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TRADITIONAL CHEMOTHERAPY DRUG CLINICAL TRIALS

DESIGNING “ONE-SIZE-FITS-ALL” DRUG TREATMENTS

In clinical trials, a number of patients with the same type of cancer are treated with a specific anti-cancer drug.  If a certain percentage of patients benefit from the drug it is then adopted by physicians as standard treatment for any patient who has that type of cancer.  The percentage of patients who must benefit from a drug could be as low as 20% or as high as 70% or 80%, depending upon the type and stage of cancer involved.  In any case, the goal of clinical trials is to identify drugs that help the average cancer patient.

The problem with that approach is that no cancer patient is “average.”  Each cancer patient is unique and patient’s cancer is unique.  If that were not true then why do some patients benefit from a drug while other patients fail to benefit from that same drug?  It happens frequently.  Or why do some patients fail to benefit from one drug but then derive benefit from different drugs, given to them in second or third-line treatment settings?  And so, it doesn't matter that a certain drug works for 70% of patients if you are among the 30% for whom the drug doesn’t work.  The situation becomes even worse when drugs that help only 10% to 20% of patients are administered blindly to 100% of patients, as is now often the case.  It means that 80% to 90% of those patients are exposed needlessly to unpleasant and potentially dangerous drug side effects, incur unnecessary expense, and waste valuable treatment time while their cancers progress.

Today, many different chemotherapy drugs are widely-accepted for use within the same cancer types.  For example, the National Cancer Institute lists 27 chemotherapy regimens for the treatment of breast cancer.  The NCI does not recommend any one of these regimens above any other.  The situation is similar in other cancer types.  So how does a physician choose? 

A cancer physician always takes into account what type of cancer a patient has, how far it has advanced, and what, if any, other types of therapy, such as surgery, radiation, and/or chemotherapy, the patient received previously.  The physician also takes into account known drug toxicities, the patient’s age, weight, physical condition and other clinical factors that might affect the patient’s ability to receive certain types of drugs.   However, none of these factors show if a patient will benefit from a specific chemotherapy drug or drug combination.

In contrast, Personalized Cytometric Cancer Profiling examines the widest possible range of biological factors as they occur in real-time within and among the actual cancer cells of each cancer patient, as an individual.  A cancer patient may then receive a chemotherapy treatment that is personalized specifically for him or her, based upon clearly-demonstrated evidence that the drugs chosen are effective at killing his or her cancer cells. 

Cancer patients are not statistics and they are not “average.”  Each patient is a person with a unique identity and a unique cancer cell biology.  Nobody should receive a cancer treatment on the uncertain hope that if it worked for some of the people who received it previously it might work for him or her.