AB051. Phase II, neo-adjuvant pembrolizumab, paclitaxel, carboplatin therapy followed by post operational pembrolizumab consolidation in locally advanced thymic epithelial tumor
Abstract

AB051. Phase II, neo-adjuvant pembrolizumab, paclitaxel, carboplatin therapy followed by post operational pembrolizumab consolidation in locally advanced thymic epithelial tumor

Sehhoon Park1, Kyungmi Yang2, Jae Myoung Noh2, Hongryull Pyo2, Yong Chan Ahn2, Yoon-La Choi3, Yeong Hak Bang1, Jinyoung Kim1, Hyun Ae Jung1, Jong-Mu Sun1, Se-Hoon Lee1, Jin Seok Ahn1, Myung-Ju Ahn1, Yeong Jeong Jeon4, Junghee Lee4, Seong Yong Park4, Jong Ho Cho4, Hong Kwan Kim4, Yong Soo Choi4, Young Mog Shim4

1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 2Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 3Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 4Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

Correspondence to: Sehhoon Park, MD, PhD. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Irwon-ro 115, Gangnam-Gu, Seoul 06355, Republic of Korea. Email: sehhoon.park@gmail.com.

Background: Thymic epithelial tumors (TETs), the most common tumors of the anterior mediastinum, are epithelial neoplasms of the thymus characterized by a wide spectrum of morphologic features. Complete surgical resection remains the primary treatment modality. However, for locally advanced disease, neoadjuvant chemotherapy is considered to increase the rate of complete resection and major pathological response, thereby prolonging both recurrence-free survival and overall survival. This study is based on the hypothesis that neoadjuvant pembrolizumab, when administered concurrently with chemotherapy, can enhance the response rate and deepen the pathological response by increasing the rate of major pathological response. We also anticipate that this combination will improve the likelihood of achieving complete surgical resection. Additionally, by administering maintenance pembrolizumab post-surgery, we aim to achieve long-term disease control.

Methods: Patients (n=40) with pathologically confirmed TET at locally advanced stages, defined as modified Masaoka stage III or IVa, were eligible for participation. Eligible patients must have no previous history of chemotherapy and must be able to tolerate trimodality treatment. The eligibility criteria for TET pathology were amended to include only World Health Organization (WHO) classification B3 and C due to safety concerns. As a neoadjuvant regimen, patients received three cycles of paclitaxel (175 mg/m2), cisplatin (75 mg/m2), and pembrolizumab (200 mg). After the neoadjuvant treatment, treatment response was re-evaluated using computed tomography (CT) and positron emission tomography (PET)-CT scans. Based on resectability, surgery was performed. Subsequent treatment intensity was decided based on surgical outcomes. For R0 resected patients, pembrolizumab was applied as maintenance therapy for 32 cycles every 3 weeks. For R1 and R2 resected patients, adjuvant radiotherapy (52.8 Gy/24 fractions and 59.4 Gy/27 fractions, respectively) was added to maintenance pembrolizumab. The primary endpoint is the major pathological response rate. The first patient was recruited in March 2020, and currently, a study is ongoing with total of 36 patients have received treatment (NCT03858582).

Keywords: Thymic epithelial tumor (TET); pembrolizumab; neoadjuvant

Acknowledgments

Funding: None.

Footnote

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://med.amegroups.com/article/view/10.21037/med-24-ab051/coif). The 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 (as revised in 2013). The study was approved by the Samsung Medical Center institutional review board (IRB # 2018-11-105) and informed consent was obtained from all individual participants.

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-24-ab051
Cite this abstract as: Park S, Yang K, Noh JM, Pyo H, Ahn YC, Choi YL, Bang YH, Kim J, Jung HA, Sun JM, Lee SH, Ahn JS, Ahn MJ, Jeon YJ, Lee J, Park SY, Cho JH, Kim HK, Choi YS, Shim YM. AB051. Phase II, neo-adjuvant pembrolizumab, paclitaxel, carboplatin therapy followed by post operational pembrolizumab consolidation in locally advanced thymic epithelial tumor. Mediastinum 2024;8:AB051.

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