Try FOLFOX-HAIC combining bevacizumab or cetuximab for initially unresectable colorectal liver metastasis patients to increase the conversion to resection rate to improve long-term survival outcomes
age 18-75 years
no history of other malignant diseases
refuse or progress in prior systemic treatment
diagnosed as CRLM confirmed by pathology, in spite of whether the primary tumor had been resected
extra-hepatic metastasis verified by medical imaging
unable to tolerate chemotherapy, anesthesia or surgery
allergy or previous intolerable to any agent of oxaliplatin, leucovorin, 5-Fu, bevacizumab or cetuximab
tumor spread in abdomen
Single group
FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
Combination productThe procedures of FOLFOX-HAIC were as follows: 1) a 5 French sheath was inserted into the femoral artery by Seldinger technique, then a 3.5 French catheter entered the coeliac trunk and superior mesenteric artery to assess the feeding arteries of tumors and identify any extra-collateral vessels which may cause drug leakage. These vessels would be embolized with gelatin sponge particles or metallic coils if necessary. A 2.7 French microcatheter was selectively inserted into the left/right/proper hepatic artery then patients were transferred to inpatient ward to start chemotherapy drug infusion. The FOLFOX regimen involving oxaliplatin (130mg/m2, day 1, 0-2h), leucovorin (400 mg/m2, day 1, 2-3h), 5-Fu (400mg/m2, day 1, bolus at 3h, then 2400 mg/m2, day 1-3, 3-49h), was administered via the microcatheter. The microcatheter and sheath were removed after HAIC finished. We didn't implanted port catheter system and repeated percutaneous femoral artery puncture and catheterization once every 3
hepatic arterial infusion chemotherapy (HAIC)
Procedure/SurgeryThe procedures of FOLFOX-HAIC were as follows: 1) a 5 French sheath was inserted into the femoral artery by Seldinger technique, then a 3.5 French catheter entered the coeliac trunk and superior mesenteric artery to assess the feeding arteries of tumors and identify any extra-collateral vessels which may cause drug leakage. These vessels would be embolized with gelatin sponge particles or metallic coils if necessary. A 2.7 French microcatheter was selectively inserted into the left/right/proper hepatic artery then patients were transferred to inpatient ward to start chemotherapy drug infusion.
Bevacizumab
DrugWe would inject bevacizumab at the dose of 7.5mg/kg once every 3 weeks if the primary tumors located from right-side to splenic flexure colon or the genotype of RAS or RAF was mutational.
Cetuximab (Erbitux)
DrugWe would inject cetuximab at an initial dose of 400mg/m2 and maintained a dose of 250mg/m2 once every week if we didn't choose bevacizumab.
liver resection
Procedure/SurgeryIf patients reached potential resectable state, we would perform liver resection.
conversion to resection rate
conversion to resection rate: the number of patients underwent liver resection/total patients underwent FOLFOX-HAIC combining with target agents
drug treatment safety assessment
Any adverse event during treatment that is incompatible with the therapeutic purpose of the medication. The incidence and severity of adverse events and serious adverse events as assessed according to CTCAE v5.0.
objective response rate
Objective response rate (ORR) was defined as the sum of cases with complete response (CR) and partial response (PR) which assessed by the RECIST 1.1 criteria.
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