• Michael Misialek, MD

Oncologists Launch Groundbreaking Study: Pathologists Play Crucial Role

The American Society of Clinical Oncology (ASCO) is launching its first ever clinical trial, “Targeted Agent and Profiling Utilization Registry” (TAPUR) Study. This will expand options of patients with advanced cancers access to targeted precision medicine therapies beyond those already with FDA approved indications. Instead of treating patients based on their cancer type (i.e. breast, lung, colon, etc.), therapy will be directed towards the unique genetic mutations of the particular cancer. Often called a “basket study” due to treating diverse cancer types, united by shared genetic mutations, this marks a new phase in the precision medicine revolution. This strategy would not be possible without a collaborative team approach to cancer care. Pathologists are crucial to its success.

The Background

A large proportion of cancers contain at least one actionable genetic abnormality. As such, the traditional clinical trial design of grouping patients by cancer type is not possible.

The Problem

Patients with advanced cancer currently have very limited options. Patient will often have their tumor profiled, discovering a potentially actionable target. Yet, there may not be an approved treatment for that patient. How are patients to get the drug? How can we learn about new indications based on this data?

About the Study

The study will enroll patients who have an advanced solid tumor, multiple myeloma or non-Hodgkin’s lymphoma with a genomic variation that can be targeted with a drug. Patients must no longer be benefitting from current treatment and are healthy enough to participate.

How it Works

  1. A patient is identified as having an actionable genetic variation through tumor profiling.

  2. Informed consent to participate in the trial is obtained.

  3. A molecular tumor board composed of oncologists, pathologists and other experts determines suitability of the proposed treatment.

  4. The drug is provided free of cost by a participating pharmaceutical company.

  5. The patient is followed, collecting outcomes data.

  6. The study’s board reviews results and determines whether a treatment is promising.

  7. ASCO publishes results to guide clinical practice and future research.

Who Benefits?

Patients receive targeted agent matched to molecular profile

Physicians receive interpretation of molecular test results, guidance in treatment recommendations, access to drugs, clinical data on off-label use

Industry receives data on drug use and outcomes to inform R&D plans and life cycle management

Regulators receive data on extent and outcomes of off label drug and test use and real world safety data

Next Steps

Patient enrollment begins in early 2016. This marks an exciting time in cancer care. Increasingly more, pathologists are collaborating with clinical colleagues to help deliver cost effective value based care. Follow Path Report for updates.

#pathology #cancer #targetedtherapy #precisionmedicine

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