545P Real world data of capecitabine plus gemcitabine in thymic epithelial tumors: A retrospective analysis

Background: Thymic epithelial tumors (TETs), including thymoma (T) and thymic carcinoma (TC), are rare malignancies with no standard therapy beyond platinumbased chemotherapy in advanced disease.Capecitabine plus gemcitabine (C+G) have reported 40% of objective response rate (ORR) in a phase II trial (n=30), but realworld evidence remains scarce. Methods:We retrospectively identified patients (pts) with TETs treated with C+G as 2nd-line therapy within the French RYTHMIC network (2016)(2017)(2018)(2019)(2020)(2021)(2022)(2023)(2024)(2025).PFS and overall survival (OS) were calculated from treatment start, estimated through Kaplan-Meier curves and compared via log-rank test.Multivariable Cox models were conducted including histology, ECOG PS, and liver metastases.Toxicity was graded according to CTCAE v5.Results: Overall, 38 pts (22 TC, 16 T) received C+G.Median age was 50 years, 39% were female, 81% had a PS 0-1 and 76% received C+G as 3rd-line.Autoimmune diseases occurred in 5% of TC and 31% of T. Among 36 pts evaluable for response, ORR was 39% (35% in TC; 44% in T).In the overall cohort (n = 38), with a median follow-up of 46.5 months, the median PFS was 5.8 months (95% CI: 4.5-9.7),while the median OS was 25.6 months (95% CI: 17.8-62.3).When stratified by histology, pts with TC had a median PFS of 5.0 months and a median OS of 16.9 months, whereas those with T achieved a median PFS of 5.9 months and a median OS of 34.0 months (Table ).At multivariate analysis, ECOG PS 2 was independently associated with worse PFS and OS.Among 28 pts with available safety data, grade 3 toxicities included thrombocytopenia (14%), neutropenia (7%), and anemia (7%); fatigue (36%), hand-foot syndrome (28%), and mucositis (11%) were the most common grade 1-2 events.No treatment-related deaths occurred; one patient discontinued due to toxicity. Conclusions:In this real-world cohort, C+G showed clinically meaningful activity and manageable toxicity in advanced TETs, supporting its use in later-line settings.

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Journal
ESMO Open
Published
2026-03-17
DOI
https://doi.org/10.1016/j.esmoop.2026.106860
Primary Topic
Myasthenia Gravis and Thymoma
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article
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article

545P Real world data of capecitabine plus gemcitabine in thymic epithelial tumors: A retrospective analysis

Alexandre Megherbi, Xavier Quantin, Daniela Miliziano, Julien Mazieres et al.
ESMO Open
Myasthenia Gravis and Thymoma
article

545P Real world data of capecitabine plus gemcitabine in thymic epithelial tumors: A retrospective analysis

Alexandre Megherbi, Xavier Quantin, Daniela Miliziano, Julien Mazieres, Lodovica Zullo, Pascale Missy, T. Molina, J. Remon Masip, N. Girard, B. Besse, A.B. Cortot, A. Lopez Gutierrez, V. Zengerling Cadot, C. Baylot
article en

Abstract

Background: Thymic epithelial tumors (TETs), including thymoma (T) and thymic carcinoma (TC), are rare malignancies with no standard therapy beyond platinumbased chemotherapy in advanced disease.Capecitabine plus gemcitabine (C+G) have reported 40% of objective response rate (ORR) in a phase II trial (n=30), but realworld evidence remains scarce. Methods:We retrospectively identified patients (pts) with TETs treated with C+G as 2nd-line therapy within the French RYTHMIC network (2016)(2017)(2018)(2019)(2020)(2021)(2022)(2023)(2024)(2025).PFS and overall survival (OS) were calculated from treatment start, estimated through Kaplan-Meier curves and compared via log-rank test.Multivariable Cox models were conducted including histology, ECOG PS, and liver metastases.Toxicity was graded according to CTCAE v5.Results: Overall, 38 pts (22 TC, 16 T) received C+G.Median age was 50 years, 39% were female, 81% had a PS 0-1 and 76% received C+G as 3rd-line.Autoimmune diseases occurred in 5% of TC and 31% of T. Among 36 pts evaluable for response, ORR was 39% (35% in TC; 44% in T).In the overall cohort (n = 38), with a median follow-up of 46.5 months, the median PFS was 5.8 months (95% CI: 4.5-9.7),while the median OS was 25.6 months (95% CI: 17.8-62.3).When stratified by histology, pts with TC had a median PFS of 5.0 months and a median OS of 16.9 months, whereas those with T achieved a median PFS of 5.9 months and a median OS of 34.0 months (Table ).At multivariate analysis, ECOG PS 2 was independently associated with worse PFS and OS.Among 28 pts with available safety data, grade 3 toxicities included thrombocytopenia (14%), neutropenia (7%), and anemia (7%); fatigue (36%), hand-foot syndrome (28%), and mucositis (11%) were the most common grade 1-2 events.No treatment-related deaths occurred; one patient discontinued due to toxicity. Conclusions:In this real-world cohort, C+G showed clinically meaningful activity and manageable toxicity in advanced TETs, supporting its use in later-line settings.

ESMO OpenVol. 11
Hôpital Necker-Enfants Malades (FR), Université de Versailles Saint-Quentin-en-Yvelines (FR), Université Paris-Saclay (FR), Institut Gustave Roussy (FR), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire de Toulouse (FR), Institut Necker Enfants Malades (FR), Intergroupe Francophone de Cancérologie Thoracique (FR), Hôpital d'Enfants (FR), Hôpital Larrey (FR), Centre Hospitalier de Rochefort (FR), Institut de Recherche en Cancérologie de Montpellier (FR), Centre Hospitalier Vétérinaire Frégis (FR)
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