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Trial Testing Genetic Profiles for Personal Cancer Therapy

Apostolia M. Tsimberidou

Apostolia M. Tsimberidou (MD Anderson Cancer Center)

15 August 2014. MD Anderson Cancer Center in Houston and Foundation Medicine in Cambridge, Massachusetts are testing the benefit of genetic profiles of tumors in determining personalized therapies for patients with metastatic cancer. The researchers conducting the trial also believe genetic profiling can better match cancer patients to studies of new treatments, and lead to faster and less expensive clinical trials.

The study, called Initiative for Molecular Profiling in Advanced Cancer Therapy or Impact2, aims to enroll 1,362 patients with metastatic cancer, that is spreading from the original tumor to other parts of the body. Patients will have tissue from their tumors analyzed to reveal mutations and other variations in their genetic compositions. Foundation Medicine, a developer of genomic analysis systems, is conducting the profiles to find if any molecular factors are contributing to their cancer.

If any genetic alterations are found in the profile, and an FDA-approved treatment for that type of tumor is available, the patients will receive that treatment. In case genetic alterations are found, but no treatments are yet approved, the patients will be randomly assigned either to take part in a clinical trial of a treatment addressing the alteration, or receive the standard of care.

Likewise, if no genetic alterations are found, patients will receive the standard of care. The primary outcome measure is progression-free survival, the length of time following treatment that the patient survives, but without the cancer getting worse.

The new trial is a follow-up to a study of molecular profiling for cancer therapies conducted by MD Anderson called Impact1 and reported in 2011. That earlier trial enrolled more than 1,100 cancer patients, of which 40 percent were found with some kind of genomic alteration. Of those receiving the targeted treatments based on the genetic analysis, 27 percent of patients responded, compared to 5 percent of those receiving the standard of care.

This approach to identifying patients aims as well to speed up the recruitment process for clinical trials. The analysis by Foundation Medicine is expected to take three weeks following initial enrollment, after which physicians can guide their patients’ treatments, including participation in a clinical trial. Foundation Medicine says its system has a more advanced analytical engine than the system used earlier, thus more patients with genetic variations in their tumors are expected to be found.

“This is a collaborative and institutional-wide effort to improve patient care and accelerate the drug development process,” says Apostolia Tsimberidou, professor cancer therapeutics at MD Anderson and study director. “If the results of IMPACT1 are confirmed, cancer treatment will be transformed and comprehensive molecular profiling will become the standard of care.”

Tsimberidou tells more about the trial in the following video.

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