Multi-centre phase II clinical trial of yttrium-90 resin microspheres alone in unresectable, chemotherapy refractory colorectal liver 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 > 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.
Cosimelli
M
M
Regina Elena National Cancer Institute, Via Elio Chianesi, 53, 00144 Rome, Italy. mcosimelli@libero.it
Golfieri
R
R
Cagol
P P
PP
Carpanese
L
L
Sciuto
R
R
Maini
C L
CL
Mancini
R
R
Sperduti
I
I
Pizzi
G
G
Diodoro
M G
MG
Perrone
M
M
Giampalma
E
E
Angelelli
B
B
Fiore
F
F
Lastoria
S
S
Bacchetti
S
S
Gasperini
D
D
Geatti
O
O
Izzo
F
F
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*
D015021:Yttrium Radioisotopes