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

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Author(s)
Kyung Ha LeeSoo Yeun ParkSeung Ho SongHye Jin KimJong Gwang KimByung Woog KangIn Kyu LeeYoon Suk LeeSo Hyun KimSeong Kyu BaekSung Uk BaeGyung Mo SonKi Beom BaeGyu-Seog ChoiJun Seok ParkJi Yeon Kim
Keimyung Author(s)
Baek, Seong KyuBae, Sung Uk
Department
Dept. of Surgery (외과학)
Journal Title
BJS Open
Issued Date
2023
Volume
7
Issue
4
Abstract
Background:
Evidence 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.

Methods:
A 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.

Results:
Between 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.

Conclusion:
Adjuvant 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.
Keimyung Author(s)(Kor)
백성규
배성욱
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
2474-9842
Source
https://academic.oup.com/bjsopen/article/7/4/zrad064/7223517?login=true
DOI
10.1093/bjsopen/zrad064
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45438
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
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