Evidence map›Paper›PMID 32340084›Full record

Trial reportCancer research and treatment2020

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

Jwa Hoon Kim, Sun Young Kim, Ji Yeon Baek, Yong Jun Cha, Joong Bae Ahn, Han Sang Kim, Keun-Wook Lee, Ji-Won Kim, Tae-You Kim, Won Jin Chang and 6 more

Open access · diamondAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer research and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 2 pooled it
7.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
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  7. Article
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  10. The current status and prospect of immunotherapy in colorectal cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Review
  11. Review
  12. The game-changing impact ofFrontiers in oncology · 2024
    Review
  13. Review
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  15. Article
  16. Current status and prospect of immunotherapy for colorectal cancer.International journal of colorectal disease · 2023
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

Jwa Hoon KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Sun Young KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Ji Yeon BaekCenter for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
Yong Jun ChaCenter for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
Joong Bae AhnDivision of Medical Oncology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Han Sang KimDivision of Medical Oncology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Keun-Wook LeeDivision of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Ji-Won KimDivision of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Tae-You KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Won Jin ChangDivision of Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Joon Oh ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Jihun KimDepartment of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Jeong Eun KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Yong Sang HongDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Yeul Hong KimDivision of Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Tae Won KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Seoul National University Bundang Hospital · KRAsan Medical Center · KRKorea University · KRNational Cancer Center · KRUniversity of Ulsan · KRSamsung Medical Center · KRSeoul National University Hospital · KRSeverance Hospital · KRYonsei University · KR

Funding

Ministry of Health and Welfare HI17C2206
6 · The paper itself

Abstract

purposeWe 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

methodsIn 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.

resultsThe 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.

conclusionAvelumab 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.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalColorectal NeoplasmsDNA Mismatch RepairDNA Polymerase IIFemaleFollow-Up StudiesHumansInfusions, IntravenousMaleMicrosatellite InstabilityMiddle AgedMutationAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalavelumabDNA Polymerase IIPOLE protein, humanPoly-ADP-Ribose Binding ProteinsAvelumabColorectal neoplasmsMicrosatellite instabilityMismatch repair deficiencyPOLE mutation

Identifiers

PMID32340084
PMCPMC7577804
OpenAlexW3018059490

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.