Benefits and risks of three versus six months of adjuvant oxaliplatin-containing chemotherapy in patients with high-risk stage II colon cancer

Outcome	Results	Absolute effect estimates		Quality of evidence	Plain language summary
		6-Month ADCT	3-Month ADCT
DFS (overall study population)	HR: 1.17 (80% CI, 1.05 to 1.31) (95% CI, 0.99 to 1.38) (3273 patients in four studies*) Follow-up: 5 years	161 per 1000	186 per 1000	Low^¶	3-Month ADCT probably has little or no effect on DFS compared with 6-month ADCT
		Difference: 25 more per 1000 (95% CI, 7 more to 44 more)
DFS (CAPOX)	HR: 1.02 (80% CI, 0.88 to 1.17) (95% CI, 0.83 to 1.28) (2019 patients in four studies*) Follow-up: 5 years	159 per 1000	162 per 1000	Low^¶	3-month ADCT probably has little or no effect on DFS (CAPOX) compared with 6-month ADCT
		Difference: 3 more per 1000 (95% CI, 18 fewer to 24 more)
DFS (FOLFOX)	HR: 1.41 (80% CI, 1.18 to 1.68) (95% CI, 1.08 to 1.84) (1254 patients in four studies*) Follow-up: 5 years	150 per 1000	205 per 1000	Low^¶	3-month ADCT probably worsens DFS (FOLFOX) compared with 6-month ADCT
		Difference: 55 more per 1000 (95% CI, 25 more to 89 more)
Grade ≥2 peripheral neuropathy	RR: 0.36 (95% CI, 0.31 to 0.42) (3273 patients in four studies*) Follow-up during treatment	360 per 1000	130 per 1000	Moderate	Patients experience significantly less peripheral neuropathy with 3 months of ADCT compared with 6 months of ADCT
		Difference: 230 fewer per 1000 (95% CI, 248 fewer to 209 fewer)

ADCT: adjuvant doublet chemotherapy; DFS: disease-free survival; HR: hazard ratio; CAPOX: capecitabine and oxaliplatin; FOLFOX: fluorouracil, leucovorin, and oxaliplatin; RR: relative risk; SCOT: Short Course Oncology Treatment; ACHIEVE2: Adjuvant Chemotherapy for Colon Cancer with High Evidence 2; TOSCA: Three or Six Colon Adjuvant; HORG: Hellenic Oncology Research Group.
* SCOT (NCT00749450), ACHIEVE2 (UMIN000013036), TOSCA (NCT0064660), and HORG (NCT01308086).
¶ Choice of CAPOX or FOLFOX was nonrandomized (chosen by treating clinician); noninferiority threshold of 1.2 not met; modified intention-to-treat analysis including only patients who received at least one dose of chemotherapy. Ninety% of patients assigned to 3-month treatment received all planned doses, compared with 65% of 6-month patients. Analyses by T4 (yes or no), inadequate nodal harvest (yes or no), and poorly differentiated histology (yes or no) were not significant. Test for interaction between duration and the regimen was not significant (p = 0.07); adjusted for multiple hypothesis tests.

From: Baxter NN, Kennedy EB, Bergsland E, et al. Adjuvant Therapy for Stage II Colon Cancer: ASCO Guideline Update. J Clin Oncol 2021. DOI: 10.1200/JCO.21.02538. Copyright © 2021 American Society of Clinical Oncology. Reproduced with permission from Wolters Kluwer Health. Unauthorized reproduction of this material is prohibited.

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خرید پکیج

Benefits and risks of three versus six months of adjuvant oxaliplatin-containing chemotherapy in patients with high-risk stage II colon cancer