key: cord-0980005-tia3jv7k
authors: Bungaro, M.; Bertaglia, V.; Audisio, M.; Parlagreco, E.; Pisano, C.; Cetoretta, V.; Persano, I.; Jacobs, F.; Baratelli, C.; Consito, L.; Reale, M. L.; Tabbò, F.; Bironzo, P.; Scagliotti, G.; Novello, S.
title: MA12.07 Oncological Procedures and Risk Assessment of COVID-19 in Thoracic Cancer Patients: A Picture From an Italian Cancer Center
date: 2021-10-31
journal: Journal of Thoracic Oncology
DOI: 10.1016/j.jtho.2021.08.174
sha: 7b10da22e95222bfbe17559241d86c2070bc11de
doc_id: 980005
cord_uid: tia3jv7k

nan

compared to pre-pandemic (mean 69.4% vs. 54.0%, p¼0.007). Respiratory complications were also significantly more common during the pandemic (mean monthly rate 26.0% vs. 20.0%, p¼0.02). No difference was observed for major complication or 30-day mortality rates.

In locations with high prevalence of COVID-19, the pandemic has impacted the rate of minor complications and respiratory complications after thoracic cancer surgery, with no impact on major complications and 30-day mortality. Larger national studies could help further evaluate the correlation between various community respiratory infection rates and thoracic surgical outcomes. Keywords: postoperative complications, covid-19, thoracic cancer surgery MA12.06 Single Fraction Lung Stereotactic Body Radiotherapy Implementation in a Multi-Center Provincial Cancer Program During the COVID-19 Pandemic B. Mou, 1 D. Hyde, 1 C. Araujo, 1 L. Bartha, 1 A. Bergman, 2 M. Liu 2 1 BC Cancer Kelowna, Kelowna/BC/CA, 2 BC Cancer Vancouver, Vancouver/BC/ CA Introduction: During the COVID-19 pandemic, cancer centers worldwide were compelled to consider shortened radiotherapy regimens to minimize the risk of infectious exposure of patients and staff members. Larger institutions with multiple treatment centers may face greater challenges when developing consensus guidelines and implementing new treatment initiatives. We describe the implementation of single fraction (SF) lung stereotactic body radiotherapy (SBRT) in a multicenter provincial cancer program. Methods: British Columbia, Canada has a provincial cancer program with radiotherapy services distributed across six regional centers serving a population of 5.1 million people. In March 2020, coordinated provincial mitigation strategies were developed in anticipation of decreased access to radiotherapy during the COVID-19 pandemic. The provincial lung radiation oncology group identified SF lung SBRT as a mitigation measure supported by high quality randomized evidence that could provide comparable outcomes and toxicity to existing fractionated SBRT protocols. A working group of radiation oncologists and medical physicists performed a literature review and drafted provincial guidelines and procedures. The guidelines were reviewed by a group of center representatives as a component of provincial lung radiotherapy mitigation strategic planning. Individual centers were encouraged to implement SF lung SBRT as their resources and staffing would permit. Centers were then surveyed about barriers encountered during the implementation process. Results: A working group was created and consensus guidelines for SF lung SBRT were drafted on March 24, 2020. The working group approved and distributed the final version of the guidelines on March 26, 2020. The provincial lung radiotherapy mitigation strategy group adopted the guidelines for implementation on April 1 st , 2020.

Implementation was completed at the first center on April 27, 2020. Barriers to implementation were identified at 5 of 6 centers. Two centers situated in regions with disproportionately high volumes of positive COVID-19 cases cited inadequate staffing as a primary obstacle for implementation. One center experienced delays attributed to prescheduled commissioning of new treatment techniques. Three centers described competing priorities as reasons for delayed implementation. As of February 2021, two centers had active SF lung SBRT programs, three centers were in the process of implementation, and one center had no immediate plans for implementation because of persistent resource issues. Conclusion: SF lung SBRT was launched in a multicenter provincial cancer program within weeks of conception during the development of radiotherapy mitigation strategies for the COVID-19 pandemic. Although consensus guidelines were adopted quickly, the actual implementation by individual centers varied owing to differences in resource allocation and staffing among the centers. Strong organizational structures and early identification of potential barriers may improve the efficiency of adopting new treatment initiatives in large distributed radiotherapy programs. Keywords: stereotactic body radiation therapy, pandemic, implementation , have rapidly spread across the globe. Since then, Italy soon became one of the most affected countries. Patients with thoracic malignancies had the highest frequency of severe complications. In this challenging situation, healthcare systems modified their practice by introducing strict infection control measures to ensure optimal cancer care. This study aimed to investigate the efficacy of pre-procedure screening for COVID-19 and whether infection influenced the opportunity of patients to receive timely diagnosis and therapy. Methods: We retrospectively collected data of oncological procedures of patients with confirmed or suspected diagnosis of thoracic malignancies treated at Oncology Department or coming from the Emergency Department of San Luigi Gonzaga University Hospital between June 2020 and March 2021 (from the end of the first wave until the middle of the third one). According to an internal protocol, outpatients were evaluated by a clinical questionnaire and a nasopharyngeal swab (NPS) performed 24/48 hours before oncological procedures. Inpatients were tested before hospitalization and after 24, 48 hours, seven days and then in case of appearance of symptoms. Descriptive statistics were used to summarize the data. Categorial variables were summarized as counts and percentage. In this abstract we present the preliminary results. Results: 125 patients were included in this analysis. Median age was 72 years (range 21-83), males were 64%. At the time of the procedures ECOG Performance Status was: 0 in 46 patients (36.8%), 1 in 66 (52.8%) and 2 in 13 (10.4%). Histological types were: 108 (86.4%) NSCLC, 9 (7.2%) SCLC, 7 (5.6%) mesothelioma and 1 (0.8%) amartochondroma. The majority of patients (80%) were in stage IV. 135 programmed procedures were performed: 102 (75.5%) were diagnostic (75 lung biopsies, 21 bronchoscopy, 1 lumbar puncture, 2 thoracoscopies, 1 thoracentesis, 1 gastroscopy and 1 thoracic surgery), 25 palliative and 8 therapeutic. Eighty-nine (66%) and 46 (34%) procedures were performed in outpatients and inpatients, respectively. Of the 132 NPS performed before the procedures, 8 (6%) were found to be positive (5 for diagnostic procedures, 1 for therapeutic loco-regional procedure and 2 for exploratory bronchoscopies). The 8 positive patients were infected during the second wave (from November 2020 to January 2021). One patient was infected during hospitalization, the other ones in community. Most of patients were asymptomatic, only 2 of them had mild symptoms (fever). Six procedures were postponed (5 diagnostic, 1 palliative), an explorative bronchoscopy was canceled and a diagnostic biopsy was performed even though the patient tested positive. The median time to resolution of the infection was 17 days (range 11-36). The median delay of the procedures was 36 days (range 14-55). Four patients started systemic treatment in a median time of 40.5 days (range 21-57). Conclusion: Our analysis pointed out that Sars-Cov2 infection led to the postponement of a small but not negligible percentage of diagnostic and therapeutic procedures and that a structured screening for COVID-19 is critical for the best management of scheduled procedures during pandemic. Introduction: Our preclinical work suggests that appropriate angiogenesis inhibition could potentiate PD-1/PD-L1 blockade, and promising anti-tumor activity was already observed with camrelizumab plus apatinib in chemotherapy-pretreated patients (pts) with advanced nonsquamous NSCLC in the phase Ib/II study (NCT03083041). We hereby further investigated its efficacy in treatment-naive advanced NSCLC pts as in cohort 4 of this study. Methods: In this multicenter, open-label study, pts of advanced non-squamous NSCLC with EGFR/ALK wild type were enrolled. All pts, regardless of PD-L1 expression, received apatinib 250 mg orally once daily, in combination with camrelizumab 200 mg as front line setting every 2 weeks until disease progression or intolerable toxicity. The primary endpoint was objective response rate (ORR), and secondary endpoints included DCR, PFS and OS. Results: As the cutoff date of Dec 11, 2020, 25 pts were enrolled with a median follow-up of 15.24 months (range, 2.0-20.17). The median age was 61 years old. Twelve (48%) pts were still on treatment at the time of analysis, including 4 receiving treatment beyond disease progression. Among them, 10 (40.0%) partial responses, 13 (52.0%) stable diseases, 1 (4%) progressive disease and 1(4%) not evaluable were observed. The ORR was 40.0% (10/25, 95% CI, 21.1-61.3) and DCR was 92.0% (23/25, 95% CI, 74.0-99.0). The median PFS was 11.0 months (95% CI, 7.3-14.8), while median DOR and OS were not reached. All of them had PD-L1 expression detection and 15 (60%) were PD-L11%. Subgroups analysis showed similar ORR of 40.0% (95% CI, 16.3-67.7) versus 40% (95% CI, 12.2-73.8) (p＞0.99), and median PFS of 9.7 versus 11.0 months (HR¼1.56, p¼0.42) in pts with PD-L1 positive and negative tumor, respectively. The most common treatment-related adverse events of grade 3 or higher were hypertension (6 [ Introduction: Cancer-associated fibroblasts (CAFs) are a key immunosuppressive component of the tumor microenvironment (TME). Nintedanib is an oral triple kinase inhibitor that suppresses CAFs. Modulating the TME through inhibition of CAFs may represent an important synergistic approach in overcoming resistance to immune checkpoint inhibitors (ICIs). Based on these observations, we initiated a phase IB/II trial to evaluate the combination of nintedanib, nivolumab, and ipilimumab in advanced NSCLC patients. The phase IB dose-escalation results were presented at WCLC 2019 and the combination of nivolumab at 3mg/kg every 2 weeks, ipilimumab 1 mg/kg every 6 weeks, and nintedanib 150 mg once daily was declared as the recommended phase II dose (RP2D). Here we present the 1st interim analysis of phase II of the combination regimen in the ICI pre-treated patients. Methods: This is a single institution, investigational, non-randomized, parallel assignment phase I/II clinical trial of patients with locally advanced or metastatic NSCLC. Eligible patients can be immunotherapy naïve (Arm A) or with disease progression following immunotherapy (Arm B). Enrollment into phase II of the trial is being performed by the Bayesian two-stage design method with the primary objective of determining the efficacy of the combination regimen in NSCLC. Key secondary objectives are overall survival (OS) and progression-free survival (PFS). Descriptive statistics were used to summarize demographic and safety data. The KaplaneMeier method with log-rank test was used for survival analysis. Results: 20 patients received therapy with the combination of nivolumab, ipilimumab, and nintedanib at the RP2D in the ICI pretreated cohort (Arm B). The majority of patients were female (60%) with a current or prior history of tobacco use (84%) and an ECOG 

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou/CN, 3 Sir Run Run Shaw Hospital