ABSTRACT
Background: Pathogenic mutations in BRCA1 and BRCA2 are associated with high risks of breast (BC) and ovarian cancer (OC). Modifiable life style factors are important in explaining some of the variation in cancer risks in both, OC and BC. Crucial steps to prevent malignant disease are increased physical activity, avoidance of smoking, limitation of the intake of red meat or alcohol. Method(s): To assess possible changes in life style, a web-based survey was placed on internet platforms of patients' support groups between 29th January and 22th April 2021. Missing data were composed of those patients who did not answer the question or who did not have a clear opinion regarding the topic. Data are presented as frequencies of selected items. Group differences were calculated by chi2-test. Result(s): During the pandemic, 10.5% of respondents consumed significantly more or more alcohol, while 31.6% consumed less or significantly less alcohol than before the pandemic. With respect to abuse of nicotine, 11.8% consumed more and 17.6% consumed less than before the pandemic. 16.2% engaged in significantly more or more physical activity, whereas 47.1% engaged in less or significantly less physical activity, respectively. 8.7% stated that they maintained a healthy body weight, while 17.4% did not. A healthy diet was strictly observed or observed by 13.9% of respondents, while 23.6% observed a healthy diet less or significantly less than before the pandemic. Discussion(s): The exact impact of life style changes during the SARS-CoV-2 pandemic on cancer (recurrence) risk, as well as on subsequent survival, is still unknown, but it has the potential to lead to important public health implications in the coming years. Conclusion(s): Thus, especially during challenging periods of life, women at high risk for cancer occurrence or recurrence should be reassured that observing a healthy lifestyle (healthy diet, control of obesity, decreased smoking etc.) is an excellent option for cancer prevention and increased survival.
ABSTRACT
Background: The SARS-CoV-2 pandemic has affected the entire world, but some subgroups of patients have been disproportionally affected. Cancer patients showed a higher prevalence of COVID-19 disease, as well as a higher incidence of severe COVID-19 illness and higher death rates from COVID-19. Method(s): To assess the perspectives and believes of women with an increased hereditary risk for breast (BC) and ovarian (OC) cancer regarding infection-specific and cancer-specific risks during the SARS-CoV-2 pandemic, a web-based survey was placed on internet platforms of support groups between 29th January and 22th April 2021. Data are presented as frequencies of selected items. Correlations were assessed by non-parametric tests. Result(s): Asked about their concerns to face a more severe disease course of COVID-19 illness, 44.2% responded, they were not concerned, while 27.3% were more concerned and 23.4% were significantly more concerned. Higher concerns were correlated with higher age (p=0.001) and were associated with a positive history of invasive breast cancer (p=0.001). When asked about concerns of being at higher risk for occurrence of breast and ovarian cancer after being infected with SARS-CoV-2, 72.7% reported no concerns, while 11.7% reported moderate concerns and 5.2% had significant concerns. Higher concerns were correlated with higher age (p<0.047), while higher resilience was a protective factor (p=0.029) Those with a positive medical history for in situ or invasive BC or OC were asked about concerns regarding an unfavorable oncological outcome as a result of an infection with SARS-CoV-2. 23.0% had no concerns, while 24.3% had moderate increased concerns and 14.9% reported significantly increased concerns. Discussion(s): Age proved to be a risk factor for health-related worries during the COVID-19 pandemic, while higher resilience proved to be protective to health-related concerns. Conclusion(s): Patients with additional risk factors may be at risk to experience health-related worries and anxiety, and should be monitored closely.
ABSTRACT
Background: Patients with cancer are at higher risk to be infected by SARS-CoV-2, are more likely to develop a severe COVID-19 illness, and are more likely to die as a result of COVID-19. Thus, several strategies were proposed to mitigate the SARS-CoV-2 pandemic crisis with respect to people at higher risk, such as implementing strict personal precautions in cancer patients or cancer survivors. Method(s): To assess the expectations and perspectives of women with an increased hereditary risk for breast and ovarian cancer regarding measures to prevent infection and implement environmental control during the SARS-CoV-2 pandemic, a web-based survey was placed on internet platforms of support groups between 29th January and 22th April 2021. Missing data were composed of those patients who did not answer the question or who did not have a clear opinion regarding the topic. Data are presented as frequencies of selected items. Result(s): 37.5% of participants stated, that they would like to be informed about the hygiene concept of the health care institution and 20.3% reported that this information would have changed their own behavior. To prevent the spread of the virus, 57.8% of respondents approved testing of patients previous to a visit to a health care facility and 95.3% stated, that health care professionals should be tested on a regular basis. 93.8% approved the change of appointments to ensure social distancing, but 75.0% would support the possibility to be escorted by a significant other during medical appointments. To avoid unnecessary possible exposure, 71.9% of participants endorsed the possibility of virtual patient consultations. Additionally, 84.4% of respondents expected, that health care personnel used at least surgical masks, and 68.8% expected, that the health care personnel used FFP-2 masks. Discussion(s): Protecting patients at risk and medical caregivers is a priority during pandemics. Conclusion(s): Our data emphasize the wish and need for reorganization of health care facilities with the aim to protect patients at risk.
ABSTRACT
Background: Triple-negativebreast cancer (TNBC) has the highest rate of distant metastasis and poorestoverallsurvival among all breast cancer subtypes. Adagloxad simolenin (AS;OBI-822)is a therapeutic vaccine comprisingthe synthetically manufactured tumor-associatedantigen Globo H linked to the carrier protein keyhole limpethemocyanin (KLH).The KLH provides antigenic immune recognition and T-cell responses. AS isco-administered witha saponin-based adjuvant OBI-821 to induce a humoralresponse. A phase 2 trial showed that AS/OBI-821exhibiteda trend for superior progression-free survival vs placebo in patientswhose breast cancers had higher GloboHexpression. Administrationof AS/OBI-821 resulted in IgM and IgG anti-Globo H humoral response and atrendtowards improved PFS in patients with metastatic breast cancer overexpressingGlobo H. We describe therationale and design of GLORIA, an ongoing Phase III,randomized, open-label study to evaluate efficacy, safety, and quality of life(QoL) of AS plus standard of care (SOC) versus SOC alone in patients with high-risk, early-stage TNBC. The primary endpoint is invasive progression-freesurvival;secondary endpoints include overall survival, QoL, breastcancer-freeinterval, distant disease-free survival, safety, and tolerability. Trial Design: A phase 3 trial was initiated inDecember 2018 and had been slowly enrolling until being put on holddue to theCovid-19 pandemic. While the study wason hold the design waschanged from a placebo-control to astandard-of-care control trial based onfeedback from investigators and leading breast cancer advisers, that thenumberof placebo injections was a serious burden on patients. Furthermore, it wasapparent that blinding wasquestionable given the expected and frequent localskin inflammation and low-grade fevers that accompany theAS/OBI-821 vaccineadministration and the absence of these obvious clinical signs and symptoms with the normalsaline placebo control.The main changes to the protocol are as follows:Methods: Eligibility includes patients with TNBC (estrogen receptor/progesterone receptor <5%,and HER2-negative) with nonmetastatic disease and 1) either residual invasive disease of ≥1 cm in breast or ≥1 positiveaxillary node following neoadjuvantchemotherapy;Pathological Stage IIB or III disease treated with adequateadjuvant chemotherapy alone;received ≥4 cycles of standard taxane- and/oranthracycline-basedchemotherapy;randomized within 12 weeks of surgery, adjuvant multi-agent chemotherapy,or radiation therapy.Inaddition, tumors must express Globo H (H-score of ≥15 by central laboratory analysis using a validatedimmunohistochemical assay). Subjects in the AS/OBI-821 group will receive 30 μg of AS in combination with 100 μgofOBI-821.This revised study will start re-enrolling patients as soon as Covid-19 restrictions are lifted with the firstcountry being South Korea with an anticipated start date in Q4/2020.