Randomized phase II trial of adjuvant hepatic arterial infusion and systemic chemotherapy with or without bevacizumab in patients with resected hepatic metastases …
NE Kemeny, WR Jarnagin, M Capanu… - Journal of Clinical …, 2011 - ascopubs.org
Purpose Add systemic bevacizumab (Bev) to adjuvant hepatic arterial infusion (HAI) plus
systemic therapy after liver resection to increase recurrence-free survival (RFS). Patients
and Methods Patients were randomly assigned to HAI plus systemic therapy with or without
Bev. If 1-year RFS of≥ 80% was obtained in Bev arm, then the regimen would be studied
further. HAI with fluorodeoxyuridine plus dexamethasone was given on days 1 to 14 of a 5-
week cycle. Systemic therapy and Bev 5 mg/kg was delivered on days 15 and 29: oxaliplatin …
systemic therapy after liver resection to increase recurrence-free survival (RFS). Patients
and Methods Patients were randomly assigned to HAI plus systemic therapy with or without
Bev. If 1-year RFS of≥ 80% was obtained in Bev arm, then the regimen would be studied
further. HAI with fluorodeoxyuridine plus dexamethasone was given on days 1 to 14 of a 5-
week cycle. Systemic therapy and Bev 5 mg/kg was delivered on days 15 and 29: oxaliplatin …
A randomized phase II trial of adjuvant hepatic arterial infusion and systemic therapy with or without panitumumab after hepatic resection of KRAS wild-type colorectal …
NE Kemeny, JF Chou, M Capanu, WK Chatila, H Shi… - 2021 - journals.lww.com
Methods: This phase II trial randomized patients with KRAS wild-type resected colorectal
liver metastases to adjuvant HAI FUDR+ SYS FOLFIRI+/–Pmab (NCT01312857). Patients
were stratified by clinical risk score and previous chemotherapy. Based on an exact binomial
design, if one arm had≥ 24 patients alive and disease-free at 15 months that regimen was
considered promising for further investigation. Results: Seventy-five patients were
randomized. Patient characteristics and toxicity were not different in the 2 arms, except for …
liver metastases to adjuvant HAI FUDR+ SYS FOLFIRI+/–Pmab (NCT01312857). Patients
were stratified by clinical risk score and previous chemotherapy. Based on an exact binomial
design, if one arm had≥ 24 patients alive and disease-free at 15 months that regimen was
considered promising for further investigation. Results: Seventy-five patients were
randomized. Patient characteristics and toxicity were not different in the 2 arms, except for …
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