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Cited 12 time in webofscience Cited 14 time in scopus
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A Phase II Study of Avelumab Monotherapy in Patients with Mismatch Repair-Deficient/Microsatellite Instability-High or POLE-Mutated Metastatic or Unresectable Colorectal Cancer

Authors
Kim, Jwa HoonKim, Sun YoungBaek, Ji YeonCha, Yong JunAhn, Joong BaeKim, Han SangLee, Keun-WookKim, Ji-WonKim, Tae-YouChang, Won JinPark, Joon OhKim, JihunKim, Jeong EunHong, Yong SangKim, Yeul HongKim, Tae Won
Issue Date
10월-2020
Publisher
KOREAN CANCER ASSOCIATION
Keywords
Colorectal neoplasms; Mismatch repair deficiency; Microsatellite instability; POLE mutation; Avelumab
Citation
CANCER RESEARCH AND TREATMENT, v.52, no.4, pp.1135 - 1144
Indexed
SCIE
SCOPUS
KCI
Journal Title
CANCER RESEARCH AND TREATMENT
Volume
52
Number
4
Start Page
1135
End Page
1144
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/52642
DOI
10.4143/crt.2020.218
ISSN
1598-2998
Abstract
Purpose We evaluated the efficacy and safety of avelumab, an anti-PD-L1 antibody, in patients with metastatic or unresectable colorectal cancer (mCRC) with mismatch repair deficiency (dMMR)/microsatellite instability-high (MSI-H) or POLE mutations. Materials and Methods In this prospective, open-label, multicenter phase II study, 33 patients with mCRC harboring dMMR/MSI-H or POLE mutations after failure of >= 1st-line chemotherapy received ave-lumab 10 mg/kg every 2 weeks. dMMR/MSI-H was confirmed with immunohistochemical staining (IHC) by loss of expression of MMR proteins or polymerase chain reaction (PCR) for micro-satellite sequences. POLE mutation was confirmed by next-generation sequencing (NGS). The primary endpoint was the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors ver. 1.1. Results The median age was 60 years, and 78.8% were male. Thirty patients were dMMR/MSI-H and three had POLE mutations. The ORR was 24.2%, and all of the responders were dMMR/MSI-H. For 21 patients with MSI-H by PCR or NGS, the ORR was 28.6%. At a median follow-up duration of 16.3 months, median progression-free survival and overall survival were 3.9 and 13.2 months in all patients, and 8.1 months and not reached, respectively, in patients with MSI-H by PCR or NGS. Dose interruption and discontinuation due to treatment-related adverse events occurred in four and two patients, respectively, with no treatment-related deaths. Conclusion Avelumab displayed antitumor activity with manageable toxicity in patients with previously treated mCRC harboring dMMR/MSI-H. Diagnosis of dMMR/MSI-H with PCR or NGS could be complementary to IHC to select patients who would benefit from immunotherapy.
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