First randomized trial of targeted cancer medicine in all tumor types

The SHIVA trial is the first randomized trial to look at patient outcomes after treatments were chosen based on individual molecular profiles of each person's tumor. It will be presented at the 2013 European Cancer Congress, which starts Friday, September 27, in Amsterdam, The Netherlands.

The SHIVA trial will be presented by Dr. Christophe Le Tourneau, who is head of the Phase I Program at the Institut Curie in Paris, France. This is the first trial to look at patient outcomes by molecular profiles for all tumor types. The enrolled patients all had recurrent or metastatic cancer that was unresponsive to standard treatment.

Preliminary results of the feasibility study, to be presented at the congress, show that this approach works, the researchers say. The ultimate goal of the phase 2 trial is to see whether the selection of drugs that target the specific molecular profiles of tumors will improve outcomes for patients.

Once the first 100 patients were included, the researchers looked at the feasibility of a biopsy of a metastasis, since the molecular profile of the primary tumor, if tissue is available, may not be the same as that found in a metastasis. They also investigated the quality of available tumor samples, the proportion of the patients for which the necessary analyses could be undertaken, the proportion for which a molecular abnormality can be identified and for which a targeted therapy exists, and the timeframe needed to establish the tumor profile.

"Recent advances in diagnostics have enabled us to ascertain the molecular profile of tumors in a timeframe which is compatible with good clinical care, but we needed to verify this in our study," said Le Tourneau.

Unlike conventional chemotherapy, molecular targeted agents only work in the presence of their targets. Side-effects are lessened and, in principle, efficacy heightened. One of the problems to date, however, is that such drugs have principally been developed based on the primary location and histology (cellular make-up) of the tumor. This has meant that many potentially promising targeted drugs have failed in early clinical trials simply because they have not induced a response in a sufficient number of patients.

"The history of breast cancer changed beyond recognition with the discovery of the role played by the ERBB2/HER2 gene, which is amplified in up to 20% of breast cancers. We now know that trastuzumab (Herceptin®), one of the most widely used targeted cancer therapies, which targets that gene, is effective in several tumor types and not just in breast when the ERBB2/HER2 gene is amplified or even mutated," said Le Tourneau. "We also know that patient outcomes in the few trials to date where the choice of treatment is based on a molecular abnormality are better than those where the treatment is not matched to the abnormality."
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