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SWOG Update
April 2011

Contents  
Welcome to the April 2011 SWOG Update.

For all members and friends of SWOG, the SWOG Update will keep you informed of what's happening with the group. News to report? Send it to communications@swog.org.

View a one-page version for printing.
 
Chair's Corner  
National Cancer Institute's Fab "Up to" Four
Laurence H. Baker photo The NCI has proposed a consolidation from the current nine cooperative groups studying adult patients and cancer to "up to four groups." We have less than two years to justify our approach and make it clear that SWOG should remain one of the "up to four" adult groups. [more]

Study Updates  

histological slide of prostate cancer S0421: Interim analysis finds no atrasentan benefit
The DSMC has closed S0421 and released its results early, finding adding atrasentan to chemo offered no benefit to patients with advanced prostate cancer. [more]

S0931: EVEREST trial underway
This phase III study will test mTOR inihibitor everolimus as an adjuvant treatment following surgery for localized renal cancer. [more]

E4A08: Bortezomib with chemo in AL
Amyloidosis patients who can't or won't undergo transplant will get chemo with or without bortezomib. [more]

 
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STUDY UPDATE: S0421

S0421 closes early; interim analysis finds no benefit in adding atrasentan to prostate chemotherapy


Histological slide (H & E stain at x300) showing prostate cancer. On the right is a somewhat normal Gleason Value of 3 (out of 5) with moderately differentiated cancer. On the left is less normal tissue with a Gleason Value of 4 (out of 5) that is highly undifferentiated. O. Brawley; NCI

SWOG trial S0421 closes early based on interim finding that atrasentan added to docetaxel and prednisone did not confer additional survival benefit to patients with hormone-refractory prostate cancer.

The Data and Safety Monitoring Committee (DSMC) has determined that patients in phase III S0421 given atrasentan in addition to a standard chemotherapy regimen for advanced prostate cancer did not have longer survival or longer progression-free survival than patients on the same chemotherapy regimen who got a placebo rather than atrasentan.

Almost 1,000 patients who had advanced, hormone-refractory prostate cancer were given up to 36 weeks of chemotherapy with docetaxel and prednisone. These patients were randomized so that one half got an additional pill with a dose of atrasentan while the other half got a placebo pill. Patients who completed their chemotherapy and showed no progression of the disease were given the option of continuing the additional blinded pill (atrasentan or placebo).

The DSMC evaluated a planned interim analysis of trial data and determined the evidence indicating no benefit from the drug was strong enough to close the study early and report the results rather than waiting another 18 months as was originally planned. The DSMC did not find evidence that the drug was harming patients.

New patient enrollment to the study had been completed in April 2010 and few patients continue to take the study pill. Patients still taking study medication should speak to their doctor about stopping safely and what to do with their remaining pills. Treatment assignment is being unblinded, so patients can learn from their study doctor whether they took atrasentan or a placebo.

SWOG sites can download model investigator and patient letters announcing the closure from the S0421 protocol abstract page.

SWOG conducted the study -- Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer -- with National Cancer Institute (NCI) support and with the participation of several other NCI cooperative groups.


Got news to tell? Send it to communications@swog.org.