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Clinical Trial
. 2022 Nov 20;40(33):3868-3877.
doi: 10.1200/JCO.21.02962. Epub 2022 Jun 30.

Oxaliplatin (3 months v 6 months) With 6 Months of Fluoropyrimidine as Adjuvant Therapy in Patients With Stage II/III Colon Cancer: KCSG CO09-07

Seung Tae Kim  1 , Sun Young Kim  2   3 , Jeeyun Lee  1 , Seong Hyeon Yun  1 , Hee Cheol Kim  1 , Woo Yong Lee  1 , Tae Won Kim  2 , Yong Sang Hong  2 , Seok-Byung Lim  2 , Ji Yeon Baek  3 , Jae Hwan Oh  3 , Joong Bae Ahn  4 , Sang Joon Shin  4 , Sae-Won Han  5 , Seong Geun Kim  6 , Seok Yun Kang  7 , Sun Jin Sym  8 , Dae Young Zang  9 , Yeul Hong Kim  10 , In Sil Choi  11 , Jung Hun Kang  12 , Min-Ji Kim  13 , Young Suk Park  1
Affiliations
Clinical Trial

Oxaliplatin (3 months v 6 months) With 6 Months of Fluoropyrimidine as Adjuvant Therapy in Patients With Stage II/III Colon Cancer: KCSG CO09-07

Seung Tae Kim et al. J Clin Oncol. .

Abstract

Purpose: The combination of oxaliplatin and fluoropyrimidine for 6 months is one of the standard options for adjuvant therapy for high-risk stage II and III colorectal cancers (CRCs). The optimal duration of oxaliplatin to diminish neurotoxicity without compromising efficacy needs to be clarified.

Patients and methods: This open-label, randomized, phase III, noninferiority trial randomly assigned patients with high-risk stage II and III CRC to 3 and 6 months of oxaliplatin with 6 months of fluoropyrimidine groups (3- and 6-month arms, respectively). The primary end point was disease-free survival (DFS), and the noninferiority margin was a hazard ratio (HR) of 1.25.

Results: In total, 1,788 patients were randomly assigned to the 6-month (n = 895) and 3-month (n = 893) arms, and 83.6% in the 6-month arm and 85.7% in the 3-month arm completed the treatment. The neuropathy rates with any grade were higher in the 6-month arm than in the 3-month arm (69.5% v 58.3%; P < .0001). The 3-year DFS rates were 83.7% and 84.7% in the 6-month and 3-month arms, respectively, with an HR of 0.953 (95% CI, 0.769 to 1.180; test for noninferiority, P = .0065) within the noninferiority margin. Among patients with stage III CRC treated by capecitabine plus oxaliplatin, the 3-year DFS of the 3-month arm was noninferior as compared with that of the 6-month arm with an HR of 0.713 (95% CI, 0.530 to 0.959; P = .0009). However, among patients with high-risk stage II and stage III CRC treated by infusional fluorouracil, leucovorin, and oxaliplatin, the noninferiority of the 3-month arm compared with the 6-month arm was not proven.

Conclusion: This study suggests that adding 3 months of oxaliplatin to 6 months of capecitabine could be considered an alternative adjuvant treatment for stage III CRC (ClinicalTrials.gov identifier: NCT01092481).

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Conflict of interest statement

Yeul Hong Kim

Stock and Other Ownership Interests: OncoMaster

Research Funding: MSD Oncology (Inst), Ono Pharmaceutical (Inst), Macrogenics (Inst), Korea Astellas (Inst), Zymeworks (Inst)

No other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
CONSORT diagram. ITT, intention-to-treat; PPA, per-protocol population analysis.
FIG 2.
FIG 2.
DFS by study group. DFS, disease-free survival; HR, hazard ratio.
FIG 3.
FIG 3.
DFS by study group, stage group, and regimen: (A) stage II high risk, (B) stage III low risk, (C) stage III high risk, (D) CAPOX, and (E) FOLFOX. CAPOX, capecitabine plus oxaliplatin; DFS, disease-free survival; FOLFOX, infusional fluorouracil, leucovorin, and oxaliplatin; HR, hazard ratio.
FIG 4.
FIG 4.
Forest plot for disease-free survival. FOLFOX, infusional fluorouracil, leucovorin, and oxaliplatin; CAPOX, capecitabine plus oxaliplatin; Het, heterogeneity; HR, hazard ratio; N, node; T, tumor.
FIG 5.
FIG 5.
OS by study group. HR, hazard ratio; OS, overall survival.
FIG A1.
FIG A1.
Comparison of DFS in the 3-month arm with that of patients in the 6-month arm who received oxaliplatin of at least 5 months. DFS, disease-free survival; HR, hazard ratio.
See this image and copyright information in PMC

References

    1. Moertel CG, Fleming TR, Macdonald JS, et al. : Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med 322:352-358, 1990 - PubMed
    1. Andre T, Boni C, Mounedji-Boudiaf L, et al. : Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 350:2343-2351, 2004 - PubMed
    1. Kuebler JP, Wieand HS, O'Connell MJ, et al. : Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: Results from NSABP C-07. J Clin Oncol 25:2198-2204, 2007 - PubMed
    1. Haller DG, Tabernero J, Maroun J, et al. : Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol 29:1465-1471, 2011 - PubMed
    1. Schmoll HJ, Van Cutsem E, Stein A, et al. : ESMO consensus guidelines for management of patients with colon and rectal cancer. a personalized approach to clinical decision making. Ann Oncol 23:2479-2516, 2012 - PubMed

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