Clinical Trials at Georgia Cancer Specialists Make National News At Annual Clinical Oncology Conference

Monday, June 18th, 2012

Georgia Cancer SpecialistsCancer research topped the national news this month as reports from the annual American Society of Clinical Oncology (ASCO) meeting in Chicago revealed positive results from clinical trials for breast cancer, prostate cancer, colon cancer, and melanoma, among others.

Researchers at Georgia Cancer Specialists (GCS) worked on a number of the major trials and the practice participated in a total of 13 presentations and abstracts presented at the conference.

Topping the conference news was a new “smart bomb” drug for breast cancer that was effective in destroying cancer cells without the side effects of conventional chemotherapy.

Researchers said the results of the trial of the breast cancer drug trastuzumab emtansine (T-DM1) from Genentech validate the long-held belief that targeted drug therapy can deliver effective treatment to the tumor while sparing normal tissue.  The results of the pivotal trial in which GCS participated have been submitted to the FDA for approval.

Dr. Mansoor N. Saleh, principal investigator and Director of Clinical Research at GCS’s community-based Phase I-IV clinical research program, said the study shows how a cancer drug can enter the tumor cell like a Trojan horse and kill only cancer cells without damaging healthy cells.

“We have long hoped this type of treatment would be more effective in treating cancer while substantially reducing the side effects of traditional chemotherapy,” Dr. Saleh said.

Reports on other important studies from the conference included prostate drugs Zytiga (abiraterone) and Aragon’s ARN-509, Ipilimumab for melanoma (an immunotherapy/vaccine, which blocks inhibitors and activates the immune system),  and Bendamustine in lymphoma

The targeted agents Zytiga and ARN-509 are used in the treatment of castration resistant metastatic prostate cancer.

The Zytiga trial showed the drug helped delay the spread of tumors and the onset of pain in men whose disease was no longer responding to chemical castration, but who hadn’t yet turned to chemotherapy. The results were so positive that the trial was stopped and the drug recommended for use in all patients.

In a Phase 1 study of ARN-509, the drug was shown to be safe and well tolerated, with promising preliminary activity based on PSA and pharmacodynamic evidence of AR antagonism. The Phase 2 portion of the study will enroll up to 90 patients with treatment-naïve non-metastatic and mCRPC.

In the breakthrough breast cancer treatment study, Dr. Saleh said trastuzumab emtansine (T-DM1) outperformed other treatment protocols in a clinical trial involving 991 patients with relapsed breast cancer that carries a mutated form of the HER2 protein. About one in five cases of breast cancer are HER2-positive.

The clinical trial showed the treatment kept tumors in check for a longer period of time, caused fewer toxic side effects, and showed it is on pace to help extend the lives of these very sick patients.

Thanks to the success of the clinical trial, Genentech, a unit of the Swiss company Roche, plans to file for Food and Drug Administration (FDA) approval this year, meaning the drug could reach the market and be available to patients outside of a clinical trial setting sometime next year. 

Dr. Kristina Bowen was also first author and presenter of a poster, “Evaluation of Variables that May Impact Chemotherapy Administration after Determination of Oncotype DX Recurrence Score Results.” 

This study analyzed the use of the Oncotype DX assay in a large group of GCS patients with early stages of breast cancer (788 eligible patients across the practice). It also analyzed the circumstances under which the test was ordered, and how the test results were utilized in making chemotherapy treatment decisions.

The analysis demonstrated that Oncotype DX results are being used appropriately in guiding treatment recommendations for GCS patients, thus confirming the utility of the Oncotype DX test in our practice. Additional analysis of our data may be done to hopefully improve the quality of patient care.

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