Original Research
AB059. Enrollment in clinical trials among Italian patients with metastatic thymic epithelial tumors: a retrospective TYME network analysis
Nadia Cordua1,2, Giuseppe Lo Russo3, Martino Tommaso De Pas4, Annalisa Trama5, Matteo Perrino1, Claudia Proto3, Fabio Conforti4, Marta Aliprandi1, Monica Ganzinelli3, Luigi Giovanni Cecchi1, Giovanni Leuzzi6, Chiara Catania7, Alessandro Bertocchi1, Giulia Montelatici3, Laura Pala4,8, Antonio Federico1, Fabio De Vincenzo1, Laura Giordano9, Ilaria Piloni4, Paolo Andrea Zucali1,2
1Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy;
2Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy;
3UOS Thoracic Oncology, Department of Medical Oncology, IRCCS National Cancer Institute of Milan, Milan, Italy;
4Division of Medical Oncology, Humanitas Gavazzeni, Bergamo, Italy;
5Evaluative Epidemiology Unit, Department of Epidemiology and Data Science, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy;
6Division of Thoracic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;
7Unit of Thoracic Oncology, Gavazzeni Humanitas Bergamo, Bergamo, Italy;
8Tumor Microenvironment Unit, IRCCS Humanitas Research Hospital, Milan, Italy;
9Biostatistics Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy
Correspondence to: Nadia Cordua, MD. Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, Milano, 20090, Italy; Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Via Alessandro Manzoni 56, Rozzano, Milano, 20089, Italy. Email: nadia.cordua@humanitas.it.
Background: Thymic epithelial tumors (TETs) are rare malignancies with a limited therapeutic armamentarium. Enrollment in prospective clinical trials involving novel agents or new treatment combinations represents a therapeutic opportunity for patients with TETs. However, the availability to such trials is often limited due to poor engagement by pharmaceutical companies in rare cancer research. This study retrospectively investigated the proportion of Italian patients with metastatic TETs treated with experimental systemic therapy (any lines) in prospective clinical trials.
Methods: Clinicoradiological, histopathological, and oncological data were retrospectively collected for 135 patients with unresectable metastatic TETs who received systemic therapy between January 2000 and December 2020. Data were sourced from the large multicenter database of the Italian collaborative group for ThYmic MalignanciEs (TYME). Survival analyses were performed using the Kaplan-Meier method and stratified by histology.
Results: A total of 135 patients were included: 73 (54%) treated within clinical trials (any lines of therapy) and 62 (46%) treated outside of trials. Among the trial group, 59 patients (80.8%) had thymoma B3 or thymic carcinoma (TC), and 14 (19.2%) had other thymoma subtypes. In the non-trial group, 35 patients (56.4%) had thymoma B3 or TC, and 27 (43.5%) had other thymoma subtypes. Overall, 46 out of 63 patients (73%) treated in a protocol study received experimental drugs in the second or third-line setting. At 36 months, the overall survival (OS) rate was 75.8% in the trial group and 83.5% in the non-trial group. Stratifying by histology, patients with TC or thymoma B3 had a 36-month OS rate of 71.5% in the trial group and 73.7% in the non-trial group. Among patients with other thymoma subtypes, the 36-month OS was 92.8% in the trial group and 95.8% in the non-trial group.
Conclusions: Our analysis showed that, within the Italian TYME network, the majority of patients with metastatic TETs were treated with systemic therapy in the context of a clinical trial. Moreover, these patients presented a higher proportion of histologies associated with a poor prognosis compared to those not treated with experimental drugs. Further data collection is needed to explore whether meaningful differences exist between patients treated within and outside.
Keywords: Thymic epithelial tumors (TETs); clinical trials; rare cancers; ThYmic MalignanciEs collaborative group (TYME collaborative group)
Acknowledgments
None.
Funding: None.
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://med.amegroups.com/article/view/10.21037/med-25-ab059/coif). P.A.Z. reports participation as board of directors in Merck Sharp and Dohme, Astellas, Janssen, Sanofi, Ipsen, Pfizer, Novartis, Bristol Meyer Squibb, Amgen, AstraZeneca, Roche, and Bayer, and received payments and financing supports from them. M.T.D.P. serves as board director for MSD, Regeneron, Roche, Lilly, BMS, Amgen, Astrazeneca, Johnson and Johnson, Merck, Novartis, Pierre Fabre, Bayer, Beigene, Pfizer, Takeda, GSK, Daiichi, and Sanofi. For his board role, he received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events and support for attending meetings and/or travel from MSD, Roche, Amgen, Sanofi, BMS. M.T.D.P. serves as board director for Roche, Astrazeneca, Daiichi, Regeneron, Lilly, Pfizer, Novartis, Eisai, Gentili and received support for attending meetings/or travel from them. Matteo Perrino received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Astellas, Johnson & Johnson, Bayer, BMS, and received support for attending meetings/or travel from them. C.C. serves as board director for Roche, Astra Zeneca, Daiichi, Regeneron, Lilly, Pfizer, Novartis, Eisai, Gentili. C.C. received consulting fees and payment for his role in Roche, Astra Zeneca, Daiich. C.C. received support for attending meetings/or travel from Roche, Astrazeneca, Daiichi, Regeneron, Lilly, Pfizer, Novartis, Eisai, Gentili. The other authors have no conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the regional ethics board (Comitato etico territoriale Lombardia 5) (No. 4370) and individual consent for this retrospective analysis was waived.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
doi: 10.21037/med-25-ab059
Cite this abstract as: Cordua N, Lo Russo G, De Pas MT, Trama A, Perrino M, Proto C, Conforti F, Aliprandi M, Ganzinelli M, Cecchi LG, Leuzzi G, Catania C, Bertocchi A, Montelatici G, Pala L, Federico A, De Vincenzo F, Giordano L, Piloni I, Zucali PA. AB059. Enrollment in clinical trials among Italian patients with metastatic thymic epithelial tumors: a retrospective TYME network analysis. Mediastinum 2025;9:AB059.
