Evidence map›Paper›PMID 30051609›Full record

Trial reportCancer medicine2018

A prospective Phase II study to examine the relationship between quality of life and adverse events of first-line chemotherapy plus cetuximab in patients with KRAS wild-type unresectable metastatic colorectal cancer: QUACK trial.

Shigeyoshi Iwamoto, Akira Ooki, Satoshi Morita, Hiroki Hara, Hiroaki Tanioka, Hironaga Satake, Masato Kataoka, Masahito Kotaka, Yoshinori Kagawa, Masato Nakamura and 10 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
0.9field-weighted citation impact, top 21% 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

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Navigating metastatic colorectal treatment options in the USA: a survey of patient acceptance of skin toxicities associated with Vectibix.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Article
  11. 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

20 authors at 18 institutions in 1 country.

Shigeyoshi IwamotoCancer Center, Aichi Medical University, Nagakute, Japan.
Akira OokiDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.ORCID 0000-0001-7618-5775
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University, Kyoto, Japan.
Hiroki HaraDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Hiroaki TaniokaDepartment of Medical Oncology, Okayama Rosai Hospital, Okayama, Japan.
Hironaga SatakeDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Masato KataokaDepartment of Surgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Masahito KotakaGastrointestinal Cancer Center, Sano Hospital, Kobe, Japan.
Yoshinori KagawaDepartment of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
Masato NakamuraComprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.
Tatsushi ShingaiDepartment of Surgery, Osaka Saiseikai Senri Hospital, Suita, Japan.
Masashi IshikawaDepartment of Surgery, Shikoku Central Hospital, Shikokuchuo, Japan.
Yasuhiro MiyakeDepartment of Surgery, Osaka Minato Central Hospital, Osaka, Japan.
Takeshi SudoDepartment of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Yojiro HashiguchiDepartment of Surgery, Teikyo University School of Medicine, Tokyo, Japan.
Taichi YabunoDepartment of Surgery, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Junichi SakamotoTokai Central Hospital, Kakamigahara, Japan.
Akihito TsujiDepartment of Medical Oncology, Kagawa University, Takamatsu, Japan.
Masahiko AndoCenter for Advanced Medicine and Clinical Research, Nagoya University, Nagoya, Japan.
Kensei YamaguchiDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Saitama Cancer Center · JPAichi Medical University · JPAizawa Hospital · JPKagawa University · JPKansai Rosai Hospital · JPKobe City Medical Center General Hospital · JPKyoto University · JPNagoya University Hospital · JPNational Hospital Organization · JPOkayama Rosai Hospital · JPOsaka Hospital · JPSaiseikaisenri Hospital · JPSanno Medical Center · JPShikoku Central Hospital of the Mutual Aid Association of Public School Teachers · JPTeikyo University · JPTokai Central Hospital · JPYamagata Prefectural Central Hospital · JPYokohama Municipal Citizen's Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A prospective trial has not been performed to investigate associations between quality of life (QOL), adverse events (AEs), and overall survival (OS) in the first-line treatment with cetuximab plus standard chemotherapy for advanced/metastatic colorectal cancer (mCRC). Associations between patient outcome and health-related QOL (HRQOL) together with skin toxicity-related QOL were prospectively evaluated using EORTC QLQ-C30 and DLQI questionnaires. One hundred and forty mCRC patients were analyzed in this study, and 87.8% received pre-emptive skin treatment. Skin toxicity had no clinical impact on HRQOL or skin-related QOL during the first 8 weeks and throughout the study period. An early skin reaction with a grade ≥2 at 8 weeks was significantly associated with a favorable OS compared with a grade of ≤1 (HR, 0.50; 95% CI, 0.24-0.95; P = .035) and was confirmed to be an independent predictor of OS (HR, 0.48; 95% CI, 0.21-0.97; P = .040). Patients symptomatic at baseline who responded to treatment had improved HRQOL compared to nonresponding patients. Severe mucositis/stomatitis had a statistically significant and clinically meaningful negative impact on HRQOL (mean changes from baseline throughout the study period in global health status were -12.64 for a grade of ≥2 vs -0.35 for a grade of 0 or 1 (P = .005)). In conclusion, severe early skin reactions predict favorable OS for patients treated with cetuximab plus chemotherapy without impairing QOL. In addition, mucositis/stomatitis was the most substantial AE compromising both QOL and treatment compliance.

Indexed as

Quality of LifeAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCetuximabColorectal NeoplasmsFemaleHealth Care SurveysHumansMaleMiddle AgedNeoplasm StagingPrognosisProportional Hazards ModelsProto-Oncogene Proteins p21(ras)CetuximabKRAS protein, humanProto-Oncogene Proteins p21(ras)adverse eventCetuximabchemotherapycolorectal cancerQuality of Life

Identifiers

PMID30051609
PMCPMC6144158
OpenAlexW2883608615

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.