Maurie Markman, MD

The greatest concern with the profoundly distressing episode that has unfolded at Duke University in recent years is whether it will truly serve as a learning experience that would help prevent future misconduct— events that have the potential to result in serious harm to highly vulnerable patients with cancer.

There is an objectively rational and scientifically valid alternative to evaluate N-of-1 experiences, and there is a critical need for the continued development of such approaches, which the oncology community increasingly recognizes as a necessary step to replace the established but untenable randomized clinical trial paradigm.

It is simply unrealistic and highly counterproductive to the future of cancer care to believe that the only acceptable approach to determining the absolute or relative clinical utility of a specific drug, regimen, device, or procedure, is through the conduct of a so-called evidence-based randomized trial.

Although legitimate questions have been raised over the years regarding the generalizability of clinical study results in the nonresearch setting, patients with cancer have benefited greatly from the appropriate conduct, completion, and ultimate reporting of such trials in the peer-reviewed medical literature.

During the past several years, there has been considerable discussion-and even intense debate- within the oncology literature regarding the currently documented benefits of precision cancer medicine.

In some ways, the Pathway Genomics test reflects the serious problem of lead time bias in the oncology arena.

Examples of the clinical relevance of an individual patient's normal polymorphisms continue to mount.

How can any analysis of the quality of cancer care being delivered by providers that focuses on a survival outcome as the ultimate measure of that quality-rather than on an evaluation of the optimization of the care process-be considered objectively valid and clinically meaningful?

Mismatch repair deficiency may serve as an immuno-oncology biomarker and may illustrate the clinical utility of analyzing the number of mutations per tumor.

A trend in the biomedical industry to bypass the rigors of scientific publishing was highlighted recently in a provocative commentary regarding the virtual absence of data in the peer-reviewed literature demonstrating the utility of a novel proprietary laboratory testing platform.

Maurie Markman, MD, discusses how the molecular complexities of cancer necessitate that clinical research evolves beyond the basket trial design.

Dr. Maurie Markman discusses how the transition to the new therapeutic paradigm of oral therapies necessitates that we consider unique aspects of this strategy that may negatively impact outcomes compared with an approach of systemic antineoplastic drug administration.

The debate over the relative impact on survival outcomes of therapy versus the inherent biology of an individual patient's cancer remains one of the most controversial areas in all of cancer medicine.

Amid the increasingly public discussion and often vigorous debate surrounding the general topic of precision cancer medicine, there appears to be a misconception of what the term is meant to imply.

Maurie Markman, MD, national director, Cancer Treatment Centers of America, discusses what he sees as future treatment paradigms in ovarian cancer.

Patients with advanced cancers of the pancreas or prostate, or where progression to this state occurs later in the course of the illness, should have tumor or germline testing performed looking for the presence of a BRCA mutation.

Maurie Markman, MD, offers examples of clinical trials where the interpretation of study results is worthy of considerable additional discussion or where justification for the actual conduct of the study can be called into question.

What if a negative study had been made available through a secure online registry where patients could sign up, with the assistance of their own oncologists?

Although there clearly are a number of worthy candidates for the single most influential event that unequivocally proclaimed the beginning of the modern era of precision cancer medicine, there would surely be many votes for the impact of imatinib on the course of the natural history of chronic myeloid leukemia.

There has been considerable discussion and debate within the gynecologic oncology community for more than two decades regarding a role for second-look surgery (open or laparoscopic) in the management of advanced ovarian cancer.

What patients with cancer perceive as relevant clinical outcomes, and how these outcomes are assessed, is important in the provision of routine care and in the arena of clinical trials.

Molecular studies are increasingly utilized to develop an individual therapeutic approach based on abnormalities present in the setting of uncommon/rare cancers or in specific clinical situations where it is virtually certain that formal regulatory-based trials will never be undertaken.

It is increasingly recognized that the era of treating individual advanced or metastatic cancers based essentially on the anatomic site of origin or histologic subtype as determined by light microscopic evaluation is rapidly coming to a close.

One of the most striking changes in our understanding of the fundamental biology of malignant disease has been the observation that "driver" molecular abnormalities may frequently cross major histologic barriers.

Oncologists Need Guideposts for Recommending Drugs Not Studied in Cancers

How can a conscientious but very busy practitioner keep up with the massive quantity of molecular data that could potentially impact an individual patient with cancer? The Moores Cancer Center at the University of California, San Diego has updated the tumor board concept for the molecular era.

Scarcely a week goes by without a report in the peer-reviewed medical literature suggesting that a novel somatic genomic alteration or a specific normal polymorphism is potentially relevant to achieving a desirable clinical outcome within cancer medicine.

There is a tension in the air these days when it comes to the manner in which evidence-based oncology research should be conducted in this revolutionary era, and that tension is evident on the pages of peer-reviewed articles describing novel findings in clinical molecular oncology, in editorials discussing these studies, and in commentaries related to future approaches to discovery.

Although oncology researchers seek to describe the significance of clinical trial outcomes with scientific rigor, the terminology used to communicate those findings in the peer-reviewed literature sometimes falls short in conveying the impact that a given therapy may have on patients in a real-world scenario.

Essentially all members of the medical community, including the most "generalist" family practice physicians, are being required to understand and incorporate into their daily practice an ever-increasing quantity of information related to the broad realm of molecular medicine