TY - JOUR
T1 - Trans-Arterial Chemoembolization with Irinotecan-Loaded Drug-Eluting Beads (DEBIRI) and Capecitabine in Refractory Liver Prevalent Colorectal Metastases: A Phase II Single-Center Study
AU - Iezzi, Roberto
AU - Marsico, Valentina Angela
AU - Guerra, Alessandra
AU - Cerchiaro, Eleonora
AU - Cassano, Alessandra
AU - Basso, Michele
AU - Devicienti, Ersilia
AU - Rodolfino, Elena
AU - Barone, Carlo Antonio
AU - Bonomo, Lorenzo
PY - 2015
Y1 - 2015
N2 - Purpose: The purpose of this study was to evaluate feasibility, safety, tolerance, and efficacy of drug-eluting beads loaded with irinotecan (DEBIRI) in combination with capecitabine in the treatment of mCRC refractory to chemotherapy in patients affected by liver predominant metastatic disease. Materials and Methods: Twenty patients affected by CRC hepatic metastasis with liver-dominant disease, who had progression after two or more lines of chemotherapy, were enrolled. TACE with 100 mg of Irinotecan loaded into 2-ml of 70–150 µm drug-eluting beads was administrated every 4 weeks in patients with unilobar disease (2 treatments) and every 2 weeks in patients with bilobar disease (4 treatments). All patients assumed capecitabine 1000 mg/m2 twice daily on days 1–14 every 3 weeks, until disease progression. Primary endpoints were safety, tolerance and overall disease control (ODC); secondary endpoints were progression free survival (PFS) and overall survival (OS). Results: A total of 54 treatments were performed (54/66, 82 %). No intra/peri-procedural death occurred. During the mean follow-up of 11 months, two partial responses (PR) were reported with ODC of 60 % (2 PR + 10 stable disease). PFS and OS were 4 and 7.3 months, respectively. Univariate analysis showed that patients presenting with KRAS wild-type, good ECOG performance status and unilobar disease had a better prognosis. Only performance status (ECOG) correlated with OS in multivariate analysis (p = 0.03). Conclusion: DEBIRI with capecitabine seem to be a safe, technically feasible and well-tolerated treatment in chemotherapy refractory liver prevalent colorectal metastases.
AB - Purpose: The purpose of this study was to evaluate feasibility, safety, tolerance, and efficacy of drug-eluting beads loaded with irinotecan (DEBIRI) in combination with capecitabine in the treatment of mCRC refractory to chemotherapy in patients affected by liver predominant metastatic disease. Materials and Methods: Twenty patients affected by CRC hepatic metastasis with liver-dominant disease, who had progression after two or more lines of chemotherapy, were enrolled. TACE with 100 mg of Irinotecan loaded into 2-ml of 70–150 µm drug-eluting beads was administrated every 4 weeks in patients with unilobar disease (2 treatments) and every 2 weeks in patients with bilobar disease (4 treatments). All patients assumed capecitabine 1000 mg/m2 twice daily on days 1–14 every 3 weeks, until disease progression. Primary endpoints were safety, tolerance and overall disease control (ODC); secondary endpoints were progression free survival (PFS) and overall survival (OS). Results: A total of 54 treatments were performed (54/66, 82 %). No intra/peri-procedural death occurred. During the mean follow-up of 11 months, two partial responses (PR) were reported with ODC of 60 % (2 PR + 10 stable disease). PFS and OS were 4 and 7.3 months, respectively. Univariate analysis showed that patients presenting with KRAS wild-type, good ECOG performance status and unilobar disease had a better prognosis. Only performance status (ECOG) correlated with OS in multivariate analysis (p = 0.03). Conclusion: DEBIRI with capecitabine seem to be a safe, technically feasible and well-tolerated treatment in chemotherapy refractory liver prevalent colorectal metastases.
KW - Aged
KW - Antimetabolites, Antineoplastic
KW - Antineoplastic Agents, Phytogenic
KW - Camptothecin
KW - Capecitabine
KW - Cardiology and Cardiovascular Medicine
KW - Chemoembolization
KW - Chemoembolization, Therapeutic
KW - Colorectal Neoplasms
KW - Disease-Free Survival
KW - Drug Delivery Systems
KW - Feasibility Studies
KW - Female
KW - Hepatic
KW - Humans
KW - Interventional Oncology
KW - Irinotecan
KW - Liver
KW - Liver Neoplasms
KW - Male
KW - Middle Aged
KW - Neoplasm
KW - Prospective Studies
KW - Radiology, Nuclear Medicine and Imaging
KW - Treatment Outcome
KW - Tumor
KW - Aged
KW - Antimetabolites, Antineoplastic
KW - Antineoplastic Agents, Phytogenic
KW - Camptothecin
KW - Capecitabine
KW - Cardiology and Cardiovascular Medicine
KW - Chemoembolization
KW - Chemoembolization, Therapeutic
KW - Colorectal Neoplasms
KW - Disease-Free Survival
KW - Drug Delivery Systems
KW - Feasibility Studies
KW - Female
KW - Hepatic
KW - Humans
KW - Interventional Oncology
KW - Irinotecan
KW - Liver
KW - Liver Neoplasms
KW - Male
KW - Middle Aged
KW - Neoplasm
KW - Prospective Studies
KW - Radiology, Nuclear Medicine and Imaging
KW - Treatment Outcome
KW - Tumor
UR - http://hdl.handle.net/10807/132967
U2 - 10.1007/s00270-015-1080-9
DO - 10.1007/s00270-015-1080-9
M3 - Article
SN - 0174-1551
VL - 38
SP - 1523
EP - 1531
JO - CardioVascular and Interventional Radiology
JF - CardioVascular and Interventional Radiology
ER -