There is insufficient evidence to routinely recommend the addition of oxaliplatin to fluoropyrimidine-based chemotherapy for patients with high-risk stage II colon cancer (Type: Evidence-based benefits may outweigh harms Evidence quality: low Strength of recommendation: weak). Patients with proficient mismatch repair/microsatellite stable (pMMR or MSS) tumors are included within guideline Recommendations 1.1-1.4. Poor differentiation is not considered a high-risk prognostic factor in patients with dMMR or MSI tumors. This qualifying statement is based on indirect evidence of a DFS benefit with the addition of oxaliplatin in the population of patients with stage II or stage III colon cancer in the MOSAIC trial. 13Īdjuvant fluoropyrimidine-only chemotherapy is not routinely recommended for patients with exhibit mismatch repair deficiency (dMMR) or high microsatellite instability (MSI) tumors (Type: Evidence-based harms outweigh benefits Evidence quality: moderate Strength of recommendation: strong).įor patients with dMMR or MSI and T4 tumors and/or other high-risk features (with the exception of poor differentiation), oxaliplatin-containing chemotherapy may be considered (see Recommendation 3.1, qualifying statements).
Jordans mod menu 1.31 trial#
11, 12 In the QUASAR trial of ACT with fluorouracil and folinic acid, therapy was initiated within 6 weeks of surgery, where possible. In the MOSAIC trial of oxaliplatin in addition to fluoropyrimidine-based chemotherapy, patients were required to have started ACT within 7 weeks of surgery.
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. The Expert Panel anticipates that data on ctDNA will be forthcoming through prospective clinical trials and included in a future version of this guideline. 10Ĭirculating 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 presence of more than one risk factor may increase the risk of recurrence 9 in an exploratory analysis of International Duration Evaluation of Adjuvant Chemotherapy (IDEA) collaboration data, the 5-year disease-free survival (DFS) was 74.8% for stage II patients with two or more risk factors, compared with 87.3% for patients with one risk factor. The number of risk factors should be considered as part of the shared decision-making process.
Duration of oxaliplatin-containing chemotherapy is also addressed, with recommendations for 3 or 6 months of treatment with capecitabine and oxaliplatin or fluorouracil, leucovorin, and oxaliplatin, with decision making informed by key evidence of 5-year disease-free survival in each treatment subgroup and the rate of adverse events, including peripheral neuropathy.Īdditional information is available at Recommendation 1.4.ĪCT may be offered to patients with stage IIA (ie, T3) colon cancer with high-risk features, including sampling of fewer than 12 lymph nodes in the surgical specimen, perineural or lymphovascular invasion, poorly or undifferentiated tumor grade, intestinal obstruction, tumor perforation, and/or grade BD3 tumor budding (≥ 10 buds) (Type: Evidence-based benefits may outweigh harms Evidence quality: low Strength of recommendation: weak). Patients with mismatch repair deficiency/microsatellite instability tumors should not be routinely offered ACT if the combination of mismatch repair deficiency/microsatellite instability and high-risk factors results in a decision to offer ACT, oxaliplatin-containing chemotherapy is recommended. The addition of oxaliplatin to fluoropyrimidine-based ACT is not routinely recommended, but may be offered as a result of shared decision making. Patients with T4 tumors are at higher risk of recurrence and should be offered ACT, whereas patients with other high-risk factors, including sampling of fewer than 12 lymph nodes in the surgical specimen, perineural or lymphovascular invasion, poorly or undifferentiated tumor grade, intestinal obstruction, tumor perforation, or grade BD3 tumor budding, may be offered ACT. Adjuvant chemotherapy (ACT) is not routinely recommended for patients with stage II colon cancer who are not in a high-risk subgroup.
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