Over the past five decades we have made substantial and sometimes dramatic progress in treating some malignancies.
An early example of this success was the emergence of effective therapy for lymphomas.
Then, in the early 1980s, several research centers attempted to improve on that success by administering ever more complex combinations of chemotherapies, with what appeared to be dramatic success. By the mid-1980s, lymphoma patients were being treated with medicine regimens known by nefarious-sounding names like ProMACE-CYTABOM. These treatments were sometimes much more toxic than the older CHOP regimen, but many believed the newer, more difficult regimens were more effective.
That might have been the end of the story, and we would still be using these difficult treatments for lymphoma. But some researchers were brave enough to challenge the conventional wisdom by subjecting these harsh treatments to Phase III clinical trial testing.
Half of the lymphoma patients were treated with the newer, more difficult ProMACE-CYTABOM, and half were treated with the older, easier CHOP. To the surprise of many, CHOP proved the superior treatment: at least as effective, but with many fewer treatment-related deaths.
This could only have been ascertained by a clinical trial, and as a result CHOP has remained the mainstay of lymphoma therapy for the past 40 years.
Quite simply, clinical trials form the essential infrastructure on which all our progress with cancer has been and will be made. Potential new medicines must go through a series of testing phases before they can become widely available. Phase I studies test for the safest doses of the new medicine and identify its toxicities. Phase II studies determine whether the safe doses of the new medicine are effective against the target cancer. Phase III studies are large, random trials that test the effectiveness of the new treatment compared to currently available standard treatment. Each testing phase is critical and requires adequate patient enrollment to succeed.
Unfortunately, however, only about 3 percent of cancer patients are enrolled in clinical trials — unfortunate because if more patients (and their oncologists) participated in clinical trials, we would undoubtedly make much more rapid progress against cancer.
Two primary reasons account for this paltry accrual of patients onto trials. First, patients are frequently reluctant to enroll. They may be fearful they will be getting some treatment other than the best therapy; they may be concerned about potential side effects of newer therapies even their oncologists can’t predict; or they may be confused by the complexities of the details of the study itself.
But we oncologists have to look to ourselves for the second primary impediment to enrolling patients on trials. Cancer treatment facilities that participate in clinical trials can be quickly overwhelmed by the requirement of time-consuming clerical work for recording data, by the need for meticulous attention to the details of study design and protocol, and by the considerable time and care required to fully explain clinical trial options to patients. But perhaps the highest hurdle for oncologists is the lack of easy accessibility to clinical trials if they practice outside the academic sphere.
For all these reasons, Commonwealth Cancer Center is very excited and very proud to be the newest (and only independent private practice) member of University of Kentucky Healthcare’s Markey Cancer Center affiliate network. The affiliate network’s resources will provide us with invaluable assistance in data management and patient screening for trials, allowing us to take the time necessary to discuss possible clinical trial enrollment with our patients.
Only through careful discussions with patients will we be able to help them fully understand their treatment options, the implications of the trials they are considering and the details of the trial treatments that might initially seem fearful and confusing.
Most importantly, Markey Cancer Center affiliate network membership will give us rapid access to an exceptionally wide array of clinical trials for almost all the cancer types we treat, giving our patients the very most up-to-date treatment options, often with access to therapies that are presently only available in the setting of a clinical trial. We feel very fortunate to be part of the network, as we look forward to a much more expansive role for clinical trials in our practice.
Board-certified Medical Oncologist/Hematologist Thomas Baeker, MD, is the Medical Director of Commonwealth Cancer Centers of Kentucky.