Friday, January 14, 2011

Why Median Survival Times Aren't (That) Helpful

The median is one of the most common statistical tools used in clinical research reports in oncology. They're also, from the patient's perspective, not as helpful as they seem at first glance. It's very important to be realistic about what statistics mean, especially when our lives are on the line. This doesn't always mean being pessimistic about the data. Rather, it means understanding what the data tells us -- and, equally importantly, what it doesn't tell us.

A median is, briefly, one type of average. There are three types of averages: mean (the most common type outside of clinical research), mode, and median. In short, the median is the point at which 50% of a sample have a particular attribute, or have accomplished some particular task. For instance, a country's median income is a dollar figure which half of the people earn less than, and half of the people earn more than. In cancer trials, median survival means the point at which half the patients recruited into the trial have died. And that's all it means -- it doesn't say when the 50% who died did so, or how long the other 50% are likely to live.

New Clinical Trial Information: Imetelstat Sodium Telemerase Inhibitor

Trial Information: 45 young patients will be recruited for a Phase I study of the new telemerase inhibitor imetelstat. Patients must be under 21 years old and have any solid tumor or lymphoma cancer, except for brain tumors or metastases. They must have relapsed or been resistant (refractory) to previous retreatment.

Thursday, January 13, 2011

New Clinical Trial Information: Lucatumumab + Bendamustine

Trial Information: 50 patients are being recruited for a Phase I trial of the new anti-CD40 monoclonal antibody lucatumumab (aka HCD122). Patients must have follicular lymphoma and have become resistant to rituximab following previous therapy. Patients will be given combination therapy of lucatumumab with bendamustine, a relatively new alkylating agent.

Urine Therapy for Follicular Lymphoma?

And I thought I'd heard (almost) everything. John Bettens says that he has kept his follicular lymphoma at bay for going on three years now, by drinking one cup of his own urine every day. Maybe. I honestly do hope that Bettens's tumours continue to shrink, and disappear, and stay that way. But I also have to say that I genuinely can't see how that would be related to urine.

The statistical record shows that around one in four or five lymphoma patients experiences meaningful regression (shrinking) of tumours, and most of the rest of follicular lymphoma patients still have a very slow disease course. This makes it a very ripe field for misleading anecdotal evidence.

Wednesday, January 12, 2011

How Clinical Trials Work

A clinical trial is the standard tool of scientific, evidence-based medicine for determining the safety and effectiveness of new drugs and drug combinations, including for cancer therapy.

The basic appeal of clinical trials for patients is the ability to gain access to potentially powerful new drugs which are not yet approved and may be unavailable in hospitals or clinics for years. However, consent to participate in a clinical trial should never be given lightly. As a patient, you need to be aware of the objectives of the trial, basic information about the drug, how likely the trial's researchers believe you might benefit from what they want to put into your body, and what the potential side effects and negative consequences of treatment might be.

Drug Information: Bendamustine

Also known as: Treanda

Canadian Status: Bendamustine is not yet approved in Canada for the treatment of follicular lymphoma. However, it is currently being used in several Canadian clinical trials, including a comparison of rituximab + bendamustine with R-CHOP/R-CVP.

New Drug Information: Lucatumumab Anti-CD40 Monoclonal Antibody

Also known as: HCD122

Drug Information: Lucatumumab is one of several experimental anti-CD40 monoclonal antibodies. CD40 is a cellular surface protein involved in immune system signaling, which is present on cancerous B cells. The drug's developer, Novartis, believes that it both blocks proliferation of malignant cells and attracts other immune system cells to attack the cancer. It is given intravenously on a weekly basis for multi-week treatment cycles.