Fighting the last war

[Guest guest]

It's nice to have rigorous clinical trials to prove this or that. However, it's

not necessary, in my opinion.

Sometimes the experience of a phase II or even a phase I trial is so remarkable,

that waiting years for a confirmation of the results border on the unethical.

Such was the case with Gleevic. Some recoveries from CML were nothing short of

astounding. One case sticks with me; a patient was in the hospital, having no

hope, when he was given Gleevic. A week later he was out on the golf course.

The experience of someone who treats hundreds of CLL patients cannot be

dismissed simply because all of his observations and conclusions have not passed

through the clinical trial process. Observation and early clinical trials can

provide much guidance towards making a decision about what treatments to

consider, and which not to consider.

FCR may provide some benefit to some, but be devastating to others. It's find

and dandy to gloss over the risk, but if you are the one to be mortally wounded

by FCR, then it's not theoretical. It's real.

As I've asserted in the past, FCR probably has a place in the armamentarium.

However, I sincerely believe there are other agents that should be tried first,

reserving FCR until one has run out of options.

I shudder to think that FCR, with all its attendant risks, should be considered

the 'gold standard'. It may be understandable at MD , where they

invented the combination and have a parental interest in seeing it succeed.

Please, consider a less-toxic regime first. I've done HDMP+R and did well, and

I did flavopiridol and done well as well. The first is readily available, the

second only in a clinical trial. However, EGCG is an option that might be

considered, as well as R & R.

The pace of medicine for CLL is very fast now. A number of ideas are quite

promising.

Why risk myelodysplastic syndrome, permanent marrow damage, and Richter's

transformation through FCR, until you have run out of other options?

**************************************************

Re: The gold standard

Posted by: " TERJOHA@... "

TERJOHA@...

 

terryhamblin

Sun Nov 21, 2010 3:10 pm (PST)

Unless a treatment has been compared with another treatment in a

randomized

controlled trial there is no way of knowing which is best. There are lots

of single arm trials where a treatment is compared with what went before,

but last years treatment is not a fair test, and lots of drug company trials

where there have been comparisons engineered by the companies to make a

particular treatment look better than others by underdosing the comparator.

But there has only been one trial that has shown that the treatment arm

makes people live longer than the comparison arm and that was the German CLL8

trial which showed that FCR is better than FC. As far as overall survival is

concerned, FC is as good as anything else that has been tried.

All the new agents that are recommended for trial are as yet untried, so

they may be better or worse than FCR. WE don't know about ofatumumab

combinations or revlimid combinations or about any of the new agents that just

consist of letters and numbers. Theoretically they may be better, but only

trials will tell. Generally guinea pigs are drawn from people who have failed

other treatments.

There are problems with FCR; it is not ideal, but it is better than

anything it has been compared with. Some patients get prolonged neutropenia

afterwards and when relapse occurs the next line of treatment is difficult.

There seems to be a small increased risk of MDS whenever F and C are used

together and there is some evidence that F increases the risk of Richter's

transformation

FCR is probably not suitable for older people especially if they have

co-morbidities but there are also reasonable amounts of evidence that if you are

going to use FCR you should use it up front for your first treatment

Terry Hamblin MD