The document "presents an achievable vision for the next decade, in which cancer research and patient care become significantly more targeted, more efficient, and more effective," according to a press release from the society.

ASCO president Michael Link, MD, of Stanford University, said the time was right to reassess the nation's cancer research effort, with the 40th anniversary of the National Cancer Act coming up in December. "That legislation led to an unprecedented investment in cancer research that has spurred significant increases in survival and revolutionized the biological understanding of cancer," he said.

But traditional models of research and clinical trial design are now too slow and inefficient and are making inadequate use of the growing knowledge of cancer's molecular underpinnings. Link noted that a few targeted therapies are now available and have revolutionized treatment of certain forms of cancer. However, these are cancers that arise from single, powerful mutations.  "We're learning that in most cases targeting one mutation will not be enough. For most cancers, effective treatment will require targeting a combination of different genes and proteins that cause the cancer to develop and spread," he said.

Every Cancer a Rare Cancer      Neal Meropol, MD, of Case Western Reserve University in Cleveland, who helped draft the blueprint, emphasized the complicated nature of cancer.

"All cancers are becoming rare cancers," he said, meaning that a type of cancer such as malignant melanoma may be associated with a number of different specific patterns of gene mutations, epigenetic alterations, and protein dysfunction, each of which may be shared by only a few patients.  As a result, he suggested, the future of cancer treatment will involve detailed molecular evaluation of each patient's cancer and an individualized set of treatments.

According to the ASCO blueprint, the current research and treatment-development system is ill-equipped to generate the integrated diagnostic, prognostic, and therapeutic tools necessary to make this vision a reality.  In addition to the many current scientific unknowns, the blueprint writers said, progress on therapies is also hampered by "financial and regulatory barriers" that interfere with collaboration between industry and the research community, and by "a labyrinth of regulatory requirements and years of underfunding" that make clinical trials unnecessarily difficult, expensive, and often useless.

John Mendelsohn, MD, chair of the Institute of Medicine's National Cancer Policy Forum and the former president of the MD Anderson Cancer Center in Houston, said the regulatory establishment has become too risk-averse -- much more so than the patients they are ostensibly protecting.  "The patients that we talk to would rather take the risk and know that there could be side effects," he said. "I think the IRBs, the institutions, and the FDA, and everyone should realize it's the patients who should make the decision about what risks they're willing to accept."

Big Changes Needed in Research      The blueprint made recommendations for changes in approaches to therapeutic development, clinical trial design, and use of health information technology.  It said the research community -- including the National Cancer Institute -- should identify and prioritize molecular targets and biomarkers most likely to have the biggest impacts on patient care. Also, incentives should be established for collaboration among academic researchers, industry, and government to develop treatments and the biomarkers necessary for tailored therapies.

The blueprint also called for "faster, smarter clinical trials" in which patients are selected on the basis of molecular characteristics and in which trial designs make greater use of surrogate, biomarker-based endpoints.  It said these must "represent meaningful measures of benefit to patients" while requiring less time to yield results than current endpoints. 

Additionally, the FDA should adopt less onerous requirements for new uses of existing treatments, ASCO urged. It also recommended that the government "revitalize" the NCI Cooperative Group program for carrying out clinical trials. Finally, ASCO threw its weight behind electronic health records (EHRs) as an important way to speed research and development in cancer. If standards are adopted that allow systems to exchange data fully and easily, it will become possible for patients to be recruited into trials on the basis of biospecimen data collected by their oncologists, for example.

EHRs could also allow researchers to see in real time whether specific treatments are yielding clinical responses, thereby allowing groups of patients likely to respond to a particular treatment to be identified quickly. Consequently, ASCO recommended that oncology EHRs be standardized and implemented as quickly as possible.

The group promised that it would work with other medical societies, the government's research establishment, and the FDA to make the necessary changes.

Source: John Gever, Senior Editor, MedPage Today, November 03, 2011