Multi-centre phase II clinical trial of yttrium-90 resin microspheres alone in unresectable, chemotherapy refractory colorectal liver metastases

作者：Cosimelli M^*; Golfieri R; Cagol P P; Carpanese L; Sciuto R; Maini C L; Mancini R; Sperduti I; Pizzi G; Diodoro M G; Perrone M; Giampalma E; Angelelli B; Fiore F; Lastoria S; Bacchetti S; Gasperini D; Geatti O; Izzo F

来源：British Journal of Cancer, 2010, 103(3): 324-331.

DOI：10.1038/sj.bjc.6605770

• radioembolisation
• selective internal radiation therapy
• SIRT
• chemorefractory
• colorectal cancer
• metastases

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 >= 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%.
CONCLUSION: Radioembolisation produced meaningful response and disease stabilisation in patients with advanced, unresectable and chemorefractory mCRC. British Journal of Cancer (2010) 103, 324-331. doi:10.1038/sj.bjc.6605770 www.bjcancer.

• 出版日期2010-7-27