Evidence map›Paper›PMID 37439066›Full record

Trial reportBJS open2023

Short-term outcomes of Early versus conventional adjuvant chemotherapy in stage III colon cancer: randomized clinical trial.

Kyung Ha Lee, Soo Yeun Park, Seung Ho Song, Hye Jin Kim, Jong Gwang Kim, Byung Woog Kang, In Kyu Lee, Yoon Suk Lee, So Hyun Kim, Seong Kyu Baek and 6 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BJS open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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  5. 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

16 authors.

Kyung Ha LeeDepartment of Surgery, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea.ORCID 0000-0002-0035-9000
Soo Yeun ParkColorectal Cancer Centre, Kyungpook National University Medical Centre, School of Medicine, Kyungpook National University, Daegu, Korea.
Seung Ho SongColorectal Cancer Centre, Kyungpook National University Medical Centre, School of Medicine, Kyungpook National University, Daegu, Korea.ORCID 0000-0003-1490-7757
Hye Jin KimColorectal Cancer Centre, Kyungpook National University Medical Centre, School of Medicine, Kyungpook National University, Daegu, Korea.
Jong Gwang KimDepartment of Oncology/Haematology, Kyungpook National University Medical Centre, Kyungpook National University School of Medicine, Daegu, Korea.
Byung Woog KangDepartment of Oncology/Haematology, Kyungpook National University Medical Centre, Kyungpook National University School of Medicine, Daegu, Korea.
In Kyu LeeDepartment of Surgery, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0000-0001-9074-5214
Yoon Suk LeeDepartment of Surgery, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0000-0002-1849-2774
So Hyun KimDivision of Colon and Rectum, Department of Surgery, College of Medicine, Yeungnam University, Daegu, Korea.ORCID 0000-0002-8625-329X
Seong Kyu BaekDepartment of Surgery, School of Medicine, Dongsan Medical Centre, Keimyung University, Daegu, Korea.
Sung Uk BaeDepartment of Surgery, School of Medicine, Dongsan Medical Centre, Keimyung University, Daegu, Korea.
Gyung Mo SonDepartment of Surgery, Busan National University, Busan, Korea.
Ki Beom BaeDepartment of Surgery, Busan Paik Hospital, Inje University, Busan, Korea.
Gyu-Seog ChoiColorectal Cancer Centre, Kyungpook National University Medical Centre, School of Medicine, Kyungpook National University, Daegu, Korea.ORCID 0000-0001-5476-4610
Jun Seok ParkColorectal Cancer Centre, Kyungpook National University Medical Centre, School of Medicine, Kyungpook National University, Daegu, Korea.
Ji Yeon KimDepartment of Surgery, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvidence is lacking regarding the earliest timing of initiating adjuvant chemotherapy to maximize its efficacy safely. A trial was designed and conducted to evaluate the safety and oncological efficacy of early adjuvant chemotherapy compared with conventional adjuvant chemotherapy. The short-term outcomes are reported here.

methodsA multicentre, randomized (1 : 1), open-label, phase III trial was conducted comparing early adjuvant chemotherapy with conventional adjuvant chemotherapy in patients with stage III colon cancer. Patients who underwent radical surgery who had stage III colon cancer confirmed by histopathological assessment were screened and randomized into the early adjuvant chemotherapy arm or the conventional adjuvant chemotherapy arm. The primary endpoint was 3-year disease-free survival. The adjuvant chemotherapy with FOLFOX was delivered between postoperative day 10 and 14 in the early adjuvant chemotherapy arm, and between postoperative day 24 and 28 in the conventional adjuvant chemotherapy arm. Toxicity and quality of life were evaluated.

resultsBetween 9 September 2011 and 6 March 2020, 443 patients consented to randomization at eight sites. The intention-to-treat population included 423 patients (209 in the early adjuvant chemotherapy arm and 214 in the conventional adjuvant chemotherapy arm), and the safety population included 380 patients (192 in the early adjuvant chemotherapy arm and 188 in the conventional adjuvant chemotherapy arm). There was no statistically significant difference in overall toxicity (28.1 per cent in the early adjuvant chemotherapy arm and 28.2 per cent in the conventional adjuvant chemotherapy arm, P = 0.244), surgical complications, and quality of life between the two arms.

conclusionAdjuvant chemotherapy can be safely initiated 2 weeks after surgery with toxicity and quality of life comparable to conventional adjuvant chemotherapy for stage III colon cancer.

Indexed as

Colonic NeoplasmsQuality of LifeChemotherapy, AdjuvantDisease-Free SurvivalHumansPostoperative Period

Identifiers

PMID37439066
PMCPMC10338899

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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.