Evidence map›Paper›PMID 26424760›Full record

Trial reportThe oncologist2015

Phase II Trial of Nilotinib in Patients With Metastatic Malignant Melanoma Harboring KIT Gene Aberration: A Multicenter Trial of Korean Cancer Study Group (UN10-06).

Su Jin Lee, Tae Min Kim, Yu Jung Kim, Kee-Taek Jang, Hyo Jin Lee, Soon Nam Lee, Mi Sun Ahn, In Gyu Hwang, Suee Lee, Moon-Hee Lee and 1 more

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

Trial report in The oncologist, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
2.6field-weighted citation impact, top 10% 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

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  4. Trial
  5. Review
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  7. Article
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  15. Article
  16. RAS pathway regulation in melanoma.Disease models & mechanisms · 2022
    Review
  17. Article
  18. Review
  19. Cancer Therapy Guided by Mutation Tests: Current Status and Perspectives.International journal of molecular sciences · 2021
    Review
  20. Review
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

11 authors at 10 institutions in 1 country.

Su Jin LeeDepartment of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Tae Min KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Yu Jung KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
Kee-Taek JangDepartment of Pathology and Translational Genomics, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Hyo Jin LeeDivision of Hematology/Oncology, Department of Internal Medicine, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.
Soon Nam LeeDivision of Hemato-Oncology, Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Republic of Korea.
Mi Sun AhnDepartment of Hematology-Oncology, Ajou University School of Medicine, Suwon, Republic of Korea.
In Gyu HwangDepartment of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
Suee LeeDepartment of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Republic of Korea.
Moon-Hee LeeDepartment of Hemato-Oncology, Inha University School of Medicine, Incheon, Republic of Korea.
Jeeyun LeeDepartment of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea jyunlee@skku.edu.
Samsung Medical Center · KRAjou University · KRChung-Ang University · KRChungnam National University · KRDong-A University Hospital · KREwha Womans University · KRInha University · KRSeoul National University Bundang Hospital · KRSeoul National University Hospital · KRSungkyunkwan University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundKIT has been suggested to be a potential therapeutic target for malignant melanoma. We evaluated the antitumor activity and safety of the KIT inhibitor nilotinib in metastatic melanoma patients harboring KIT gene mutations or amplifications.

methodsWe conducted a phase II multicenter trial of nilotinib in metastatic malignant melanoma with KIT mutations or amplifications. Patients received 400 mg oral nilotinib twice daily. The primary endpoint was response rate, and if seven or more responders were observed from the cumulative 36 patients, nilotinib would be considered worthy of further testing in this study population.

resultsBetween October 2009 and June 2013, 176 patients underwent molecular screening for KIT gene aberrations, and 42 patients harboring KIT gene mutations and/or amplification were enrolled in the study. Overall, 25 (59.5%), 15 (35.7%), and 2 (4.8%) patients had KIT mutations, KIT amplifications, and both KIT mutations and amplification, respectively. Of the 42 enrolled patients, 1 patient achieved complete response, 6 patients achieved partial response, and 17 patients achieved stable disease, resulting in an overall response rate of 16.7% (95% confidence interval [CI]: 5.4%-28.0%) and a disease control rate of 57.1% (95% CI: 42.1%-72.1%). The median duration of response was 34 weeks (range: 5-55 weeks). Of the 7 responders, 6 patients had KIT mutations (exon 11: 5 patients; exon 17: 1 patient), and 1 patient had KIT amplification only.

conclusionAlthough this study did not meet its primary endpoint of response rate, nilotinib showed durable response in a subset of metastatic melanoma patients with specific KIT mutations. IMPLICATIONS FOR PRACTICE: KIT aberration can be detected in a subset of metastatic melanoma patients. This phase II trial showed that nilotinib demonstrates durable response in a subset of patients with KIT mutations. The safety profile was very tolerable. This study suggests that a KIT inhibitor may benefit a small subset of metastatic melanoma patients with KIT mutations.

Indexed as

AdultAgedAged, 80 and overDisease-Free SurvivalFemaleGene AmplificationHumansMaleMelanomaMiddle AgedMutationNeoplasm MetastasisProto-Oncogene Proteins c-kitPyrimidinesnilotinibProto-Oncogene Proteins c-kitPyrimidinesKIT amplificationKIT mutationMelanomaNilotinib

Identifiers

PMID26424760
PMCPMC4718426
OpenAlexW2156027275

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.