ABSTRACT
Background: The COVID-19 pandemic has led to higher levels of stress, anxiety and depression in the population. Oncological patients might be particularly vulnerable, since structural changes and limited resources within medical care might affect treatment. Besides, due to their underlying condition, most are at-risk patients. The aim of this study was to identify the specific stressors and current needs of cancer patients. Method(s): Between 11/2020 and 02/2021 122 outpatient cancer patients of the Comprehensive Cancer Center Munich participated in the study after giving informed consent. Based on a standardized, semi-structured interview, participants were asked about their knowledge and concerns about COVID-19, risk perception, confidence in the national health system and readiness to get vaccinated against COVID-19. Psychosocial distress, symptoms of anxiety and depression, somatic symptoms and self-efficacy were collected via standardized questionnaires. Additionally, socio-demographic and medical data were collected. Result(s): More than a third of the patients (34.2%, n = 41) require additional information about the effects of the coronavirus on their cancer and/or treatment. Patients most often mentioned unanswered questions regarding the impact of a COVID-19- infection on cancer, followed by vaccination and treatment. About 17% had faced changes concerning their current or planned treatment. 34.7% (n=42) of the patients were significantly distressed (mean distress score: 3.7;scale: 0-10). A possible overload of the health care system was the most commonly reported, COVID-related fear (77.9%). Discussion(s): Findings suggest that oncologists should educate and support patients by exploring and responding to their diverse questions regarding the effect of COVID-19 on their disease and treatment. Conclusion(s): Providing emotional support and offering reliable sources of information can help cancer patients navigate through uncertainties and reduce anxiety.
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
We sought to determine parameters of the acute phase response, a feature of innate immunity activated by infectious noxae and cancer, deranged by Covid-19 and establish oncological indices' prognostic potential for patients with concomitant cancer and Covid-19. Between 27/02 and 23/06/2020, OnCovid retrospectively accrued 1,318 consecutive referrals of patients with cancer and Covid-19 aged 18 from the U.K., Spain, Italy, Belgium, and Germany. Patients with myeloma, leukemia, or insufficient data were excluded. The neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), prognostic nutritional index (PNI), modified Glasgow prognostic score (mGPS), and prognostic index (PI) were evaluated for their prognostic potential, with the NLR, PLR, and PNI risk stratifications dichotomized around median values and the pre-established risk categorizations from literature utilized for the mGPS and PI. 1,071 eligible patients were randomly assorted into a training set (TS, n=529) and validation set (VS, n=542) matched for age (67.9±13.3 TS, 68.5±13.5 VS), presence of 1 comorbidity (52.1% TS, 49.8% VS), development of 1 Covid-19 complication (27% TS, 25.9% VS), and active malignancy at Covid-19 diagnosis (66.7% TS, 61.6% VS). Among all 1,071 patients, deceased patients tended to categorize into poor risk groups for the NLR, PNI, mGPS, and PI (P<0.0001) with a return to pre-Covid-19 diagnosis NLR, PNI, and mGPS categorizations following recovery (P<0.01). In the TS, higher mortality rates were associated with NLR>6 (44.6% vs 28%, P<0.0001), PNI<40 (46.6% vs 20.9%, P<0.0001), mGPS (50.6% for mGPS2 vs 30.4% and 11.4% for mGPS1 and 0, P<0.0001), and PI (50% for PI2 vs 40% for PI1 and 9.1% for PI0, P<0.0001). Findings were confirmed in the VS (P<0.001 for all comparisons). Patients in poor risk categories had shorter median overall survival [OS], (NLR>6 30 days 95%CI 1-63, PNI<40 23 days 95%CI 10-35, mGPS2 20 days 95%CI 8-32, PI2 23 days 95%CI 1-56) compared to patients in good risk categories, for whom median OS was not reached (P<0.001 for all comparisons). The PLR was not associated with survival. Analyses of survival in the VS confirmed the NLR (P<0.0001), PNI (P<0.0001), PI (P<0.01), and mGPS (P<0.001) as predictors of survival. In a multivariable Cox regression model including all inflammatory indices and pre-established prognostic factors for severe Covid-19 including sex, age, comorbid burden, malignancy status, and receipt of anti-cancer therapy at Covid-19 diagnosis, the PNI was the only factor to emerge with a significant hazard ratio [HR] in both TS and VS analysis (TS HR 1.97, 95%CI 1.19-3.26, P=0.008;VS HR 2.48, 95%CI 1.47- 4.20, P=0.001). We conclude that systemic inflammation drives mortality from Covid-19 through hypoalbuminemia and lymphocytopenia as measured by the PNI and propose the PNI as the OnCovid Inflammatory Score (OIS) in this context.
ABSTRACT
Purpose: The COVID-19 pandemic has had detrimental impacts on all our daily lives. Besides the serious threats the coronavirus poses to people's physical health, it leads to higher levels of stress, anxiety and depression in the general population. Oncological patients are particularly vulnerable to these negative implications: due to their underlying condition, most are at-risk patients and need to be especially precautious regarding contagion. Additionally, structural changes and limited resources within medical care might lead to postponed or modified treatments and restricted access to psychological support. All these challenges might cause/increase uncertainty and psychosocial distress. Therefore, the aim of this study was to identify the specific stressors and current needs of cancer patients. Methods: Between 11/2020 and 02/2021 122 outpatient cancer patients of the Comprehensive Cancer Center Munich participated in the study. After giving informed consent, participants completed a survey via telephone or in person. They were interviewed about their knowledge and concerns about COVID-19, both in general and regarding their cancer, as well as risk perception and precautionary measures concerning COVID-19. Psychosocial distress, symptoms of anxiety and depression, somatic symptoms and self-efficacy were collected via standardized questionnaires. Additionally, socio-demographic and medical data were raised. Results: The results showed that n=42 (34.7%) were significantly distressed (mean distress score: 3.7;scale: 0-10). About a third of the patients (34.2%, n=41) still had unanswered questions regarding the effect of the coronavirus on their cancer and/or treatment. Patients most often mentioned questions regarding the impact of an infection with Covid-19 on cancer (n=11), followed by vaccination (n=9) and treatment (n=9). The willingness to receive an anti-covid-vaccination is high (71%). At the time of the interview, 22% had not made a decision yet. Frequent reasons for indecisiveness or refusal were a) a need for a conversation with their oncologist before decision (63.3%) and b) a need for information about toleration of the vaccine and cancer (treatment) (36.7%). Conclusions: Findings suggest that oncologists should educate and support patients by responding to the diverse questions cancer patients still have regarding the effect of COVID-19 on their disease and treatment as well as clarifying uncertainties regarding the anti-COVID-vaccination.
ABSTRACT
Introduction: Cancer patients are at increased risk of developing severe COVID-19 disease. Possible side effects of their systemic therapy and the lack of clinical data on safety and efficacy of COVID-19 vaccination in cancer patients cause uncertainty regarding the vaccination. Here, we evaluated attitude towards and effects of COVID-19 vaccination in patients with breast or gynecological cancer undergoing systemic therapy. The aim was to improve counseling of our patients in clinical routine. Methods: Since March 15th 2021 patients who received one of the approved COVID-19 vaccines were routinely interviewed about immediate (0-2 days) and late side effects (within two weeks after vaccination). Clinical parameters such as current therapy, time interval between therapy administration and vaccination, and changes in the therapy schedule due to the vaccination were documented. Furthermore, the willingness of non-vaccinated patients for vaccination was assessed. The collected data were anonymously analyzed as a part of routine quality assurance. Results: By May 10th 2021, 111 out of the 217 (51.1%) interviewed patients had received at least one shot of two-dose COVID-19 vaccine and 21 patients both shots. More than half of the vaccinated patients were >55y (60.2%;mean: 60.7y, range 30-92y). 68.7% had been diagnosed with breast and 25.1% with ovarian cancer;69% presented with UICC/ FIGO stage III/IV cancer. 74.6% received Conmirnaty (BioNTech/ Pfizer), 18.9% Vaxzevria (Astra Zeneca) and 6.5% Covid-19 Vaccine Moderna. After the first shot, 33.3% of the patients described no side effects, 49.1% reported a local reaction (swelling or pain), 23.4% flu-like symptoms, 10.8% headache and 3.6% nausea. 11 patients had symptoms that lasted longer than two days. In 11 cases, COVID-19 vaccination had an impact on delivery of the systemic therapy (n=10 postponements of therapy and n=1 dose reduction in advance to increase the leukocyte count before vaccination). 61.3% of the non-vaccinated patients (in total n=118) were already registered to get vaccinated;32.8% chose to postpone vaccination for various reasons (e.g. until there is more information on side effects in cancer patients);5% refused vaccination. Conclusions: Breast and gynecologic cancer patients appear to tolerate COVID-19 vaccination under systemic therapy and only in few cases the vaccination interfered with the treatment schedule. Updated results will be presented at the DGHO Congress.
ABSTRACT
Background: Cancer patients are at increased risk of developing severe COVID-19 disease. Possible side effects of systemic therapy and the lack of clinical data on safety and efficacy of COVID-19 vaccination in cancer patients cause uncertainty regarding the vaccination. Here, we evaluated attitude towards and effects of COVID-19 vaccination in patients with breast or gynecological cancer. The aim was to improve counseling of our patients in clinical routine. Methods: Since March 15th 2021, patients who received one of the approved COVID-19 vaccines were routinely interviewed about immediate (0-2 days) and late side effects (within two weeks after vaccination). Clinical parameters such as current therapy, time interval between therapy administration and vaccination, and changes in the therapy schedule due to the vaccination were documented. Furthermore, the willingness of non-vaccinated patients to be vaccinated was assessed. The collected data were anonymously analyzed as a part of routine quality assurance. Results: By May 10th 2021, 111 out of 217 (51.1%) interviewed patients had received at least one shot of COVID-19 vaccine and 21 patients both shots. More than half of the vaccinated patients were >55y (60.2%;mean: 60.7y, range 30-92y);69% with UICC/ FIGO stage III/IV cancer. 74.6% received Conmirnaty (BioNTech/ Pfizer), 18.9% Vaxzevria (AstraZeneca) and 6.5% Covid-19 Vaccine Moderna. After the first shot, 33.3% of the patients described no side effects, 49.1% reported a local reaction (swelling or pain), 23.4% flu-like symptoms, 10.8% headache and 3.6% nausea. 11 patients had symptoms that lasted longer than two days. In 11 cases, COVID-19 vaccination had an impact on delivery of the systemic therapy (n=10 postponements of therapy and n=1 dose reduction). 61.3% of the non-vaccinated patients (in total n=118) were already registered to get vaccinated;32.8% chose to postpone vaccination for personal reasons;5% refused vaccination. Conclusions: Breast and gynecological cancer patients appear to tolerate COVID-19 vaccination well under systemic therapy and only in few cases the vaccination interfered with the treatment schedule. Updated results will be presented at the ESMO Congress. Legal entity responsible for the study: LMU University Hospital. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
ABSTRACT
Background: The ongoing SARS-CoV-2 pandemic and ensuing coronavirus disease (COVID-19) is challenging cancer care and services worldwide. Methods: A 95 items survey was distributed worldwide by 20 oncologists from 10 of the most affected countries in order to evaluate the impact on organization of oncological care. Results: 109 representatives from oncology centers in 18 countries (62.4% academic hospitals) filled out the survey (June 17 – July 14, 2020). A swab or gargle test is systematically performed before day care unit or overnight stay admissions in 27.5% and 58.7% of the centers, respectively. A local registry (64.2%) and systematic tracing (77.1%) of infected patients was organized in many centers. Treatment modalities mostly affected by the pandemic (cancellation/delay) were surgery (44.1%) and chemotherapy (25.7%). Earlier cessation of palliative treatment was observed in 32.1% of centers, and 64.2 % of participants agree that under-treatment is a major concern. At the pandemic peak, teleconsultations were performed for follow-up (94.5%), for oral therapy (92.7%), but also for patients receiving immunotherapy (57.8%) or chemotherapy (55%). Approximately 82% of participants estimate that they will continue to use telemedicine. Most participants reported more frequent use of virtual tumor boards (82%) and oncological team meetings (92%), but 45% disagree that virtual meetings are an acceptable alternative to live international meetings. Although 60.9% report reduced clinical activity during the pandemic peak, only 28.4% had an increased scientific activity. Only 18% of participants estimate that their well-being will not recover to previous levels by the end of the year;63% indicate easily accessible psychological support for caregivers, but only 10% used or planned to use it. All clinical trial activities are or will soon be reactivated in 72.5% of the centers. Major study protocol violations/deviations were observed in 27.5% and significant reductions of clinical trial activities are expected by 37% of centers this year. Conclusions: COVID-19 has a major impact on organization of patient care, well-being of caregivers, continued medical education and clinical trial activities in oncology. Legal entity responsible for the study: The authors. Funding: Fondation Léon Fredericq. Disclosure: G. Jerusalem: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly;Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen;Advisory/Consultancy, Travel/Accommodation/Expenses: BMS;Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca;Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo;Advisory/Consultancy: AbbVie;Travel/Accommodation/Expenses: MedImmune;Travel/Accommodation/Expenses: Merck KGaA. G. Curigliano: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Advisory/Consultancy, Speaker Bureau/Expert testimony: Seattle Genetics;Speaker Bureau/Expert testimony, Writing engagement: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly;Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer;Advisory/Consultancy, Speaker Bureau/Expert testimony: Foundation Medicine;Advisory/Consultancy, Speaker Bureau/Expert testimony: Samsung;Advisory/Consultancy, Speaker Bureau/Expert testimony: Celltrion;Leadership role, Scientific Affairs Group: Ellipsis;Speaker Bureau/Expert testimony, Writing engagement: BMS;Speaker Bureau/Expert testimony: MSD;Advisory/Consultancy: Mylan. M. Campone: Honoraria (self), Advisory/Consultancy: GT1;Honoraria (institution), Advisory/Consultancy: Sanofi;Honoraria (institution), Advisory/Consultancy: Pierre-Favre;Honoraria (institution), Advisory/Consultancy: AstraZeneca;Honoraria (institution), Advisory/Consultancy: Servi r;Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Honoraria (institution), Advisory/Consultancy: AbbVie;Honoraria (institution), Advisory/Consultancy: Accord;Honoraria (institution), Advisory/Consultancy: Pfizer;Speaker Bureau/Expert testimony: Lilly. M. Martin: Advisory/Consultancy, Research grant/Funding (institution): Roche;Advisory/Consultancy, Research grant/Funding (institution): Novartis;Advisory/Consultancy, Research grant/Funding (institution): Puma;Advisory/Consultancy: AstraZeneca;Advisory/Consultancy: Amgen;Advisory/Consultancy: Taiho Oncology;Advisory/Consultancy: Daichii Sankyo;Advisory/Consultancy: PharmaMar;Advisory/Consultancy: Eli Lilly;Advisory/Consultancy: Pfizer. M. Cristofanilli: Advisory/Consultancy: CytoDyn;Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer;Advisory/Consultancy: Lilly;Advisory/Consultancy: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony: Foundation Medicine;Advisory/Consultancy: G1 Therapeutics;Advisory/Consultancy: Sermionexx;Advisory/Consultancy: Genentch. L. Pusztai: Honoraria (self), Research grant/Funding (institution), Clinical trial support: Merck;Honoraria (self), Research grant/Funding (institution), Clinical trial support: AstraZeneca;Honoraria (self), Research grant/Funding (institution), Clinical trial support: Seattle Genetics;Honoraria (self): Novartis;Honoraria (self), Research grant/Funding (institution), Clinical trial support: Roche Genentech;Honoraria (self): Eisai;Honoraria (self): Daiichi;Honoraria (self): Syndax;Honoraria (self): Immunomedics. R. Bartsch: Advisory/Consultancy: Accord;Honoraria (self): AstraZeneca;Advisory/Consultancy, Research grant/Funding (institution): Daiichi;Advisory/Consultancy, Travel/Accommodation/Expenses: Eli-Lilly;Advisory/Consultancy, Travel/Accommodation/Expenses: MSD;Advisory/Consultancy, Research grant/Funding (institution): Novartis;Advisory/Consultancy, Research grant/Funding (institution): Roche;Advisory/Consultancy: Puma;Advisory/Consultancy: Pierre-Favre;Advisory/Consultancy: Sandoz;Advisory/Consultancy: Eisai. M. Tagliamento: Travel/Accommodation/Expenses: Roche;Travel/Accommodation/Expenses: Bristol-Myers Squibb;Travel/Accommodation/Expenses: AstraZeneca;Travel/Accommodation/Expenses: Takeda;Travel/Accommodation/Expenses: Novartis;Travel/Accommodation/Expenses: Amgen. J. Cortés: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche;Honoraria (self), Advisory/Consultancy: Celgene;Advisory/Consultancy: Cellestia;Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca;Advisory/Consultancy: Biothera Pharmaceutical;Advisory/Consultancy: Merus;Advisory/Consultancy: Seattle Genetics;Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo;Advisory/Consultancy: Erytech;Advisory/Consultancy: Athenex + Polyphor;Advisory/Consultancy, Shareholder/Stockholder/Stock options: MedSIR;Honoraria (self), Advisory/Consultancy: Lilly;Advisory/Consultancy: Servier;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp Dome;Advisory/Consultancy: GSK;Advisory/Consultancy: Leuko;Advisory/Consultancy: Bioasis;Advisory/Consultancy: Clovis Oncology;Advisory/Consultancy: Boehringer Ingelheim;Honoraria (self), Travel/Accommodation/Expenses: Novartis;Honoraria (self), Travel/Accommodation/Expenses: Eisai;Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Honoraria (self): Samsung Bioepis;Research grant/Funding (institution): Ariad Pharmaceuticals;Research grant/Funding (institution): Baxalta GMBH/Servier Affaires;Research grant/Funding (institution): Bayer Healthcare;Research grant/Funding (institution): F. Hoffmann-La Roche;Research grant/Funding (institution): Guardanth Health;Research grant/Funding (institution): Piqur THerapeutics;Research grant/Funding (institution): Puma C;Research grant/ unding (institution): Queen Mary University of London. E.M. Ciruelos: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche;Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly;Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer. H.S. Rugo: Research grant/Funding (institution): Eisai;Research grant/Funding (institution): Genentech;Research grant/Funding (institution): Lilly;Research grant/Funding (institution), Travel/Accommodation/Expenses: MacroGenics;Research grant/Funding (institution): Merck;Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis;Research grant/Funding (institution): Obi Pharma;Research grant/Funding (institution): Odonate Therapeutics;Research grant/Funding (institution): Immunomedics;Research grant/Funding (institution), Travel/Accommodation/Expenses: Daiichi-Sankyo;Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Advisory/Consultancy: Samsung;Advisory/Consultancy: Celtrion;Travel/Accommodation/Expenses: Mylan;Travel/Accommodation/Expenses: AstraZeneca. All other authors have declared no conflicts of interest.