Just a reminder that we can expect the initial data at some point over the next few months.
My understanding is that the final cohort of 6 pts had doses well above the 300 Gy of the 5th cohort.
From the Sirtex web site;
In general, 1 GBq (27 mCi) of Yttrium-90/kg of tissue provides the equivalent of 50 Gy of radiation dose.1
Table 2 – The Recommended Patient Dose
The % Involvement by the Tumour in the Liver Recommended Y-90 Dose*
> 50 % 3.0 GBq
25 % - 50 % 2.5 GBq
< 25 % 2.0 GBq
So, 3 GBq being the maximum recommended dose equates to about 150 Gy. If the pts in the RESIRT trial are able to tolerate 300 Gy then it will be most interesting to see the data.
One has to assume that the 300 Gy was considered reasonably safe in order to continue with much higher doses.
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According to SEER1 , there were estimated to be 61,560 new cases of kidney cancer in the United States during 2015, representing 3.7% of all cancer cases. Kidney cancer is the 13th most common cancer worldwide, with approximately 338,000 cases globally in 20122 . RCC accounts for approximately 90% of all new kidney cancers.
Initial results of the RESIRT study are anticipated to be available during the fourth quarter of calendar year 2016.
About RESIRT A total of 21 patients were recruited serially into six dose escalating cohorts: 75 Gray (Gy), 100 Gy, 150 Gy, 200 Gy, and 300 Gy of intended radiation dose to tumour. The sixth cohort allowed the delivery of SIR-Spheres microspheres until cessation of blood flow in the renal artery. SIR-Spheres microspheres were administered once only with each patient receiving one allocated radiation dose. The primary endpoint of the study is safety and toxicity at 30 days, with secondary endpoints of tumour response rates, Progression-Free Survival (PFS), Overall Survival (OS) and Quality of Life (QoL). The study is listed on the Australian New Zealand Clinical Trials Registry (ANZCTR) under the identifier ACTRN12610000690055.
Just a reminder that we can expect the initial data at some...
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