MONEO: A phase II study of avelumab (Av) plus FLOT in the peri-operative treatment for patients (pts) with resectable gastric or gastroesophageal junction cancer (GC)

Background: GC represents a worldwide problem;radical surgery remaining the gold standard of curative treatment. In the West, even with peri-operative chemotherapy, 5-year survival rate is approximately 40%. GC is a heterogeneous disease, well characterized by different molecular classifications, all having in common the role of the immune system and a T-cell inflamed phenotype across all subtypes. The anti-PD-L1 Av antibody has demonstrated efficacy in GC with response rates of around 10% in the refractory setting. The addition of other immune checkpoint inhibitors to chemotherapy have demonstrated efficacy in the metastatic setting. The combination of Av to perioperative chemotherapy may increase pathological responses by a synergistic effect, and then improving the survival (OS). Methods: The MONEO is an open-label, non-randomized, multicentric, phase II study that explores the combination of Av plus peri-operative FLOT (docetaxel, oxaliplatin, fluorouracil/leucovorin) in resectable GC pts. EudraCT 2019-000782-21;ClinicalTrials NCT03979131. Main inclusion criteria require pts with histologically proven GC, stage Ib (T1N1 only) - IIIC (7th AJCC Ed), available paraffin block from diagnosis and surgery, evaluable disease (RECIST 1.1) amenable to radical surgery. Significant comorbidities and active autoimmune diseases are excluded. Treatment consists of surgery with 4 peri-operatory cycles of FLOT + Av, followed by Av up to one year. The primary objective is the pathological complete response (pCR) rate, compared to historical data. Secondary objectives include OS, disease-free survival, R0 resection rate, tolerability and biomarker analysis. Key point is the comprehensive biomarker analysis from tissue and blood samples (pathological immune response, TCR clonality, immune contexture characterization, immunodynamic monitoring). Statistics for an estimated 33% pCR (historical 16%), 82% power, 0.1 one-side type I error. 37 pts will be recruited from 10 Spanish centers. The sponsor is Vall d'Hebron Institute of Oncology (VHIO), principal investigators Dr. Melero and Dr. Alsina. In compliance with the Helsinki Declaration. At a data cut-off day of 5 of February 2021, 38 patients have been enrolled, 27 of them have had the surgery. Although the difficulties during the COVID19 pandemia, only two patients had been withdrawn from the study.

Identifying and preventing burnout in young oncologists, an overwhelming challenge in the COVID-19 era: a study of the Spanish Society of Medical Oncology (SEOM).

BACKGROUND: Young oncologists are at particular risk of professional burnout, and this could have a significant impact on their health and care of their patients. The coronavirus disease 2019 (COVID-19) pandemic has forced rapid changes in professionals' jobs and training, with the consequent physical and psychological effects. We aimed to characterize burnout levels and determinants in young oncologists, and the effects of the pandemic on their training and health. METHODS: Two online surveys were conducted among oncology residents and young oncology specialists in Spain. The first addressed professional burnout and its determinants before the COVID-19 pandemic, while the second analyzed the impact of the pandemic on health care organization, training, and physical and psychological health in the same population. RESULTS: In total, 243 respondents completed the first survey, and 263 the second; 25.1% reported significant levels of professional burnout. Burnout was more common among medical oncology residents (28.2%), mainly in their second year of training. It was significantly associated with a poor work-life balance, inadequate vacation time, and the burnout score. Nearly three-quarters of respondents (72%) were reassigned to COVID-19 care and 84.3% of residents missed part of their training rotations. Overall, 17.2% of this population reported that they had contracted COVID-19, 37.3% had scores indicating anxiety, and 30.4% moderate to severe depression. Almost a quarter of young oncologists (23.3%) had doubts about their medical vocation. CONCLUSIONS: Burnout affects a considerable number of young oncologists. The COVID-19 pandemic has had a profound impact on causes of burnout, making it even more necessary to periodically monitor it to define appropriate detection and prevention strategies.

COVID-19 impact and predictive factors for mortality in cancer patients

Background: SARS-CoV-2 is a novel coronavirus that has been responsible for the largest pandemic in the last century: COVID-19. This disease has widely affected Spain with a high lethality in ancient patients (pts) and with comorbidities. Oncological pts were not an exception. Methods: We evaluated the association between COVID-19 mortality and clinical/laboratory/radiological parameters in cancer pts from March to April 2020 at our institution. Past medical history and COVID-19-related parameters (symptoms, laboratory/x-ray findings and treatments) were retrospectively collected. Univariate analysis (UA) has been done using Fisher exact and U-Mann-Withney test for qualitative and quantitative variables, respectively. Multivariant analysis (MA) has been done using logistic regression. Results: Forty three hospitalized pts were diagnosed with COVID-19;30 pts (69.8%) were symptomatic on admission and 13 pts (30.2%) were hospital-acquired cases. Median age was 68.8 ± 7.8 years. Most part of the pts had gastrointestinal (GI) (13;30.2%), thoracic (Tx) (12;27.9%) and breast (6;14%) cancer. A higher prevalence of Tx tumours compared to our new pts prevalence is observed (9%). Fever was the most common symptom (27;62.8%) and bilateral pneumonia was observed in 24 pts (55.8%). SARS-Co-V-2 PCR was positive in 34 pts (79.1%). Hydroxychloroquine was administered in 35 pts (81.4%), steroids and antiretrovirals in 19 pts (44.1%) and tocilizumab in 12 pts (27.9%). Mortality rate due to COVID-19 was 30.23% (13 pts) and 8 pts could resume oncological treatment. Hypertension (HTA) and previous daily steroids given during last month before admission;as well as performance status, fever, Curb-65, SOFA score and D-Dimer (DD) at admission were associated with COVID-19 mortality in UA. Similarly, high flow oxygen requirements during hospitalization and DD at 72 hours are predictors of mortality. HTA [OR: 8.3 (1-5-70.1)], steroids [OR: 10.7 (1.3 – 143.8)] and fever [OR: 0.09 (0.01 – 0.55)]were also associated in MA. Conclusions: COVID-19 showed a relative higher incidence in pts with Tx and GI tumours. Some clinical and laboratory parameters were found to be predictive factors for mortality as previously reported in non-cancer pts. Further investigations with larger number of pts are needed. Legal entity responsible for the study: HM Hospitales. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

COVID-19 severe pneumonia in cancer patients: Impact and predictive factors

Background: SARS-CoV-2 is a novel coronavirus that has been responsible for the largest pandemic in the last century: COVID-19. Some patients (pts) develop a severe pneumonia with higher mortality rate. Oncological population could be at higher risk. Methods: We evaluated the association between COVID-19 severe pneumonia and clinical/laboratory/radiological parameters in cancer pts admitted to our institution from March to April 2020. We considered a severe pneumonia if the patient required more than 5L supplemental oxygen. Past medical history and COVID-19-related parameters (such as symptoms, laboratory/x-ray findings and specific treatments for the COVID-19) were retrospectively collected. Univariate and multivariate analysis have been done using logistic regression. Results: Forty-three cancer pts were hospitalized with COVID-19 diagnosis;27 pts (62.8%) were male. Median age was 68.8 ± 7.8 years. Most part of the pts had gastrointestinal (13;30.2%), thoracic (12;27.9%) and breast (6;14%) cancer. 33 pts (83.7%) presented pneumonia, which was bilateral in 24 pts (55.8%). Median basal saturation of oxygen (O2) was 92% (87-94.5). Severe pneumonia was observed in 23 pts (53.5%). In these patients, the most common symptoms were dyspnea (16;69.6%), cough (14;60.9%) and fever (11;47.8%). Hydroxychloroquine was administered in 20 pts (87%), antiretrovirals in 14 pts (60.9%), steroids in 13 pts (56.5%) and tocilizumab in 9 pts (39%). Mortality rate due to COVID-19 was 84.6% in pts with severe pneumonia versus 15.4% in the rest of patients (p=0.03). Thoracic cancer and diabetes were associated with severe pneumonia development in univariate analysis. Thoracic cancer [OR: 12.0 (1.8 – 246.5)] was also associated in multivariate analysis. Conclusions: Severe pneumonia was frequent in cancer patients with COVID-19 admitted to our institution and was associated with a high mortality rate. Thoracic tumours were found to be a risk factor for developing severe pneumonia. Further investigations with larger number of pts are needed. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.