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Tie, Jeanne; Cohen, Joshua D; Lahouel, Kamel; Lo, Serigne N; Wang, Yuxuan; Kosmider, Suzanne; Wong, Rachel; Shapiro, Jeremy; Lee, Margaret; Harris, Sam; Khattak, Adnan; Burge, Matthew; Harris, Marion; Lynam, James; Nott, Louise; Day, Fiona; Hayes, Theresa; McLachlan, Sue-Anne; Lee, Belinda; Ptak, Janine; Silliman, Natalie; Dobbyn, Lisa; Popoli, Maria; Hruban, Ralph; Lennon, Anne Marie; Papadopoulos, Nicholas; Kinzler, Kenneth W; Vogelstein, Bert; Tomasetti, Cristian; Gibbs, Peter
The New England journal of medicine, 06/2022, Volume: 386, Issue: 24Journal Article
The role of adjuvant chemotherapy in stage II colon cancer continues to be debated. The presence of circulating tumor DNA (ctDNA) after surgery predicts very poor recurrence-free survival, whereas its absence predicts a low risk of recurrence. The benefit of adjuvant chemotherapy for ctDNA-positive patients is not well understood. We conducted a trial to assess whether a ctDNA-guided approach could reduce the use of adjuvant chemotherapy without compromising recurrence risk. Patients with stage II colon cancer were randomly assigned in a 2:1 ratio to have treatment decisions guided by either ctDNA results or standard clinicopathological features. For ctDNA-guided management, a ctDNA-positive result at 4 or 7 weeks after surgery prompted oxaliplatin-based or fluoropyrimidine chemotherapy. Patients who were ctDNA-negative were not treated. The primary efficacy end point was recurrence-free survival at 2 years. A key secondary end point was adjuvant chemotherapy use. Of the 455 patients who underwent randomization, 302 were assigned to ctDNA-guided management and 153 to standard management. The median follow-up was 37 months. A lower percentage of patients in the ctDNA-guided group than in the standard-management group received adjuvant chemotherapy (15% vs. 28%; relative risk, 1.82; 95% confidence interval CI, 1.25 to 2.65). In the evaluation of 2-year recurrence-free survival, ctDNA-guided management was noninferior to standard management (93.5% and 92.4%, respectively; absolute difference, 1.1 percentage points; 95% CI, -4.1 to 6.2 noninferiority margin, -8.5 percentage points). Three-year recurrence-free survival was 86.4% among ctDNA-positive patients who received adjuvant chemotherapy and 92.5% among ctDNA-negative patients who did not. A ctDNA-guided approach to the treatment of stage II colon cancer reduced adjuvant chemotherapy use without compromising recurrence-free survival. (Supported by the Australian National Health and Medical Research Council and others; DYNAMIC Australian New Zealand Clinical Trials Registry number, ACTRN12615000381583.).
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