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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:
- That which has been established to be effective,
- That which has a good chance of being effective, and
- 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:
- Evaluating the molecular biology of the tumor cell population
- Analyzing the patient's living tumor cells to determine sensitivity or resistance to chemotherapy
- Protecting against anemia
- Inhibiting the cyclooxygenase-2 (COX-2) enzyme
- Suppressing r R as oncogene expression
- Correcting coagulation abnormalities
- Maintaining bone integrity
- Inhibiting angiogenesis
Step One: Evaluating the Molecular Biology of the Tumor Cell Population
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
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. | 
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