LM02 trial Perioperative treatment with panitumumab and FOLFIRI in patients with wild-type RAS, potentially resectable colorectal cancer liver metastases—a phase II study

Background Twenty percent of colorectal cancer liver metastases (CLMs) are initially resectable with a 5-year survival rate 25%–40%. Perioperative folinic acid, 5-fluorouracil, oxaliplatin (FOLFOX) increases progression-free (PFS). In advanced disease, the addition targeting therapies results in an overall (OS) advantage. The aim this study was to evaluate panitumumab and FOLFIRI as perioperative therapy CLM. Methods Patients previously untreated, wild-type Rat sarcoma virus (RAS), CLM were included. Preoperative four postoperative eight cycles irinotecan (FOLFIRI) administered. Primary objectives efficacy safety. Secondary endpoints included PFS OS. Results We enrolled 36 patients seven centers Austria (intention-to-treat analyses, 35 patients). There 28 men women, median age 66 years. About 91.4% completed preoperative 82.9% underwent resection. R0 resection 82.7%. started 12 chemotherapy. objective radiological response after 65.7%. 20% 5.7% had stable disease progressive respectively. most common grade 3 adverse events diarrhea, rash, leukopenia during therapy. One patient died because sepsis, one pulmonary embolism 4. After surgery, two hepatic failure. Most skin toxicities/rash leukopenia/neutropenia, 4 stroke intestinal obstruction. Median 13.2 months. OS at 24 months 85.6% 73.3%, Conclusions Panitumumab for result 65.7% manageable diarrhea 14.3%. months, 24-month 73.3%. These data insufficient widen indication from unresectable setting