The PRONOUNCE study used the “Sandler” regimen as a control and compared it to a non-Bev-containing regimen (Carbo/Pem followed by Pem maintenance), and although no difference was reported, the study was relatively small and used the unusual endpoint of “Grade 4 PFS.” What this means for clinical practice is up for debate, and while it seems somewhat unlikely that this one relatively small study will counteract the large volume of data supporting regimens including Bev, it does provide some solace to Bev-ineligible patients that an alternative regimen has similar clinical value.
The original presentation of the Phase III PointBreak trial last year was updated at ASCO 2013, this time focusing specifically on patients over and under age 70. This important and much-anticipated study evaluated Carbo/Pem/Bev followed by Pem/Bev maintenance versus the Sandler regimen (Pac/Cb/Bev followed by Bev maintenance) and demonstrated that the 2 approaches resulted in similar outcomes. The ASCO update demonstrated similar efficacy and tolerability with the 2 regimens in older patients. Although disappointment was expressed that the “Patel” regimen did not demonstrate a clinically significant advantage, this analysis is important to consider because some oncologists routinely withhold Bev from older patients and these data bring that practice into question. A current ECOG study will further tease out the role of maintenance therapy with Pem or Bev alone versus the combination for Bev-eligible patients.