up visits were remotely conducted and palliative care activation was delayed in 40% of cases. Conclusions: This survey explored how cancer HCW suffered and reacted in different phases of SARS-CoV-2 pandemic. To know the discomforts, fears and perplexities of HCW must indicate where to act to restart and continue to guarantee patients and their families the best therapies and paths.
ABSTRACT
Background: Dimension and speed of the COVID19 health emergency forced pressing reorganization of the hospital machine with foreseeable repercussions on both cancer patients and healthcare professionals. A survey to the latter had the aim to describe oncology reaction at the time of Coronavirus spread in Piedmont and Valle d'Aosta. Material and methods: An electronic survey containing questions regarding the organizational, relational and management aspects of the emergency COVID19 as sent to Piedmont and Valle d'Aosta health workers in oncology on April 7th 2020. Results: 201 questionnaires were completed: 60% oncologists, 33% nurses, 7% palliativists;41% <45y;33% university hospital, 32% non-university hospital 32% ASL. 91% considered the pre-triage model and COVID questionnaire as essential for identifying suspected patients. Structures were converted for assistance of COVID patients in 76% of cases and 26% of the health workers accepted a role change:18% on voluntary basis, while only 24% believe to have received adequate training. On clinical activity, significant reduction (48%) was registered only for first visits (CAS) while interdisciplinary discussions (GIC) have been maintained although with alternative modalities (remotely,77%). 88% of follow-up visits were remotely conducted. Considering relational aspects, discomfort mainly concerned absence of physical contact and forms of non-verbal communication hampered by the PPE, increased communication time. However, healthcare provider-patient relationship has not changed (20%), even allowing a more transparent and empathic interaction despite the use of alternative means of communication. Health professionals suffered the lack of a reference in the management of the pandemic and/or guidelines of behavior and specific skills. Major concern was the lack of PPE and the fear to be a source of infection for one's family (in 67% of cases a physical distancing from one's family nucleus was carried out or would have been desired). 52% operators report they have not yet received the swab test;in case of swab test, this was carried out due to presence of symptoms (8%) or intermediate-high risk due to prolonged contact with a COVID case, with 60% believing times and procedures were inadequate. Conclusions: This picture is a precious benchmark to face with in order to reorganize the oncological activity in the immediate future, taking great account of the perception and experience of oncology operators. Submitted on behalf of the AIOM Piemonte & Valle d'Aosta Regional Board.