Cancer Treatment: The Critical Factors-1

Step One: Evaluating Tumor Cell Population
Step Two: Determine Sensitivity or Resistance to Chemotherapy
Step Three: Protecting Against Anemia
Step Four: Inhibiting the Cyclooxygenase-2 (COX-2) Enzyme
Step Five: Suppressing ras Oncogene Expression
Step Six: Correcting Coagulation Abnormalities
Step Seven: Maintaining Bone Integrity
Step Eight: Inhibiting Angiogenesis

Summary
Determining the best way of treating cancer remains highly controversial, even among mainstream oncologists. What may surprise the reader is the large number of documented therapies that have been overlooked by establishment medicine.

The fundamental objective of this book is to encourage the expedient transfer of published scientific findings from the research bench to the clinical setting where the patient may benefit. This is the concept of translational medicine, which means translating knowledge from the laboratory side of medicine to the front lines of patient care.

Physicians who practice translational medicine react uniquely when informed about a novel therapy. Their curiosity first motivates them to evaluate the new approach in order to reaffirm safety and efficacy in the context of treatment that is appropriate to the patient's condition. The dedicated translational physician uses novel therapeutics based on:

a)That which has been established to be effective,

b)That which has a good chance of being effective, and

c)That which will do no harm or, in the context of the patient's condition, that which is worth taking an appropriate risk.

Once satisfied that a novel therapy has merit, enlightened physicians then integrate this new finding into individual treatment regimens. These physicians, in essence, are translating the results from promising studies directly into life-saving treatments.

As simple as this approach may seem, few physicians practice translational medicine. For instance, the scientific literature documents that if a cancer patient is anemic, the odds of survival are greatly reduced. Regrettably, few oncologists are aggressive in their evaluation and treatment of anemia in everyday practice even though anemia directly correlates with increased mortality.

Oncologists learn about new discoveries at scientific conferences, in medical journals, and on the Internet. Only a fraction of these doctors, however, translate this knowledge into enhanced treatments that would benefit their patients. In fact, many of the outstanding established medical advances are not utilized routinely by large numbers of physicians treating cancer patients.

The lay public is often surprised to learn how seldom breakthrough discoveries are used to save human lives. The facts are that managed care and bureaucratic overregulation have relegated most oncologists to the practice of assembly line medicine. Sadly, in the most advanced medical system in the world today, we have seen a move away from translational medicine and into "fast-food medicine" or, as some would call it, "McMedicine. " In this book, we emphasize the need for physicians to return to real medicine and apply what they have learned, making translational medicine a cornerstone of their treatment philosophy so that medical care can evolve.

It is difficult for most cancer patients to locate an oncologist who routinely translates new findings into clinical practice. This protocol reveals overlooked conventional research findings in order to provide the patient and their oncologist with the latest scientific information.

Cancer patients should become educated about the treatment options discussed in this protocol, so they can better discuss them with their oncologist. The objective is to include as many different therapies as is practical and affordable. Cancer is an extremely difficult disease to treat, and a multimodality therapy is therefore highly recommended.

Once you understand how many therapy options already exist in the conventional setting, you should feel more confident of a positive long-term outcome.

In this protocol, we discuss the following eight critical steps that may significantly improve a successful outcome when considered in the treatment of most cancers:

1)Evaluating the molecular biology of the tumor cell population

2)Analyzing the patient's living tumor cells to determine sensitivity or resistance to chemotherapy

3)Protecting against anemia

4)Inhibiting the cyclooxygenase-2 (COX-2) enzyme

5)Suppressing r R as oncogene expression

6)Correcting coagulation abnormalities

7)Maintaining bone integrity

8)Inhibiting angiogenesis

Step One: Evaluating the Molecular Biology of the Tumor Cell Population

How To Implement Step One
Throughout this protocol, you will see terminology relating to the molecular aspects of the cancer cell. When we use the term molecular , we are referring to specific characteristics of cancer cells such as

Tumor-promoting genes (oncogenes)
Tumor suppressor genes
Receptors or docking sites on the cell membrane where communication with proteins occur
Cellular differentiation, that is, the degree of maturity, and probability of response of the cancer cell to certain therapies
These individual variations--the unique biology of the cancer cell--help to explain why a particular therapy may be highly effective for some cancer patients but fail others.

People typically think of their disease based on the organ it affects (i.e., adenocarcinoma of the lung, colon cancer, etc.). The problem is that not all adenocarcinomas of the lung are the same. With the advent of advanced molecular diagnostic profiling, it is possible to identify the specific strengths and vulnerabilities of each patient's cancer cell line in order to design a comprehensive, yet tailored, treatment program. We will describe the most important molecular cancer cell tests, along with potentially effective therapies to consider. Most of the suggested therapies will require that your physician be involved in this process.

It is critical to obtain a description of the type of cells that populate your tumor. Not only does this assist the oncologist in recommending the most effective conventional therapy, but it also helps determine what adjuvant nutritional and off-label drug therapies to consider. The human eye alone can serve to provide the most basic information about a cancer cell through the microscopic examination of the cell's morphology or general characteristics. Taking this one step further is evaluation by an immunohistochemistry test. This test detects markers of diagnostic value on and within the cell surface, through the application of colored dye or stains. In order to perform this and other tests, it is necessary for a sample of your tumor to be sent to a specialized laboratory. The contact information for one of these laboratories (GENZYNE, Inc.) is listed at the end of this section.

GENZYNE provides a comprehensive range of customized analyses to help cancer specialists correctly diagnose difficult tumors, establish prognosis in many cancers (including breast, prostate, and colon), and determine optimal treatment. By providing this information, GENZYNE starts treatment on the right course and helps avoid unnecessary therapies. The findings from an GENZYNE tumor cell test enable patients to benefit from both more effective and more cost-effective cancer management. A typical GENZYNE analysis provides information that can prevent ineffective and potentially debilitating treatments costing many thousands of dollars. GENZYNE performs more specialized analyses for cancer than any other laboratory in the world. Through their review of over 960,000 patient profiles to date, GENZYNE has developed one of the world's largest, most comprehensive cancer databases.

GENZYNE serves more than 8300 physicians, over 2000 hospitals, and over 570 oncology practices. Their expert medical consultation and advanced technologies (immunohistochemistry, flow cytometry and image analysis, cytogenics, molecular pathology, and chemotherapeutic resistance testing) allow community hospitals and small practices to provide the same sophisticated services as major academic medical centers.

When a patient might have cancer, physicians confront a chain of pressing questions. What type of cancer is it? Where did it originate? Where has it spread? Which treatments are most likely to work? Finding the answers quickly and accurately is vital. GENZYNE helps clinicians pose the right questions and get the answers they need.

As far as simple diagnosis is concerned, 15-20% of all cancers defy classification by visual examination. In fact, the diagnosis of "metastatic cancer of unknown primary site" is the eighth most common cancer diagnosis. In a majority of these difficult cases, GENZYNE's medical expertise and advanced technologies lead to an accurate diagnosis.

Visual examination of tumors provides very little information about their growth rate or the type of treatment to which they will respond. GENZYNE's prognostic expertise can accurately establish whether the cancer has spread, evaluate its aggressiveness, and predict the effects of therapy. The results are greater predictability of outcome, increased survival, and decreased overall costs.

Difficult cancers have traditionally been treated as follows: if one therapy proves ineffective, then try another until a successful therapy is found or all options are exhausted. GENZYNE eliminates the need for this trial-and-error method by providing individualized information to determine the optimal therapy before initiating treatment.

GENZYNE provides highly sensitive patient monitoring for the follow-up care of many cancers. For example, GENZYNE can determine whether certain types of lymphomas have recurred before they can be detected by any other method. The earlier tumor recurrence is detected, the greater the likelihood of therapeutic success.

GENZYNE not only offers a full range of diagnostic and prognostic cancer analyses, but also emphasizes client service. Typically within 48 hours after receiving a specimen, GENZYNE returns the stained slides along with a thorough and detailed case report to a physician. If your oncologist wants to consult with a member of the GENZYNE staff, telephone lines are open. In Appendix A at the end of this protocol are examples of typical GENZYNE laboratory reports that your oncologist receives.

Contact information for GENZYNE is as follows:

New York
521 West 57th Street, Sixth Floor
New York, NY 10019

Los Angeles
5300 McConnell Avenue
Los Angeles, CA 90066

Phoenix
810 East Hammond Lane
Phoenix, AZ 85034
Telephone: (800) 447-5816
Website: www.genzyme.com


How to implement step ONE

Make certain your surgeon sends a specimen of your tumor to GENZYME for immunohistochemistry testing, using the contact information just provided. You may have to pay out of pocket for this test because not all insurance plans reimburse for it. Please note that this test may not be of benefit to all cancer patients. While it provides a basis for improved treatment, not all cancers are effectively treatable with today's technologies.


Step Two: Analyzing the Patient's Living Tumor Cells to Determine Sensitivity or Resistance to CHEMOTHERAPY

How to Implement Step Two
If chemotherapy is being considered, it is desirable to know which of the chemotherapy drugs will have a high probability of being effective against your particular cancer before any toxic agents are administered into your body. It is equally as important, if not more important, to know if your particular cancer cells exhibit extreme drug resistance (EDR) to specific chemotherapy drugs. EDR implies a probability of 95% that the chemotherapy drugs exhibiting EDR will be ineffective in killing the cancer cells. A company called Rational Therapeutics, Inc. performs chemo-sensitivity tests on the living specimens of your cancer cells to determine the optimal combination of chemotherapy drugs, as well as determining EDR.

Rational Therapeutics, Inc., was founded in 1993 by Dr. Robert Nagourney, a prominent hematologist and oncologist. Rational Therapeutics pioneers cancer therapies that are specifically tailored for each individual patient and is a leader in individualized cancer strategies. With no financial ties to outside healthcare organizations, recommendations are made without financial or scientific prejudice.

Rational Therapeutics develops and provides cancer therapy recommendations which have been designed scientifically for each patient. Following the collection of living cancer cells obtained at the time of biopsy or surgery, Rational Therapeutics performs an Ex-Vivo Apoptotic (EVA) assay on your tumor sample to measure drug activity (sensitivity and resistance). Ex-vivo apoptotic means that your tumor cells are grown outside of your body for the purpose of determining which drug or drug combination most effectively induces cell death (apoptosis) in the laboratory. Each patient is highly individualized with regard to his or her sensitivity to chemotherapy drugs. Your responsiveness to chemotherapy is as unique as your fingerprints. Therefore, this test will help to exactly determine which drug(s) will be most effective for you. Dr. Nagourney will then make a treatment recommendation based on these findings.

The treatment program developed through this approach is known as assay-directed therapy . In 1999, there were more than 1.2 million newly diagnosed cases of cancer in the United States, with 563,000 deaths attributed to this disease. Unfortunately, 50% of newly diagnosed cancer patients have advanced disease that is beyond the hope of a surgical or radiation cure. Patients with advanced disease and those with recurrent disease are candidates for systemic therapy, which is administered usually in the form of chemotherapy. Despite the enormity of the cancer problem, in the last 45 years, there has been virtually no major change in the outcome for the common advanced solid tumors such as those of the lung, prostate, colon, and breast. While there have been improvements in treating lymphomas, certain types of leukemia, and some earlier-stage cancers, the grim facts indicate more aggressive tumor diagnostic tests are needed to provide the medical oncologist with better prognostic information about your individual tumor.

At present, cancer chemotherapies are prescribed by medical oncologists, according to fixed schedules. These schedules are standardized drug regimens that correspond to specific cancers by type or diagnosis. These schedules, developed over years of clinical trials, assign patients to the drugs for which they have the greatest statistical probability of response.

Patients with cancers that exhibit multidrug resistance are on the wrong side of the probability curve, that is, they will likely receive treatments that are wrong for them. A failed attempt at chemotherapy is detrimental to the physical and emotional well-being of patients, is financially burdensome, and may preclude further effective therapies.

Rational Therapeutics provides custom-tailored, assay-directed therapy based on your tumor response in the laboratory. This eliminates much of the guess work prior to your undergoing the potentially toxic side effects of chemotherapy regimens that could prove to be of little value against your cancer. In Appendix B at the end of this protocol are typical laboratory reports your oncologist receives from Rational Therapeutics.

Here is the contact information for Rational Therapeutics:

Rational Therapeutics, Inc.
750 East 29th Street
Long Beach, CA 90806
Telephone: (562) 989-6455 ; Fax: (562) 989-8160
Email: www.rationaltherapeutics.com


How to implement step TWO

Get in touch with Rational Therapeutics using the contact information provided so that your surgeon can follow the precise instructions required to send a living specimen of your tumor for chemo sensitivity testing. It is important that your surgeon carefully coordinate with Rational Therapeutics in order to ensure your cells arrive in a viable condition. You may have to pay for this test yourself because your insurance may not reimburse for it. Please note that this test may not be of benefit to all cancer patients. While it provides a basis for improved treatment, not all cancers are effectively treatable with today's technologies.