ASCO GUIDELINES Bundle

Stage II Colon Cancer Adjuvant Therapy

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Treatment Recommendation 1.3 ➤ ACT should be offered to patients with stage IIB and stage IIC colon cancer (i.e., T4, lesions either penetrating visceral peritoneum or invasive of surrounding organ, respectively), with a discussion of the potential benefits and risks of harm associated with ACT. (Weak recommendation; EB-B-M) Recommendation 1.4 ➤ ACT may be offered to patients with stage IIA (i.e., T3) colon cancer with high-risk features, including sampling of fewer than 12 lymph nodes in the surgical specimen, perineural or lymphatic invasion, poorly or undifferentiated tumor grade, intestinal obstruction, tumor perforation, and/or grade BD3 tumor budding (≥10 buds). (Weak recommendation; EB-B-L) Qualifying statements: ▶ The number of risk factors should be considered as part of the shared- decision making process. The presence of more than one risk factor may increase the risk of recurrence; in an exploratory analysis of IDEA collaboration data, 5-year disease free survival (DFS) was 74.8% for stage II patients with 2 or more risk factors, compared to 87.3% for patients with one risk factor. ▶ Circulating tumor DNA (ctDNA) was identified as an emerging potential predictive factor, however, insufficient evidence of predictive value of chemotherapy was available to warrant its inclusion in the list of high-risk features within the main recommendation. The Expert Panel anticipates that data on ctDNA will be forthcoming through prospective clinical trials, and included in a future version of this guideline. ▶ The Expert Panel notes that there is controversy around the timing of chemotherapy; data on this topic were not reported in the included observational studies. In the Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) trial of oxaliplatin in addition to fluoropyrimidine-based chemotherapy, patients were required to have started ACT within 7 weeks of surgery. In the Quick and Simple and Reliable (QUASAR) trial of ACT with FU and folinic acid, therapy was initiated within 6 weeks of surgery, where possible.

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