Surgical resection alone is regarded as the standard of care for patients with liver metastases from colorectal cancer, but relapse is common.
Professor Bernard Nordlinger and colleagues from France assessed the combination of perioperative chemotherapy and surgery compared with surgery alone for patients with initially resectable liver metastases from colorectal cancer.
|Progression-free survival at 3 years increased by 9% in patients undergoing resection|
The investigators conducted a parallel-group study.
The team report the trial's final data for progression-free survival for a protocol unspecified interim time-point, while overall survival is still being monitored.
The investigators randomized 364 patients with histologically proven colorectal cancer and up to 4 liver metastases to either 6 cycles of FOLFOX4 before, and 6 cycles after surgery or to surgery alone.
There were 182 in the perioperative chemotherapy group vs 182 in the surgery group.
The primary objective was to detect a hazard ratio of 0.7 or less for progression-free survival.
Primary analysis was by intention to treat.
The team repeated analyses for all eligible, and resected patients.
The investigators found in the perioperative chemotherapy group, 83% were resected after a median of 6 preoperative cycles, and 63% received a median of 6 postoperative cycles.
The team reported that 84% of patients were resected in the surgery group.
The absolute increase in rate of progression-free survival at 3 years was 7%, from 28% to 35% in randomized patients.
Progression-free survival at 3 years increased by 8%, from 28% to 36% in eligible patients, and 9%, from 33% to 42% in patients undergoing resection.
The investigators noted that 139 patients died, of which 64 were in the perioperative chemotherapy group vs 75 in the surgery group.
The team found reversible postoperative complications occurred more often after chemotherapy than after surgery.
The investigators found 2 deaths in the surgery alone group, and 1 in the perioperative chemotherapy group.
Professor Nordlinger's team concluded, "Perioperative chemotherapy with FOLFOX4 is compatible with major liver surgery, and reduces the risk of events of progression-free survival in eligible and resected patients."