title: Multi-centre phase II clinical trial of yttrium-90 resin microspheres alone in unresectable, chemotherapy refractory colorectal liver metastases.
abstract: BACKGROUND
  This multi-centre phase II clinical trial is the first prospective evaluation of radioembolisation of patients with colorectal liver metastases (mCRC) who failed previous oxaliplatin- and irinotecan-based systemic chemotherapy regimens.
  
  
  METHODS
  Eligible patients had adequate hepatic, haemopoietic and renal function, and an absence of major hepatic vascular anomalies and hepato-pulmonary shunting. Gastroduodenal and right gastric arteries were embolised before hepatic arterial administration of yttrium-90 resin microspheres (median activity, 1.7 GBq; range, 0.9-2.2).
  
  
  RESULTS
  Of 50 eligible patients, 38 (76%) had received > or =4 lines of chemotherapy. Most presented with synchronous disease (72%), >4 hepatic metastases (58%), 25-50% replacement of total liver volume (60%) and bilateral spread (70%). Early and intermediate (>48 h) WHO G1-2 adverse events (mostly fever and pain) were observed in 16 and 22% of patients respectively. Two died due to renal failure at 40 days or liver failure at 60 days respectively. By intention-to-treat analysis using Response Evaluation Criteria in Solid Tumours, 1 patient (2%) had a complete response, 11 (22%) partial response, 12 (24%) stable disease, 22 (44%) progressive disease; 4 (8%) were non-evaluable. Median overall survival was 12.6 months (95% CI, 7.0-18.3); 2-year survival was 19.6%.
  
  
  CONCLUSIONS
  Radioembolisation produced meaningful response and disease stabilisation in patients with advanced, unresectable and chemorefractory mCRC.
authors.affiliation: Regina Elena National Cancer Institute, Via Elio Chianesi, 53, 00144 Rome, Italy. mcosimelli@libero.it
authors.forename: M
authors.initials: M
authors.lastname: Cosimelli
authors.forename: R
authors.initials: R
authors.lastname: Golfieri
authors.forename: P P
authors.initials: PP
authors.lastname: Cagol
authors.forename: L
authors.initials: L
authors.lastname: Carpanese
authors.forename: R
authors.initials: R
authors.lastname: Sciuto
authors.forename: C L
authors.initials: CL
authors.lastname: Maini
authors.forename: R
authors.initials: R
authors.lastname: Mancini
authors.forename: I
authors.initials: I
authors.lastname: Sperduti
authors.forename: G
authors.initials: G
authors.lastname: Pizzi
authors.forename: M G
authors.initials: MG
authors.lastname: Diodoro
authors.forename: M
authors.initials: M
authors.lastname: Perrone
authors.forename: E
authors.initials: E
authors.lastname: Giampalma
authors.forename: B
authors.initials: B
authors.lastname: Angelelli
authors.forename: F
authors.initials: F
authors.lastname: Fiore
authors.forename: S
authors.initials: S
authors.lastname: Lastoria
authors.forename: S
authors.initials: S
authors.lastname: Bacchetti
authors.forename: D
authors.initials: D
authors.lastname: Gasperini
authors.forename: O
authors.initials: O
authors.lastname: Geatti
authors.forename: F
authors.initials: F
authors.lastname: Izzo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015179:Colorectal Neoplasms / Q000473:pathology*; D003131:Combined Modality Therapy; D004621:Embolization, Therapeutic / Q000379:methods; D005260:Female; D006499:Hepatic Artery; D006801:Humans; D007958:Leukocyte Count; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D015021:Yttrium Radioisotopes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D015021:Yttrium Radioisotopes