Details

Autor(en) / Beteiligte

• COSIMELLI, M
• GOLFIERI, R
• PERRONE, M
• GIAMPALMA, E
• ANGELELLI, B
• FIORE, F
• LASTORIA, S
• BACCHETTI, S
• GASPERINI, D
• GEATTI, O
• IZZO, F
• CAGOL, P. P
• CARPANESE, L
• SCIUTO, R
• MAINI, C. L
• MANCINI, R
• SPERDUTI, I
• PIZZI, G
• DIODORO, M. G

Titel

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

Ist Teil von

• British journal of cancer, 2010-07, Vol.103 (3), p.324-331

Ort / Verlag

Basingstoke: Nature Publishing Group

Erscheinungsjahr

2010

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. 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). 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%. Radioembolisation produced meaningful response and disease stabilisation in patients with advanced, unresectable and chemorefractory mCRC.