Abstract
Background
Thymic carcinoma (TC) is a rare thymic epithelial tumor, and advanced or recurrent
TC has limited prognosis. Treatment for chemotherapy-naïve, advanced, or recurrent
TC remains unchanged with the combination of carboplatin and paclitaxel; therefore,
a new treatment strategy is warranted. Immune checkpoint blockades inhibiting the
programmed cell death-1 (PD-1) pathway (PD-1 and its ligand, PD-L1) have shown potential
as a monotherapy for TC, although the efficacy of monotherapy was moderate for previously
treated TC. We hypothesized that the combination of an anti-PD-L1 antibody, atezolizumab,
with carboplatin and paclitaxel, would be effective in inducing immunogenic cell death
in patients with advanced or recurrent TC.
Methods
We initiated a multicenter, single-arm, open-label phase II study of atezolizumab
combined with carboplatin and paclitaxel for metastatic or recurrent TC. Eligible
patients will receive atezolizumab plus carboplatin and paclitaxel every three weeks
for up to six cycles, followed by atezolizumab every three weeks for up to two years
until progression or unacceptable toxicity. A total of 47 patients will be enrolled
in this study, with a 24-month enrollment period and 12-month follow-up. The primary
endpoint is the objective response rate (ORR), based on an independent central review.
The secondary endpoints are the investigator-assessed ORR, disease control rate, progression-free
survival, duration of response, overall survival, and safety.
Results
This study aims to establish the safety and efficacy of atezolizumab combined with
carboplatin and paclitaxel in patients with advanced or recurrent TC.
Trial registration
Japan Registry of Clinical Trials (jRCT), jRCT2031220144. Registered on June 18, 2022,
https://jrct.niph.go.jp/en-latest-detail/jRCT2031220144.
Keywords
Abbreviations:
AUC (Area under the curve), CI (Confidence interval), ECOG (Eastern Cooperative Oncology Group), HR (Hazard ratio), ICI (Immune checkpoint inhibitor), ICR (Independent central review), INV (Investigator-assessed), jRCT (Japan Registry of Clinical Trials), ORR (Objective response rate), OS (Overall survival), PD-1 (Programmed cell death-1), PD-L1 (Programmed cell death ligand-1), PFS (Progression-free survival), PS (Performance status), TC (Thymic carcinoma), TET (Thymic epithelial tumor)To read this article in full you will need to make a payment
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Article info
Publication history
Accepted:
May 15,
2023
Received in revised form:
May 14,
2023
Received:
February 7,
2023
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Elsevier Inc. All rights reserved.
