Hello, I'm Dr. Maurie Markman,
President of Medicine and Science
Cancer Treatment Centers of America,
and also a Clinical Professor of Medicine,
Drexel University, College of Medicine in Philadelphia, Pennsylvania.
The title of my lecture is
Clinical Research and Care in the Era of 'N-of-1' Precision Cancer Medicine.
What I'm going to be doing in this lecture is really
discussing what I believe are the requirements for
a new paradigm in the evaluation of new anti-neoplastics in cancer management,
and I hope that you will find this to be quite enjoyable.
It is impossible to downgrade the role that
randomized trials have played in
the establishment of the standard-of-care in cancer medicine.
Today, all our standard treatment approaches are
based upon this well-established paradigm.
This includes the efficacy/toxicity of the established modalities of surgery, radiation,
and neoplastic drug delivery,
and in the case of anti-neoplastics,
this includes cytotoxic, 'targeted' and immunotherapeutic agents.
Further randomized trials have been the cornerstone of
the development of multi-modality approaches to cancer management.
And finally, it is important to note that it is the randomized trials that
historically have really helped end practices that quite frankly were harmful.
They were based solely on physician belief,
their own experience, rather than objective clinical evidence,
and there's no more powerful example of this than
the experience with the radical mastectomies for early breast cancer,
which characterized the management of this disease based upon
the unfortunate, mistaken belief that
somehow you could just take more and more of the breast,
and more and more of the chest wall,
and somehow remove all of the breast cancer.
It took phase III randomized trials,
conducted a number of decades ago to demonstrate, unequivocally,
that not only was this aggressive surgery not helpful,
but it was obviously harmful to the individual patient.
And again, it was the randomized trials that demonstrated the role and
the establishment of a less aggressive surgery and then obviously,
subsequently, with the use of adjuvant radiation and chemotherapy.