NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Ah, but wait a minute, that was a separate study of only 41 patients that looked at less than six maintenance cycles.

A third study completed a long-term analysis of radiotherapy plus concomitant and adjuvant TMZ. This study was smaller than the original and only analyzed 41 patients with newly diagnosed GBM. The Stupp treatment protocol was used in this study. The median OS was 16.7 months. This study confirmed the finding that this particular treatment regimen increases survival. In addition the researchers noted that OS was 19 months for patients who received adjuvant TMZ and 9.8 months for patients not given adjuvant TMZ. It was also found that the number of adjuvant TMZ cycles had a significant effect on survival. Patients with less than or equal to three cycles had an OS of 8.7 months. Patients with greater than or equal to three cycles had OS of an 20 months. There was no significant difference between the groups who did not have adjuvant therapy and those who had less than or equal to three cycles of adjuvant TMZ (Erpolat et al., 2009).

It makes me wonder if there really is any definitive info on 2 to 5 maintenance cycles, and whether those in the lower number of cycles stopped early because they progressed. Which is exactly Pyrr's criticism in other trials.

It seems there is not much debate on receiving chemoradiation up front (+ at least one maintenance cycle) in most subgroups, but as one increases to 2 (and certainly 3) maintenance cycles and beyond, there is not enough data yet until one exceeds 6 doses, where it then appears there is enough data in prior trials to demonstrate no value to continue TMZ cycles. JMO.

Of course, we may find out something unprecedented when immunotherapy is added to the equation.