Evidence map›Paper›PMID 29043567›Full record

Trial reportPharmacoEconomics2018

Impact of Adverse Events on Health Utility and Health-Related Quality of Life in Patients Receiving First-Line Chemotherapy for Metastatic Breast Cancer: Results from the SELECT BC Study.

Yasuhiro Hagiwara, Takeru Shiroiwa, Kojiro Shimozuma, Takuya Kawahara, Yukari Uemura, Takanori Watanabe, Naruto Taira, Takashi Fukuda, Yasuo Ohashi, Hirofumi Mukai

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in PharmacoEconomics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Association of adverse events and quality of life in patients with unresectable hepatocellular carcinoma.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
    Trial
  3. Cost-Effectiveness Analysis ofJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Quality of life of patients with hematological malignancies and factors affecting health state utility values.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  10. Article
  11. Article
  12. Observational
  13. Article
  14. Article
  15. Real-world data of the association between quality of life using the EuroQol 5 Dimension 5 Level utility value and adverse events for outpatient cancer chemotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Article
  16. Assessing health-related quality of life in cancer survivors: factors impacting on EORTC QLU-C10D-derived utility values.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2020
    Article
  17. Article
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 at 8 institutions in 1 country.

Yasuhiro HagiwaraDepartment of Biostatistics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. hagiwara@epistat.m.u-tokyo.ac.jp.ORCID 0000-0003-3792-5368
Takeru ShiroiwaDepartment of Health and Welfare Services, National Institute of Public Health, Wako, Japan.
Kojiro ShimozumaDepartment of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, Kusatsu, Japan.
Takuya KawaharaBiostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.
Yukari UemuraBiostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.
Takanori WatanabeDepartment of Breast Surgery, National Hospital Organization Sendai Medical Center, Sendai, Japan.
Naruto TairaDepartment of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.
Takashi FukudaDepartment of Health and Welfare Services, National Institute of Public Health, Wako, Japan.
Yasuo OhashiDepartment of Integrated Science and Engineering for Sustainable Society, Faculty of Science and Engineering, Chuo University, Tokyo, Japan.
Hirofumi MukaiDepartment of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
National Institute of Public Health · JPUniversity of Tokyo Hospital · JPChuo University · JPNational Cancer Center Hospital East · JPOkayama University Hospital · JPRitsumeikan University · JPSendai Medical Center · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to investigate the impact of adverse events (AEs) on health utility and health-related quality of life (HRQOL) in patients with metastatic breast cancer undergoing first-line chemotherapy.

methodsWe analyzed the data from the SELECT BC study, a multicenter, open-label, randomized, phase III study conducted in Japan, which compared first-line S-1 with taxane therapies. Heath utility and HRQOL were assessed using the EQ-5D-3L and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at baseline and 3, 6, and 12 months after treatment initiation. Health utility was calculated based on societal preferences, and AEs were reported at each cycle of the study treatment. Linear marginal mean models were used to quantify the impact of the last AEs (with 10 or more incidences) observed before HRQOL assessment on health utility and HRQOL.

resultsAnalysis included 380 patients and 12 (of 15) AEs. Grade 1 nausea and oral mucositis, grade 1 and 2 edema, and grade 2 fatigue, motor and sensory neuropathy, and myalgia were significantly associated with disutility, measured using the EQ-5D-3L. Grade 1 oral mucositis, grade 1 and 2 fatigue, and grade 2 sensory neuropathy were significantly associated with impaired global health status in the EORTC QLQ-C30. AEs associated with decrements in the five functioning scales included fatigue, oral mucositis, nausea, edema, motor and sensory neuropathy, and myalgia.

conclusionsWe reported disutilities caused by AEs in patients with metastatic breast cancer under chemotherapy. These findings can be applied to future model-based cost-effectiveness analyses. TRIAL REGISTRATION NUMBER: C000000416.

Indexed as

AgedAntineoplastic AgentsBreast NeoplasmsDrug CombinationsFemaleHealth StatusHumansJapanMiddle AgedNeoplasm MetastasisOxonic AcidQuality of LifeSurveys and QuestionnairesTaxoidsTegafurTime FactorsAntineoplastic AgentsDrug CombinationsOxonic AcidS 1 (combination)TaxoidsTegafur

Identifiers

PMID29043567
PMCPMC5805818
OpenAlexW2766024739

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.