16 59

Cited 0 times in

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

DC FieldValueLanguage
dc.contributor.author김한상-
dc.contributor.author안중배-
dc.date.accessioned2020-12-01T17:25:16Z-
dc.date.available2020-12-01T17:25:16Z-
dc.date.issued2020-10-
dc.identifier.issn1598-2998-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/180262-
dc.description.abstractPurpose: 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 avelumab 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 microsatellite 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.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish, Korean-
dc.publisherOfficial journal of Korean Cancer Association-
dc.relation.isPartOfCANCER RESEARCH AND TREATMENT-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleA Phase II Study of Avelumab Monotherapy in Patients with Mismatch Repair-Deficient/Microsatellite Instability-High or POLE-Mutated Metastatic or Unresectable Colorectal Cancer-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorJwa Hoon Kim-
dc.contributor.googleauthorSun Young Kim-
dc.contributor.googleauthorJi Yeon Baek-
dc.contributor.googleauthorYong Jun Cha-
dc.contributor.googleauthorJoong Bae Ahn-
dc.contributor.googleauthorHan Sang Kim-
dc.contributor.googleauthorKeun-Wook Lee-
dc.contributor.googleauthorJi-Won Kim-
dc.contributor.googleauthorTae-You Kim-
dc.contributor.googleauthorWon Jin Chang-
dc.contributor.googleauthorJoon Oh Park-
dc.contributor.googleauthorJihun Kim-
dc.contributor.googleauthorJeong Eun Kim-
dc.contributor.googleauthorYong Sang Hong-
dc.contributor.googleauthorYeul Hong Kim-
dc.contributor.googleauthorTae Won Kim-
dc.identifier.doi10.4143/crt.2020.218-
dc.contributor.localIdA01098-
dc.contributor.localIdA02262-
dc.contributor.localIdA02262-
dc.relation.journalcodeJ00453-
dc.identifier.eissn2005-9256-
dc.identifier.pmid32340084-
dc.subject.keywordAvelumab-
dc.subject.keywordColorectal neoplasms-
dc.subject.keywordMicrosatellite instability-
dc.subject.keywordMismatch repair deficiency-
dc.subject.keywordPOLE mutation-
dc.contributor.alternativeNameKim, Han Sang-
dc.contributor.affiliatedAuthor김한상-
dc.contributor.affiliatedAuthor안중배-
dc.contributor.affiliatedAuthor안중배-
dc.citation.volume52-
dc.citation.number4-
dc.citation.startPage1135-
dc.citation.endPage1144-
dc.identifier.bibliographicCitationCANCER RESEARCH AND TREATMENT, Vol.52(4) : 1135-1144, 2020-10-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.