BMC Cancer | |
Phase I prospective trial of TAS-102 (trifluridine and tipiracil) and radioembolization with 90Y resin microspheres for chemo-refractory colorectal liver metastases | |
Research | |
M. Alexandra Milloy1  Katherine Van Loon1  Julia Carnevale1  Alan P. Venook1  Nicholas Fidelman1  Chloe E. Atreya1  Madeline Griffith1  Pelin Cinar1  | |
[1] University of California, San Francisco, USA; | |
关键词: TAS-102; Lonsurf; Trifluridine; Tipiracil; Yttrium-90; Radioembolization; colon cancer; | |
DOI : 10.1186/s12885-022-10401-0 | |
received in 2022-09-01, accepted in 2022-12-05, 发布年份 2022 | |
来源: Springer | |
【 摘 要 】
BackgroundExtrahepatic disease progression limits clinical efficacy of Yttrium-90 (90Y) radioembolization (TARE) for patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). Trifluridine and tipiracil (TAS-102) has overall survival benefit for patients with refractory mCRC and may be a radiosensitizer.MethodsSequential lobar TARE using 90Y resin microspheres in combination with TAS-102 in 28-day cycles were used to treat adult patients with bilobar liver-dominant chemo-refractory mCRC according to 3 + 3 dose escalation design with a 12-patient dose expansion cohort. Study objectives were to establish safety and determine maximum tolerated dose (MTD) of TAS-102 in combination with TARE.ResultsA total of 21 patients (14 women, 7 men) with median age of 60 years were enrolled. No dose limiting toxicities were observed. Treatment related severe adverse events included cytopenias (10 patients, 48%) and radioembolization-induced liver disease (2 patients, 10%). Disease control rate in the liver lobes treated with TARE was 100%. Best observed radiographic responses were partial response for 4 patients (19%) and stable disease for 12 patients (57%).ConclusionsThe combination of TAS-102 and TARE for patients with liver-dominant mCRC is safe and consistently achieves disease control within the liver.Trial registrationClinicalTrials.gov identifier NCT02602327 (first posted 11/11/2015).
【 授权许可】
CC BY
© The Author(s) 2022
【 预 览 】
Files | Size | Format | View |
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RO202305067390268ZK.pdf | 1078KB | download | |
Fig. 2 | 1121KB | Image | download |
Fig. 4 | 2160KB | Image | download |
MediaObjects/12974_2022_2667_MOESM7_ESM.xlsx | 2852KB | Other | download |
Fig. 1 | 328KB | Image | download |
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