Evidence map›Paper›PMID 30284603›Full record

Trial reportCancer chemotherapy and pharmacology2018

A phase II study of NK012, a polymeric micelle formulation of SN-38, in unresectable, metastatic or recurrent colorectal cancer patients.

Tetsuya Hamaguchi, Akihito Tsuji, Kensei Yamaguchi, Koji Takeda, Hiroyuki Uetake, Taito Esaki, Kenji Amagai, Daisuke Sakai, Hideo Baba, Masami Kimura and 2 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 15% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.

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  8. Nanotheranostics: A Cutting-edge Technology for Cancer Management.Current pharmaceutical biotechnology · 2025
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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

12 authors at 12 institutions in 1 country.

Tetsuya HamaguchiGastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan. thamaguc@saitama-med.ac.jp.
Akihito TsujiDivision of Medical Oncology, Kochi Health Science Center, Kochi, Japan.
Kensei YamaguchiDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Koji TakedaDepartmentof Medical Oncology, Osaka City General Hospital, Osaka, Japan.
Hiroyuki UetakeDepartment of Specialized Surgeries, Tokyo Medical and Dental University, Tokyo, Japan.
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
Kenji AmagaiDepartment of Gastroenterology, Ibaraki Prefectural Central Hospital, Ibaraki, Japan.
Daisuke SakaiDepartment of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Masami KimuraDepartment of Surgery, Japan Community Health Care Organization, Hitoyoshi Medical Center, Kumamoto, Japan.
Yasuhiro MatsumuraDivision of Developmental Therapeutics, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Chiba, Japan.
Tetsuji TsukamotoNippon Kayaku Co., Ltd., Tokyo, Japan.
Chiba Cancer Center · JPIbaraki Prefectural Central Hospital · JPKochi Medical School Hospital · JPKumamoto Medical Center · JPKumamoto University · JPNational Cancer Center Hospital East · JPNational Hospital Organization Kyushu Cancer Center · JPNippon Kayaku (Japan) · JPOsaka City General Hospital · JPOsaka University · JPSaitama Cancer Center · JPTokyo Medical and Dental University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNK012 is a polymeric micelle formulation of SN-38, the active metabolite of irinotecan. We evaluated the efficacy and safety of NK012 in Japanese patients with unresectable metastatic colorectal cancer.

methodsWe conducted a multicenter open-label phase II trial of NK012 monotherapy in 58 patients who had been treated with an oxaliplatin-based chemotherapy regimen (group A: 53 patients with UGT1A1 genotype -/-, *6/-, or *28/-; group B: 5 patients with UGT1A1 genotype *6/*28 or *6/*6). The primary endpoint was the response rate (RR). Initial doses of 28 and 18 mg/m

resultsIn group A, the RR was 3.8%, and the median progression-free survival and overall survival were 3.30 months and 15.03 months, respectively. In both groups, the most common grade ≥ 3 adverse drug reaction (ADR) was neutropenia and the incidence of grade ≥ 3 diarrhea was low or zero. In group A, 17 serious ADRs were observed in 10 patients (17%); all improved or recovered. In group B, no serious ADRs were observed. No treatment-related deaths were reported in either group.

conclusionsNK012 monotherapy yielded an RR similar to the RR of irinotecan monotherapy that was reported in the phase III EPIC trial (4.2%), and the incidence of grade ≥ 3 diarrhea was low. Based on the incidence and severity of febrile neutropenia and grade ≥ 3 neutropenia, the initial dose of NK012 28 mg/m

Indexed as

Colorectal NeoplasmsDrug CarriersFemaleGlucuronosyltransferaseHumansInfusions, IntravenousIrinotecanKaplan-Meier EstimateMaleMicellesMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPolymersPolymorphism, GeneticProgression-Free SurvivalDrug CarriersGlucuronosyltransferaseIrinotecanMicellesPolymersTopoisomerase I InhibitorsUGT1A1 EnzymeColorectal cancerNK012Phase IIPolymeric micelleSN-38

Identifiers

PMID30284603
PMCPMC6267673
OpenAlexW2895472244

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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.