Abstract CT051: Double lung transplant registry aimed for lung-limited malignancies (DREAM) - a prospective registry study of bilateral lung transplantation for medically refractory cancers confined to the lungs

Abstract

Abstract Background: According to a consensus document from the International Society for Heart and Lung Transplantation (ISHLT), adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) are listed as ‘special circumstances’ for lung transplantation (Weill D et al., 2015). There have been five reported studies of lung transplantation in carefully selected subsets of patients with multifocal lung adenocarcinoma (Raemdonck DV et al., 2016; Glanville AR et al., 2018). The 5-year survival rate of bilateral sequential lung transplantation was estimated at over 50% in patients with multifocal BAC, invasive adenocarcinoma, and NSCLC (Ahmad U et al., 2012; Paloyan EB et al., 2000; Zorn GL et al., 2003; de Perrot M et al., 2004). In 1999, a case series reported a post-transplant recurrence-free survival of 23 to 56 months in three patients (Garver RI et al., 1999). There is also an unmet need for patients who have lung-limited metastasis after successful treatment for primary tumors such as sarcomas or colorectal cancer (CRC). As with liver transplantation for CRC patients who have liver-confined metastases (Dueland S et at., 2020; Hernandez-Alejandro R et al., 2022), the applicability of lung transplantation in lung-limited metastasis patients should be explored. Methods: This is a prospective registration trial to evaluate outcomes of patients who undergo lung transplantation for the treatment of the select groups of medically refractory cancers (primary lung cancers or metastatic cancers in lungs). Overall survival (OS), disease-free survival (DFS), allograft rejection (AR) and allograft survival (AS) will be monitored as well as molecular and genetic biomarkers to investigate the correlation with prognosis. The study duration will be 10 years including surveillance. Recruitment to occur during the first 5 years of the study. The goal is to enroll 175 participants through the Lurie Comprehensive Cancer Center of Northwestern University. Essential Criteria: The tumor should be without any involvement of mediastinal lymph nodes involvement confirmed by endobronchial ultrasound (EBUS) or mediastinoscopy. The patient who are resistant or refractory to or without available standard of care treatment options or experimental treatment options that are known to increase survival outcome. Study cohorts: • Cohort A: Primary lung cancers - Examples include, but not limited to, invasive mucinous/non-mucinous non-small cell lung cancers and multifocal carcinomas. • Cohort B: Metastatic cancers to the lung only - Examples include, but not limited to, germ cell tumors, head & neck tumors, colorectal tumors, renal cell tumors, testicular cancers. Clinical trial registry number: NCT05671887. Enrollment began November 16, 2022. Trial is open and recruiting as of January 12, 2023. Citation Format: Young Chae, Liam Il-Young Chung, Rade Tomic, Ankit Bharat. Double lung transplant registry aimed for lung-limited malignancies (DREAM) - a prospective registry study of bilateral lung transplantation for medically refractory cancers confined to the lungs [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT051.