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To: Icebrg who wrote (68)	8/9/2003 2:22:22 PM
From: Miljenko Zuanic	Respond to of 295

Data Safety Monitoring Board also has power to stop trial early IF there is clear separation between drug and placebo. Due to long period for reaching certain numbers of death (OST) suggest to me that placebo group did extra well in this trial. Miljenko

To: Icebrg who wrote (68)	8/9/2003 3:08:49 PM
From: Icebrg	Read Replies (1) \| Respond to of 295

>> There was an abstract as ASCO this year giving some background on the stratification done in the trial>> There are - it turns out - also some slides from the presentation given by Dr. Escudier. Some more meat for the bones, but nothing mind-boggling. If nothing else, the "drug" appears to be extremely safe. There had, at the time of the presentation at ASCO - when the study had almost been concluded, only been recorded three serious adverse events, which according to the investigator might have been caused by Neovastat (or the placebo). Erik media.asco.org

To: Icebrg who wrote (68)	8/10/2003 1:40:28 PM
From: Icebrg	Read Replies (1) \| Respond to of 295

The ASCO presentation gives some idea about the condition of the patients who were participating in the study. Comparing these data against the "riskgrading" I quoted earlier from an Abstract gives the following result. Abstract RESULTS: The median survival time was 10 months (95% confidence interval [CI], 9 to 11 months). Fifty-seven of 670 patients remain alive, and the median follow-up time for survivors was 33 months. Pretreatment features associated with a shorter survival in the multivariate analysis were low Karnofsky performance status (<80%), high serum lactate dehydrogenase (> 1.5 times upper limit of normal), low hemoglobin (< lower limit of normal), high "corrected" serum calcium (> 10 mg/dL), and absence of prior nephrectomy. These were used as risk factors to categorize patients into three different groups. The median time to death in the 25% of patients with zero risk factors (favorable-risk) was 20 months. Fifty-three percent of the patients had one or two risk factors (intermediate-risk), and the median survival time in this group was 10 months. Patients with three or more risk factors (poor-risk), who comprised 22% of the patients, had a median survival time of 4 months. Data from the ASCO slides. Low Karnofsky performance status (<80%). This appears to be more or less the same thing as status on the ECOG scale. It seems that the patients with an ECOG of 1 would meet the criteria of a K status of less than 80 %. In the trial population 52 % had an ECOG status of 0 and 48 % a status of 1. High serum lactate dehydrogenase (> 1.5 times upper limit of normal). In the trial population 20 % were in high risk class and 80 % in the low one. Low hemoglobin (< lower limit of normal) Here there was an even split in the trial population. 50 % in each of the two groups. High "corrected" serum calcium (> 10 mg/dL). I suppose this is the same thing as the Albumin level. In the trial population 22 % had a low level, 75 % were normal and only 3 % had the riskier high level. Absence of prior nephrectomy. On this score the participants did almost all qualify. Only six percent had not had a kidney removed. Based on these criteria it appears that the condition of the participants could be found in the intermediate group (10 months MST), but with perhaps some tilting towards the group with a prognosis for a very short remaining lifespan (4 month MST). A remaining 8-10 MST does therefore not seem to be completely out of the picture. Which in its turn should make it fairly probable that the therapy indeed has some positive effects. ( finance.messages.yahoo.com ) Erik