Regarding the 7 Reasons to Consider Clinical Trials

[Guest guest]

Regarding the 7 Reasons to Consider Clinical Trials: based on your clinical

circumstances . meeting the dual requirements: Good Science AND Good

Medicine

Greetings,

Cure might be defined as an outcome where the disease never returns, or

never returns to a level that is detectable or clinically relevant. . We die

of something else.

Noting that going for a cure with aggressive therapy is not always

appropriate (such as for a low risk disease), and that it can take many

years to determine if an indolent (slow growing) cancer is cured with any

protocol - and how many are likely to achieve the goal . 1 in 10? Or 7 in

10?

Further, we need to consider the risks of therapies that may have the

potential to achieve this goal - the possibility that the intervention is

higher risk than the condition we are treating.

For example, an allogeneic stem cell transplant appears to have curative

potential for indolent lymphoma, but it also has significant risks,

including the risk of death, and therefore it might not compare favorably to

management of this lower-risk disease with lower-risk therapies as needed.

The potential for an investigational therapy to cure depends on the type of

the lymphoma (the typical natural history*), and the available evidence from

clinical trials (ranging from preliminary to substantial), and also our

unique clinical circumstance, such as number of prior therapies and types of

therapies, our general health, and age.

* The challenge for the indolent lymphomas being there is no " typical

natural history! "

The urgency to achieve a cure depends on the anticipated clinical course of

the lymphoma (aggressive vs. indolent), but sometimes the age and

preferences of the patient. The urgency can change as circumstances change

- such as if the behavior of the lymphoma becomes aggressive.

Please note, we at PAL are not qualified to recommend therapies, standard or

investigational!

By definition the true risks and potential benefits of an investigational

protocol are not fully understood - even by the smartest experts on the

planet.

So the potential or possibility that a new protocol is curative (or can

provide clinical benefit) is not a guarantee that the goal will be realized,

else researchers would not need to do the study.

Noting here that case reports - positive or negative - do not tell us what

the risks and potential benefits are for others - the RATE of ill or

favorable outcomes; nor do such accounts account for how long the benefits

lasted, the possible long-term secondary complications.

That said, for some types of lymphoma the standard of care is not

satisfactory. It might benefit fewer than it helps, it may rarely cure, it

might lead to serious late-term complications, and so on. Thus, risk and

uncertainty are not exclusive to investigational therapies and so I think it

follows that in some circumstances investigational protocols can compare

favorably to standard treatments.

So we need to ask informed questions and to rely on experts to help us with

these complex decisions. Unfortunately, waiting for our treating oncologist

to bring up the subject will not always lead to the conversation. Indeed,

most time it will not.

For PAL's part, we can assist by increasing awareness about new agents and

trials -- without being promotional about it, because like everyone else on

the planet we possess no inside knowledge or ability to predict winners and

losers.

Karl

PAL www.lymphomation.org