MA06.05 Consolidation Nivolumab and Ipilimumab or Nivolumab Alone Following Concurrent Chemoradiation for Patients with Unresectable Stage III NSCLC

Introduction: The PACIFIC trial demonstrated that a year of consolidation PD-(L)1 inhibition following concurrent chemoradiation (CRT) for unresectable stage III NSCLC improves overall survival (OS). The optimal duration of consolidation IO therapy in this setting is undefined. Studies in metastatic NSCLC demonstrate that combination PD-(L)1/CTLA-4 inhibition improves OS over chemotherapy alone. This trial evaluated the use of combination Nivolumab (N) plus Ipilimumab (IPI) or N alone for up to 6 months in unresectable stage III NSCLC after concurrent CRT. Methods: This is a randomized phase II, multicenter trial of 105 pts with unresectable stage IIIA/IIIB NSCLC. All pts received concurrent CRT and were then enrolled and randomized 1:1 to receive N 480mg IV q4wks (Arm A) for up to 24 weeks or N 3mg/kg IV q2 wks + IPI 1mg/kg IV q6 wks (Arm B) for up to 24 weeks. The primary endpoint is 18-month PFS compared to historical controls of CRT alone for arm A (30%) and CRT followed by Durva for arm B (44%). Secondary endpoints include OS and toxicity. Results: From 9/2017 to 4/2021, 105 pts were enrolled and randomized, 54 to N alone (A) and 51 to N + IPI (B). The baseline characteristics for arm A/B: median age (65/63), male (44.4%/56.9%), stage IIIA (55.6%/56.9%), stage IIIB (44.4%/43.1%), non-squamous (57.4%/54.9%), and squamous (42.6%/45.1%). The percentage of pts completing the full treatment was 70.4% in A and 56.9% in B (p=0.15). Median f/u was 24.5 and 24.1 months on A and B, respectively. The 18-month PFS was 62.3% on A (p <0.1) and 67% on B (p <0.1), and median PFS was 25.8 months and 25.4 months, respectively. Median OS was not reached on either arm, but the 18- and 24-month OS estimates were 82.1% and 76.6% for A and 85.5% and 82.8% for B, respectively. Treatment-related adverse events (trAE) on arm A/B were 72.2%/80.4%, and grade ≥3 trAEs on arm A/B were 38.9%/52.9%. There was 1 grade 5 event in each arm (COVID19-A, Cardiac Arrest-B). The number of pts with grade ≥2 pneumonitis were 12 (22.2%) in A and 15 (29.4%) in B, with 5 (9.3%) and 8 (15.7%) grade ≥3 events, respectively. The most common (>10%) non-pneumonitis trAEs in A were fatigue (31.5%), rash (16.7%), dyspnea (14.8%), and hypothyroidism (13%), and in B were fatigue (31.4%), diarrhea (19.6%), dyspnea (19.6%), pruritus (17.7%), hypothyroidism (15.7%), rash (15.7%), arthralgia (11.8%), and nausea (11.8%). Conclusions: Following concurrent CRT for unresectable stage III NSCLC, both N and N + IPI demonstrated improved 18-month PFS compared with historical controls despite a shortened interval (6 months) of treatment. OS data are still maturing but 18- and 24-month OS estimates compare favorably to prior consolidation trials. Toxicity for N alone was similar to prior single-agent trials, and the combination of N + IPI resulted in a higher incidence of trAE’s, although consistent with prior reports. Keywords: Consolidation Immunotherapy, Stage III NSCLC

COVID-19 Vaccine Hesitancy Among Reproductive- Aged Females

INTRODUCTION: Initial COVID-19 vaccine trials excluded pregnant individuals, making eventual vaccine recommendations nongeneralizable. After noninferiority was established, the Centers for Disease Control and Prevention, World Health Organization, and American College of Obstetricians and Gynecologists supported vaccination of this group. However, only 31% of pregnant patients accepted vaccination. This study aims to assess COVID-19 vaccine hesitancy in reproductive-aged females. METHODS: We developed a REDCap survey using a validated COVID-19 vaccine hesitancy survey tool. From August to November 2021, women aged 18-50 years were recruited from inpatient and outpatient obstetrics and gynecology services at the University of Illinois Hospital. We performed t tests and ANOVA statistics using SPSS. RESULTS: A total of 51 patients partially or fully completed the survey. The results revealed that Black individuals are more hesitant than Hispanic and White individuals (F2,44=3.45, P<.50). Specifically, Black women differed in the belief that the COVID-19 vaccine is safe overall (F2,44=5.62, P<0.01) and in pregnancy (F2,46=4.95, P<0.01). Pregnant patients were less confident that the COVID-19 vaccine is safe overall (F2,45=7.44, P<0.01) as well as in pregnancy (F2,47=6.26, P<0.01) compared to those recently pregnant or not pregnant. Individuals who declined the flu vaccine were more likely to be vaccine hesitant (t46=-4.49, P<.001). Participants' age, occupation, and contraception status were not associated with vaccine hesitancy. CONCLUSION: Existing vaccine hesitancy highlights the need to study misconceptions regarding the safety of the COVID-19 vaccine.

Aggregate prevalence of chemosensory and sinonasal dysfunction in SARS-CoV-2 and related coronaviruses. (Special issue on COVID-19.)

Much of the published literature regarding the novel coronavirus disease 2019 (COVID-19) constitutes lower respiratory system symptomatology, while there exists a paucity of data describing the complicated sequelae of the upper respiratory system, including chemosensory and/or sinonasal dysfunction. This study utilized the National Library of Medicine's PubMed/MEDLINE database to query for articles describing COVID-19, SARS-CoV-2, SARS-CoV-1, MERS-CoV, and other coronaviruses, with any mention of smell, taste, or other chemosensory or sinonasal dysfunction. Aggregate analysis demonstrated an incidence of 49.6% (n = 497 of 1002;95% CI, 46.5%-52.7%), 47.9% (n = 480 of 1002;95% CI, 44.8%-51.0%), and 17.9% (n = 880 of 4909;95% CI, 16.9%-19.0%) for smell loss, taste loss, and smell or taste loss, respectively, in patients infected with SARS-CoV-2. Additionally, there were significantly higher incidences of runny nose/rhinorrhea/rhinitis and nasal congestion/obstruction/blockage in other coronaviruses as compared with SARS-CoV-2 (P < .001). Understanding these less well-characterized symptoms may help develop measures for estimating early markers of disease prevalence and/or resolution.

Impact of COVID-19 Pandemic on Ambulatory and Operating Room Rhinology Practice in the US.

INTRODUCTION: The pandemic caused by the novel coronavirus virus has altered all facets of clinical practice in the United States. The goal of this study is to better understand the impact of COVID-19 on rhinologic ambulatory and operative practice. METHODS: A 27-item survey to assess these objectives was created and approved by the Division of Rhinology faculty at Rush University Medical Center in April 2020. The survey was then distributed to rhinologists in a web based format via www.surveymonkey.com from April 10 through April 23, 2020. RESULTS: A total of 277 U.S based rhinologists responded to the survey (23.04%). The most common practice types were single specialty private (44.9%) and academic (24.6%). 90.2% practice in a state under a shelter in place order. Comparing pre-COVID baseline to during-COVID, there was statistically significant reduction in the number of patients of seen daily in clinic (p < 0.001). The number of nasal endoscopies in the office and surgical procedures fell dramatically. Overall, 5 respondent rhinologists have been infected with COVID-19 and 27 have been furloughed. CONCLUSION: COVID-19 has drastically affected rhinologic practice. There is a dramatic reduction of in person care in the office setting and surgical management of sinonasal and skull base disease. Enhanced PPE is being used in only half of potentially aerosolizing procedures which represents an area of further education. Novel approaches such as use of virtual encounters and point of care testing should be considered as options to facilitate care.