re: Catching up with technical data...

[Guest guest]

re: I actually don't even know what is preferred over another therapy (at

this time) because of all of the new " pending reports " on effectiveness.

Then the report comes, I read and digest the material, and I find that I am

even more confused than before. Does this sound familiar to you?

Hi Jama,

Yes, very familiar. And thank you for your candor. I think the key word

you've used is " pending " It is rare that a single study changes clinical

practice.

I think of the bulk of reports at ASH as being very small steps that need to

be validated and reproduced by others (pending). ASH is also an opportunity

for scientists to talk, share, and connect the dots: does my finding fit

with hers? ... (the reason it's important to publish studies also that do

not support your hypothesis.) That is, there's much to be skipped over, as

too early to be relevant to patients, ... as impossible to know if they

will be validated (most won't) and change clinical practice.

Worth noting that the standards for ASH is good (based on peer review) but

not as high as for the main journals, and not as rigorous as FDA review for

marketing approval - which is the most conscientious of all. .. How could

ASH have a rigourous review process, given the number of abstracts received!

ASH 2008 abstracts: http://ash.confex.com/ash/2008/webprogram/start.html

So only a handful of clinical studies submitted to ASH may change clinical

practice in the near term, if that many. How to find these? Most times

they will be the trials with large numbers of patients that test one

protocol against another in a RANDOMIZED study.

From ASH: in the search box, you might type: Randomized FOLLICULAR / MCL /

MALT / DLBCL ...

Sometimes larger single-arm studies will show compelling evidence that

affect clinical practice, but most times these must be validated by follow

up studies. For example, there have been many single-arm studies of

maintenance rituxan, and yet we still await the results of the large

randomized studies with sufficient follow up to inform if this is overall a

good practice .... compared to rituxan as needed.

The first piece of information I look for in the abstract is the sample

size, denoted as N=300 or N = 12. But also the age, clinical status,

diagnosis, and treatment history of the participants. This helps the most

in judging how much confidence we can have in the findings - how likely they

are to predict outcomes for others. A condition with a predictable

clinical course (such as relapsed DLBCL) requiring a smaller N than a

condition with a variable course (such as untreated indolent lymphoma) to

judge efficacy.

I look also for agents that have unique mechanisms of action that may be

effective when standard treatments are not. These obviously having the

potential to meet urgent clinical needs. But I don't generally look at

pre-clinical studies (in mice, in cell culture) unless the agent has been

tested in clinical phase -- it has an established therapeutic dose with

acceptable toxicity. Then I might look back at the pre-clinical stuff to

see what the mechanisms are and how these might complement other

ents. -- Here the Number of participants will probably be small, but the

urgent need (refractory disease) could justify the risk of considering these

novel treatment agents in a clinical trial, even if early in testing phase,

and even modest results in this population could be a signal of a promising

new drug.

Search for example: follicular single agent refractory

Probably easiest to wait for experts like Bruce Cheson to review ASH. Look

also at NCCN clinical practice guidelines for updates. See

http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf

We provide a link to NCCN and also Cancer.gov Best Practice near the top of

the Treatment page on lymphomation:

http://www.lymphomation.org/treatment-overview.htm

Best practices are determined by expert consensus, based on the results of

well designed studies.

Hope this helps.

~ Karl