Sponsored by Roche Laboratories, a

¶ … sponsored by Roche Laboratories, a new drug is show promising results for certain types of cancer patients. The drug, Herceptin, is currently being given to stomach cancer patients, in addition to other forms of chemotherapy (Pollack, 2009). This drug belongs to a new class of compounds, called PARP inhibitors, that shows promise in many forms of cancer that were formerly difficult to treat. This information was presented at the annual meeting of the American Society of Clinical Oncology (Pollack, 2009).

The following examines the study parameters and discussing the strengths and weaknesses of the research method. For regulatory reasons, the original study or specific product information is not available (F. Hoffman-L Roche Ltd., 2009). Therefore, the information obtained about the drug and trials must be obtained from secondary sources. However, from the article, one can still determine many of the study elements that are important to its analysis. Information in the New York Times allows us to examine many of the study parameters that are not available to the public.

The drug Herceptin was originally used to treat breast cancer patients. PARP inhibitors are a new class of drugs that may give patients with non-Hodgkins lymphoma, that had been unresponsive to treatment two times, a second chance at life (Pollack, 2009). PARP inhibitors block the ability of the cancer cell to repair itself, resulting in the death of tumor cells (Pollack, 2009). Herceptin was not designed as a stand alone treatment, but was designed to be used in combination with other chemotherapy treatments.

The hypothesis was that Herceptin would significantly prolong the life of patients with stomach cancer, when used in combination with standard chemotherapy treatments. The null hypothesis was that Herceptin would no demonstrate a significant increase in the lives of patients with stomach cancer, when used in combination with standard chemotherapy treatments. It cannot be determined if the study had any further hypotheses of alternate hypotheses, as the original report was not made public. The breast cancer study involved patients were found to be triple-negative.

These types of canter lack receptors for estrogen, progesterone, and Her2. The rationale for this hypothesis was based on the knowledge that roughly 20% of women with breast tumor have an abundance of a protein called Her2 (Pollack, 2009). A new study revealed that approximately 22% of all patients with metastatic stomach cancer also have increased levels of Her2 protein (Pollack, 2009). This led to the hypothesis that Herceptin may be useful in the treatment of patients with hard to treat stomach cancers, in addition to those with difficult breast cancers.

The sample population in the breast cancer study included 116 women with advanced triple-negative breast cancer (Pollack, 2009). The sample population for the stomach cancer trials included 594 patients that were Her2 positive. It is not known if patients in the stomach cancer trial included both males and females. Exclusionary criteria were not made available for either of the studies. All of the patients were receiving standard chemotherapy treatments, in addition to receiving Herceptin (Pollack, 2009). The sample populations for these studies were large for a clinical trial.

Many times, it is difficult to find patients that fit the criteria for inclusion in the study. This was not a problem for these studies. The sample population of the study improves the validity of the study and confidence in the drug to be effective in patients that meet the criteria for administration of Herceptin. The study design in both cases used a comparative study. One group was the test group and would receive the treatment being tested, in this case Herceptin.

The other group would be the control group and would not receive the drug. Although it was not revealed in the article, many clinical trials at this stage are double-blind studies. In this study technique, a sham treatment is designed that mimics the real treatment, only without the active ingredients. Neither the doctor, nor the patient knows which study group to which they belong. They do not know if they have received the real or sham treatment.

This helps to eliminate external bias in the study and improvise the validity of the results obtained. Conclusion The results of the stomach cancer study found that patients that received Herceptin, in addition to standard.