<<For the patients in the trial, 10 months is the company's estimate of median survival time for those on placebo (trial criteria excluded those "in a very bad state").>>
This should be reached last year (~Nov), or +10 months after last pts enrolled, or ~16-18 months from 2/3 point of the enrollment time-frame (2000-2001 end, if one assume linear enrollment rate). If majority of the pts enrolled in late 2001 than time for analysis (75% death) should be April-May 2003. Do you have dealt rate curve or some other information that can help track down what is going on?
Miljenko
PS:
For comparison, T + IL-2 in mRCC:
<<THALOMID in Combination with IL-2 for Metastatic Renal Cell Carcinoma
Robert J. Amato, D.O. of Baylor College of Medicine presented data from a Phase II study of THALOMID in combination with Interleukin-2 (IL-2) for the treatment of metastatic renal cell carcinoma. Thirty-seven patients received 400 mg/day of THALOMID plus IL-2 7m IU/m2 days one-five, weeks one-four. All patients had prior nephrectomy and had an average of three metastatic sites (range: one to five). Of 36 evaluable patients, two (six percent) achieved a complete response, 11 (31 percent) achieved a partial response and six (17 percent) experienced disease stabilization. Dr. Amato also presented data from a completed Phase I study of THALOMID plus IL-2 in metastatic renal cell carcinoma. In the Phase I study, 15 patients received a daily THALOMID dose of 200 mg (three patients), 400 mg (six patients) or 600 mg (six patients). IL-2 was administered by subcutaneous injections of 7 mIU/m2 on days one-five, weeks one-four. Of the 15 patients, one (7 percent) achieved a complete response, five (33 percent) achieved a partial response and two (13 percent) achieved disease stabilization. Dr. Amato reported that the combined results of both the Phase I and Phase II trial demonstrated that twenty-seven of fifty-one patients (53 percent) treated in both trials achieved either an objective response or disease stabilization. In addition, the three patients who achieved a complete response continue to respond on therapy at longer than 15, 17 and 19 months. Patients who experienced a partial response to therapy achieved overall survival of four to longer than 23 months and patients who experienced stable disease achieved overall survival of ten to longer than 24 months. Adverse events observed during the trials were sedation, fatigue, constipation, skin rash, deep venous thrombosis, fluid retention, flu-like symptoms, bradycardia and neuropathy.>>
There is no way that placebo pts will respond (maybe few lucky ones), so majority of theis pts still alive *must* be on Neovastat????? |
