Evidence map›Paper›PMID 36217496›Full record

Trial reportInternational journal of nanomedicine2022

Multicenter Randomized Open-Label Phase II Clinical Study Comparing Outcomes of NK105 and Paclitaxel in Advanced or Recurrent Breast Cancer.

Yoshimasa Kosaka, Toshiaki Saeki, Toshimi Takano, Tomoyuki Aruga, Toshinari Yamashita, Norikazu Masuda, Yukio Koibuchi, Akihiko Osaki, Junichiro Watanabe, Ryu Suzuki

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of nanomedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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

9 citing papers in PubMed.

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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

10 authors.

Yoshimasa KosakaDepartment of Breast and Endocrine Surgery, Kitasato University School of Medicine, Sagamihara-shi, Kanagawa, Japan.
Toshiaki SaekiDepartment of Breast Oncology, Saitama Medical University International Medical Center, Hidaka-shi, Saitama, Japan.
Toshimi TakanoDepartment of Medical Oncology, Toranomon Hospital, Minato-ku, Tokyo, Japan.
Tomoyuki ArugaDepartment of Breast Surgery, Tokyo Metropolitan Center and Infectious Diseases Center Komagome Hospital, Bunkyo-ku, Tokyo, Japan.
Toshinari YamashitaDepartment of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan.ORCID 0000-0002-6479-1660
Norikazu MasudaDepartment of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka-shi, Osaka, Japan.ORCID 0000-0002-7302-0278
Yukio KoibuchiDepartment of Breast and Endocrine Surgery, National Hospital Organization Takasaki General Medical Center, Takasaki-shi, Gunma, Japan.
Akihiko OsakiDepartment of Breast Oncology, Saitama Medical University International Medical Center, Hidaka-shi, Saitama, Japan.
Junichiro WatanabeDivision of Breast Oncology, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan.
Ryu SuzukiPharmaceuticals Group, Nippon Kayaku Co., Ltd, Kita-ku, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: NK105 is a paclitaxel (PTX)-incorporating "core-shell-type" polymeric micellar nanoparticle formulation composed of block copolymers (polyethylene glycol and a polyamino acid). The efficacy and safety of NK105 and paclitaxel in advanced or recurrent breast cancer have never been compared at equivalent dose levels. Patients and Methods: Patients were randomly assigned to either NK105 or PTX in a 1:1 ratio. The study drug was administered on Day 1, 8, and 15 of a 28-day cycle with 80 mg/m Results: A total of 123 patients (NK105, n=62; PTX, n=61) received one of the two drugs. There was no significant difference in ORR, the median PFS, or OS (NK105 group: 41.9%, 9.1, and 27.5 months, respectively; PTX group: 45.9%, 7.8, and 32.4 months, respectively). Neutropenia occurred more frequently in the NK105 group, but most patients did not require granulocyte-colony stimulating factor or dose-reduction. The median time to onset of peripheral sensory neuropathy (PSN) in the NK105 group was significantly longer than that in the PTX group (p=0.001), and PSN (≥ grade 3) was not observed in the NK105 group. Conclusion: Weekly NK105 administration was well-tolerated. Efficacy was similar in both groups. The PSN profile was better in the NK105 group.

Indexed as

Breast NeoplasmsPeripheral Nervous System DiseasesAntineoplastic Combined Chemotherapy ProtocolsColony-Stimulating FactorsFemaleHumansPaclitaxelPolyethylene GlycolsPolymersColony-Stimulating FactorsNK105PaclitaxelPolyethylene GlycolsPolymersanti-polyethylene glycol antibodieschemotherapy-induced peripheral neuropathyoverall response ratepolymeric micellar nanoparticlestaxane

Identifiers

PMID36217496
PMCPMC9547548

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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.