Advances in the Treatment of CANCER

Cancer

Finding treatments for rare cancers at specific stages for patients unresponsive to existing treatment might be the toughest—and most gratifying—work a scientist could ever attempt.

Cancer is a group of diseases in which abnormal cells develop and spread through parts of the body. Anyone can develop cancer. The National Cancer Institute estimates that 9.8 million Americans with a history of cancer were alive in 2001. Some were cancer-free; others were continuing to undergo treatment.¹³²

Patient Perspective: Thankful for Another Day

PHARMACEUTICAL ADVANCES
Disrupting DNA Adds Months for Severe Brain Cancer Patients
In the two most aggressive forms of astrocytoma, brain tumors grow rapidly and spread to other parts of the body. Astrocytoma is classified into four grades (Grade I being the least aggressive and IV most aggressive). Grade III is anaplastic astrocytoma, which affects 2,000-3,000 people a year with an average survival of two to three years. Grade IV is glioblastoma multiforme, which affects 8,000-10,000 people each year and is usually fatal within one year.¹³³

Temozolomide can add an average of two and a half additional months—an enormous amount of time in the world of cancer treatment—for patients with glioblastoma multiforme.^134,135 "It doesn't sound like much... but if you can demonstrate that you can extend life for two or three months for the average patient, that's a significant advance," says Dr. Warren Mason, the co-author of a New England Journal of Medicine study about the drug.¹³⁶ Patients taking temozolomide for treatment of anaplastic astrocytoma experienced an average survival time of nearly 16 months.¹³⁷

Approved in 1999, temozolomide is the first major new treatment for anaplastic astrocytoma in 20 years, and with a second indication approved in 2005, it is the first in over 30 years for glioblastoma.^138,139 It works by disrupting DNA to prevent cancer cells from multiplying and prolongs survival when combined with standard radiation.¹⁴⁰ Additionally, it is a more convenient therapy for patients; it is an oral treatment allowing patients to take their medication in the comfort of their own homes rather than having to receive intravenous treatments at a physician's office or hospital.

Dual-Action Therapy Initiates Immune Response and Attacks
Tumor Cells Directly
Non-Hodgkin's lymphoma is a cancer of lymphatic tissues, such as lymph nodes, spleen, and other immune system organs. There are several different types of non-Hodgkin's lymphomas. One of those types, follicular lymphoma, makes up 22 percent of all non-Hodgkin's lymphomas. Follicular lymphoma is not curable, but due to its slow growth, 60 to 70 percent of patients live at least five years; it occurs mainly in adults, with an average age of 60.¹⁴¹ People with follicular non-Hodgkin's lymphoma usually have lymphoma in many parts of the body. According to the FDA Office of Orphan Products, the condition affects 193,500 people in the United States.

With the 2003 approval of tositumomab and Iodine-131 tositumomab, patients with a subset of follicular non-Hodgkin's lymphoma—CD20 positive follicular non-Hodgkin's lymphoma—gained a new treatment option with an innovative therapeutic twist. The drug is made up of an immune system protein, called an antibody, attached to radioactive Iodine-131. Combined, they form a "radiolabeled" monoclonal antibody that is able to bind to a protein found only on the cancer cells, thus targeting the radioactivity directly to the cancer cell, killing it.^142,143

This new medicine is used for patients with CD20 positive follicular non-Hodgkin's lymphoma who have not responded to other treatments or whose cancer has returned after chemotherapy.¹⁴⁴ For more than two years, on average, two-thirds of patients who took this medication during clinical trials experienced either improved condition or full remission of the disease.¹⁴⁵

First Ray of Hope for Asbestos-Related Lung Cancer
When someone first experiences symptoms and is diagnosed with malignant pleural mesothelioma, the fatal cancer is often already in advanced stages, and doctors expect them to live just nine to 13 months.¹⁴⁶ Malignant pleural mesothelioma is a cancer of the lining of the lung and chest cavity, called the pleura. This is a very rare type of cancer affecting only 2,000 new people each year, and it is associated with exposure to asbestos.

Now the first drug approved for this rare cancer, pemetrexed, combined with other treatments, gives patients 40 percent longer survival time compared with current treatment alone. "Before [pemetrexed] was available, patients suffering from mesothelioma had no hope—rarely living a year after diagnosis," said Nicholas J. Vogelzang, MD, Director of the Nevada Cancer Institute in Las Vegas. "At 18 months, there is still a statistically significant difference in survival, which demonstrates patients are living longer when treated with this [pemetrexed] combination," Volgelzang said.¹⁴⁷

Approved in 2004, pemetrexed is a novel antifolate, a class of drugs that targets the folic acid metabolic pathway, which affects availability of certain B complex vitamins.¹⁴⁸ It is indicated for patients with the advanced form of the disease who have already had chemotherapy. Pemetrexed was found in clinical trials to be as effective as other cancer drugs, but with fewer side effects, such as hair loss and subsequent infections.

There are approximately 6,000—7,000 rare diseases.149

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Endnotes:

132 American Cancer Society, Inc., Cancer Facts and Figures 2005, http://www.cancer.org/downloads/STT/CAFF2005f4PWSecured.pdf (accessed 8 September 2005).
133 Brain Tumor Society, Patient Resources: Common Brain Tumors, http://www.tbts.org/itemDetail.asp?categoryID=292&itemID=16532 (accessed 15 July 2005).
134 S. Ubelacker, "New Drug Offers Hope to Brain Cancer Victims," Canadian Press (9 March 2005).
135 Brain Tumor Society, op. cit.
136 S. Ubelacker, op. cit.
137 Schering-Plough Corporation, "First New Chemotherapy Agent for Brain Tumors in 20 Years," press release, 11 August 1999, http://virtualtrials.com/temodar%5Cpress.cfm (accessed 21 September 2005).
138 Pharmaceutical Research and Manufacturers of America, New Drug Approvals in 1999 (Washington, DC: PhRMA, 2000).
139 R. Stupp et al., "Radiotherapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma," The New England Journal of Medicine 352, no. 10 (10 March 2005): 987-986.
140 Pharmaceutical Research and Manufacturers of America, Innovation.org, http://www.innovation.org/data/newsletter/archives/?id=84 (accessed 3 October 2005).
141 American Cancer Society, Inc., "What Is Non-Hodgkin Lymphoma?" American Cancer Society, http://www.cancer.org/docroot/CRI/content/ (accessed 3 October 2005).
142 Lymphoma Information Network, "Monoclonal Antibody Therapy: Bexxar®," Lymphoma Information Network: Your Comprehensive Guide to Hodgkins and Non-Hodgkins Lymphoma, http://www.lymphomainfo.net/therapy/immunotherapy/bexxar.html (accessed 3 October 2005).
143 Doctor's Guide Publishing Limited, "FDA Approves Bexxar in Patients with Follicular Non-Hodgkin's Lymphoma," Doctor's Guide Personal Edition, http://www.docguide.com/news/content.nsf/news/ (accessed 8 September 2005).
144 Lymphoma Information Network, op. cit.
145 National Cancer Institute, "Newly Approved Cancer Treatments: Bexxar®," National Cancer Institute, http://www.cancer.gov/clinicaltrials/developments/ (accessed 21 November 2005).
146 Food and Drug Administration, "FDA Approves First Drug for Rare Type of Cancer," February 2004, http://www.fda.gov/bbs/topics/NEWS/2004/NEW01018.html (accessed 29 August 2005).
147 Eli Lilly and Company, "Thoracic Cancer Patients Find New Reasons for Hope with Alimta®," press release, 3 July 2005, http://newsroom.lilly.com/ReleaseDetail.cfm? ReleaseID=167952 (accessed 3 October 2005).
148 National Cancer Institute, "Clinical Trial Results: Largest-Yet Mesothelioma Study Shows Survival Benefit with New Drug," National Cancer Institute, May 2002, http://www.cancer.gov/clinicaltrials/results/mesothelioma-study0502 (accessed 7 September 2005).
149 National Institutes of Health, Office of Rare Diseases, Access to Quality Testing for Rare Diseases: A National Conference, Overview, (Rockville, MD: NIH, 26 September 2005), http://rarediseases.info.nih.gov/QTRD/overview.html.