The experience of a district general hospital when recruiting patients from across the region into a national study within a rare cancer

Introduction: Mesothelioma is a rare cancer with over 2500 cases diagnosed annually in UK. The disease is historically associated with poor survival and high symptom burden. Prior to 2022, there was only one NICE approved NHS treatment option and no agreed, long term second line therapy. Clinical trials investigating new therapies often opened in a small number of specialist centres resulting in significant travel for patients. Harrogate District General Hospital is part of the Harrogate & District NHS Foundation Trust (HDFT) and the smallest organisation within the West Yorkshire & Harrogate Cancer Alliance. Method(s): HDFT became a regional recruitment centre for CONFIRM, a double blinded, single agent immunotherapy versus placebo, clinical trial. Initially aimed at the third line setting, involving a 2:1 randomisation, HDFT enrolled patients from across the Yorkshire Region. The team included a Consultant Medical Oncologist, 2 Research Nurses, trial administrator and Regional Mesothelioma UK CNS, helping identify the trial and providing additional support to the research nurses and patients recruited. The team had to employ new strategies to manage the complexities involved. At the time, there was no consensus on alternative NHS treatment options. The window of opportunity to enter was often short making good lines of communication with referring teams essential. Co-ordination of appointments to minimise the burden of travel on this vulnerable group of patients was also vital. Result(s): CONFIRM showed improved overall survival in patients with relapsed malignant pleural and peritoneal mesothelioma [1], possibly influencing change in treatment options when NHS England announced interim drug use approvals during the COVID Pandemic [2]. HDFT recruited 18 patients (5.4% of 322 Nationally). 27 patients were referred and approached, 21 consented, 3 failing screening. Conclusion(s): CONFIRM at HDFT demonstrates that small teams can contribute to national research. References: [1] Fennell et al. (2021) [2][NHS England (2020) Disclosure: No significant relationships.Copyright © 2023 Elsevier B.V.

Referral patterns of metastatic breast cancer patients to Palliative Care team at a Cancer Center in Brazil

Introduction: Breast cancer is the most common cancer in women and the leading cause of cancerrelated death in women worldwide. The high prevalence of physical and psychosocial suffering among breast cancer patients and their families justifies the need for an early interdisciplinary approach by a palliative care team. The effectiveness of early palliative care for patients with advanced cancer has been demonstrated in many studies. Early referral to outpatient palliative care services improves symptom control, reduces suffering and improves quality of end-of-life care. Aim(s): Evaluation of referral patterns of metastatic breast cancer patients to the outpatient embedded palliative care team. Method(s): We retrospectively retrieved data from electronic medical records of patients who were treated at a private community oncology practice in Brazil who died from metastatic breast cancer during the years of 2018 until 2021.We evaluated the patient's follow-up time by the palliative care team (follow-up > 12 weeks or not) and the year of referral to the service (pre-2020 vs 2020 and later) associated to the service referral type: Late referral (more than 8 weeks of metastatic diagnosis) or early referral. Each group was followed-up by cancer physicians and after referral was also followed-up by a palliative care multidisciplinary team who regularly evaluated cancer patients during their treatments at outpatient setting. During COVID-19 pandemic, some patients were evaluated by telemedicine appointments. We performed univariate comparisons analysis by Fisher's Exact Test. p < 0.1 was deemed as statistically significant. Result(s): Of the 211 patients whose data were assessed, 99 patients were referred to Palliative Care team before 2020 and 112 patients after 2020. 13.1% of patients pre-2020 received early palliative care versus 33.9% of patients in the post-2020 referral group, resulting in a 3.37-fold odds of an early palliative care integration after 2020 (OR 3.37, CI95: 1.61 - 7.45;p< 0.001). Overall, 30.4% of longer follow-up patients were an early referral versus 19.3% of the shorter follow-up, resulting in an 82% greater chance (OR 1.82, CI: 0.92-3.63;p< 0.1) of prolonged assistance with early referral. Conclusion(s): In this analysis, early palliative care integration for patients with metastatic breast cancer has increased after 2019 despite the COVID-19 pandemic, leading to prolonged time of accompaniment by the multidisciplinary palliative care team. This suggests that even in the face of this challenging moment, a mature and consolidated service is offered by the palliative care team. Also, according to previous data in literature, prematurely integration show signs of correlation with better quality of life and death, supporting early palliative care for this group of patients. However, further work is needed to examine the effect of this care model in our cohort.

Twitterchats as a means to educate patients with CRC and caregivers and stimulate collaborations

Background: During the COVID-19 pandemic, Twitter has been instrumental in accelerating knowledge dissemination and forging collaborations within the medical community and amongst patient advocates. Tweetchats within Twitter are scheduled conversations on a specific topic. In oncology, Tweetchats have been used by cancer advocates to spread awareness and for patient and caregiver education. A colorectal cancer (CRC) specific tweetchat did not previously exist. This describes the creation, and experiences with a CRC specific tweetchat. Method(s): The #CRCTrialsChat tweetchat was created by a patient advocate for colorectal cancer patients, caregivers and clinicians to meet and exchange clinical trial-related information. Two gastrointestinal (GI) medical oncologists and two radiation oncologists were enlisted as moderators. The topic for each session is chosen by the patient advocate, who creates an outline and divides the content, which is designed to last a one hour session. The idea is to create engaging, technical, but easy to understand content. Each moderator then works on the answers to their assigned section, which is edited to fit tweet character limit. Sessions may also have guest moderators with expertise on a specific topic. Through tweeting, moderators answer specific questions that come up during the session and later. Result(s): To date, we have had four sessions covering the following topics: Clinical trial basics, CRC Updates from ASCO22, ClinicalTrialFinders and BRAF-mutated tumors. The content created has been simple and engaging, the format has functioned smoothly, and the reach of #CRCTrialsChat has been steadily increasing. After the most recent session on BRAF in September 2022, the @CRCTrialsChat has 281 followers, 17K impressions and 14.6K profile visits, a reflection of its excellent content. From a clinician perspective, this is a great format to interact with colleagues, discuss enrolling trials and also become familiar with using Twitter. Conclusion(s): A CRC clinical trial focused tweetchat is an engaging way to deliver trial-related content to an audience of clinicians, patients and caregivers. The current format appears to be an effective way to create and disseminate information. Future sessions will focus on ctDNA, molecular markers such as KRAS and HER2, and rectal cancer trials. Our hope is that #CRCTrialsChat will stimulate continued patient and clinician engagement, increase awareness of clinical trials, enhance trial participation and initiate patient-centric research and collaborations.

Optimizing Precision Medicine Cancer Clinical Trials

With the advent of precision medicine, getting the right treatment for the right patient at the right time has illuminated a variety of challenges and opportunities for innovation in trial design and conduct. Although there is no onesize- fits-all approach to precision medicine, a number of approaches, particularly basket and umbrella trial platforms that permit simultaneous evaluation of multiple treatments in multiple patient cohorts, have evolved to improve trial efficiency. The novel coronavirus pandemic has illuminated the need for, and feasibility of, conducting trials with fewer requirements, greater flexibility, and more decentralization. Through the lens of precision medicine cancer clinical trials, successes and challenges will be discussed to share practical solutions of how to improve evidence generation in the era of precision medicine. Through discussion of precision medicine cancer clinical trials within the United States, this session will provide an overview of how best to optimize these clinical trials. This session comprises the following three main topic areas: matching treatments to patients, including the use of novel patient identification strategies, genomic matching rules, molecular tumor boards (MTBs), decision-support tools, incorporating precision medicine trials into a research portfolio, and how to overcome challenges;accelerating evidence development, including the use of adaptive trial designs, cohort management strategies and data sharing plans;and improving diversity of trial participants and increasing generalizability of study results through expanded eligibility criteria and site selection strategies. This topic will be explored through 90 min of invited talks and a panel discussion with Q&A. Moderator and session chair, Richard L Schilsky, MD, FACP, FSCT, FASCO, will introduce the session and speakers and provide an introduction on the basics of precision oncology. Timothy Cannon, MD, a medical oncologist and clinical trial researcher, will present a case study of two patients with the same alteration and discuss how the care for each differed based on access to a precision medicine cancer clinical trial. Dr. Cannon will also discuss how to implement precision medicine trials within a research portfolio and how to identify patients at a site. Christine Walko, PharmD, BCOP, FCCP, a pharmacist and researcher, will then discuss the basics of matching therapies to genomics, how to use decision support tools, the role of an MTB, and identifying therapeutic options for patients. Edward S Kim, MD, MBA, FACP, FASCO, a medical oncologist, will talk about MTBs from a clinician perspective and precision medicine cancer clinical trials from a community practice perspective. Dr. Kim will also speak about how to extend the research team to create an adequate community research portfolio and about using broader eligibility criteria that might facilitate enrollment of diverse populations. Jane Perlmutter, PhD, MBA, FASCO, a cancer survivor and patient advocate, will discuss what pragmatic trials are, how they increase the opportunity for diversity and generalizability, and patient perspectives regarding pragmatic and precision cancer clinical trials. Susan Halabi, PhD, FASCO, FSCT, a researcher and professor of biostatistics and bioinformatics, will talk about the best ways to design an adaptive trial, especially its role in real-world settings, how these types of designs can be used for efficient signal finding in rare populations, and how these trials can create opportunities for data sharing and collaboration. Pam K Mangat, MS, a research scientist and the Director of Clinical Research for American Society of Clinical Oncology's (ASCO) Targeted Agent and Profiling Utilization Registry (TAPUR) Study, will discuss the operations behind a precision medicine study, advantages and disadvantages of a pragmatic trial, cohort closing and collapsing rules to help with management of large numbers of small cohorts, and contributing knowledge to other trials. The session will conclude with a panel di cussion moderated by session chair, Richard L Schilsky, MD, FACP, FSCT, FASCO, for approximately 10 min, with 5 min for a Q&A session.

Early together: A randomized phase III study of early palliative care in metastatic uveal melanoma (MUM)

Background: Uveal melanoma is a rare cancer. Up to 50% of patients (pts) develop metastasis, mainly hepatic. Overall survival in metastatic pts is 12 months (mo), contrasting with a good overall condition until death. To evaluate the impact of integrating early palliative care on patient needs and self-efficacy, we designed a comparative randomized trial in MUM pts. Methods: 162 pts will be randomized (1:2) between the control and the experimental groups in two French centres (Institut Curie-Paris and Centre Antoine Lacassagne-Nice). In the control group, palliative care is introduced according to international guidelines. In the experimental group, it is added earlier, concomitant to the announcement of metastases by the medical oncologist. The main objective is to assess if early supportive care impacts on patient psychological needs at 6 mo, versus standard of care, based on the SCNS-SF34 questionnaire. Secondary objectives include patient's other needs at 6 and 12 mo, quality of life (QLQC30), progression-free and overall survival, and partners' needs (SCNS-P&C). MUM pts, suitable for a treatment with no curative intent, ECOG PS 0-1, with no physical or biological sign of disease, and capable of filling questionnaires are eligible. Questionnaires are completed by all pts at each oncological visit (baseline, 3, 6, 9 and 12 mo). Supportive care visits take place every 6 weeks if needed and address patient's information needs, disease and treatment understanding, social and psychological status, symptoms, and partners' involvement. Prognostic uncertainty and disease seriousness in the absence of symptom is addressed depending on pts' expressed needs. Medical oncologists and supportive care physicians from both centres attend communication skill training provided by an expert during the study. Analyses: SCNS-SF34 psychological needs scale scores at 6-mo will be compared with a Student's t-test, in an ITT analysis. For 10 points mean score difference expected between groups (within standard deviation of 20 points) and a two-sided type 1 error of 5%, inclusion of 54 pts (control group) and 108 pts (experimental group) provides the study 85% of power. The planned inclusion period is 3 years, pts will be followed for one year, for a total study duration of 4 years. From July 2020 to January 2022, 63 pts have been enrolled in the trial;2 pts declined. Five pts were removed early from the study: one for consent retrieval, 4 for early death due to metastasis. COVID-19 delayed enrollment for 5 months. We plan to complete the study Q4 2023 and to analyze the data Q4 2024.

Characterization of remote second-opinion oncology patients and associated changes in management

Background: The utilization of virtual second opinions in oncology has increased considerably in the last decade, driven by the increased complexity of care and desire for expert opinion, improved technologies in telemedicine, and the acceleration of virtual services due to the Covid-19 pandemic. Therefore, it is important to further understand the patient populations that currently use virtual second opinion programs and to measure their effectiveness. Virtual second opinion programs provide a platform for patients to submit their medical history and questions regarding their condition to remote specialists who then render their opinions on diagnosis and management. Currently there is a paucity of research on the types of patient populations that seek second opinions and the outcomes of these rendered opinions. Here we describe the patient characteristics and changes in management associated with utilization of a virtual second opinion service at an academic medical center. Methods: In this IRB-approved retrospective review, we identified 657 cancer patients that utilized a virtual digital health platform to engage in second opinions at Stanford Healthcare. Patient demographics, cancer staging, site of origin, and prior therapeutic and surgical history were collected. Physician opinions rendered were self-classified into “major change in treatment”, “minor change in treatment”, or “no change in treatment.”. Results: The majority of patients who utilized the virtual second-opinion platform had a diagnosis late-stage cancer (with 77.2% at Stage III or IV). Breast cancer was the most common primary tumor site (24.7% of patients) followed by GI (21.9%) and GU malignancies (14.0%). Patients diagnosed with dermatological (4.4%), head and neck (3.3%), and neurological (3.2%) malignancies were least common. Physicians providing the virtual second-opinion were primarily medical oncologists (67.6%), followed by gynecologists (6.8%), urologists (5.2%), radiation oncologists (5.0%), and surgical oncologists (4.4%). Physicians self-reported that in more than half of cases reviewed (53.8%) a minor or major treatment change was recommended. Conclusions: This study showed that patients access second opinion platforms at late stage of cancer disease progression. With treatment changes recommended for more than half of the cases, virtual second opinion programs can potentially have a significant impact on cancer care. Patient satisfaction and clinical outcomes from virtual second opinion programs is an area of on-going research.

Burnout among early-career medical oncologists: A single-institution experience

Background: Burnout is a psychological syndrome defined by the Maslach Burnout Inventory (MBI) as emotional exhaustion, depersonalization, and a low sense of personal accomplishment. Risk of job-related burnout for early-career medical oncologists can significantly impact career longevity and health outcomes for providers and patients alike. Because little is known about burnout specific to early-career academic oncologists, we sought to characterize the prevalence of burnout and associated factors among Assistant Professors at MD Anderson Cancer Center (MDACC). Methods: For this IRB-approved retrospective study, an electronic survey was developed for Assistant Professors in medical oncology at MDACC. Participants were all involved directly in patient care with at least some clinical effort. Our survey included nine questions validated in the MBI addressing equally the 3 aforementioned domains of burnout. An additional 31 questions were formulated to assess personal and professional factors that may contribute to burnout at our institution (clinical workload, research expectations, communication, COVID, and home-life). Each question was scored on a scale of 1 to 5, with higher scores correlating to higher levels of burnout. Descriptive statistics were used to describe the prevalence of burnout, and logistic regression analyses were performed to identify characteristics associated with burnout. Results: Among 70 (of 86 total) Assistant Professors who responded, mean duration on faculty was 3.1 years (standard deviation +/-1.8). Mean clinical effort was 67% (range, 19-95). Gender identifications were 44% female, 54% male, and 2% non-binary. 54% of respondents reported symptoms of burnout already, including 21% endorsing severe burnout. Severe burnout was more common for solid tumor providers than liquid tumor providers (55% vs 13%, p =.03). Using the MBI, severe emotional exhaustion (25%) was more prevalent (p <.0001) than depersonalization (6%) or lack of personal accomplishment (17%). Sentiments of being “emotionally drained” (20%), fatigue to face another day on the job” (37%), and “becoming more callous” (30%) were especially concerning among early-career faculty. Emotional exhaustion was associated with a feeling of less autonomy over personal decision making (p =.03) and female gender (p =.04). Conclusions: Burnout exists with high prevalence among early-career medical oncologists in this single-institution analysis. Emotional exhaustion was the specific manifestation of burnout in this population. Further validation of these data nationwide is anticipated. Interventions focusing on reducing emotional exhaustion are under development to reduce medical oncology-specific burnout in an academic setting for faculty retention and for deliverance of optimal care to patients with cancer.

Cervical cancer prevention program in Nepal: A comprehensive “train the trainer” approach

Background: Cervical cancer is the leading cause of cancer and cancer-related deaths among women in Nepal, due in part to a lack of access to screening and limited medical providers trained to diagnose and treat women with preinvasive cervical disease. Cancer Care Nepal has partnered with The University of Texas MD Anderson Cancer Center (MD Anderson) and the American Society of Clinical Oncology (ASCO) to implement a 'train the trainer' (TOT) program to teach visual inspection with acetic acid (VIA), colposcopy, cervical biopsy, cryotherapy, thermal ablation, and loop electrosurgical excision procedure (LEEP). Methods: An initial cervical cancer prevention course was held in Kathmandu, Nepal in November 2019, supported by ASCO and with faculty from Civil Service Hospital, Bhaktapur Cancer Hospital, and National Academy of Medical Sciences and MD Anderson. As a continuation of this program, a TOT course was implemented for local specialists from five participating institutions throughout Nepal to learn how to deliver these trainings. Each participating institution then holds their own local course for nurses and doctors in their region. The training is complemented with monthly Project ECHO (Extension for Community Healthcare Outcomes) telementoring videoconferences. Results: The program was launched in November 2021. To date, two TOT training courses (2-day duration) have been held for clinicians from the 5 participating regions. Due to COVID-19 pandemic travel restrictions, didactic lectures were held virtually with MD Anderson and ASCO staff and included epidemiology of cervical cancer, screening guidelines, colposcopy, and treatment of cervical dysplasia. This was followed by hands-on training using simulation models to teach VIA, colposcopy, ablation and LEEP, led by the Nepalese faculty who had participated in the 2019 course. There were 41 participants in total (23 in the first course and 18 in the second course), including 21 gynecologists, 4 gynecologic oncologists, 1 medical oncologist, 1 general practitioner, and 14 nurses. 39 participants (73%) completed both the pre-and post-survey results. 86% of respondents from the first course and 100% of respondents from the second course reported that they intended to change their practice as a result of knowledge gained from the course. In addition, Cancer Care Nepal became a new hub for Project ECHO and held its first session in January 2022, with 20 participants representing two regions. The specialists from each of the 5 participating sites will be holding local courses for doctors and nurses in their respective regions throughout 2022. Conclusions: Our work shows that the TOT strategy can widen the reach of training in cervical cancer prevention in Nepal. Despite travel restrictions during the COVID-19 pandemic, global health training and mentoring can continue, though they require adaptions and use of virtual platforms.

The role of telemedicine in care of patients with cancer: A real-world experience from a Peruvian cancer institute during the COVID-19 pandemic

Background: For patients with cancer, the COVID-19 pandemic has increased morbidity and mortality due to their bigger susceptibility to infection and to the discontinuity of treatment. In this context, telemedicine has become an invaluable tool for cancer care. The purpose of this study is to describe the impact of telemedicine in the care of cancer patients from a Latin American public institution. Methods: Retrospective, descriptive and cross-sectional study of cancer patients who received medical care through telemedicine from the Department of Medical Oncology of the Instituto Nacional de Enfermedades Neoplasicas (INEN) during the COVID-19 pandemic, from March 2020 to February 2021. Data collection was performed in real time by medical oncologists. Impact was mesuared with a comparison between the amount of cancer care during the COVID 19 pandemic vs the previous year. A modified version of the University of Kansas Cancer Center telephone satisfaction survey was conducted. Variables included the process of requesting an appointment by telemedicine, satisfaction with telemedicine service and distribution of drugs. Results: 16 456 telemedicine visits were carried out in one year time, 96.1% were conducted by telephone and only 3.9% used a video communication platform. 73% of patients were female and 62% were in the age group from 31 to 60 years old. 43% corresponded to solid tumors where breast cancer was the most frequent diagnosis. Patients in active treatment represented 70% (n = 11587), with 64% of patients being treated with curative intent and 36% within the palliative setting. Regarding the result of telemedicine visits, 62% (n = 10,281) had a medical prescription (40% corresponded to hormonal therapy;and 19%, to intravenous or subcutaneous systemic treatment). Overall, 8% (n = 56) of cases required an in-person visit. In the annual comparative analysis (against in-person visits during the previous year), the gap was 23% (60%, 20%, 8% and 13% during the first, second, third and fourth quarters, respectively). According to the type of medical care, telemedicine accounted for the 27.6% of the total medical care employed during in the year. The maximum level of usage was in May 2020 with 52% and in February 2021 with 48%, coinciding with the first and second waves of COVID in Peru. The satisfaction survey was applied to 5765 randomly chosen patients from July to October 2020. The mean scores for the 3 variables studied were: 4.6 / 5 points for the process of requesting an appointment, 4.58 / 5 points for telemedicine service and 4.33 / 5 points for the distribution of medicines and orders. Conclusions: Telemedicine is key to guarantee the continuity of care for cancer patients with an adequate level of satisfaction. If the Telemedicine service had not been implemented, the number of medical consultations would have dropped to 40% in comparison to the previous year.

Oncology: navigating the COVID-19 Pandemic and Steer the Course

Medical oncologists are steering a difficult course during the COVID-19 pandemic between three opposing forces: revisiting optimal standards of cancer care, facing constantly evolving shortages as some resources are being redirected, and acknowledging the paradoxical need to keep patients away from the health care facility. This article compiles recommendations from cancer societies and expert opinions to provide guidance and practical solutions for the oncology clinic. We propose that optimal standards of care be upheld, and short-term safety concerns due to exposure to SARS-CoV-2 be weighed against a long-term compromise in cancer prognosis when deciding on adjustments in cancer care. Proper mitigation strategies in the clinic and use of less resource-heavy but equivalent treatment alternatives often allow optimal cancer care. The magnitude of benefit of cancer treatments needs to be systematically considered.

Impact of the COVID-19 pandemic on primary care access for patients with gastrointestinal malignancies

Background: Primary care physicians (PCPs) provide essential support for cancer patients. Both primary and cancer care have been affected by the COVID-19 pandemic. In the US, cancer related encounters and screening decreased over 40% and 80% respectively in January to April 2020 compared to 2019 (London et al JCO Clin Cancer Inform 2020). However, the impact of the pandemic on primary care access for cancer patients remains unclear. Methods: This was a population-based, retrospective cohort study using administrative healthcare databases held at ICES in Ontario, Canada. Patients with a new gastrointestinal (GI) malignancy diagnosed within the year prior to the pandemic, between July 1 and Sept 30, 2019 (COVID-19 cohort), were compared to patients diagnosed in years unaffected by the pandemic, between July 1 - Sept 30, 2018 and July 1 - Sept 30, 2017 (pre-pandemic cohort). Both groups were followed for 12 months after initial cancer diagnosis. In the COVID-19 cohort, this allowed for at least 4 months of follow-up data occurring during the pandemic. The primary outcome was number of in-person and telemedicine visits with a PCP. Secondary outcomes were number of in-person and telemedicine visits with a medical oncologist, number of emergency department (ED) visits, and number of unplanned hospitalizations. Outcomes, reported as number of visits per person-year, were compared between the COVID-19 and pre-pandemic cohorts. Results: 2833 individuals diagnosed with a new GI malignancy in the COVID-19 cohort were compared to 5698 individuals in the pre-pandemic cohort. The number of in-person visits to PCPs per person-year significantly decreased from 7.13 [95% CI 7.05 - 7.20] in the pre-pandemic cohort to 4.75 [4.66 - 4.83] in the COVID-19 cohort. Telemedicine visits to PCPs increased from 0.06 [0.05 - 0.07] to 2.07 [2.01 - 2.12]. Combined in-person and telemedicine visits to PCPs decreased from 7.19 [7.11 - 7.26] to 6.82 [6.71 - 6.92]. In-person visits to medical oncologists decreased from 3.73 [3.68 - 3.79] to 2.87 [2.80 - 2.94], and telemedicine visits increased from 0.10 [0.10 - 0.11] to 0.95 [0.91 - 0.99]. Combined in-person and telemedicine visits to medical oncologists remained stable (3.84 [3.78 - 3.89] vs. 3.82 [3.74 - 3.90]). The number of ED visits per person-year decreased from 1.04 [1.01 - 1.07] in the pre-pandemic cohort to 0.93 [0.89 - 0.97] in the COVID-19 cohort. Unplanned hospitalizations did not show a significant change (0.56 [0.54 - 0.58] vs. 0.53 [0.50 - 0.56]). Conclusions: PCP visits for patients with newly diagnosed GI malignancies overall decreased during the pandemic, with a dramatic shift from in-person to telemedicine visits. Visits to medical oncologists also shifted from in-person to telemedicine, but the overall combined visits remained the same. While the number of ED visits decreased, the shift in ambulatory practices did not seem to impact the number of unplanned hospitalizations.

A Prospective Survey to Understand the Preferences and Perspectives of Patients with Hematological Malignancies in a Tertiary Cancer Care Setting in India (CANCOV SURVEY)

Introduction: From its emergence in China on 31 st December 2019, the COVID-19 infection has spread to affect more than 185 million people across the world with approximately 4 million deaths. A systematic review and meta-analysis which included various studies across the world showed that the risk of mortality in cancer patients with COVID-19 infection is 21.1% and the risk of severe disease and mortality due to COVID-19 appears to be higher in patients with hematological malignancies likely due to immunosuppression induced by both the underlying disease and intensive treatment. The experts suggest individualization of treatment based on the prevalence of COVID-19 infection, available infrastructure and social support. Guidelines are driven by opinion from a clinician's perspective. There is a need to evaluate a patient's preference in the present situation when they are faced with the dual problem of cancer and a potentially life-threatening infection. Purpose of study: To document the patients preferences and perspectives using a structured questionnaire when they are on cancer-directed chemo/immune or targeted therapy or treatment naive in our hospital during the current COVID-19 pandemic. Objectives: The primary objective was to determine the proportion of patients who opt to continue on full intensity therapy. The secondary objectives were - to study the factors that lead to treatment discontinuation or dose reduction, to study the level of perceived risk at which patients opt for treatment discontinuation or dose reduction, to study the preferences for treatment continuation in different scenarios (COVID-19 adverse event and different relapse risk) (table 2 and 3) and to understand the difference in preferences for therapy between patients and oncologists/hematologists. Material and methods: This prospective survey was conducted between July 10, 2020 and October 16, 2020. A preconceived standard questionnaire was administered to each patient along with their caregivers (Figure 1). Along with this, we subjected the survey questionnaire separately to the set of medical oncologists/hematologists who were not a part of the patient's treating team and the responses were recorded and studied. Sample Size Assuming that 50% of the patients will continue the full intensity therapy, a sample of 203 will produce a two-sided 90% confidence interval with a precision of 12%. Considering a non-response proportion of 5%, a sample size of 213 was required to achieve primary objective. Results: A total of 200 patients were enrolled in this study with male to female ratio of 1.9:1 and a median age of 42 years (15- 78). Most common hematological malignancy in our study is acute leukemia (29%) followed by CML (23%), NHL (22%), multiple myeloma (16%). Baseline details are represented in Table 1. In this study, 47% patients were willing to receive full intensity chemotherapy (95% CI: 40.4 -54.7). Nature of disease (slow growing vs fast growing) and the intent of treatment (cure vs control of disease) were shown to significantly affect preferences of patients. There was no impact of various socio-economic or logistic factors in their preference for therapy. As high as 50% of the patients were willing to accept only 5% risk of covid 19 related complications to receive full intensity therapy. The acceptable risk of relapse over and above the baseline to receive lesser intensity chemotherapy was 5% for almost 1/3 rd of the patients. If covid related complications are mild, 40% of patients are ready to accept only 1 % risk of relapse to receive lesser intensity chemotherapy. As the risk of covid related complications increases from mild to severe, almost 50% of the patients are ready to accept ≥ 20% risk of relapse to receive lesser intensity chemotherapy (table 4). There was a statistically significant disagreement between physician and patient responses at 5%, 20%, 30% and 40% risk of covid related complications to receive full intensity therapy. When we consider the risk of relapse if lesser intensity therapy is opted, patient and physician responses are in good agreement at 1, 5, 10 and 20% risk levels. Conclusion: Almost 50% of patients are willing to opt for reduced intensity therapy because of fear of covid related complications and there is significant disagreement between patient and physician perspectives in certain clinical contexts. [Formula presented] Disclosures: No relevant conflicts of interest to declare.

Classical Hodgkin Lymphoma;Real-World Observations from Physicians, Patients, and Caregivers on the Disease and Its Treatment (CONNECT): Observations of Physicians on Treatment and Interim PET-Adapted Regimens

Background Current NCCN guidelines recommend 1 of 3 first-line (1L) regimens for stage III or IV classical Hodgkin lymphoma (cHL): ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine), A+AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine), or escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone);preferred regimens vary by region (e.g., North America vs Europe). The NCCN recommends positron emission tomography/computerized tomography (PET/CT) imaging after cycle 2 (interim PET2) to guide ABVD escalation or de-escalation. We surveyed physicians on their cHL treatment decision-making process and how PET/CT scan access, reimbursement, and comprehension influence their choices as part of CONNECT, the first real-world survey of physicians, patients, and caregivers in cHL. Methods Medical oncologists, hematologist/oncologists, or hematologists who treat cHL were invited to participate in an Institutional Review Board-approved, 30-minute online anonymous survey. Eligible participants had ≥2 years of practice experience in the United States (US) and treated ≥1 adult (aged ≥18 years) with stage III or IV cHL and ≥1 adult with cHL in the 1L setting within the prior 12 months. Surveys were completed from October 19, 2020-November 16, 2020. Results Of 301 participating physicians, 80% were hematologist/oncologists with a median practice duration of 15 years;62% practiced in community and 38% in academic settings. Participants were located in the US (South, 34%;Northeast, 26%;West, 21%;Midwest, 20%) and spent 90% of their professional time in direct patient care. In the preceding 12 months, participants treated a median (interquartile range) of 16 (7-40) patients with active cHL (stage III [median], 4;stage IV, 5) and 15 (8-40) cHL survivors. When treating cHL, 88% of participants reported giving NCCN guidelines somewhat/significant consideration. Overall, 94% of participants (n=284) reported using a PET/CT combined scan to diagnose/stage cHL, in line with current guideline recommendations. Of these participants, 97% reported typically getting an interim PET/CT scan for stage III or IV cHL with 65% typically getting the scan after cycle 2 (Figure A). Participants reported both escalating and de-escalating treatment based on interim PET/CT results (Figure B) with 61% making decisions after cycle 2. Of participants using a PET/CT scan, 42% reported receiving both a Deauville score and a standardized uptake value (SUV;Figure C) with 62% of participants noting that the Deauville score was the primary system used for reviewing PET/CT results (Figure D). However, 19% of participants reported challenges interpreting PET/CT results. Among participants using a Deauville score (n=209), consensus was limited on what defined a positive scan (≥3, 44%;≥4, 37%). Challenges obtaining PET/CT scans were reported by 16% of participants using PET/CT scans. However, despite not reporting challenges 55% of participants on average were unable to obtain a PET/CT scan 20% of the time. Of participants using PET/CT scans, 86% reported typically receiving results within 2 business days and 14% within 3-5 business days. Twenty-one percent of participants reported that delays in PET/CT results affected their ability to use a PET-adaptive approach. Forty-nine percent of those using PET/CT scans reported increased difficulty in PET/CT access for stage III or IV cHL due to lack of insurance coverage. In absence of a PET/CT scan, 36% of participants reported using an interim biopsy and 63% an interim CT scan to inform treatment choices. Among all participants, 36% reported increased difficulty in getting patients with cHL access to PET/CT scans due to COVID-19. Conclusions Although participants consider NCCN guidelines when treating cHL, interim PET scans are not universally obtained after cycle 2 for stage III or IV cHL, with 65% of participants who use PET/CT scans obtaining an interim PET scan after cycle 2 for stage III or IV cHL. When PET/CT scans are obtained, Deau ille scores are commonly provided;however, there is variability in what is termed a positive or negative Deauville score. Challenges in obtaining PET/CT scans, with increased difficulty during COVID-19, were reported. Also, there are other barriers, such as lack of insurance, that may prohibit the optimal adherence to guidelines on interim PET/CT utilization. [Formula presented] Disclosures: Parsons: SeaGen: Consultancy. Yu: Seagen, Inc: Current Employment, Current equity holder in publicly-traded company. Liu: Seagen, Inc: Current Employment, Current equity holder in publicly-traded company. Kumar: Seagen, Inc: Consultancy. Fanale: Seagen, Inc: Current Employment, Current equity holder in publicly-traded company. Flora: Seagen, Inc: Research Funding.

Preliminary results of an Innovative educational method on lifestyles for cancer prevention in secondary school

Background: Teenagers are at age when they start making decisive choices. Without adequate information on correct lifestyles they run health risks, particularly with regard to future cancers. However, they have curiosity, interest and strong desire to learn in medical issues. This trial was developed to promote knowledge of cancer development and prevention program by informing students about correct lifestyles by teaching, playing an educational game, involving them interactively both in presence and on digital platform. Methods: Since September 2019, medical oncologists with teachers from 2 first grade classes in two schools started a shared teaching path. Educational meetings were held for class presenting slides on neoplasms development and wrong lifestyles causing their onset. Slides were illustrated with comics. Students built with comics some of 90 boxes of a pathway similar to game of goose, set in their country in Middle Age. Players were two classes competing throwing dices to reach box number 90,equal to the years of cancer-free life expectancy conquered with correct lifestyle. Each box corresponded to a card like “tarot cards”, prepared to slow down the path, if it represented a wrong conduct or event, and to speed up otherwise. During the second year of class, lessons illustrated H&N with gastrointestinal cancers. Impact of course was evaluated through a questionnaire prepared by a dental hygienist and proposing a healthy snack at least once a week at school. Results: We performed 40 educational meetings of 30 minutes, followed by 20 minutes of play. Six medical oncologists, 1 psychologist, 1 dietician, 1 dental hygienist, 4 teachers actively contributed;4 classes joined the initiative, 92 teenagers participated in 15 in-presence meetings and 25 on online platform during COVID19. All contributed to build and enjoyed the game. They wanted to start following course directions by bringing to school a snack proposed by dietician once a week. Ten of them offered to participate in the peer education course in other classes. Fifty-two questionnaires were completed at the beginning of the course and re-proposed at the conclusion. Students answered: 52/52(100%) knew tumors of oral cavity, 37/52(71%) knew color of precancerous lesions, 42/52(79%) knew risk factors, 48/52(92%) replied they would never start to smoke. Conclusions: Teaching teenagers correct lifestyle preventing cancer by innovative method playing an educational game is achievable and can give results.

Modena experience of first year of Diagnostic and Therapeutic Care pathways of utero and cervix cancer

Background: Gynecological cancers of the uterus and cervix are common malignancies in women. The correct management of these tumors involves many figures. Material and methods: Therefore, to respond to these multidisciplinary needs in June 2019 in Azienda Ospedialiero-Universitaria of Modena was born a Diagnostic and Therapeutic Care Pathways (DTCP) with gynaecologists, radiotherapists, medical oncologists, radiologists, nuclear medical doctors, pathologists, anaesthesiologists, a nurse Case Manager and a patients' association representative. A molecular biologist, endocrinologists and nutritionists have already enriched the team after the first year of activity. The group performs weekly collegial discussions of clinical cases and cohort visits, continued in the COVID era. Results: The new diagnoses in the first year of activity were 53 endometrial cancers (EC) and 24 cervical ones (CC). The median age at diagnosis was 51 years between EC patients and 70 years in CC. 87% of EC were endometrioid subtypes, while 65% CC were squamous cell ones. 70% EC patients (pts) were stage (st) I (52% IA and 48% IB), 5,5% st II, 9,4% st III and 11,3% st IV. Immunohistochemical analysis for estrogen and progesterone receptor, p53 and mismatch repair (MMR) proteins were performed on 20 EC. All tumours tested are p53 negative. We found 3 pts who had MMR deficiency, none of them diagnosed with Lynch syndrome at the subsequent genetic counselling. After surgery, 66% pts in st I underwent observation and 34% made radiotherapy (RT). Among st II pts, 1 patient performed RT, one other platinum- based chemotherapy (pCT) and the third did not perform any adjuvant treatment for ECOG. All except one st III pts (67%) underwent pCT with RT. Among st IV one received surgery, pCT and palliative RT, the others (83%) made pCT. Most CC were diagnosed in early st. 9 pts underwent upfront surgery, followed in 2 cases with RT and in 3 with RT and pCT. One patient received neoadjuvant chemo-RT. Radical RT with weekly cisplatin was performed in 9 pts, other 4 pts made RT alone due to advanced age and/or ECOG. One patient started observation for age, ECOG and absence of symptoms. Conclusions: In our experience, DTCP allows the optimization of the diagnostic and therapeutic strategy in EC and CC pts, especially in most complex cases.

Cancer treatment at home, the project “HER Home”

Background: In December 2020, thanks to the collaboration among the U.O.C. Oncologia, Roche Italia, and our Association, was set up a project for the domiciliation of antiblastic treatment titled “HER Home”, at the ASP 7 Ragusa in Sicily. The project involving patients with HER2 positive breast cancer concerns treatment at home with subcutaneous antiblastic therapy. Aims include the enhancement of patients' quality of life reducing the need for travel and visits to the hospital and making them more comfortable to receive the therapy. During the current pandemic situation, this means a greater safety for patients who are fragile subjects and may be more exposed to the risk of infection;and, also, the improvement in organizational efficiency. Materials and methods: Admission of patients takes place according to the evaluation of the Medical Oncologists who establish the schedule of treatments and prescribe the drug. The drug is prepared and dispensed by the hospital pharmacy. Our Association, already active for home palliative care, deals with the transport of the drug from the hospital pharmacy to the patients' home, where our Doctor, after a clinical evaluation of the patient, administers the drug. The project foresees the participation of 20 women and about 240 administrations. Quality of life will be assessed at baseline and every 4 administrations, using patient's self-reported outcome measures (PROMs). Results: To date, have been assisted 4 patients and carried out 13 administrations. No adverse events have occurred and no organizational criticalities were recorded. All administrations were performed safely, within the foreseen times and methods. Conclusions: The project has allowed the patients involved to have more free time since there are no needs for transfers and waiting times in the Day Hospital and so allowing them don't change the course of their daily routine;we, also, expect a measurable improvement in the quality of life. For the regional health system, this project achieved a simplification of the pathways and a reduction in the crowding of the Hospital, both essential during the COVID-19 pandemic. From the economic point of view, the project reduced costs and resources applied for about 30% less. The potential shown by this preliminary project could be fully realized in the evaluation of the possibility of home administration of other antiblastic therapies favoring above all the patients who lead a very active working and family life.

Access to early phase clinical trials during the Covid-19 pandemic

Background: The Covid-19 pandemic has radically changed healthcare organizations. Here, we describe the attitude among Italian physicians toward referring patients to early-phase clinical trials during the pandemic. Methods: We analyzed the responses recorded in the first 72 hours from the beginning of the survey. A 20-question web survey was sent to all the associates of the Italian Association of Medical Oncology. Results: Ninety-five physicians completed the survey;87 (96%) were medical oncologists. Table 1 summarizes participants' characteristics. Overall, 37% of the respondents work in an early clinical trial unit. The vast majority of interviewees (74%) already used to refer patients to early clinical trials in the pre- COVID era. Among these, about 30% sent fewer patients during the pandemic particularly due to logistical issues. Interestingly, 25 (26%) never referred patients because of ineffective networking among institutions. It will take more than 12 months to return to pre-pandemic attitude according to half of the physicians. Most of the respondents affirm that one possible tool to facilitate the recovery is: fostering the clinical research network, favouring alliances between referral and satellite centers, and strengthening telemedicine. More than 70% of participants believe that the COVID-19 pandemic will have an impact on the development of new molecules in the coming years both due to a decrease in the number of open studies and to a diversion of funds towards Covid-19 research. Conclusions: In this analysis, we intended to offer an early snapshot of the Covid -19 effects on early phase trials in Italy. One-third of the participants had to decrease the number of referred patients due to the difficulties of a system exposed to unprecedented stress. Furthermore, the challenges of the last year will have repercussions on drug development in the coming years for the majority of interviewees.