title: Trans-Arterial Chemoembolization with Irinotecan-Loaded Drug-Eluting Beads (DEBIRI) and Capecitabine in Refractory Liver Prevalent Colorectal Metastases: A Phase II Single-Center Study.
abstract: OBJECTIVE
  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.
  
  
  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/m(2) 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).
  
  
  CONCLUSIONS
  DEBIRI with capecitabine seem to be a safe, technically feasible and well-tolerated treatment in chemotherapy refractory liver prevalent colorectal metastases.
authors: Department of Bioimaging and Radiological Sciences, Institute of Radiology, "A. Gemelli" Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy. roberto.iezzi.md@gmail.com.
authors: Roberto
authors: R
authors: Iezzi
authors: Department of medical Oncology, "A. Gemelli" Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy. valentina.marsico@gmail.com.
authors: Valentina Angela
authors: VA
authors: Marsico
authors: Department of Bioimaging and Radiological Sciences, Institute of Radiology, "A. Gemelli" Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy. ale.gue@libero.it.
authors: Alessandra
authors: A
authors: Guerra
authors: Department of medical Oncology, "A. Gemelli" Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy. eleonoracerc@hotmail.com.
authors: Eleonora
authors: E
authors: Cerchiaro
authors: Department of medical Oncology, "A. Gemelli" Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy. alessandra.cassano@rm.unicatt.it.
authors: Alessandra
authors: A
authors: Cassano
authors: Department of medical Oncology, "A. Gemelli" Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy. michele.basso@rm.unicatt.it.
authors: Michele
authors: M
authors: Basso
authors: Department of Bioimaging and Radiological Sciences, Institute of Radiology, "A. Gemelli" Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy. ersadev@yahoo.it.
authors: Ersilia
authors: E
authors: Devicienti
authors: Department of Bioimaging and Radiological Sciences, Institute of Radiology, "A. Gemelli" Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy. elenarodolfino@alice.it.
authors: Elena
authors: E
authors: Rodolfino
authors: Department of medical Oncology, "A. Gemelli" Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy. carlobarone@rm.unicatt.it.
authors: Carlo
authors: C
authors: Barone
authors: Department of Bioimaging and Radiological Sciences, Institute of Radiology, "A. Gemelli" Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy. lbonomo@rm.unicatt.it.
authors: Lorenzo
authors: L
authors: Bonomo
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000069287:Capecitabine / Q000008:administration & dosage*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D015179:Colorectal Neoplasms / Q000556:secondary* / Q000628:therapy*; D018572:Disease-Free Survival; D016503:Drug Delivery Systems; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008113:Liver Neoplasms / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D000069287:Capecitabine; D000077146:Irinotecan; D002166:Camptothecin
keywords: Chemoembolization; Hepatic; Interventional Oncology; Liver; Neoplasm; Tumor