Drug Trial for Cancer Medication

Paper Summary:

In this article, the writer notes that the research and development on a new drug is expensive and time-consuming, followed by a lengthy trial and a lengthy approval process by the Food and Drug Administration (FDA). The writer points out that Zometa was approved for the treatment of hypecalcemia, a common metabolic complication associated with cancer. The writer discusses that research into the action of the bisphosphonate zoledronic acid (marketed as Zometa) was undertaken to gain FDA approval for use of the drug for the treatment of osteolytic bone metastases, and research is also under way for use of the drug for other purposes as well. The writer concludes that so far, approval has only been given for its use in treating cancer patients with bone metastases, though there are indications that it will be valuable for breast cancer patients facing other difficulties.


Outline:
Introduction
Medical Problems to be Addressed
Drug Action
Approval of the Drug
Conclusion

From the Paper:

"Hypercalcimia of malignancy is considered the most common life-threatening metabolic complicastin of malignancy. It affects some 10 to 20 percent of patients with advanced cancer, varying widely with the type of cancer involved. It occurs most often in patients with multiple myeloma and carcinomas of the lung, breast, kidney, and the head and neck. Antihypercalcemic therapy is used, but median survival under these conditions has been found to be 30 days. Certain symptoms diminish the quality of life for these patients, such as nausea, vomiting, and altered mental states. HCM can also produce renal failure. Patients with bone metastases can also develop HCM. Factors that mediate hypercalcemia stimulate excess bone resorption and the release of calcium from the bone matrix, meaning that patients experience bone loss, a weakened bone structure, and higher circulating calcium levels. Bisphosphonates inhibit bone resorption and are the most effective therapy for HCM. Pamidronate has been one of the most commonly used treatments for HCM."

Sample of Sources Used:

• "Biphosphonate, Zoledronic Acid (Zometa) for Treatment of Osteopenia and Osteoporosis in Women with Breast Cancer and Receiving Letrozole Therapy." Mayo Clinic (2007). http://clinicaltrials.mayo.edu/clinicaltrialdetails.cfm?trial_id=100360.
• Berenson, James R. et al. "Zoledronic Acid Reduces Skeletal-Related Events in Patients with Osteolytic Metastases." Cancer 91(7)(1 April 2001), 1191-1199.
• Berenson, James A., Robert A. Vescio, et al. "A Phase I Dose-Ranging Trial of Monthly Infusions of Zoledronic Acid for the Treatment of Osteolytic Bone Metastases." Clinical Cancer Research 7 (March 2001), 478-485.
• Bossier, Sandrine et al. "Bisphosphonates Inhibit Breast and Prostate Carcinoma Cell Invasion, an Early Event in the Formation of Bone Metastases." Cancer Research 80 (1 June 2000), 2949-2954.
• Bujoli, Bruno et al. "Novel Phosphate-Phosphonate Hybrid Nanomaterials Applied to Biology." Progress in Solid State Chemistry 34 (2006), 257-266.

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