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Clinical Trial
. 2010 Jul 27;103(3):324-31.
doi: 10.1038/sj.bjc.6605770. Epub 2010 Jul 13.

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

M Cosimelli  1 , R Golfieri, P P Cagol, L Carpanese, R Sciuto, C L Maini, R Mancini, I Sperduti, G Pizzi, M G Diodoro, M Perrone, E Giampalma, B Angelelli, F Fiore, S Lastoria, S Bacchetti, D Gasperini, O Geatti, F Izzo; Italian Society of Locoregional Therapies in Oncology (SITILO)
Affiliations
Clinical Trial

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

M Cosimelli et al. Br J Cancer. .

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%.

Conclusion: Radioembolisation produced meaningful response and disease stabilisation in patients with advanced, unresectable and chemorefractory mCRC.

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Figures

Figure 1
Figure 1
Preliminary angiographic evaluation (A) and subsequent administration of 90Y resin microspheres (B) after embolisation of gastroduodenal artery and branches in 64-year-old man with CRC liver metastases. Small diffuse hypervascular areas are observed throughout the liver parenchyma, confirming infiltrative malignant disease.
Figure 2
Figure 2
Contrast-enhanced CT scans of patient in Figure 1, showing pre-radioembolisation hypoattenuating lesions (A/B); 3-month post-radioembolisation decreased lesion size, decreased intra-lesional vascular enhancement, increased intra-lesional necrosis, thin peripheral enhancement (C/D) and reduced compression/narrowing of large posterior right portal vein branch (D).
Figure 3
Figure 3
Contrast-enhanced pre-radioembolisation arterial (A) and portal-venous-phase (B) CT scans showing large CRC liver metastasis. 6-month post-radioembolisation (C) including significant attenuation, sharp margins and thin peripheral enhancement compatible with complete lesion necrosis; confirmed by post-resection evaluation (D), showing fibrotic capsule (arrow).
Figure 4
Figure 4
Kaplan–Meier plots of overall survival following radioembolisation with 90Y resin microspheres in unresectable, chemotherapy refractory CRC liver metastases in all patients (n=50); and among responders (CR+PR+SD; n=24) and non-responders (PD; n=22).
See this image and copyright information in PMC

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