Dataset Information

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.

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).

SUBMITTER: Kim ST

PROVIDER: S-EPMC9671755 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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

Kim Seung Tae ST Kim Sun Young SY Lee Jeeyun J Yun Seong Hyeon SH Kim Hee Cheol HC Lee Woo Yong WY Kim Tae Won TW Hong Yong Sang YS Lim Seok-Byung SB Baek Ji Yeon JY Oh Jae Hwan JH Ahn Joong Bae JB Shin Sang Joon SJ Han Sae-Won SW Kim Seong Geun SG Kang Seok Yun SY Sym Sun Jin SJ Zang Dae Young DY Kim Yeul Hong YH Choi In Sil IS Kang Jung Hun JH Kim Min-Ji MJ Park Young Suk YS

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20220630 33

<h4>Purpose</h4>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.<h4>Patients and methods</h4>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 mo ...[more]

PMID: 35772045

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