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Background: The interaction between checkpoint inhibitors (CPI) and Sars-COV-2 vaccines has been understudied. One potential complication in pts receiving CPI is immune-mediated adverse events (irAEs) resulting from overactivation of the immune system. It is unknown whether concurrent CPI and Sars-COV-2 vaccine administration increases the risk of irAEs. This retrospective study examined the incidence of severe irAEs in cancer patients receiving CPI therapy at the time of vaccination against Sars CoV-2. Method(s): Following IRB approval, pts with solid tumors who received any approved CPI since FDA authorization of the COVID-19 vaccine in December 2020 were identified via institutional electronic health record. Pts who received one or more doses of an authorized vaccine within 60 days of CPI treatment were included. The primary endpoint was to evaluate the incidence of severe irAE (one or more of the following: grade 3 AE or above, multi-system involvement, need for hospitalization). Secondary endpoints included time between CPI and vaccination, need for immunosuppressive therapy, and rate of discontinuation of CPI due to irAE. Data was analyzed using descriptive statistics. Result(s): 290 pts with bladder, head/neck, liver, skin (melanoma, SCC), renal, and gynecologic cancer were included in analysis. The median age was 67 years (IQR: 59.0-74.0) and 66% pts were male. At the time of vaccination, 201 pts (69.3%) received CPI monotherapy, 53 pts (18.3%) received combination (combo) CPI therapy, and 36 pts (12.4%) received other therapies (chemo, TKIs, etc.) with CPI. The vaccine manufacturer was Pfizer Bio-N-Tech in 162 pts (55.9%), Moderna in 122 pts (42.1%), and Johnson and Johnson in 6 pts (2.1%). The number of vaccinations received was >/= 3 in 214 pts, 2 in 64 pts, and 1 in 11 pts. 30 pts (11.5%) experienced severe irAEs following vaccination. The rate of severe irAEs was 10.3% (30/290) in the total population [6% (12/201) with CPI monotherapy, 19% (10/53) with combo CPI, and 22% (8/36) in the combo CPI-other group]. Severe irAEs occurred after the first vaccine dose in 5 pts (16.7%), second dose in 16 pts (53.3%), and third dose in 9 pts (30%) pts. The median time between CPI treatment and vaccination in pts who experienced irAE was15.5 days (IQR: 10.2-23.0). Hospitalization was required for 19 patients (63.3%). 24 pts (80.0%) required immunosuppressive therapy with a median therapy duration of 98.5 days (IQR 40.2-173.0). 16 pts (53.5%) discontinued CPI therapy following severe irAEs Conclusion(s): In this retrospective study, we observed a 10.3% rate of severe irAE in cancer pts receiving CPI concurrently with COVID-19 vaccines. Further investigation in pts with additional cancer types is warranted to help determine best practice guidelines for COVID-19 vaccination in cancer patients receiving CPI.
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Introduction: Incidental elevations in Carbohydrate Antigen 19-9 (CA19-9) can trigger extensive medical evaluations for malignancy. Though classically associated with pancreatic cancer, CA19-9 is a nonspecific manifestation of multiple benign and malignant disease processes. Case Description/Methods: An asymptomatic, healthy 50-year-old female presented to primary care for an elevated CA19-9 level obtained for pancreatic cancer screening in Asia in 2019. Her evaluation in 2019 included abdominopelvic CT and magnetic retrograde cholangiopancreatography, which were normal. She was offered endoscopic ultrasonography to further evaluate pancreaticobiliary etiologies but was lost to follow-up amid the COVID-19 pandemic. She returned to the US in 2021, and basic laboratory testing and routine cervical cancer screening were performed. She was referred to Gastroenterology (GI) for further evaluation. Cervical cytology revealed atypical endometrial cells, and endometrial biopsy by gynecology was concerning for gastric-type endocervical adenocarcinoma. Transvaginal ultrasound revealed a thickened endometrial stripe, and pan CT revealed duodenal thickening, for which GI performed bidirectional endoscopy without significant abnormalities and no pancreatic or metastatic disease. Repeat CA19- 9 increased. She was referred to gynecologic oncology, where cervical biopsy and pelvic MRI confirmed an endocervical mass. She was diagnosed with Stage IIB gastric-type endocervical adenocarcinoma and underwent hysterectomy and left salpingectomy with adjuvant chemoradiation. Discussion(s): CA19-9 is synthesized in multiple organ systems. Elevations in asymptomatic patients are rarely predictive of pancreatic cancer but may expose patients to unnecessary testing and inadvertent harms without identifying malignancy. Thus, CA19-9 is not recommended for pancreatic cancer screening. Incidental elevations do warrant repeat testing. Benign processes will yield stable or decreasing levels, while rising levels suggest progressive or malignant processes. If concern for pancreatic malignancy is low, a reasonable investigation includes chest X-ray or CT, metabolic studies, hemoglobin A1c, liver and thyroid function panels, abdominopelvic CT or gynecologic cancer evaluation, and any other age-indicated cancer screening. In this case, prior imaging studies suggested low concern for pancreatic cancer. Her subsequent evaluation aligned with this suggested work-up and revealed gynecologic cancer as the ultimate etiology for her elevated CA19-9.
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Case Report: West Nile Virus (WNV) was first isolated from the West Nile district of Northern Uganda in 1937, but was first detected in the United States well over half a century later in 1999. The arthropod-borne virus has since persisted, with 2,401 cases reported to the CDC on average annually. The infection typically causes a nonspecific acute systemic febrile illness with occasional gastrointestinal and skin manifestations;however, in less than 1% of infected patients, it can cause severe and potentially fatal neuroinvasive disease, presenting as meningitis, encephalitis or acute flaccid paralysis. Immunosuppression is one of the risk factors associated with the development of neuroinvasive disease, and chemotherapy thus places patients at risk. Uterine leiomyosarcoma is a rare gynecological malignancy. Palliative chemotherapy is common in late stage disease, but may predispose patients to conditions that present as neutropenic fever, leading to a diagnostic conundrum. This is the first case report where patient with neutropenic fever was found to have West Nile neuroinvasive disease, so it is important to include West Nile disease in the differential diagnosis. Case Description: This is a case of a 45-year-old female with history of diabetes, hypothyroidism and recently diagnosed uterine leiomyosarcoma status post tumor debulking with metastasis on palliative chemotherapy with gemcitabine that presented to the Emergency Room for a fever of 103.8 degrees Fahrenheit. Given the history of advanced leiomyosarcoma, the patient was admitted for neutropenic fever with an absolute neutrophil count of 1000. During the hospitalization, the patient became acutely altered and confused. CT head without contrast and lumbar puncture were performed. Due to clinical suspicion of meningitis, she was started on broad spectrum antibiotics. Lumbar puncture revealed leukocytosis of 168 with lymphocytic predominance and elevated protein level in the cerebrospinal fluid, therefore acyclovir was started due to high suspicion of viral meningoencephalitis. An EEG showed severe diffuse encephalopathy as the patient was persistently altered. A broad workup of infectious etiology was considered including HIV, syphilis, hepatitis A, B, C, COVID-19, adenovirus, pertussis, influenza, WNV, HHV6, coccidiomycosis, aspergillus, and tuberculosis. Patient was ultimately found to have elevated IgM and IgG titers for West Nile Virus. Discussion(s): It is important to consider a broad spectrum of diagnosis in patients with metastatic carcinoma presenting with new-onset fever and acute encephalopathy. This includes working up for other causes of altered mental status including cardiac, neurologic, psychiatric, endocrine, metabolic, electrolyte, drug, and infectious etiology. While uncommon in the healthy population, WNV encephalitis should be on the radar for any patient who is immunocompromised or on immunosuppressive therapy, especially those who present with a neutropenic fever.
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Objectives: To identify the unmet, actionable social needs of gynecologic oncology patients using a self-administered social needs assessment tool and quantify the interventions subsequently provided to our patients. Method(s): This is a study of data collected in an ongoing performance improvement initiative in a gynecologic oncology clinic at a safety net hospital and was determined to be exempt from review by the institutional IRB. Eligible patients completed the social needs screening tool from October 2021 to March 2022. The following social needs domains were assessed: food insecurity, utility insecurity, housing insecurity, transportation insecurity, need for childcare, exposure to violence, lack of companionship, difficulty reading, or difficulty accessing medical care due to fear of losing job. Patients were asked if they desired to speak with a social worker and if any needs were urgent. Data from the screening tool was collected and supplemented by data from the EMR. Univariate descriptive statistics were used to report the patient demographic information, prevalence of social needs, and referral rates for social needs identified. Result(s): There were 475 patients seen in the gynecologic oncology clinic since October 2021. 286 (60%) patients completed the screening tool. 139 (49%) screened positive for at least 1 social need;of those 98 (70%) were Hispanic with a median age of 56 years. 27 (6%) patients were receiving treatment for a gynecologic malignancy, of whom 19 (70%) had at least 1 social need. 25 (92%) patients were insured through Medi-Cal. 12 (44%) patients were being treated for endometrial cancer, followed by ovarian (7, 26%) and cervical (4, 15%). The social needs identified in all patients and in patients actively receiving cancer treatment are summarized in Fig. 1. Patients reporting lack of companionship were referred to mental health or cancer support groups through the American Cancer Society or the Los Angeles County Department of Public Health. Those needing transportation or utility services were linked with services available through their insurance or LA County, ride share vouchers, low-income energy assistance programs, COVID rent/mortgage relief programs. Patients with food and housing insecurity were assisted in applying for public housing or food stamps;local food banks were provided. Patients were assisted with applying for disability insurance as needed. To date, all actively treated patients reporting lack of companionship, need for transportation, avoiding medical care for fear of losing their job, and utility insecurity were provided resources;80% received resources for food insecurity. Conclusion(s): Universal screening for social needs in gynecologic cancer patients identifies a high rate of unmet needs within a safety net hospital. Cancer care navigators can successfully provide these patients community-based resources tailored to their individual social needs. Our next steps will be to determine if and how these resources impact our patients' experiences and treatment outcomes.[Formula presented]Copyright © 2022 Elsevier Inc.
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Background: On March 2020, the federal government of Kosovo declared a nationwide lockdown due to the COVID-19 pandemic until May 2020. Since the lockdown, examinations and routine checkups have been restricted. This resulted in a severe decline in patient referrals to the hospitals. We want to assess the impact of the COVID-19 pandemic on the rate of newly diagnosed gynecological cancers. Method(s): The data are taken from our patient database. Data from 752 patients from the only cancer centre in Kosovo with newly diagnosed gynaecological cancer between 2019, 2020 and 2021 were collected. Incidence, age group, stages of diagnosis and geographical distribution were compared between the time before and after the COVID-19 outbreak. Result(s): Our results showed a slight decline in newly diagnosed cancers in 2020 as compared with 2019 and 2021: -17 % in 2020 versus an increase of 18% in 2019. We expected to have a major increase in 2021 but data shows that it was a slight increase of 17%. As we not expected after the COVID-19 pandemic we have a strong decline of metastatic new cases of 39% in 2021 compared to 2020 and a 60% decline in 2020 compared to 2019. The results show a slight increase of 13 % in the early stages from 2020 to 2021 and the same rates come up from 2019 to 2020. In all three years in a row the dominant type of cancer according to localization is corpus uteri then cervix uteri and ovarian cancer with respectively 39%, 26%, and 33% in 2019, 36%, 33%, and 29% in 2020 and the last, 40%, 26% and 32% in 2021. The groupages have a slight shift from 45-49 years old the peak of new cases in 2021. Conclusion(s): The lockdown led to a slight decrease in the number of newly diagnosed cases. The decreased accessibility of the medical services has not led to significant higher number of metastatic new diagnosed cases, on contrary lower metastatic cases and higher number of early cases and slight increase on advanced cases were presented in 2021. The impact on incidence were not significantly higher in 2021 despite the lockdown. Therefore, new strategies to manage early cancer detection are needed to optimize cancer care in a time of pandemic in the future. Effective, appropriate and affordable cancer prevention and control strategies are urgently needed in Kosovo for gynaecological cancer especially cervical cancer. Legal entity responsible for the study: The authors. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Copyright © 2023 European Society for Medical Oncology
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Background: It has been almost three years since the COVID-19 outbreak, yet evidence of its impact on the cancer care landscape remains scant. The present single-center study examines patterns in gynecological cancer diagnoses before and during the pandemic. Method(s): All female patients diagnosed in our academic hospital with gynecological cancer, between January 2017 and December 2020, were retrospectively identified. Pre-defined subgroup analyses were performed in patients who had been newly diagnosed during 2020 and in the pre-pandemic 3-year period. The study was approved by the Institutional Ethical Committee and was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice. Result(s): In total, 1,193 women were included in this case-control study;1,001 (83.91%) were identified in the pre-pandemic period as a control, while 192 (16.09%) cases were allocated in the pandemic group. The two cohorts were similar regarding demographic and clinical characteristics. For the pre-pandemic period, the mean yearly number of patients with newly identified cancer was highest for endometrial (149;44.61%), followed by ovarian (92;27.5%) carcinomas. During the first year of the pandemic, the number of new diagnoses significantly decreased by 42.5% (from 334 to 192) for all types of malignancies combined (one sample t-test p-value= 0.014). Declines ranged from 36.96% to 49% for ovarian and endometrial cancer, respectively. Conclusion(s): This is the first study to appraise a timely snapshot of the effect of COVID-19 on newly diagnosed gynecological tumors in a European Society of Gynaecological Oncology (ESGO)-certified center in Greece, demonstrating an alarmingly sharp decline in the number of new cases during the pandemic. It is of utmost importance the gynecologic oncologists to ensure the continuum of care for their patients. [Formula presented] Legal entity responsible for the study: The authors. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Copyright © 2023 European Society for Medical Oncology
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Introduction: Patients presenting for radiation therapy (RT) at a single institution were analysed regarding treatment delays and disparities during the coronavirus disease 2019 (COVID-19) pandemic. Methods: The study was conducted at an urban multidisciplinary cancer centre. In April 2020, the institution's radiation oncology department implemented universal COVID-19 screening protocols prior to RT initiation. COVID-19 testing information on cancer patients planned for RT from 04/2020 to 01/2021 was reviewed. Trends of other lifetime COVID-19 testing and overall care delays were also studied. Results: Two hundred and fifty-four consecutive cancer patients received RT. Median age was 63 years (range 24-94) and 57·9% (n = 147) were Black. Most (n = 107, 42·1%) patients were insured through Medicare. 42·9% (n = 109) presented with stage IV disease. One (0·4%) asymptomatic patient tested positive for COVID-19 pre-RT. The cohort received 975 lifetime COVID-19 tests (median 3 per patient, range 1-18) resulting in 29 positive test results across 21 patients. Sixteen patients had RT delays. Identifying as Hispanic/Latino was associated with testing positive for COVID-19 (p = 0·015) and RT delay (p = 0·029). Conclusion: Most patients with cancer planned for RT tested negative for COVID-19 and proceeded to RT without delay. However, increased testing burden, delays in diagnostic workup and testing positive for COVID-19 may intensify disparities affecting this urban patient population. © The Author(s), 2022. Published by Cambridge University Press.
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Background At least 80% of new cervical cancer cases and deaths occur in low- and middleincome countries. Vietnam is a middle-income country where cervical cancer is the second most common and the deadliest gynecologic cancer. Cervical cancer incidence in Southern Vietnam has been shown to be 1.5-4 times higher than that in Northern Vietnam. However, less than 10% of Southern Vietnamese women have received the Human papillomavirus (HPV) vaccine and only 50% have ever been screened for cervical cancer. No study has examined the perceptions toward cervical cancer prevention and screening in Southern Vietnamese women. Hence, this study aimed to explore cervical cancer awareness, barriers to screening, and acceptability of HPV self-sampling for cervical cancer screening among rural and urban women in Southern Vietnam. Methods In October-November 2021, three focus groups were conducted in the rural district of Can Gio (n=21 participants) and three were conducted in the urban District Four (n=23 participants) in Ho Chi Minh City, Southern Vietnam. All participants were cervical cancer-free women aged 30-65 years. Awareness of, attitudes toward, and experience with cervical cancer prevention and screening were explored using audio-recorded, semi-structured discussions in Vietnamese. During the focus groups, participants also watched four short videos with Vietnamese subtitles and voiceover about cervical cancer screening methods and discussed their views on each. The recordings were transcribed, translated into English, and coded and analyzed using Dedoose 9.0.46. Results Four main themes emerged. First, women showed low awareness, but high acceptance of cervical cancer screening and HPV vaccination. Second, screening barriers were related to logistics (e.g., cost, time, travel distance), psychology (e.g., fear of pain, embarrassment, fear of the test revealing they had cancer), and healthcare providers (e.g., doctors' impolite manners, male doctors). Third, women were concerned about self-sampling incorrectly and pain, but believed HPV self-sampling to be a feasible screening tool in some circumstances (e.g., during the COVID-19 pandemic, those living in remote areas). Fourth, women related cervical cancer prevention to COVID-19 prevention;they believed strategies that have been successful for COVID-19 control in Vietnam could be applied to cervical cancer. No differences in themes emerged by rural/urban areas. Conclusions Southern Vietnamese women showed low awareness but high acceptance of cervical cancer screening despite barriers. Strategies for successful COVID-19 control in Vietnam, including campaigns to increase public awareness, advocacy from the government and doctors, and efforts to increase access to screening and vaccination, should be applied to cervical cancer control. Health education programs to address HPV self-sampling concerns and promote it as a cervical cancer screening tool are warranted given its potential to improve screening uptake in this low-resource setting.
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Background: Incidence of cancer is constantly increasing in the United States, and Puerto Rico is no exception. The island is currently experiencing low birth rates, signifying that its population is primarily composed of aging citizens that experience a growing need for access to healthcare and medical literature, especially in those with cancer. In this study, we aimed to characterize an aging Puerto Rican cohort with a diagnosis of cancer. Method(s): A questionnaire with sociodemographic and medical inquiries was administered to participants receiving an mRNA vaccine at a COVID-19 vaccination clinic between December 2020 and June 2021. Participants of age 60+ with a diagnosis of cancer, along with their comorbidities, were identified. Multivariate analyses were executed. This study is IRB approved. Result(s): A total of 100 aging participants with a diagnosis of cancer were included: 55 were female and 45 were male, with a mean age of 72.70+/-8.07 (age range: 61-95). When assessing race, participants identified as follows: 68% White, 23% Black or African American, 8% other race, and 1% American Indian or Alaska Native. Concerning ethnicity, 97% identified as Hispanic or Latino, while 3% did not regard themselves as such. When evaluating the cancer diagnoses provided, 27% of female participants had breast cancer and 7% had some form of gynecologic malignancy. Whereas, in males, 42% indicated a diagnosis of prostate cancer. Regarding concomitant comorbidities, 45% of participants had hypertension, 30% had diabetes mellitus, 18% had hypothyroidism, 15% had asthma, and 3% had chronic obstructive pulmonary disease. There was no statistically significant difference when comparing sex and prevalence of concomitant diabetes mellitus or hypertension (p=0.2125). There was also no statistically significant difference when assessing racial identity and presence of concomitant diabetes mellitus or hypertension (p=0.7373). Out of 91 participants who answered the health insurance inquiry, 82% possessed private insurance, 13% had public insurance, and 4% did not have insurance. There was no statistically significant difference when assessing private, public, or no health insurance status and the presence of concomitant diabetes mellitus or hypertension (p=0.9086). Conclusion(s): Data evidenced a diverse aging Puerto Rican cohort with cancer, showing a predominance in prostate cancer in men and breast cancer in women. Analysis suggested that the presence of concomitant diabetes mellitus or hypertension in an aging population with cancer was not linked to sex or racial identity. Additionally, the type or lack of health insurance did not influence the prevalence of concomitant diabetes mellitus or hypertension. Characterizing the aging Hispanic population in Puerto Rico and the United States is important, as these studies could be beneficial in the future approach, understanding and treatment of this population with historically limited medical data available.
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Background: People with systemic lupus erythematosus (SLE) are at greater risk of developing infections, including COVID-19. This study describes the characteristics and outcomes of COVID-19 infection among patients with SLE seen in a tertiary hospital in Manila, Philippines. Method(s): This cross-sectional study included patients with diagnosed SLE seen over 24 months from March 2020 to February 2022, who were confirmed with COVID-19 infection. We collected data from patients' electronic records and clinic charts and analyzed underlying SLE characteristics including disease activity and medications, COVID-19 involvement, vaccination status and outcomes including hospitalization and mortality. Result(s): Of the 507 patients with SLE, 53 patients reported positive for COVID-19. Cough, fever, dyspnea, diarrhea, anosmia, ageusia, and sore throat were the common presenting complaints. Three were asymptomatic, 41 had mild symptoms, 2 had moderate, and 7 had severe COVID-19 infection. Sixteen patients (30%) were hospitalized, and 37 (70%) were confined at home or an isolation facility. More than half of patients were unvaccinated during the time of COVID-19 infection (28, 54%), 3 (6%) were partially vaccinated and 21 (40%) were fully vaccinated. Use of methotrexate, mycophenolate mofetil, prednisone <10 mg/day, and hydroxychloroquine did not affect the risk for moderate to severe COVID-19 infection. Patients in low disease activity or remission tended to have asymptomatic to mild COVID-19 infection. Two (4%) died with severe COVID 19 infection: a lupus nephritis patient with end-stage renal disease on hemodialysis and a lupus nephritis patient with concomitant double gynecologic malignancy (vulval and cervical) who underwent 35 cycles of radiotherapy prior to COVID-19 infection. Conclusion(s): This study on SLE patients with COVID-19 infection showed that patients with high disease activity, co-morbidity especially ESRD and the use of high dose glucocorticoid had higher risk for moderate to severe COVID-19 infection and hospitalization. Use of immunosuppressants and prednisone <10 mg/day did not appear to contribute to increased severity of COVID-19 infection, hospitalization and mortality.
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Background: Severe unstableness has occurred during the Covid pandemic in 2020/21 regarding the accessibility of health care structures. Patients with symptoms did either not consult their gynecologists, or were not able to get access to their gynecologists, due to canceled outpatient consultation hours. Method(s): The first lockdown due to Covid-19 in Berlin occured in March 2020. We compared the cancer data and cancer patients consultation to three gynecological centers in three academic hospitals in Berlin in the years 2018/2019 to 2020/2021. Consultations and stages of tumors in 840 patients were compared and matched monthly between the years. Result(s): In the first lockdown March 2020- June 2020 20% less cancer patients consultated our clinics. The results were found to be significant. Elder patients did tend to consult the health care system less during the lockdown as compared to before the lockdown. In the first lockdown March 2020- June 2020 20% less cancer patients consultated our clinics. The results were found to be significant. Elder patients did tend to consult the health care system less during the lockdown as compared to before the lockdown. After the first lockdown a tendency to more advanced cancer stages were observed in the cancer patients. Discussion(s): During the Covid-19 pandemic medical care for cancer patients was impaired, as compared to the time before the pandemic. Significantly less patients consulted the health care system and found support for their symptoms. Conclusion(s): The alterations due to the pandemic will, most probably, affect the long term survival of these cancer patients.
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Purpose: Since the corona pandemic, the use of video consultation has increased markedly. For vulnerable groups such as oncological patients, the advantages seem obvious. But how, compared to face-to-face consultation, does video consultation potentially change the doctor-patient relationship? Which barriers may hinder the effective use of this consultation format in practice? We are presenting first results from a study, funded by Federal Ministry of Health, which will provide the basis for a hands-on guide for both physicians and patients on how to improve the video consultations. Method(s): We use a quasi-experimental mixed-methods design to analyze qualitative and quantitative differences between face-to-face and video consultations. Data collection will be completed by June 2022. We will record N = 64 videos (n = 32 for each consultation format) with gynecological and urological cancer patients. After the consultation, all patients answer a questionnaire with questions about their consultation experience. For quantitative analyses, the counseling sessions will be systematically compared in terms of verbal and nonverbal communication patterns. Relative frequencies of eye contact and the information exchanged will be compared using chi2 -tests. The validated questionnaire MAPPIN'Obsdyad will be used to assess the quality of shared decision-making parameters. In addition, semi-structured interviews will be conducted with n = 10 physicians and n = 10 patients experienced with video consultation, for which a qualitative content analysis will be conducted. Expected results: We present a complex methodological approach we used to approach the comparison of video vs. face-to-face consultations. We will also present first evidence on how video consultations change the doctor-patient interaction. Discussion(s): We show possible limitations and barriers of video consultations. Within the framework of a Delphi process, we will use the results to develop recommendations outlining best practices of video consultations for both physicians and patients.
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Objectives The magnitude of adverse outcomes caused by the disrupted surgical cancer care during the COVID-19 pandemic is unclear. Our aim was to evaluate the changes in care and short-term outcomes of surgical patients with gynecological cancers during the initial phase of the COVID-19 pandemic internationally. Methods A multicenter, international prospective cohort study including consecutive patients with gynecological cancers who were initially planned for non-palliative surgery. Primary Outcome: 30-day postoperative SARS-CoV-2 infection rate. Secondary Outcomes: 30-day perioperative mortality and morbidity, COVID-19-related treatment modifications. Results We included 3973 patients (52 countries;7 world regions). Lower-than-reported rate (22/3778;0.6%) of perioperative SARS-CoV-2 infections was observed. This group had higher morbidity (63.6% vs 19.1%;p<0.0001) and mortality (18.2% vs 0.7%;p<0.0001), compared to the uninfected cohort. In 20.7% (823/3973), standard of care was adjusted. Significant delay (>8 weeks) was observed in 11.2% (424/ 3784), particularly in those with ovarian cancer (213/1355;15.7%). This delay was associated with a composite of adverse outcomes including disease progression and death (95/ 424;22.4% versus 601/3360;17.9%, p=0.024), compared to those who had operations within 8 weeks of their MDT decisions. One in thirteen did not receive their planned operations (189/2430;7.9%), in whom 1 in 20 (5/189;2.7%) died and 1 in 5 (34/189;18%) experienced disease progression or death within 3 months of decisions for surgery. Conclusions One in five surgical patients with gynecological cancer worldwide experienced management modifications during the COVID-19 pandemic. Significant adverse outcomes were observed in those with delayed or cancelled operationscoordinated mitigating strategies are urgently needed.
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Introduction/Background The magnitude of adverse outcomes caused by the disrupted surgical cancer care during the COVID-19 pandemic is unclear. The aim of CovidSurg-Gynaecological Cancer study was to evaluate the changes in care and short-term outcomes of surgical patients with gynecological cancers during the initial phase of the COVID-19 pandemic internationally. Methodology A multicenter, international prospective cohort study including consecutive patients with gynecological cancers who were initially planned for non-palliative surgery. Primary outcome The incidence of pandemic-related changes in care Secondary outcomes 30-day postoperative morbidity and mortality rates A composite outcome of unresectable disease or disease progression, emergency surgery and death Results We included 3973 patients (52 countries;7 world regions;27% from low-and-middle-income countries). Lower-than-reported rate (22/3778;0.6%) of perioperative SARS-CoV-2 infections was observed. This group had higher morbidity (63.6% vs 19.1%;p<0.0001) and mortality (18.2% vs 0.7%;p<0.0001) rates, compared to the uninfected cohort. In 20.7% (823/3973), standard of care was adjusted. Significant delay (>8 weeks) was observed in 11.2% (424/3784), particularly in those with ovarian cancer (213/1355;15.7%). This delay was associated with the use of neoadjuvant chemotherapy (p<0.0001), a composite of adverse outcomes including disease progression and death (95/424;22.4% versus 601/ 3360;17.9%, p=0.024), compared to those who had operations within 8 weeks of their MDT decisions. One in thirteen did not receive their planned operations (189/2430;7.9%), in whom 1 in 20 (5/189;2.7%) died and 1 in 5 (34/189;18%) experienced disease progression or death within 3 months of MDT decisions for surgery Conclusion One in five surgical patients with gynecological cancer worldwide experienced management modifications during the COVID-19 pandemic. Significant adverse outcomes were observed in those with delayed or cancelled operations. This global data on the magnitude of care changes and their consequences could be used to leverage resources for the ongoing mitigating strategies worldwide.
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Background: Dostarlimab is a programmed death 1 (PD-1) inhibitor approved in the EU as a monotherapy in patients (pts) with dMMR/MSI-H AR EC that has progressed on or after platinum-based chemotherapy;and in the US as a monotherapy in pts with dMMR AR EC that has progressed on or after platinum-based chemotherapy or dMMR solid tumors that have progressed on or after prior treatment, with no satisfactory alternative treatment options. We report on PFS and OS in 2 expansion cohorts of the GARNET trial that enrolled pts with EC. Methods: GARNET is a multicenter, open-label, single-arm phase 1 study. Pts were assigned to cohort A1 (dMMR/MSI-H EC) or A2 (MMRp/MSS EC) based on local immunohistochemistry assessment. Pts received 500 mg of dostarlimab IV every 3 weeks for 4 cycles, then 1000 mg every 6 weeks until disease progression, discontinuation, or withdrawal. PFS and OS are secondary efficacy endpoints. Results: 153 pts with dMMR/MSI-H and 161 pts with MMRp/MSS EC were enrolled and treated. The efficacy-evaluable population included 143 pts with dMMR/MSI-H EC and 156 pts with MMRp/MSS EC with measurable disease at baseline and ≥6 mo of follow-up. Median follow-up was 27.6 mo for dMMR/MSI-H and 33.0 mo for MMRp/MSS EC (Table). For pts with dMMR/MSI-H EC, median PFS (mPFS) was 6.0 mo, with 3-year estimated PFS rate of 40.1%. With 37.3% of pts experiencing an event, mOS was not reached;estimated 3-year OS was >50%. For pts with MMRp/MSS EC, mPFS was 2.7 mo. mOS was 16.9 mo with 68.9% of pts experiencing an event. Safety has been previously reported. [Formula presented] Conclusions: Dostarlimab demonstrated durable antitumor activity in dMMR/MSI-H and MMRp/MSS AR EC. dMMR/MSI-H was associated with longer PFS and OS than MMRp/MSS as expected. Clinical trial identification: NCT02715284. Editorial acknowledgement: Writing and editorial support, funded by GlaxoSmithKline (Waltham, MA, USA) and coordinated by Heather Ostendorff-Bach, PhD, of GlaxoSmithKline, was provided by Shannon Morgan-Pelosi, PhD, and Jennifer Robertson, PhD, of Ashfield MedComms, an Ashfield Health company (Middletown, CT, USA). Legal entity responsible for the study: GlaxoSmithKline. Funding: GlaxoSmithKline. Disclosure: A.V. Tinker: Financial Interests, Institutional, Sponsor/Funding: AstraZeneca;Financial Interests, Personal, Other: AstraZeneca, Eisai, GlaxoSmithKline. B. Pothuri: Financial Interests, Institutional, Funding: AstraZeneca, Celsion, Clovis Oncology, Eisai, Genentech/Roche, Karyopharm, Merck, Mersana, Takeda Pharmaceuticals, Tesaro/GSK;Financial Interests, Personal, Other: Arquer Diagnostics, AstraZeneca, Atossa, Clovis Oncology, Deciphera, Elevar Therapeutics, Imab, Mersana, Tesaro/GSK, Merck, Sutro Biopharma, Tora, GOG Partners;Financial Interests, Personal, Advisory Board: Arquer Diagnostics, AstraZeneca, Atossa, Deciphera, Clovis Oncology, Eisai, Elevar Therapeutics, Imab, Merck, Mersana, Sutro Biopharma, Tesaro/GSK, Toray;Financial Interests, Personal, Leadership Role: GOG Partners, NYOB Society Secretary, SGO Clinical Practice Committee Chair, SGO COVID-19 Taskforce Co-Chair. L. Gilbert: Financial Interests, Institutional, Funding: Alkermes, AstraZeneca, Clovis, Esperas, IMV, ImmunoGen Inc, Karyopharm, Merck Sharp & Dohme, Mersana, Novocure GmbH, OncoQuest Pharmaceuticals, Pfizer, Roche, Tesaro;Financial Interests, Personal, Other: Merck, Alkermes, AstraZeneca, Eisai, Eisai-Merck, GlaxoSmithKline. R. Sabatier: Financial Interests, Institutional, Funding: AstraZeneca, Eisai;Financial Interests, Personal, Other: AstraZeneca, GlaxoSmithKline, Novartis, Pfizer, Roche;Non-Financial Interests, Personal, Other: AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Pfizer, Roche. J. Brown: Financial Interests, Personal, Advisory Role: Caris, Clovis, Eisai, GlaxoSmithKline;Financial Interests, Personal, Funding: GlaxoSmithKline, Genentech. S. Ghamande: Financial Interests, Personal, Advisory Role: Seattle Genetics;Financial Interests, Personal, Speaker’s Bureau: GlaxoSmithKline;Financial Interests, Institutional, Funding: Abbv e, Advaxis, Bristol Myers Squibb, Clovis, Genentech, GlaxoSmithKline, Merck, Roche, Seattle Genetics, Takeda. C. Mathews: Financial Interests, Institutional, Research Grant: Astellas, AstraZeneca, Deciphera, Moderna, GSK, Regeneron, Seattle Genetics;Financial Interests, Personal, Advisory Board: IMAB biopharma. D. O'Malley: Financial Interests, Personal, Advisory Board: AstraZeneca, Tesaro/GSK, Immunogen, Ambry, Janssen/J&J, Abbvie, Regeneron, Amgen, Novocure, Genentech/Roche, GOGFoundation, Iovance, Eisai, Agenus, Merck, SeaGen, Novartis, Mersana, Clovis, Elevar, Takeda, Toray, INXMED, SDP Oncology (BBI), Arquer Diagnostics, Roche Diagnostics MSA, Sorrento, Corcept Therapeutics, Celsion Corp;Financial Interests, Personal, Funding: AstraZeneca, Tesaro/GSK, Immunogen, Janssen/J&J, Abbvie, Regeneron, Amgen, Novocure, Genentech/Roche, VentiRx, Array Biopharma, EMD Serono, Ergomed, Ajinomoto Inc, Ludwig Cancer Research, Stemcentrx, Inc, Cerulean Pharma, GOGFoundation, Bristol-Myers Squibb Co, Serono Inc, TRACON Pharmaceuticals, Yale University, New Mexico Cancer Care Alliance, INC Research, Inc, inVentiv Health Clinical, Iovance, PRA Intl, Eisai, Agenus, Merck, GenMab, SeaGen, Mersana, Clovis, SDP Oncology (BBI);Financial Interests, Personal, Other: Myriad Genetics, Tarveda. V. Boni: Financial Interests, Personal, Advisory Board: OncoArt, Guidepoint Global;Financial Interests, Personal, Speaker’s Bureau: Solti;Financial Interests, Personal, Other: START, Loxo, IDEAYA Biosciences;Financial Interests, Institutional, Research Grant: Sanofi, Seattle Genetics, Loxo, Novartis, CytomX Therapeutics, Pumo Biotechnology, Kura Oncology, GlaxoSmithKline, Roche/Genentech, Bristol-Myers Squibb, Menarini, Synthon, Janssen Oncology, Merck, Lilly, Merus, Pfizer, Bayer, Incyte, Merus, Zenith Epigenetics, Genmab, AstraZeneca, Seattle Genetics, Adaptimmune, Alkermes, Amgen, Array BioPharma, Boehringer Ingelheim, BioNTech AG, Boston Biomedical. A. Gravina: Financial Interests, Personal, Other: Gentili, Pfizer. S. Banerjee: Financial Interests, Personal, Advisory Board: Amgen, Genmab, Immunogen, Mersana, Merck Sereno, MSD, Roche, Tesaro, AstraZeneca, GSK, Oncxerna;Financial Interests, Personal, Invited Speaker: Clovis, Pfizer, Tesaro, AstraZeneca, GSK, Takeda, Amgen, Medscape, Research to Practice, Peerview;Financial Interests, Personal, Stocks/Shares: PerciHealth;Financial Interests, Institutional, Research Grant: AstraZeneca, GSK, Tesaro;Non-Financial Interests, Principal Investigator, Phase II clinical trial Global lead, ENGOTov60/GOG3052/RAMP201: Verastem;Non-Financial Interests, Principal Investigator, ENGOT-GYN1/ATARI phase II international trial (academic sponsored): Astrazeneca;Non-Financial Interests, Advisory Role: Epsilogen;Non-Financial Interests, Other, Member of membership committee: ESGO;Non-Financial Interests, Advisory Role, Medical advisor to UK ovarian cancer charity: Ovacome Charity;Non-Financial Interests, Other, Received research funding from UK based charity I have provided medical advice (non-remunerated): Lady GardenFoundation Charity. R. Miller: Financial Interests, Personal, Other: AZD, Clovis Oncology, Ellipses, GlaxoSmithKline, MSD, Shionogi, AZD, GlaxoSmithKline;Financial Interests, Personal, Speaker’s Bureau: AZD, Clovis Oncology, GSK, Roche. J. Pikiel: Financial Interests, Personal, Other: Amgen, Clovis Oncology, GlaxoSmithKline, Incyte, Novartis, Odonate Therapeutics, Pfizer, Regeneron, Roche. M.R. Mirza: Financial Interests, Personal, Advisory Board: AstraZeneca, Biocad, GSK, Karyopharm, Merck, Roche, Zailab;Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK, Karyopharm;Financial Interests, Personal, Stocks/Shares: Karyopharm;Financial Interests, Institutional, Research Grant: GSK, AstraZeneca, ultimovacs, Apexigen;Financial Interests, Institutional, Invited Speaker: Deciphera;Non-Financial Interests, Advisory Role: Ultimovacs, Apexigen. T. Duan: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. G. Antony: Financial Interests, Personal, Fu l or part-time Employment: GlaxoSmithKline. S. Zildjian: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. E. Zografos: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. J. Veneris: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. A. Oaknin: Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis Oncology, Deciphera Pharmaceuticals, Genmab, GSK, Immunogen, Mersana Therapeutics, PharmaMar, Roche, Tesaro, Merck Sharps & Dohme de España, SA, Agenus, Sutro, Corcept Therapeutics, EMD Serono, Novocure, prIME Oncology, Sattucklabs, Itheos, Eisai, F. Hoffmann-La Roche,;Financial Interests, Personal, Other, Travel and accomodation: AstraZeneca, PharmaMar, Roche;Financial Interests, Institutional, Funding: Abbvie Deutschland, Advaxis Inc., Aeterna Zentaris, Amgen, Aprea Therapeutics AB, Clovis Oncology Inc, EISAI limited LTD, F. Hoffmann –La Roche LTD, Regeneron Pharmaceuticals, Immunogen Inc, Merck, Sharp & Dohme de España SA, Millennium Pharmaceuticals Inc, PharmaMar SA, Tesaro Inc., Bristol Myers Squibb;Non-Financial Interests, Leadership Role, Executive Board member as a Co-Chair: GEICO;Non-Financial Interests, Leadership Role, Phase II Committee and Cervix Cancer Committee Representative on behalf of GEICO: GCIG;Non-Financial Interests, Officer, Chair of Gynaecological Track ESMO 2019. Scientific Track Member Gynaecological Cancers ESMO 2018, ESMO 2020, ESMO 2022. Member of Gynaecological Cancers Faculty and Subject Editor Gyn ESMO Guidelines.: ESMO;Non-Financial Interests, Member: ESMO, ASCO, GCIG, SEOM, GOG.
ABSTRACT
Objectives: To determine the rate and identify factors associated with potentially avoidable admissions following a minimally invasive hysterectomy. Methods: Patients who underwent a minimally invasive hysterectomy for a suspected or known gynecologic malignancy between January 2019 to July 2021 were identified in our institution's prospectively curated quality improvement surgical database. Preoperatively, patients were assessed for planned same-day discharge versus a planned admission. Reasons for those who were admitted despite a planned same-day discharge were characterized as the following: anesthesia-related, comorbid conditions, intraoperative factors, social factors, system issues, and uncontrolled pain. For planned admissions, reasons for admission were categorized as necessary and potentially unavoidable. Descriptive statistics were used to summarize the cohort. Results: A total of 380 patients were identified, of which 267 (70%) patients had a planned same-day discharge, and 113 (30%) had an anticipated admission. Same-day surgery discharge rates increased over time (Figure 1). Two hundred and thirty-five patients (88%) were successfully discharged the same day. Of these patients, 17 (7%) presented to the emergency department (ED) within 30 days, and the re-admission rate in this group was 12% (n=2). Thirty-two patients did not successfully discharge on the same day, and five patients (15%) presented to the ED for evaluation within 30 days. Most unplanned admissions were anesthesia-related (n=15, 47%), followed by system issues (n=7, 22%), such as failure to recognize comorbid conditions in the preoperative period, intraoperative factors (n=5, 16%), postoperative pain (n=3, 9%), and social factors (n=2, 6%). Among the 113 anticipated admissions, 78 (69%) patients were deemed necessary due to multi-factorial comorbid conditions or surgical complexity. However, 35 (31%) patients could have been optimized for same-day discharge;reasons for which included patients with comorbid conditions that could have been optimized preopera- tively, such as poorly controlled diabetes (n=13, 12%), system issues, (n= 8, 7%), social factors (n= 7, 6%), anesthesia-related (n= 4, 4%), and surgical complexity (n=3, 3%). [Formula presented] Conclusions: Most patients were successfully discharged the same day, and of those who were deemed unsuitable for same-day discharge, nearly half could have been optimized for same-day discharge. Unplanned admissions in the anticipated same-day discharge cohort were primarily due to anesthesia-related concerns in the immediate postoperative period and where patient comorbid conditions could have been better optimized in the preoperative period. Recognizing potential areas for improvement and further optimizing same-day discharge will allow hospital systems to continue providing care for gynecologic oncology patients during COVID-19 surges.
ABSTRACT
Objectives: Financial toxicity (FT) impacts approximately 50% of patients with gynecologic malignancies. Still, little is known about factors that predispose patients receiving radiation therapy to financial distress or what impact the COVID-19 pandemic had on their financial well-being. We evaluated FT in patients with gynecologic cancer treated with radiation before and after the start of the COVID- 19 pandemic. Methods: Patients from an urban, academic gynecologic radiation oncology practice completed a survey one month after completing radiation from August 2019-March 2020 and November 2020-June 2021. The survey included demographic questions, the Comprehensive Score for Financial Toxicity (COST) tool, and the EQ-5D to measure the quality of life (QOL). Pandemic-related questions were added during the second survey period (pandemic cohort). As with our prior work, high FT was defined as a COST score of ≤23. We assessed the correlation of COST scores with QOL. We used logbinomial regression to examine associations between FT and costcoping strategies, adjusting for age and insurance. Results: Of 97 respondents (92% response rate), 49% completed the survey before, and 51% completed it after the pandemic started. Among the participants, 76% identified as White, 11% as Black, and 8% as Asian. Most patients had uterine (64%), followed by cervical (24%) and vaginal (6%) cancer. Two-thirds (60%) received external beam radiation with or without brachytherapy;the remaining 40% had brachytherapy alone. The median COST score was 15 (IQR: 7-19) in the high FT group (n=27) and 33 (IQR: 28-36) in the low FT group (n=70). High FT correlated with worse QOL (r=-0.37, p<0.01) and was associated with younger age and type of insurance (both p <0.03). Patients with high FT were more likely to move from full- to parttime employment (22% vs 1%, p<0.01), six (95% CI: 1.0-36) times more likely to delay/avoid medical care, 14 (95% CI: 3-64) times more likely to borrow money, and seven (95% CI: 2-27) times as likely to reduce spending on basic goods. Patients with high FT were more likely to report that decreased ability to work (48% vs 13%), medical bills (41% vs 13%), and transportation or parking (15% vs 3%) mostly contributed to their financial stress (p<0.05 for all). The pandemic cohort had fewer patients with high FT than the pre-pandemic cohort (20% vs 35%, p=0.10) and a higher median COST score (32 [IQR: 25-35] vs 27 [IQR: 19-34], p=0.07). The use of cost-coping strategies did not differ between cohorts. Conclusions: Privately insured, younger patients who received radiation for gynecologic cancer were at risk for FT. High FT correlated with worse QOL and was associated with delays or avoidance of medical care and other cost-coping strategies. The prevalence of high FT was not statistically different before and during the pandemic, though we observed less FT in the pandemic cohort. More work is needed regarding the impact of the COVID-19 pandemic on the financial well-being of patients with cancer.