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 Field | Value | Language |
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dc.contributor.author | Kim, Jwa Hoon | - |
dc.contributor.author | Kim, Sun Young | - |
dc.contributor.author | Baek, Ji Yeon | - |
dc.contributor.author | Cha, Yong Jun | - |
dc.contributor.author | Ahn, Joong Bae | - |
dc.contributor.author | Kim, Han Sang | - |
dc.contributor.author | Lee, Keun-Wook | - |
dc.contributor.author | Kim, Ji-Won | - |
dc.contributor.author | Kim, Tae-You | - |
dc.contributor.author | Chang, Won Jin | - |
dc.contributor.author | Park, Joon Oh | - |
dc.contributor.author | Kim, Jihun | - |
dc.contributor.author | Kim, Jeong Eun | - |
dc.contributor.author | Hong, Yong Sang | - |
dc.contributor.author | Kim, Yeul Hong | - |
dc.contributor.author | Kim, Tae Won | - |
dc.date.accessioned | 2021-08-30T12:59:33Z | - |
dc.date.available | 2021-08-30T12:59:33Z | - |
dc.date.created | 2021-06-19 | - |
dc.date.issued | 2020-10 | - |
dc.identifier.issn | 1598-2998 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/52642 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | KOREAN CANCER ASSOCIATION | - |
dc.subject | JAVELIN SOLID TUMOR | - |
dc.subject | OPEN-LABEL | - |
dc.subject | PD-1 BLOCKADE | - |
dc.subject | MULTICENTER | - |
dc.subject | DEFICIENT | - |
dc.title | 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.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Yeul Hong | - |
dc.identifier.doi | 10.4143/crt.2020.218 | - |
dc.identifier.scopusid | 2-s2.0-85089654265 | - |
dc.identifier.wosid | 000579859000014 | - |
dc.identifier.bibliographicCitation | CANCER RESEARCH AND TREATMENT, v.52, no.4, pp.1135 - 1144 | - |
dc.relation.isPartOf | CANCER RESEARCH AND TREATMENT | - |
dc.citation.title | CANCER RESEARCH AND TREATMENT | - |
dc.citation.volume | 52 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 1135 | - |
dc.citation.endPage | 1144 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART002636098 | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | JAVELIN SOLID TUMOR | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | PD-1 BLOCKADE | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | DEFICIENT | - |
dc.subject.keywordAuthor | Colorectal neoplasms | - |
dc.subject.keywordAuthor | Mismatch repair deficiency | - |
dc.subject.keywordAuthor | Microsatellite instability | - |
dc.subject.keywordAuthor | POLE mutation | - |
dc.subject.keywordAuthor | Avelumab | - |
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