NOA-08 is out!

[Palex80]

Hi everybody!

I just read the current issue of Lancet Oncology and found out that NOA-08 is out. The trial randomized Astro°III & GBMs to radiation therapy vs. temozolomide.

http://www.sciencedirect.com/science/article/pii/S147020451270164X

Through a very tricky definition of the study endpoint, the authors are trying to make the point, that temozolomide is a viable alternative to radiation therapy, although OS in the temozolomide group is one month less than in the RT group.

What do you guys think? Will we be seeing less patients sent for radiation therapy, who are not fit enough to take on the "golden standard" of combined radiation therapy and temozolomide.

Interesting is a subgroup analysis showing that MGMT+ patients actually fare better with TMZ than with RT, although this conclusion is drawn with data of something like 100 patients only.

On the other hand, I am questioning myself:
If a patient is over 65 and too "unfit" to tolerate combined treatment with RT&TMZ, what makes him fit enough to tolerate TMZ alone? Usually the med. oncs are scared of giving TMZ concurrently with RT in some patients because of bad liver function, risk of infection, etc. Erasing RT from the treatment of these patients does not exactly enhance their liver function or limit their risk of infection.

---

Members don't see this ad.

 

[medgator]

I don't see the point of this study, really. Maybe the med oncs are getting jealous of us giving XRT alone for elderly patients? It doesn't look like the chemo was any better, and youve still got the side effects of it.

It's interesting they chose 60 Gy/30 Fx as the XRT alone arm, as there is good data from Canada for doing 40 Gy/15 Fx for "elderly" patients who aren't eligible for combined chemoRT. For the healthier patients, we generally want to give these patients the kitchen sink when they can tolerate it. Maybe if they include only MGMT methylated patients, this study might be more meaningful, although the Stupp trial did not differentiate MGMT+ vs - (and still managed to show an OS benefit).

 

[Charles_Carmichael]

Looks like TMZ had a lot more Grade 3 and Grade 4 adverse events. Wouldn't it be better to treat with RT alone when taking that into account? Equivalent OS + lesser risk of bad side-effects.

 

[Palex80]

I agree with you guys, TMZ had lots of more side-effects than the RT arm.
However the paper is written in a heavily biased form, if you ask me.

TMZ+RT became standard of care, showing an OS advantage of almost 2.5 months vs RT in the "Stupp trial". In the NOA-08 publication TMZ alone results into 1 month worse survival than RT alone, yet the authors propagate TMZ as a "viable alternative" to RT. It's all based

No word in the entire paper on costs of TMZ vs. RT, including hospitalization & management of all these Grade 3/4 side effects.

 

[RSAOaky]

not to be cynical, but

Funding
Merck Sharp & Dohme.

 

[HQAMIGO]

"The most frequent grade 3—4 intervention-related adverse events were neutropenia (16 patients in the temozolomide group vs two in the radiotherapy group), lymphocytopenia (46 vs one), thrombocytopenia (14 vs four), raised liver-enzyme concentrations (30 vs 16), infections (35 vs 23), and thromboembolic events (24 vs eight)."

TMZ had MUCH more grade 3-4 toxicities than RT which likely landed people in the hospital. Which would you prefer? Living the last 9 month of your life with your family or in the isolation ward cuz your bone marrow got shredded by TMZ? No even taking into account the extra month you get with RT. Although there does seem to be something with the MGMT status, perhaps these patients can be given TMZ only?