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A Phase 2 Study of Palbociclib for Recurrent or Refractory Advanced Thymic Epithelial Tumors (KCSG LU17-21)

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Author(s)
Hyun Ae JungMiso KimHae Su KimJoo-Hang KimYoon Hee ChoiJinhyun ChoJi Hyun ParkKeon Uk ParkBo Mi KuSehhoon ParkJong-Mu SunSe-Hoon LeeJin Seok AhnKeunchil ParkMyung-Ju Ahn
Keimyung Author(s)
Park, Keon Uk
Department
Dept. of Internal Medicine (내과학)
Journal Title
J Thorac Oncol
Issued Date
2023
Volume
18
Issue
2
Keyword
PalbociclibPlatinum-based combination chemotherapyThymic carcinomaThymic epithelial tumorsThymoma
Abstract
Introduction:
Thymic epithelial tumors (TETs) are rare but are the most common tumors of the anterior mediastinum. Platinum-based combination chemotherapy is the standard of care for such tumors and is associated with a 50% to 90% objective response rate (ORR) in metastatic disease. Nevertheless, there is no standard chemotherapeutic option after failure of platinum-based combination chemotherapy. Genetic alterations associated with the cell cycle, including pRB, p16INK4A, and cyclin D1, are most often observed in TETs. On the basis of these results, we conducted a phase 2 trial to evaluate the efficacy and safety of palbociclib in patients with recurrent or refractory advanced TETs.

Methods:
This is a phase 2, multicenter, open-label, single-arm study of palbociclib monotherapy in patients with recurrent or metastatic advanced TETs who failed one or more cytotoxic chemotherapies. The patients received 125 mg of oral palbociclib daily for 21 days, followed by a 7-day break. The primary end point was progression-free survival (PFS). The secondary end points were ORR, duration of response, overall survival, and safety.

Results:
Between August 2017 and October 2019, a total of 48 patients were enrolled. The median number of previous chemotherapies was one (range: one to four), and 21 (43.7%) of 48 patients received thymectomy. By the WHO classification, the patients were type A (n = 1), type B1 (n = 2), type B2 (n = 8), type B3 (n = 13), thymic carcinoma (n = 23), and unknown (n = 1). With a median follow-up of 14.5 months (range: 0.8-38.2), the median number of cycles of palbociclib monotherapy was 10 (range: 1-40). The ORR was 12.5% (four partial responses in thymoma and two partial responses in thymic carcinoma). The PFS at 6 months was 60.2%, and the median PFS was 11.0 months (95% confidence interval: 4.6-17.4). The median overall survival was 26.4 months (95% confidence interval: 17.4-35.4). The most common treatment-related adverse events of any grade were neutropenia (62.5%), anemia (37.5%), and thrombocytopenia (29.1%), and the most common grade 3/4 treatment-related hematologic adverse event was neutropenia (41.7%). Neutropenia above grade 3 was reversible, and there were no cases with neutropenic fever.

Conclusions:
Palbociclib monotherapy was well tolerated and had encouraging efficacy in patients with TETs who failed platinum-based combination chemotherapy.
Keimyung Author(s)(Kor)
박건욱
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1556-1380
Source
https://www.sciencedirect.com/science/article/abs/pii/S1556086422018585?via%3Dihub
DOI
10.1016/j.jtho.2022.10.008
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/44731
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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