BMC Cancer 2005, 5:132 http://www.biomedcentral.com/1471-2407/5/132 Actuarial Curve - progression free survival (PFS) and overall survival(OS) 5FU alone v multiply pretreated - PFS 100 tn 80 e c re 60 p , tsn 40 e i ta 20 P 0 PFS OS 0 3 6 9 12 15 18 21 Months SFuigrvuirvael 1curves for the 30 patients treated Survival curves for the 30 patients treated. drugs. The suggestion from our results is that benefit from the addition of SIR-spheres will be greater if used earlier, but this will need to be confirmed in larger studies. The toxicity data from our experience was consistent with findings from earlier trials involving SIR-spheres. The 13% severe gastric/duodenal ulceration rate is significant and is consistent with a recent larger study reporting a 12% GI ulceration rate [14]. Gastrointestinal ulceration occurred despite strictly adhered to protocols of pre-treat- ment workup and treatment only by experienced inter- ventional radiologists. The product information recommends routine use of a H-2 antagonist prophylacti- cally the day before the procedure and for a month after- wards in view of the known association of peptic ulceration with SIR-spheres treatment [15]. Although this was not part of our treatment protocol, the prophylactic use of proton-pump inhibitors or H-2 antagonists should be considered in patients treated with SIR-spheres. In our analysis there were no apparent indicators of which patients were likely to experience toxicity. In particular this did not appear related to disease bulk or patient per- formance status. Conclusion In summary, this series has demonstrated that treatment with SIR-spheres produces encouraging responses in pre- treated patients with colorectal cancer. Further studies in this group of patients should be pursued. On the basis of our results, thought should be given to stratifying patients according to the presence or absence of extrahepatic dis- A B 100 t en 80 c re 60 p ,ts 40 n ite 20 a p 0 tn100 rce 80 ep 60 ,ts 40 ien 20 ta 0 p 5FU/Xeloda All others 5FU/Xeloda All others 0 3 6 9 12 15 18 21 months 5FU alone v multiply pretreated - OS 0 3 6 9 12 15 18 21 months (tFAhaiioagn)tsuiPnehrgaetodhrg2earrtgeeihsmcsaeiedoivnnperdferaevteiolsueuasrlsyvtiroveancleefoiovrexdathli5ep-lFatwUtinooogrrxoieruliopnsdoatoe,facpnaandtictehononts-e, (A) Progression free survival for the two groups of patients, those that had previously received 5-FU or xeloda, and those that had received at least one oxaliplatin or irinotecan con- taining regimen. (B) Overall survival for the two groups of patients, those that had previously received 5-FU or xeloda, and those that had received at least one oxaliplatin or iri- notecan containing regimen. ease and according to performance status. We have also demonstrated the potential for significant toxicity, and such treatment should only be conducted in centres with experienced interventional radiologists. The results of ongoing phase I/II trials that are exploring the combination of SIR-spheres with multi-agent chemo- therapy (including irinotecan and oxaliplatin containing regimens) are eagerly awaited. Ultimately however, there remains a need for large phase III clinical trials evaluating the efficacy of standard therapy plus SIR-spheres com- pared to standard therapy alone. Such trials will define the true value of SIR-spheres and will permit insight into opti- mal patient selection. Finally the financial costs of this Page 5 of 6 (page number not for citation purposes)