Quality of Life

My PALs at Lymphomation.org have put together a petition to the FDA. I hope you'll take a look at it and sign it.

The petition is  called "Assessing Changes to the Patient's Quality of Life (QoL) is Integral to Interpreting the Efficacy of Study Treatments for Cancer."

Here's the background: In the United States, the FDA is in charge of evaluating cancer treatments (among other things) before they can be fully available to patients. They make those decisions based on the data that researchers give them. In order for a treatment to be approved, the data need to show that it is better than what is already available -- it helps more people, or it has fewer side effects.

The petition asks the FDA to consider some additional information: how a treatment affects a patient's Quality of Life, or QoL.

QoL would be measured by Patient-Reported Outcomes, or PROs. According to the petition, "PROs are reports of the status of a patient's health condition that come directly from the patient, without interpretation of the patient's response by a clinician or anyone else."

In other words, FDA approval would take into account not just what the researchers have to report, but also what the patients have to report -- directly, without the researchers interpreting what it means. It would mean patients have a much greater voice in the process.

That would have huge implications. The FDA would hear patient voices, but that information (as the petition points out) would also help other patients decide whether or not a treatment is right for them, and help oncologists make those decisions with the patients.

A big issue (again, as the petition points out) has to do with PFS (Progression Free Survival). In a disease like Follicular Lymphoma, most treatments do not seem to show an improvement over other treatments when it comes to Overall Survival. CHOP, Bendamustine, with or without Maintenance -- none of them really show a longer Overall Survival for FL patients (though individual patients might benefit). 

But some of them do show a PFS benefit -- some treatments work well enough to allow patients to go a long time between treatments. Of course, that comes at a cost -- there may be harsher side effects. And those side effects might result in a lower Quality of Life.

And, of course, that's where the PROs come in. Patient-Reported Outcomes can help other patients make a decision. Is is better to have more frequent treatments with relatively mild side effects and a good QoL (for example, Rituxan every couple of years), or less frequent treatments with harder side effects and a lower QoL (for example, CHOP, but no other treatment for 10 years).

Having information from other patients might make that easier to decide.

And that information would be easier to find if the FDA required it.

Again, you can read the petition here. I hope you'll take a look. And then I hope you'll go here and sign.

Thanks for considering it.