Personalized Therapy Benefits Late-Stage Cancer Patients in Clinical Trial

Customized treatment that matches specialized cancer drugs to their targets on each patient's tumor has been found to increase survival of people with late-stage disease in a Phase I clinical trial at MD Anderson.

Researchers presented results today at the annual meeting of the American Society for Clinical Oncology in Chicago. ASCO also chose to highlight this project to the news media from among thousands submitted to the meeting.

Patients who enroll in Phase I clinical trials have no regular treatment options left and have advanced disease that has spread to other organs or can't be surgically removed.

How this research was done In this trial, patients' tumors were analyzed for genetic flaws and when there were drugs available to attack that defect, patients received those drugs rather than those thought to target their type of cancer, such as breast or lung. Patients with just about every type of solid tumor -- lung, breast, colorectal, prostate, brain, pancreas, liver, kidney, melanoma, thyroid and many others -- participated.

"This preliminary study strongly suggests that molecular analysis is needed to use the right drug for the right patient. Up to this point, we have generally treated tumor types, but this study shows we cannot treat all patients with a tumor type the same way," says study principal investigator Apostolia-Maria Tsimberidou, M.D., Ph.D., associate professor in MD Anderson's Department of Investigational Cancer Therapeutics. "We need to take into consideration a number of factors, and this study suggests that a personalized approach is needed to improve clinical outcomes for patients with cancer."

Researchers analyzed tumors of 1,144 patients with metastatic or inoperable cancer. Their median age was 58, and the median number of prior treatments was four. Of these, 460 had one or more gene defects targetable by available approved or experimental drugs.

For the 175 patients with one aberration, the medical response rate was 27% with matched targeted therapy. The response rate was 5% in 116 patients when treated with non-matched therapy.

Patients who received matched targeted therapy had median survival of 13.4 months, compared to nine months for unmatched targeted therapy. Median survival without cancer progression was 5.2 months for those receiving matched therapy, compared to 2.2 months for patients who received unmatched therapy.

How this changes cancer treatment Cancer chemotherapy is migrating from blunt-instrument drugs that affect both cancer and healthy cells to more focused drugs that hit tumors while doing less damage to normal cells. Individual tumors vary on the genetic level among patients with the same type of cancer. Some genetic defects are found in multiple types of cancer.

Study results will need to be confirmed in randomized, controlled clinical trials. But the findings mark another step toward individualized care, which has been hindered by lack of targeted drugs and expensive tumor-testing technology.

"This study affirms what we in the cancer community have been talking about for a decade -- matching drugs to patients," says Razelle Kurzrock, M.D., chair of the Department of Investigational Therapeutics and director of MD Anderson's Phase I clinical trials program. "The time is now. The drugs are here. The technology is here. With our program at MD Anderson, we can bring the two together to offer the most personalized care for our patients."

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