Evidence map›Paper›PMID 33094919›Full record

Trial reportCancer medicine2020

Overnight fasting before lapatinib administration to breast cancer patients leads to reduced toxicity compared with nighttime dosing: a retrospective cohort study from a randomized clinical trial.

Moe Tsuda, Hiroshi Ishiguro, Naoko Toriguchi, Norikazu Masuda, Hiroko Bando, Masahiro Ohgami, Masato Homma, Satoshi Morita, Naohito Yamamoto, Katsumasa Kuroi and 4 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Impact of intermittent fasting on patients with cancer undergoing chemotherapy and/or targeted therapies: a systematic review of the literature.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  2. Review
  3. Review
  4. 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

14 authors.

Moe TsudaDepartment of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Hiroshi IshiguroBreast Oncology Service, Saitama Medical University International Medical Center, Hidaka, Japan.ORCID 0000-0002-9859-5932
Naoko ToriguchiOncology Products, Medicine Development Unit Japan, Eli Lilly Japan K.K, Kobe, Japan.
Norikazu MasudaDepartment of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, Japan.ORCID 0000-0002-7302-0278
Hiroko BandoBreast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Masahiro OhgamiDepartment of Pharmacy, Ibaraki Prefectural Central Hospital, Kasama, Japan.
Masato HommaDepartment of Pharmaceutical Sciences, Division of Clinical Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics. Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Naohito YamamotoDivision of Breast Surgery, Chiba Cancer Center, Chiba, Japan.
Katsumasa KuroiDepartment of Breast Surgery, Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital, Tokyo, Japan.
Yasuhiro YanagitaDepartment of Breast Oncology, Gunma Prefectural Cancer Center, Gunma, Japan.
Toshimi TakanoBreast Medical Oncology, Breast Oncology Center, The Cancer Institute Hospital of JFCR, Tokyo, Japan.ORCID 0000-0002-8417-5291
Satoru ShimizuBreast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Masakazu ToiDepartment of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe bioavailability of lapatinib is affected by food, even following the 1 hour fast recommended by the package insert. We hypothesized that overnight fasting would minimize food-drug interactions. Here, we investigated if lapatinib administration timing is associated with its tolerability, efficacy, and pharmacokinetics.

methodsThis is a retrospective cohort study utilizing the medical records of patients enrolled in the JBCRG-16/Neo-LaTH randomized phase 2 trial for breast cancer patients treated with lapatinib. Lapatinib administration timing was divided into three groups: before breakfast (BB), between meals (BM), and at bedtime (AB). Side effects (SE), treatment discontinuation rate (TDR), relative dose intensity (RDI), pathological complete response (pCR) rate, and lapatinib serum trough concentration were compared between groups.

resultsAbout 140 patients were included in this study: BB 15, BM 51, and AB 74. A reduced risk of diarrhea {adjusted hazard ratio (HR), 0.51, 95% confidence interval (CI), 0.27-0.89, p = 0.018}, and rash {adjusted HR, 0.37; 95% CI, 0.17-0.70, p = 0.002} was seen in BB versus AB. Fewer patients with low RDI (< 0.85/<0.6) were in the BB group (BB 13% / 0%, BM 22% / 3.9%, AB 24% / 14%, p = 0.70 / 0.11). pCR was not diminished (p = 0.75). BB group had the lowest serum lapatinib concentration and variability (mean ±SD were 0.35 ± 0.15, 0.65 ± 0.32, 0.96 ± 0.43 µg/ml).

conclusionsCompared to bedtime administration, lapatinib administration after overnight fasting reduces its toxicity without diminishing its therapeutic efficacy.

Indexed as

Antineoplastic Agents, ImmunologicalBreast NeoplasmsDatabases, FactualDisease-Free SurvivalDrug Administration ScheduleErb-b2 Receptor Tyrosine KinasesFastingFemaleHumansLapatinibMiddle AgedProtein Kinase InhibitorsRetrospective StudiesTrastuzumabAntineoplastic Agents, ImmunologicalERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLapatinibProtein Kinase InhibitorsTrastuzumabbreast cancerdrug discovery and deliverymedical oncologyquality of lifeTyrosine kinase inhibitors

Identifiers

PMID33094919
PMCPMC7774723

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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.