An experimental drug that attacks cancer in an entirely new way has shown promise in treating advanced melanoma, delaying progression of the disease and prolonging the 1) ___ of patients. New research presented September 26 at the European Cancer Conference in Barcelona found that giving the new drug in addition to 2) ___ more than doubled the amount of time patients survived without progression of their cancer. The drug is the first in a new class called 3) ____ ___ ____. It works by 4) ___ the amount of reactive oxygen species (ROS), such as hydrogen peroxide and superoxide, in cells. When the level exceeds the antioxidant capacity of cells, the cells are in a state of oxidative 5) ___. All cells have some low level of ROS, but cancer cells naturally operate with a 6) ___ level of ROS and oxidative stress relative to normal cells. However, too much oxidative stress for too long results in cell 7) ___. STA-4783 kills only tumor cells because the additional stress introduced pushes cancer cells, but not 8) ___ cells, over the critical threshold. 9) ___ is one of several cancer types that are known to operate at a higher level of oxidative stress. The concept of cancer cells operating at a higher level of oxidative stress than normal cells has been around for many years. However, it is only recently becoming a greater focus of attention in the field of 10) ___. Metastatic melanoma, where the skin cancer has spread to other parts of the body, is difficult to treat. Current therapies either have limited power or are highly 11) ___. The average survival of patients diagnosed with advanced melanoma is about six months. This study also indicated that STA-4783 might boost the efficiency of chemotherapy drugs that induce cell death, or 12) ___, because it appears to lower the hurdle for activating that process. These results are encouraging not only because of the findings, but also because there are so few treatment options for patients. STA-4783, appears to have the potential to improve survival with a manageable side effect profile. It is believed, there is nothing unique about metastatic melanoma and that oxidative stress has the potential to be an entirely new class of cancer treatment that could have applications in other types of cancer.

ANSWERS: 1) lives; 2) chemotherapy; 3) oxidative stress inducers; 4) increasing; 5) stress; 6) higher; 7) death; 8) healthy; 9) Melanoma; 10) oncology; 11) toxic; 12) apoptosis

More info on this study:

The study, included 81 patients with metastatic melanoma. Of those, 28 received treatment with the chemotherapy drug paclitaxel alone and 53 received paclitaxel plus the new drug, STA-4783. The median progression free survival was 1.8 months in the group who got chemotherapy alone, but 3.7 months in the group who got the combination. This doubling in progression free survival is impressive for this cancer, and the result was achieved without substantial additional toxicity. Progression-free survival was linked to improvements in overall survival. Patients on the experimental combination survived on average for 12 months after being diagnosed, while those getting only paclitaxel survived on average 7.8 months. This is the first time an improvement in survival has been seen in a randomized, double-blind, multi-center controlled trial for metastatic melanoma. A larger study of STA-4783 in melanoma patients across Europe is now under way to further investigate the drug’s potential. Synta Pharmaceuticals Corp. in Lexington, Massachusetts, USA, the drug’s developer, funded the study presented at ECCO. Note: This story has been adapted from material provided by European Cancer Conference, on September 29, 2007.

One of Target Health’s clients performed a small paper CRF study in Vietnam in the newborn. Part of the study’s requirements was to do a long-term safety followup over several years. As a result, we have set up an EDC study to collect the long-term data. While we will enter the initial paper CRF data into Target e*CRF®, all subsequent safety data will be entered by the Vietnamese site.

For another client, Target Health has built a postmarketing product complaint module for both drugs and devices. The module spans over 10 products, and can be used anywhere in the world. It can be used by their call center or within the company. One great feature is that it automatically generates a 3500A MedWatch Form.