摘要
AIM: To investigate efficacy and safety of second-line treatment with irinotecan-loaded drug-eluting beads(DEBIRI) and cetuximab(DEBIRITUX) of unresectable colorectal liver metastases.METHODS: Patients with the following characteristics were included in the study: unresectable hepatic metastases from colorectal carcinoma(CRC-LM), progression after first line chemotherapy(any type of chemotherapeutic drug and combination was allowed), second line treatment(mandatory), which included for each patient(unregarding the KRas status) two cycles of DEBIRI(using 100-300 μm beads loaded with irinotecan at a total dose 200 mg) followed by 12 cycles of cetuximab that was administered weekly at a first dose of 400 mg/m2 and then 250 mg/m2; good performance status(0-2) and liver functionality(alanine aminotransferase and gamma-glutamyl transferase not exceeding three times the upper limit of normal, total bilirubin not exceeding 2.5 mg/m L). Data were collected retrospectively and included: tumor response(evaluated monthly for 6 mo then every 3 mo), overall response rate(ORR), KRas status, type and intensity of adverse events(G according to the Common Terminology Criteria for Adverse Events v3.0, CTCAE), overall survival(OS) and progression free survival(PFS).RESULTS: Forty consecutive cases of CRC hepatic metastases were included in the study. Median duration of DEBIRITUX was 4.4 mo(range, 4.0-6.5). Sixteen patients(40%) received the planned 2 cycles of DEBIRI and an average of 10 cetuximab cycles. ORR of the whole sample was 50%, in particular 4 patients were complete responders(10%) and 16(40%) partial responders. The most observed side effects(G2) were: post-embolization syndrome(30%), diarrhea(25%), skin rushes(38%) and asthenia(35%). The retrospective evaluation of KRas status(24 wild type, 16 mutated) showed that the group of patients with wild type KRas had ORR significantly higher than mutant KRas. Median follow-up was 29 mo(8-48 range); median PFS was 9.8 mo and OS was 20.4 mo. Future randomized trials are required in this setting to establish a role for DEBIRITUX compared with systemic chemotherapy.CONCLUSION: DEBIRITUX seems to be efficacious after first line chemotherapy for the treatment of unresectable CRC-LM.
AIM To investigate efficacy and safety of second-linetreatment with irinotecan-loaded drug-eluting beads（DEBIRI） and cetuximab （DEBIRITUX） of unresectablecolorectal liver metastases.METHODS： Patients with the following characteristicswere included in the study： unresectable hepaticmetastasesfrom colorectal carcinoma （CRC-LM）,progression after first line chemotherapy （any type ofchemotherapeutic drug and combination was allowed）,second line treatment （mandatory）, which includedfor each patient （unregarding the KRas status） twocycles of DEBIRI （using 100-300 μm beads loadedwith irinotecan at a total dose 200 mg） followed by 12cycles of cetuximab that was administered weekly ata first dose of 400 mg/m2 and then 250 mg/m2; good performance performance status （0-2） and liver functionality （alanineaminotransferase and gamma-glutamyl transferase notexceeding three times the upper limit of normal, totalbilirubin not exceeding 2.5 mg/mL）. Data were collectedretrospectively and included： tumor response （evaluatedmonthly for 6 mo then every 3 mo）, overall responserate （ORR）, KRas status, type and intensity of adverseevents （G according to the Common TerminologyCriteria for Adverse Events v3.0, CTCAE）, overall survival（OS） and progression free survival （PFS）.RESULTS： Forty consecutive cases of CRC hepaticmetastases were included in the study. Median durationof DEBIRITUX was 4.4 mo （range, 4.0-6.5）. Sixteenpatients （40%） received the planned 2 cycles of DEBIRIand an average of 10 cetuximab cycles. ORR of thewhole sample was 50%, in particular 4 patients werecomplete responders （10%） and 16 （40%） partialresponders. The most observed side effects （G2）were： post-embolization syndrome （30%）, diarrhea（25%）, skin rushes （38%） and asthenia （35%）. Theretrospective evaluation of KRas status （24 wild type,16 mutated） showed that the group of patients withwild type KRas had ORR significantly higher thanmutant KRas. Median follow-up was 29 mo （8-48range）; median PFS was 9.8 mo and OS was 20.4 mo.Future randomized trials are required in this setting toestablish a role for DEBIRITUX compared with systemicchemotherapy.CONCLUSION： DEBIRITUX seems to be efficaciousafter first line chemotherapy for the treatment ofunresectable CRC-LM.
