• Annals of surgery · May 2023

    First-in-Human Intrathoracic Implantation of Multidrug-Eluting Microdevices for In Situ Chemotherapeutic Sensitivity Testing as Proof of Concept in Non-Small Cell Lung Cancer.

    • Lillian L Tsai, William W Phillips, Yin P Hung, Christine Dominas, Kyle Deans, Sebastian Ahn, Benjamin Ferland, Kathleen Weiss, Michael Lanuti, Hugh Auchincloss, Lana Schumacher, Oliver Jonas, and Yolonda L Colson.
    • Division of Thoracic Surgery, Department of Surgery, Massachusetts General Hospital, Boston, MA.
    • Ann. Surg. 2023 May 1; 277 (5): e1143e1149e1143-e1149.

    ObjectiveTo evaluate the safety and feasibility of implantation and retrieval of a novel implantable microdevice (IMD) in NSCLC patients undergoing operative resection.BackgroundAdjuvant therapy has limited impact on postsurgical outcomes in NSCLC due to the inability to predict optimal treatment regimens.MethodsAn IMD measuring 6.5 mm by 0.7 mm, containing micro-reservoirs allowing for high-throughput localized drug delivery, was developed and loaded with 12 chemotherapeutic agents. Five patients with peripheral lung lesions larger than 1.0 cm were enrolled in this phase 1 clinical study. IMDs were inserted into tumors intraoperatively under direct vision, removed with the resected specimen, and retrieved in pathology. Surrounding tissues were sectioned, stained, and analyzed for tissue drug response to the IMD-delivered microdoses of these agents by a variety of pharmacodynamic markers.ResultsA total of 14 IMDs were implanted intraoperatively with 13 (93%) successfully retrieved. After technique refinement, IMDs were reliably inserted and retrieved in open, Video-Assisted Thoracoscopic Surgery, and robotic cases. No severe adverse reactions were observed. The one retained IMD has remained in place without movement or any adverse effects. Analysis of patient blood revealed no detection of chemotherapeutic agents. We observed differential sensitivities of patient tumors to the drugs on the IMD.ConclusionsA multi-drug IMD can be safely inserted and retrieved into lung tumors during a variety of surgical approaches. Future studies will encompass preoperative placement to better examine specific tumor responsiveness to therapeutic agents, allowing clinicians to tailor treatment regimens to the microenvironment of each patient.Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.

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