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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  ;  Sun Young Kim  ;  Jeeyun Lee  ;  Seong Hyeon Yun  ;  Hee Cheol Kim  ;  Woo Yong Lee  ;  Tae Won Kim  ;  Yong Sang Hong  ;  Seok-Byung Lim  ;  Ji Yeon Baek  ;  Jae Hwan Oh  ;  Joong Bae Ahn  ;  Sang Joon Shin  ;  Sae-Won Han  ;  Seong Geun Kim  ;  Seok Yun Kang  ;  Sun Jin Sym  ;  Dae Young Zang  ;  Yeul Hong Kim  ;  In Sil Choi  ;  Jung Hun Kang  ;  Min-Ji Kim  ;  Young Suk Park 
 JOURNAL OF CLINICAL ONCOLOGY, Vol.40(33) : 3868-3877, 2022-11 
Journal Title
Issue Date
Antineoplastic Combined Chemotherapy Protocols / therapeutic use ; Capecitabine / therapeutic use ; Chemotherapy, Adjuvant ; Colonic Neoplasms* / drug therapy ; Colonic Neoplasms* / pathology ; Disease-Free Survival ; Fluorouracil / therapeutic use ; Humans ; Leucovorin / therapeutic use ; Neoplasm Staging ; Organoplatinum Compounds* / therapeutic use ; Oxaliplatin* / therapeutic use
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).
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Shin, Sang Joon(신상준) ORCID logo https://orcid.org/0000-0001-5350-7241
Ahn, Joong Bae(안중배) ORCID logo https://orcid.org/0000-0001-6787-1503
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