IN THIS CHAPTER YOU’LL DISCOVER
→ Clinical Trials and How to Enroll
→ Questions to Ask: Clinical Studies
THE ROOTS OF MODERN cancer treatment reach back to 1846, when anesthetic practices became widely utilized in the Western world, and surgery to treat cancer became feasible. The first mastectomy was performed in 1882. Radiation therapy can be traced back to the discovery of X-rays in 1895, and the development of chemotherapy dates back to World War II.
It may not seem that much has changed — conventional cancer treatment still relies on the same basic methods: surgery, radiation, and chemotherapy. But a revolution in cancer treatment is underway, utilizing targeted treatments that are more effective and cause fewer side effects.
First we will focus on those long-established treatments, followed by the targeted treatments. Bear in mind that the course of cancer treatment you receive will depend on factors specific to your case. These may include the following:
Before getting started, you’ll want to create the next section of your healthcare record, labeled, “Treatment.” Record the following questions to ask your doctor about treatments that may be considered for your particular type of cancer:
In many cases, the first line of cancer treatment is the removal of the mass or affected area. Surgery is most effective on small tumors, or tumors that are localized to a specific part of the body. Sometimes, especially in the case of cancers that are discovered early, surgery is all that is needed to cure the disease.
Often, surgical procedures are combined with other treatments, such as chemotherapy, radiation, or hormonal treatments to reduce the risk of recurrence (commonly used for breast and prostate cancers). Historically, surgery is the oldest treatment for cancer and it is still the one most commonly used, both to cure cancer and sometimes if the disease recurs. Surgery is generally not used if the cancer is advanced and has spread to other organs.
Surgery is generally performed in a hospital or surgical center under anesthesia, and preparations, length of hospital stay, and recuperation vary depending on the type of surgery involved. All surgery carries some risk, including infection, blood clots, and also the potential removal of an organ, which can produce side effects. The outcome also depends on several factors, including the health and condition of the patient, the skill of the surgical team, and the facilities.
A very important term you’ll hear in connection with cancer surgery is clear margins. When the surgeon removes the tumor, tissue samples from the same site are also taken and examined for cancer cells. If the surrounding area is free of cancer, this is the best indication that the disease has not spread.
Sometimes, surgery will still be warranted even though clear margins cannot be achieved. In such cases, a surgical procedure called debulking may be used instead. This refers to removing as much of a malignant tumor as possible, so that chemotherapy and/or radiation will be more effective. Debulking, or cytoreduction surgery, is often used in the case of brain or ovarian cancer.
Chemotherapy is the use of specific chemical agents or drugs that target cancer cells. It can be used before surgery, but most often it is used afterward or in conjunction with radiation. While it can cure some types of cancers that have spread within the body, it is also used to eradicate any cancerous cells that may remain after surgery. In addition, it can be used to control the growth of cancer if it returns. For some cancers, chemotherapy is given as a “maintenance” therapy to help keep the disease in check.
Rapidly dividing cells are a hallmark of cancer. However, not all cells that grow quickly are necessarily cancer. Chemotherapy cannot differentiate — it also kills healthy cells, like the ones that cause hair growth, or those that line the mouth and intestines. This causes the unpleasant side effects for which chemotherapy is known: hair loss, nausea, and vomiting. Most of these side effects improve or disappear after the chemotherapy is stopped; but some types of chemotherapy can permanently damage the heart, lungs, and other organs.
The type of chemotherapy used depends on the kind of cancer you have, how advanced the disease is, and your general physical condition (whether you have any other medical conditions, such as heart or kidney disease, etc.).
There are different ways to administer chemical therapy, but it is most often given intravenously. It is also usually given in cycles with rest periods in-between, which enable the body to recover and grow new, healthy cells to replace those that were eradicated during the cancer treatment.
Hyperthermic intraperitoneal chemotherapy (HIPEC), known as a chemo bath, is an aggressive form of chemotherapy and surgery given to patients with advanced cancer who may have run out of treatment options. This two-step procedure, which is performed in one lengthy operation that can last several hours, can be used on cancers that have spread to the abdominal wall, such as late-stage colon cancer, and those of the appendix and stomach.
First, the surgeon removes all visible signs of tumor with cytoreductive surgery. Then, the chemotherapy drug, cisplatin, is heated to 103 degrees Fahrenheit and pumped into the abdominal cavity. The patient, who is lying on a cooling table, is physically rocked back and forth to make sure the chemical mixture is spread throughout the abdomen, killing any remaining cancer cells. The entire procedure can last from eight to 18 hours.
Significantly riskier than conventional treatments, the extreme nature of this procedure has stirred considerable controversy due to a lack of studies proving its effectiveness. However, a study published in 2013 in the journal Cancer Medicine looked at 112 patients with very advanced colon cancer. One-half of the patients were treated with this method, and the remaining half with conventional chemotherapy. According to the results, this procedure was no more risky than the conventional treatment, and one in three patients survived at least five years, compared to a survival rate that is usually measured in months.
Heated chemotherapy is a highly involved and extremely invasive treatment with potentially severe toxic effects, so it should only be performed by an exceedingly skilled surgical team on carefully selected patients.
Cancer treatment using high-energy X-rays or similar high-energy (ionizing) particles — radiation therapy — has been in practice for over 100 years. There are two main forms of radiation: external radiation involves receiving treatment from outside the body, with the use of a machine; internal radiation, known as brachytherapy, is performed by placing radioactive material inside the body, into the cancer itself or the tissue surrounding it.
Like chemotherapy, radiation has the same drawback — this treatment also can kill healthy cells nearby, as well as causing side effects. Therefore, other forms of radiation systems are being developed in order to kill cancer cells while sparing as much healthy tissue as possible. They include:
Although surgery, chemotherapy, and radiation are still the dominant forms of cancer treatment, more and more targeted therapies are being developed to treat different forms of cancer. This is the long-awaited revolution in cancer treatment, and it is no longer the “future” of cancer therapy — it’s our present reality!
These targeted therapies do not treat cancer as broadly as surgery, chemotherapy, or radiation, but they are specialized treatments that block the spread of cancer by interfering with specific molecules involved in tumor growth and progression.
These drugs, too, have a drawback, though — they don’t work for all types of cancer or even on all cancers within a certain type. They only work on tumors or cancer cells that have characteristics such as certain hormone receptors or genetic markers.
There are different types of targeted therapies, so this section contains a general rundown of them.
Hormones are chemicals produced by glands in the body. There are many types of hormones, but two major are involved in cancer treatment: estrogen, which is produced primarily by the ovaries, but also found in small amounts in men; and testosterone, which is mainly manufactured by the testicles, as well as being found in lesser amounts in women. These hormones oversee development and functioning of the body’s reproductive organs, but they can also fuel the growth of some types of cancer.
Hormone therapy means manipulating the amount of these hormones in the body, either by adding or reducing certain ones in order to kill cancer cells or halt their proliferation. This type of therapy can be used alone or in conjunction with other treatments.
Not all cancer tumors respond to hormone therapy, so to find out if yours does, your doctor will recommend a hormone receptor test. This test measures the amount of certain proteins (hormone receptors) in the cancer tissue. If the test results are positive, then hormone therapy can be used to treat the cancer cells.
Hormone therapy can be administered in many ways. Most of the time it involves taking medications that stop or block the production of the hormones. Surgery can also be performed to remove the gland that is producing the hormones. In addition, hormone therapy has proven useful in preventing cancer; for instance, tamoxifen can be used both to treat breast cancer and to prevent it in women at high risk for the disease.
Also know as “biological treatment” or “biologics,” immunotherapy is a type of cancer treatment that marshals your immune system to fight cancer. Some of these agents use living organisms, substances derived from them, or synthetic versions of such substances to accomplish this.
Although the immune system is known primarily for fighting off infections one of its most important functions is to protect the body by killing cells that become cancerous. This is not a foolproof system, however. Your body is programmed to recognize any substance that is foreign, or believed foreign (like germs), and set off an alarm, creating antigens to attack it. But cancer cells can fool the immune system. In addition, it grows weaker as we age, a reason most cancer occurs in those 60 and above. Immunotherapy is designed to bolster the immune system’s cancer fighting power.
The following are different types of biological treatments:
You may recall hearing about the cytokine interferon (IFN), which was the anticipated wonder drug for cancer treatment. Those hopes didn’t pan out, but interferon has proven to be valuable in the treatment of some forms of cancer. Another cytokine, interleukin, can be used in this manner. A third type, hematopoietic growth factors, help lessen the side effects of some types of chemotherapy and boost bone marrow function.
A bone marrow transplant (known also as a stem cell transplant) is a very aggressive way of treating cancers, particularly those types that don’t form solid tumors. These include leukemia, multiple myeloma, and some types of lymphomas, including non-Hodgkin’s.
Bone marrow is the soft, flexible tissue that fills the cavities of our larger bones; the stem cells in bone marrow are responsible for the manufacture of red blood cells, platelets, and most white blood cells. The goal of the bone marrow or blood stem cell transplantation in leukemia, for instance, is to replace the diseased or nonfunctional stem cells with healthy stem cells. A bone marrow transplant can also enable a person to undergo chemotherapy at higher doses than that which would ordinarily damage the bone marrow.
“This type of procedure was once used to treat advanced breast cancer, but it did not prove to be effective; however, there are currently some programs that are looking at treating testicular and ovarian cancer this way, but this is not standard treatment,” says Dr. Tulio Rodriguez, medical director of bone transplantation at Loyola University Medical Center.
“When it comes to bone marrow transplantation, patient selection is very important,” notes Dr. Rodriguez. “These treatments are usually reserved for younger patients, as opposed to those who are elderly, but there is also a ‘gray area,’ so patients should be carefully screened.” In addition, the center should have a good cancer survivorship program so patients can be followed for complications for the rest of their lives. “Some people withstand a bone marrow transplant with minimal discomfort, while others may have complications throughout their life, so patients need to be prepared for this,” he adds.
Before a new drug or other type of cancer treatment goes on the market, the Food and Drug Administration (FDA) must grant it approval. In order to gain approval, the treatment must pass through a multi-phase research study during which it has been tested on human subjects to prove safety and effectiveness. This is where you, the cancer patient, come in.
When it comes to clinical studies, many are under the impression that this is a treatment option of last resort. In reality, though, clinical trials are a valid and viable option, especially when we consider that cancer drugs available today made their way to the marketplace via this same rigorous testing process. For example, there may be courses of treatment being studied that have fewer side effects or are easier to tolerate than those on the market. When battling cancer, it is crucial not to discount any possible treatment alternatives. An excellent resource is CureLauncher.com, an Internet-based, personalized service that matches patients with research studies.
Pharmaceutical and other types of medical companies are constantly seeking patients for clinical trials. But finding the right trial can be daunting. Traditionally, the way to find a trial was to go through ClinicalTrials.gov, a site run by the National Institutes of Health, which lists all clinical trials underway; however, a current look found more than 163,000 trials underway throughout the United States, as well as in 185 other countries.
At any given time, there are 10,000 trials in the United States enrolling patients: 4,000 for cancer, 500 for breast cancer, 50 for testicular cancer, and so on. With such numerous opportunities, it’s no wonder that patients aren’t being referred to clinical trials, because doctors simply don’t have the time to learn about them.
Especially in the case of advanced cancer, patients may be understandably reluctant to enroll in a double-blind study. In such a study, half of the patients receive the therapy, and the other half receives a placebo, or an inactive treatment; for those desperately seeking life-sustaining, medical intervention, being placed in a placebo group compromises their very precious time. In the case of CureLauncher, if a patient has no interest in a placebo study, the service will find them one that ensures the individual will get the treatment. Alternatively, a cancer patient may be worn out from the toxic effects of chemotherapy and is seeking a gentler treatment. CureLauncher will also factor this in when matching a patient with a clinical study.
Internet search sites for clinical trials are popping up, but CureLauncher differs from these because, from the moment a patient clicks on the website, a window opens and a person is greeted by a relationship manager who offers them help. These relationship managers are not simply computer-generated, customer service reps, but real people who are trained to sort through all the possible clinical trial opportunities and match the patient with the best possible option.
Because of its approach, the health outcome is so much better — instead of being a company that markets a trial, CureLauncher starts out with one person and matches them to any one of the clinical trials, and this creates a better experience for the patient.
Clinical trials are divided into specific, defined phases. Contrary to what many people believe, most clinical trials have already completed their earlier stages, such as animal research projects, and are in the latter stages of testing, when large-scale enrollment begins.
Here’s a rundown of the phases of a clinical trial:
The following are questions, provided by the Center for Information & Study on Clinical Research Participation, which you should include in your healthcare record and ask when you are considering participating in a particular clinical study.
QUESTIONS TO ASK
To find other helpful Internet sites for clinical trials, refer to the appendix.