Personalized Cancer Therapy Requires New Strategies for Cancer Drug Development

Millions of cancer patients worldwide may soon be able to receive more effective, personalized treatments for their disease thanks to developments in the understanding of cancer biology, experts will say at the Cancer Biology for Clinicians Symposium organized by the European Society for Medical Oncology (ESMO) in Nice, France on 26-27 November.

To make the most of this coming transformation, governments, pharmaceutical companies and doctors urgently need to adapt the way drugs are developed, the experts say.

"Cancer therapy is arguably at the most exciting time in its history," said José Baselga, from MGH Cancer Center in Boston, USA, co-chair of the symposium and ESMO Past-President. "It is at the confluence of two new movements, one toward personalized medicine and the other toward the use of new molecularly targeted cancer therapeutics that exploit the tumor's genetic and molecular signature. These movements provide many challenges, but also the opportunity for making paradigm shifts in the way we think of and treat cancer."

Personalized treatment has become increasingly available for cancers over the past decade. This has partly come about as scientists have found that common tumors such as breast cancer are in fact a mixture of several disease types with distinct molecular features. Meanwhile, molecular targeted drugs have also been developed that inhibit particular molecular targets involved in some cancers.

"As our understanding of cancer biology develops further, these kinds of personalized treatments are expected to become available for many more cancer types," said Fabrice André, from Institut Gustave Roussy, France, ESMO spokesperson co-chairing a session at the symposium. "If we want to facilitate the implementation of this kind of personalized medicine, then we urgently need to develop new strategies for cancer drug development."

In particular, it is time to rethink whether the standard model of testing drugs in large phase-III trials is an effective way to bring these targeted cancer drugs to patients, Dr André noted.

"Regulatory processes are becoming increasingly restrictive in providing patient access to potentially innovative new drugs, because even the largest cancer trials generally involve only a small portion of the cancer patient population, and because the drug development process is often more than a decade from the first preclinical study," he added.

This is related to the fact that drug approval usually needs large confirmatory trials that are being done in an unselected population. There is a need for smaller trials done with selected patients to be highly sensitive, a concept that requires the development of molecular selection and relative platforms for doing that.

"It’s clear that we urgently need a new paradigm for drug development, including targeted patient selection for clinical trials, shorter duration of clinical trials and improvement of the cost effectiveness of bringing a new drug to the market."

The ESMO Cancer Biology for Clinicians Symposium, a two-day meeting featuring some of the most eminent researchers in the field, is designed to inform oncologists about the ways cancer biology is changing clinical practice.

"What is most exciting today is the active dialogue between clinicians and laboratory scientists who share an interest in applying the new knowledge of cancer biology to the diagnosis, treatment, and prevention of the disease," said meeting co-chair Mario Dicato, from Centre Hospitalier de Luxembourg.

"In the near future, cancer treatment decisions will be based on biology," said the third meeting co-chair Jean-Charles Soria, ESMO spokesperson from Institut Gustave Roussy, France. "It is therefore vital that medical oncologists have the skills and the knowledge to bring these advances to their patients. The future of oncology will be personalized medicine, and the community needs to discuss how this will be implemented."

The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care. The organization is a powerful alliance of more than 6,000 committed oncology professionals from over 100 countries.

For more information:
Cancer Biology for Clinicians Symposium Program Book

This article was first published online at Onco'Zine - The International Cancer Network

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Particle Beam Radiation Therapy Promising but Unproven for Treating Cancer

Particle beam radiation therapy, a technology used to treat several types of cancer, is considered by some clinicians to be better than traditional radiation, but there is limited evidence about its safety compared with other types of radiation therapy, according to a new comparative effectiveness report funded by the Department of Health & Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ)."

As technologies develop and new clinical interventions arise, it is important to balance access to potentially beneficial new technologies with ongoing research and evaluation to determine whether the technologies deliver what they promise," said AHRQ Director Carolyn M. Clancy, M.D. "Increased funding for comparative effectiveness research is an exciting opportunity to continue important research on medical therapies and interventions."

Particle beam radiation therapy, also known as charged particle radiation therapy or proton beam radiation therapy, uses beams of protons or other charged particles for cancer radiation treatment. This therapy is an alternative to other types of cancer radiation therapy such as external radiotherapy with ionizing photon (X- or gamma-ray) beams or brachytherapy with implanted radioactive sources.

All types of radiation therapy can harm both cancerous and healthy tissues, so clinicians strive to target the radiation to the cancer while avoiding adjacent healthy tissues. This is particularly important for tumors adjacent to critical body parts such as those in the eye, brain, head and neck. Particle beam radiation therapy can target the radiation with a high degree of precision, but its potential advantages over other radiotherapy alternatives have not been verified in long-term outcome studies, according to the new AHRQ technical brief.

Particle beam radiation therapy was introduced as an experimental treatment in the 1950s but was not cleared for widespread use by the U.S. Food and Drug Administration until 2001. The technology is very expensive—an estimated $175 million for each device—and is usually only available in large academic medical centers. Only seven centers in the United States currently provide the therapy, with an additional center currently under construction and expected to be operational by 2010. Although details have not been disclosed, several other hospitals are considering developing smaller treatment facilities based on upcoming technologies that have not yet been cleared by the Food and Drug Administration.

The technical brief did not indicate that particle beam radiation therapy is riskier than conventional radiation therapy. However, most studies about the therapy were conducted on small numbers of patients and did not compare the safety of particle beam radiation therapy against other therapies. For many cancers other than head and neck cancers, there are not enough comparative studies in the literature to base an evaluation of the clinical or cost effectiveness of particle beam radiation therapy compared with other treatments.

AHRQ is currently reviewing scientific studies on radiation therapies for head and neck cancers that will evaluate the clinical effectiveness of particle beam radiation therapy for those cancers.

The report is the Agency's first in a series of technical briefs—rapid-turnaround reports that summarize key issues regarding emerging treatments. Technical briefs highlight where more research is needed and where research may be sufficient to warrant a full systematic review. Technical briefs are produced by AHRQ's Effective Health Care program. Future technical briefs will describe the evidence on fetal surgery, stereotactic surgery for non-brain cancers and percutaneous heart valves.

AHRQ's new report, Technical Brief: Particle Beam Radiation Therapies for Cancer, is the newest research review from the Agency's Effective Health Care program. That program, authorized by the Medicare Prescription Drug, Improvement and Modernization Act, represents an important federal effort to compare alternative treatments for health conditions and make the findings public. The program is intended to help patients, doctors, nurses, pharmacists and others choose the most effective treatments.