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No Survival Benefit for Chemotherapy After Hepatic Resection in Colorectal Cancer
Adjuvant chemotherapy with mFOLFOX6 or capecitabine oxaliplatin improves survival in stage III colon cancer. Treatment guidelines recommend adjuvant chemotherapy after potential curative resection of liver metastases in patients with colorectal cancer despite limited data from randomized clinical trials.
Investigators in Japan randomized 300 patients with colorectal cancer and resectable hepatic metastases to hepatectomy alone or hepatectomy followed by 6 months of adjuvant chemotherapy with mFOLFOX6. Most patients had colon primaries (77%), 0 to 3 positive nodes (82%), 1 to 3 liver metastases (91%), and synchronous metastases (56%); a minority had received prior non–oxaliplatin-containing fluorinated pyrimidine adjuvant chemotherapy after primary tumor resection (22%).
At a median follow-up of 59.2 months, the primary endpoint of superior 5-year disease-free survival (DFS) with chemotherapy after hepatectomy compared with hepatectomy alone was achieved (49.8% vs. 38.7%; hazard ratio, 0.67; P=0.006). However, 5-year overall survival (OS) trended inferior for chemotherapy compared with surgery alone (71.2% vs. 83.1%; HR 1.25; P=0.42). No subgroup had an OS benefit from adjuvant chemotherapy. In the subgroup of patients who had received prior adjuvant therapy after primary tumor resection, those treated with mFOLFOX had inferior survival compared with those treated with hepatectomy alone (HR, 2.76). Liver recurrence was more common with hepatectomy alone compared with chemotherapy (51% vs. 37%), whereas extrahepatic recurrence was more common with chemotherapy than hepatectomy alone (63% vs. 48%). The median number of courses of adjuvant therapy was 12. No new safety signals were observed.
These provocative results call into question the benefit of adjuvant chemotherapy after hepatic resection of colorectal cancer metastases in patients who largely had not received any prior chemotherapy. These results are consistent with those reported from EORTC Trial 40983 (Lancet Oncol 2013; 14:1208 and Lancet 2008; 371:1007). The potential for a disease-free survival benefit without a clear overall survival benefit with adjuvant chemotherapy should be discussed with patients.
Kanemitsu Y et al.
Title: Hepatectomy followed by mFOLFOX6 versus hepatectomy alone for liver-only metastatic colorectal cancer (JCOG0603): A phase II or III randomized controlled trial.
Source: J Clin Oncol 2021 Dec 1; [e-pub]. (Abstract/FREE Full Text)