Evidence map›Paper›PMID 30745582›Full record

Trial reportBritish journal of cancer2019

A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients.

Yasuhiro Fujiwara, Hirofumi Mukai, Toshiaki Saeki, Jungsil Ro, Yung-Chang Lin, Shigenori E Nagai, Keun Seok Lee, Junichiro Watanabe, Shoichiro Ohtani, Sung Bae Kim and 7 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01644890 (A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer), which is not on this map. Cited by 71 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 2 pooled it
7.0field-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.

NCT01644890 phase3completednot on this map

A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer

TypeinterventionalSponsorNippon Kayaku Co., Ltd.Ran2012 to 2017Enrolled436ConditionsBreast Cancer Nos Metastatic RecurrentArmsNK105, Paclitaxel
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 2 syntheses or guidelines pooled it, 123 citations in OpenAlex.

  1. Application of nanoparticles in breast cancer treatment: a systematic review.Naunyn-Schmiedeberg's archives of pharmacology · 2024
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11 more citing papers are in PubMed but not listed here.

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

17 authors at 15 institutions in 3 countries.

Yasuhiro FujiwaraDepartment of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Hirofumi MukaiDivision of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan. hrmukai@east.ncc.go.jp.
Toshiaki SaekiDepartment of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Jungsil RoGraduate School of Cancer Science and Policy, National Cancer Center, Goyang, Korea.
Yung-Chang LinDivision of Haematology and Oncology, Chang-Gung Memorial Hospital, Linko, Taoyuan, Taiwan.
Shigenori E NagaiDivision of Breast Oncology, Saitama Cancer Center, Saitama, Japan.
Keun Seok LeeCenter for Breast Cancer, National Cancer Center, Goyang, Korea.
Junichiro WatanabeDivision of Breast Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Shoichiro OhtaniDepartment of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Sung Bae KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Katsumasa KuroiDepartment of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Koichiro TsugawaDivision of Breast and Endocrine Surgery, Department of Surgery, St. Marianna University School of Medicine, Kawasaki, Japan.
Yutaka TokudaDepartment of Breast and Endocrine Surgery, Tokai University School of Medicine, Isehara, Japan.
Hiroji IwataDepartment of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Yeon Hee ParkDivision of Hematology-Oncology, Samsung Medical Center, Seoul, Korea.
Youngsen YangDivision of Hematology-Oncology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
Yoshihiro NambuPharmaceuticals Group, Nippon Kayaku Co., Ltd., Tokyo, Japan.
National Cancer Center · KRAichi Cancer Center · JPChang Gung Memorial Hospital · TWChina Medical University · TWHiroshima City Asa Citizens Hospital · JPNational Cancer Center Hospital East · JPNippon Kayaku (Japan) · JPSaitama Cancer Center · JPSaitama Medical University · JPSamsung Medical Center · KRShizuoka Cancer Center · JPSt. Marianna University School of Medicine · JPTokai University · JPTokyo Metropolitan Komagome Hospital · JPUniversity of Ulsan · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNK105 is a novel nanoparticle drug delivery formulation that encapsulates paclitaxel (PTX) in polymeric micelles. We conducted an open-label phase III non-inferiority trial to compare the efficacy and safety of NK105 and PTX in metastatic or recurrent breast cancer.

methodsPatients were randomly assigned in a 1:1 ratio to receive either NK105 (65 mg/m

resultsA total of 436 patients were randomised and 211 patients in each group were included in the efficacy analysis. The median PFS was 8.4 and 8.5 months for NK105 and PTX, respectively (adjusted hazard ratio: 1.255; 95% confidence interval: 0.989-1.592). The median overall survival and overall response rates were 31.2 vs. 36.2 months and 31.6% vs. 39.0%, respectively. The two groups exhibited similar safety profiles. The incidence of peripheral sensory neuropathy (PSN) was 1.4% vs. 7.5% (≥Grade 3) for NK105 and PTX, respectively. The patient-reported outcomes of PSN were significantly favourable for NK105 (P < 0.0001).

conclusionsThe primary endpoint was not met, but NK105 had a better PSN toxicity profile than PTX. CLINICAL

trial registrationClinicalTrials.gov: NCT01644890.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Agents, PhytogenicBreast NeoplasmsEquivalence Trials as TopicFemaleHumansMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPaclitaxelPeripheral Nervous System DiseasesProgression-Free SurvivalProportional Hazards ModelsAntineoplastic Agents, PhytogenicNK105Paclitaxel

Identifiers

PMID30745582
PMCPMC6461876
OpenAlexW2912831482

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.