Management oral cancer therapies in oncology clinic during covid19 pandemia

Background: Since 2017 to optimize the dispensing and administration of the so-called oral cancer therapies, it was decided to set up at our Oncology Unit of the Sondrio Hospital a dedicated clinic. In recent years, since the number of oral therapies available has increased, above all due to the growing indications,consequently the flow of patients to our clinic has increased. The onset of the pandemic COVID 19 has therefore imposed on us, in order to reduce the gathering of patients and caregivers in the rooms of the clinic, an reorganization to minimizing outpatient visits to mitigate exposure and possible further transmission and, at the same time, to maintain the safety of oncological therapy. Material and methods: Based on the low haematological toxicity profile, we chose to dispense the therapy bi-monthly instead of monthly to patients in stabilized therapy: 14 receiving enzalutamide therapy, 5 patients in imatinib (3 GIST and 2 CML), 2 patients in sunitinib, 4 patients on pazopanib, 2 patients on osimertinib, 4 patients on alectinib. However, telephone contact was made in the event of any problem. Results: All 21 patients showed no relevant toxicity (no G 3 or G 4) and no cases of Covid infection 19 occurred. Conclusions: In consideration of the absence of significant toxicity, it could be thought to test this outpatient practice on a greater number of patients, perhaps by setting up surveillance by telematic means and not only by telephone, also in anticipation of future epidemic outbreaks.

Oncology clinical trials' management in Italy during the covid-19 emergency: Challenges and improving opportunity

Background: The global COVID-19 pandemic has adversely affected all aspects of clinical care and it has not spared even clinical trials on cancer. Indeed the need to adopt precautionary measures for the containment of COVID-19 infection have affected the access of cancer patients in clinical trials. The devastating effects of this global crisis have also negatively impacted the work of our Oncology Unit which has so far conducted more than 120 phase I-III studies. Method: We faced numerous challenges with conducting clinical trials due to COVID-19. In order to contain infection all the actor involved had to apply several precautions. Pharmaceutical companies, no-profit Sponsors, CROs and either our organization have applied or extended smartworking in order to continue their activities related to clinical trials but monitoring visit on site were suspended. When possible remote monitoring visits have been performed. Start initiation visit for new trial, for which it is essential the presence on site, were strongly postponed. Ethics Committee evaluation of clinical trials or substantial amendments have suffered inevitable strong delays nearly to 3 months because they had to adapt their activities also with organize their meetings by web-conferences. Only access to compassionate use was ever granted. Results: At site particular attention was needed in the enrollment of new patients in the trials evaluating the risk/ benefits ratio. For each patient the possible postponement of access to receive treatment has been assessed on the basis of the relationship between the risks, for the patient and the community related to access to the site, and the expected benefits of the treatment itself. The closure of several Hospital Units due to spread of contagion and limited availability of ancillary services caused the interruption of enrollment in clinical trials. Conclusions: Our clinical research activity during the pandemic has suffered negative repercussions but we think that what happened could be an useful opportunity to improve and transform clinical trial conduction system for example by simplifying the study design, optimizing the number of on-site monitoring visits and reducing patient's access to the hospital.

Sars cov2 pandemic: Is cancer a real risk factor

Background: Recent literature suggests that cancer patients are more susceptible to SARS CoV-2 infection and have higher infection-related mortality. These data are certainly influenced by age, stage of the disease, type of antitumour treatment and presence of cardiovascular comorbidity. Methods: We conducted a retrospective observational study to evaluate the characteristics of patients with a history of oncological/haematological disease who acquired SARS CoV-2 infection during oncologic follow-up or active antineoplastic therapy in our Institution (ASST Valtellina e Alto Lario, Province of Sondrio) from March 1 to April 30, 2020. Eligibility required positive molecular testing on nasopharyngeal swab or bronchoalveolar lavage. Results: At the present analysis, a total of 1471 subjects resulted positive for SARS COV-2 infection in our Province;among them 43 subjects (2.94%) had a history of oncological or haematological disease. 24/43 (55.8%) were males and 19/43 (44.2%) females;median age was 71.5 (range 53-91). 42/43 patients (97.6%) were hospitalized on a total of 613/1459 positive people who required hospitalization (42/613, 6.8%). 48.8% (21/43) patients died due to viral infection on a total number of deaths of 150 (21/150, 14%);55% were males and 45% females;40% had an age range between 70 and 79, 25% between 50 and 59, 20% between 60 and 69 and 15% over 80. 25% of patients had stage IV disease;80% of patients had cardiovascular comorbidities and preexistent pulmonary diseases. Breast, lung and colon were the tumor types most represented. Conclusions: In our case study, oncologic/haematologic patients are not significantly represented, constituting only less than 3% of total infected and about 7% of hospitalized subjects. Although the limited sample, our data reveal, meanwhile, high mortality for SARS CoV-2 in cancer patients. This data suggests the need for new strategies for an earlier detection of positive subjects from SARS Cov-2 within the cancer population.

Management of a breast unit at the time of covid 19 (Asst Valtellina E Alto Lario Experience)

Background: Revision of the therapeutic diagnostic path of breast cancer during the COVID-19 pandemic. Material (patients) and methods: The COVID-19 emergency has made appropriate changes in breast cancer treatment in Italy. The Lombardy region organized itself through first level structures connected to several more specialized centers (spoke), this model was sometimes difficult to apply for mileage distances and fear of infection;so the local organization was the best solution. What we changed in our organization in agreement with recommendations by National and International Oncology Societies (AIOM /ESMO): • First level screening and surgical activity concerning benign tumor pathology and reconstructive surgery have been suspended. • Access to the breast surgery visit was guaranteed once a week. • The surgery was performed according to the priority classes considering the biological characteristics of the tumor. • Hospital access was planned the day before surgery for preoperative tests provided that nasopharingeal swab for Covid-19 research had to be already done. • The hospitalization was performed with the utmost respect for preventive hygiene standards and physical distancing;the access to relatives was not allowed. • Patients were discharged on the evening of the operation if residing nearby the hospital. • A multidisciplinary discussion was ensured through videoconferencing with subsequent and timely sharing of the treatment program with the patient. • Access to systemic treatment was a priority for patients with aggressive biological tumor characteristics (triple negative, HER-2 positive, high disease volume). Results: From the beginning of the pandemic today 56 breast tests and 22 surgical procedures (19 quadrantectomies and 3 mastectomies) have been performed. Multidisciplinary discussions were done every 2 weeks through multimedia support. Hospital access has been maintained only for patients with high priority features who needed to systemic therapy, while the telephone management was performed for those with low priority characteristics. Conclusions: 5-year survival has been shown to reach 83.9% in high-volume facilities. The efficient work of a multidisciplinary team produces appropriateness, consistency, and better use of human and economic resources. The main purpose of each Breast Unit is trying to keep these results even during the COVID-19 pandemic.

Immune chechpoint inhibitors (ICIS) in the era of covid-19

Background: The coronavirus pandemic resulted in nearly 400,000 victims. Cancer patients under active treatment with chemotherapy, target therapy, or immunotherapy (ICIs) are considered to be at high risk of SARS-cov-2 infection and of a severe form of Covid 19. In this case (patients on active treatment), it seems appropriate that the possible postponement of access to treatment should be assessed and discussed on a case by case basis, based on the relationship between the risks (for the individual and for the community) related to hospital access and expected benefits from the treatment itself. Material (patients) Method: Here we assessed the impact that the pandemic had as well as the advice of scientific societies on the administration of immunotherapy in patients who refer to the Day Hospital of Medical Oncology of the Sondrio hospital. Data from the medical records of all patients who were treated with ICIs from the 1st of March until the 06 th of July 2020 were collected. Patients were contacted by telephone the day before the infusion of therapy and on the day of administration they accessed the DH only with a face mask and after measurement of the body temperature. Results: 29 patients, 15 women, with an age range between 46 and 85 years were identified. There are 14 patients treated with Nivo and 15 patients treated with Pembro (4 of whom have had combination immunotherapy with chemotherapy ) The treated tumors were NSCLC, Melanomas, Renal Cancer, Bladder Cancer, Head and Neck cancer. A total of 74 biweekly doses of Nivo and 53 threeweekly doses of Pembro were administered. There was no postponement of therapy. In 3 patients who underwent restaging with TC Chest/ Abbdomen there was a suspicious radiological immaging that was not confirmed as SARS-cov 2 infection. Conclusions: In the current context of the COVID-19 pandemic clinical decisions about cancer patients deserving immunotherapy should be characterized by separated reflections, avoiding generalizations. A careful collection of clinical data in all cancer patients and multicenter retrospective studies will be required to provide more definitive guidance for clinicians.

Rapid serological test in the covid-19 era: Our experience

Background: The COVID-19 was first reported in Wuhan, China, in December 2019 and then spread rapidly around the world also affecting our country. It caused many deaths, not sparing health workers. The active detection of infection among health professionals is essential to ensure the safety of them and to reduce the spread of the virus. We evaluated use of the qualitative serological test in asymptomatic healthcare workers in the Sondrio Hospital. Material (patients) and methods: We analyzed 220 asymptomatic healthcare workers assessed for qualitative serological test from March 2020 to date;trial is actually ongoing. We chose qualitative NADALR COVID-19 IgG/IgM Rapid Test (test cassette) REF 243001N-10, by Nal Von Minden GmbH (Germany). This is a lateral flow chromatographic immunoassay for the qualitative detection of anti-SARSCoV-2 IgG and IgM in human whole blood, serum or plasma specimens. The test procedure is not automated and requires no special training or qualification. It is necessary a fingerprick blood sample and provides a qualitative result within 15 minutes. It has a high sensitivity with 94,1% and 99,2% specificity. Some of the subjects analyzed were also evaluated with quantitative serological test (Diasorin test). Results: 25/220 asymptomatic cases tested resulted positive to qualitative serological rapid test (Table 1), 5 of which were conniving with people positive to COVID-19 but not been swabbed. In 7/25 subject positive we had a quantitative positive IgG response;these people are found to be positive to nasopharyngeal swab. We have had 195/220 cases with qualitative negative response, in 43 of which the result of the rapid test has been confirmed by the quantitative serological test;in 152 cases the quantitative test was not carried out. Conclusions: Rapid qualitative serological test is ready, economic and able to identifies asymptomatic subjects who may have developed immunity. It could be useful as a rapid screening procedure in the healthcare workers to identify immune or infected people that should be isolated to reduce spread of the COVID-19.

Psychoncology in front of covid-19

Background: The emergency state we are living today and the implementation of COVID-19 related restrictions has increased the psychologic distress levels for cancer patients. Measures such as not beingallowed to see other people and forced social distancing, have triggered in in patients negative memories and increased their concerns about the efficacy of their treatment plan. For these patients, lonelinessis linked to a higher likelihood of death and social distancing has a negative impact on their mental health, by increasing their worries. In order to limit these downsides, an important unlock has been to be able to provide continuous psycho-oncology treatments through the remote use of tablets, PCs and smartphones,and thereby reducing the number of visits to hospital. Material (patients) and methods: The effectiveness of the remote psychologic treatments has been possible by the use of the psychologic distress thermometer and its impact overall. Psychoeducation has helped to normalize the psychologic reactions against COVID-19;patients have experienced daily activities shifts, such as sleep, diet and level of attention, that have reduced security and personal equilibrium in their day to day life. Analysis of individual coping skills and use of mindfulness were key to increase patients personal resilience. Results: From a 3-month research on cancer patients, from March 3rd to June 3rd, the following results are shown: Conclusions: Technology has allowed the continuity of this service in such vulnerable times and it has enabled the implementation of new functional approaches from a personal, relational and social point of view. Now it's time to a new challenge: go back to normality. Without psychooncology treatments through the remote use of tablets, PCs and smartphones this would not have been possible, this method will remain a valid alternative over time.

Volunteering and complementary services in oncology during the covid-19 emergency

Background: Volunteering in oncology has been a wellknown and consolidated reality for decades. Alongside this fundamental component, complementary services that deal with providing image consultancy, wigs and onco-aesthetic services to women who undergo oncological surgery and chemotherapy treatments, have been integrated for years Material (patients) and methods: In the context of the emergency we are going through, within the containment measures of the covid-19 pandemic, volunteering and complementary services have been suspended. Volunteers are people who for sensitivity devote their time to those who are experiencing a situation of suffering. They follow a specific training path and their activity is supervised by the psychoncologist. Despite their absence, enhancement of the group and their role, they have been supported through periodic supervisions conducted by the psycho-oncologist online and through the creation of a chat that represents a physical and psychological space for the group. Technology has made it possible to keep the group united by making each member perceive a sense of continuous belonging overcoming physical distances. The members of the group remained in constant contact with each other and with the operators of the department. The supervision activity also continued with the onco-aesthetics operators who remained in contact with Medical staff and offered their availability through telephone consultations on body image care. Body image is related to a positive self-image in female patients who undergo surgery or body changes for chemotherapy treatments. Results: Despite the social distancing measures and the removal of the volunteers from the department the group and its internal dynamics have been preserved. The use of technology in this context ensured the cohesion of the group, the members actively participated in overcoming the limits of physical distance. Conclusions: Nobody knows how this emergency will evolve and when it will be possible to return to normal. During the upcoming months the group of volunteers can keep their motivation and their investment in oncology services alive and it will be important to keep on working on their involvement and internal cohesion. Patients who are going through a difficult time and who need moments of 'normalcy' along their oncological care pathways know how precious the presence of volunteers is.

Have we changed our work during Covid19 pandemic

Background: Pain is one of the most debilitating symptoms in oncological diagnosis, and is present in most cancer patient (in the literature range 20 to 95%). Cancer pain is a chronic pain with multifactorial pathogenesis with which intense episodic transient acute pain can coexist (Btcp). Hence the need to assess / correctly measure pain to set an appropriate drug therapy (treatment based on the 'three steps of pain' -OMS 1986-) and it is possible to have a more objective evaluation of the results of the established analgesic therapy. During the emergency period, outpatient visits were reduced both in terms of organization and frequency and the reduction in the number of doctors available and the limitations of patient access to hospital clinics for their protection led to a new approach to taking load. Material (patients) and methods: Experience of our center, from 1 March 2020 to 31 May 2020, during the covid 19 emergency compared with the pre-covid period from 1 November 2019 to 31 January 2020 regarding the evaluation of pain, the need to set specific analgesic therapy, the need to modify this therapy in the course of time (switching between opioids or association between opioids of two different classes) and the need to add adjuvant drugs. Results: During this time we followed 15 patients versus 17 patients in pre-covid period. Pain was measured in all the first evaluation (using one-dimensional measurement scales-numerical scale -), in 90% of cases this was done by telephone (versus 0% pre covid). Furthermore, the cargiver's telephone involvement was necessary, especially in monitoring over time to evaluate pain control, Btcp episodes and side effects (in the pre-covid period it was the patient who exposed these data during the visit). On the other hand, as regards the specific analgesic therapy set, the need to rotate the opioids or to associate two opioids of different classes, the prescription of the rescue dose and the adjuvant drugs, there were no differences compared to the pre-emergency period. Conclusions: During the emergency period, in consideration of the high frequency of pain and the impact on the patient's quality of life, it was necessary to modify our approach to manage the patient with cancer, make a correct assessment (repeated over time) and set up an effective analgesic therapy.

Penalty for simultaneous care during the emergency covid-19

Background: Simultaneous care represents an organizational model based on the global care of the cancer patient through continuous assistance and a progressive integration between cancer therapies and palliative care. The model responds to global needs (physical, psychological, social) of the patient and his family managed by a multidisciplinary team made up of oncologists, palliativists, radiotherapists, psychologists. As compared with cancer patients receiving standard care, patients receiving early palliative care had less aggressive care at the end of life and longer survival. In the province of Sondrio ASST Valtellina and Alto Lario has activated simultaneous care for cancer patients for about a year. Material (patients) and methods: The simultaneous care clinics are structured on defined days and times, managed by a multidisciplinary team which always involve family members. During the emergency period the surgeries underwent changes in terms of organization and frequency. The reduction in the number of doctors available and the limitations of patient access to hospital clinics for their protection have led to a significant reduction in the numbers of cancer patients treated early in simultaneous treatment. The analysis of the data defines a number of 12 cancer patients followed simultaneously in a pre-covid period from 1 November 2019 to 31 January 2020. During the covid-19 emergency, in the period from 1 March 2020 to 31 May 2020, they were followed 5 patients. On average 3 patients versus 1 in the emergency period. Results: During the covid-19 emergency, the results show a significant reduction in simultaneous care paths. In this phase, the simultaneous care clinic was managed as needed by a single professional with telephone consultations and few home visits without the direct involvement of family members. Conclusions: The reduction in simulataneous care during the emergency period penalized cancer patients who, in a moment of clinical fragility, experienced a lived experience of abandonment that affected their quality of life. In memory of dr. Fabio Rubino, Responsible for the Palliative Care Service.