Mona Yeary,  AOCNP

Cancer clinical trials are utilized in hopes of finding better ways to diagnose, treat and prevent cancer.  Most of the standard cancer treatments that we use today are based on previous clinical trial results. These investigational trials evaluate surgery, radiation, gene therapy, vaccine therapy as well as experimental drugs. There are very strict criteria, which guide these trials, and only ones that have shown promising results in the laboratory or on animals are then tested on people.

Surveys of the general population have shown support for cancer clinical trials especially where children are involved. In the United States 1.2 million patients are diagnosed with cancer each year but only 1-3% of patients are treated on a clinical trial. There are possible benefits to being treated on a trial –these include

• Playing an active role in your health care
• Gaining access to new treatments before they are widely available
• Obtaining expert care while on the trial
• Helping others who will come after you by contributing to research

It is important to always be open and honest concerning clinical trials and there are some possible risks to being treated on a trial- these may include

• Unexpected or unpleasant side effects to the treatment
• The experimental treatment may not help the participant
• The participation in the trial my require more time and trips to the office

Even with these possible risks the majority of patients realize the importance of these trials to themselves and everyone in the future who will develop cancer.

The ideas for clinical trials come from researchers as well as clinicians caring for patients with cancer. The trials are sponsored or funded by organizations or individuals such as physicians, medical institutions, foundations, pharmaceutical companies as well governmental agencies such as the National Institutes of Health and the Department of Veteran’s Affairs (VA).

All clinical trials have a protocol that is the study plan, it is carefully designed to protect the participants as well as answer a specific research question.  The protocol tells the type of patient who may participate in the trial, the schedule of the treatments and all procedures and tests required to monitor the effectiveness of the treatment being studied.

Clinical Trials are conducted in phases and each phase has a particular purpose.

• Phase 0 – Trials use drugs or treatments that have shown promise in the lab. They are given for the first time to a small amount of patients (10-15). The drugs are monitored for safety and effectiveness.

• Phase I – Trials test drugs or treatments in a small group of patients to see if a dose is safe and how often it should be given. The researchers watch closely for side effects.

• Phase II – Trials study the effectiveness of an agent and how it affects the human body. It is tried on fewer than 100 patients.

• Phase III – Trials compare the new drug with the current standard therapy. Participants are randomly assigned to the standard treatment or the new treatment.  This trial uses larger number of patients across the country or even multinational.

• Phase IV – Trials are conducted after the treatment has been approved for standard use. These trials look at long-term safety and effectiveness. This trial may be conducted with several hundreds to thousands of patients.

There are numerous cancer clinical trials in the United States as well as many other countries around the world. We refer our patients to many respectable institutions when there is a need for a specific trial.  We are very proud that we can offer many cutting edge clinical trials in our office to our patients or any patients in this area. At this time we have cancer clinical trials for multiple myeloma, lung, gastric, pancreatic, T-cell lymphoma, prostate, liver and others soon to be open for additional cancers.

If you are interested in any of these trials available at Associates in Oncology and Hematology please call 423-622-2337 and ask for the research department.

There are important questions you need to ask.

How was the cancer diagnosed?

Most often the cancer is diagnosed by a rectal exam. Every man should get after age 50 or sooner, if there is a family history of prostate cancer history. The cancer is often felt as a firm nodule in the prostate. This often is followed by examining a PSA. For men under 50the PSA should be under 4. This however is a highly inaccurate test with a lot of controversy as to what impact it would have on your longevity.

Many men with “high” PSA but never have cancer! To make matters more confusing a person can have a “normal” PSA and have a serious cancer. So the PSA test actually adds more confusion than it gives any helpful direction in treatment or prognosis.

What did the biopsy show and how extensive was the gland involved?

Once prostate cancer is suspected an ultrasound guide biopsy will be done.

A “Gleeson’s Score” is then given. This score gives a number to the grade of the cancer. If it is 6 or lower and the gland is not extensively involved many prostate specialists will advice to watch and observe. This obviously will cause anxiety but may often be the safest and best advice. A lot of time would have to be spent in each individual to advice a personal treatment plan. Over the last ten years conservative treatment is now often recommended. So don’t panic, just because a cancer been diagnosed, for it may never become a significant health impairment.

What additional tests does he need?

Other tests may be ordered to establish the extent of the cancer such as a bone scan, CT scan and in select cases a MRI scan. MRI scans are being used more in Europe and now in the US and may even give us an idea as the how aggressive the prostate cancer will be and “see” areas not usually visualized on a prostate ultrasound,

What treatments are available and how does it fit your lifestyle?

Once treatment is needed and after careful thought and seeking opinions, many options are available.

Radical Prostatectomy vs Radiation Therapy (External Beam, IMRT, Proton Beam or Seed Implants). All of these have pros and cons. So discuss them with a surgeon and a Radiation oncologist. Prostate cancer is often a slow cancer so don’t rush into a decision.

If the cancer is metastatic and stage 4 what options do we have?

In less than 10 % of patient the cancer is diagnosed in the advanced stages. Even then there are many options for treatments and it is not unusual to live for more than two years with hormone therapy and chemotherapy and now vaccines.

Over 200,000 new prostate cancers are diagnosed but only 10% actually die of it. So do your homework, ask questions and don’t rush to a treatment plan until you have sought opinions.

Melinda Helton, A.P.N.

Jitendra G Gandhi, M.D.

Breast cancer is well known to run in families. Major research over the last three decades has helped us understand the actual beast cancer risk. Only 5- to 10 percent have a real risk of the cancer being inherited. It is only human to overestimate your individual risk hence it is best to seek an expert’s opinion.

If a close relative such as your mother has cancer, it increases the risk by a factor of two.

If however multiple family members are affected it does increase the risk and needs close consideration for testing, counseling and the need to see a specialist.

So, what do you need to worry about if a family member is diagnosed with breast cancer?

The breast cancer expert will ask the following questions to establish your individual risk

1. Who is affected (mother, sister, aunt — paternal or maternal)?

2. What is their age?

3. What type of breast cancer?

4. Is a male member affected?

5. Does any family member have cancer in both breasts?

6. Any genetic testing results available?

7. Any other cancers, such ovarian, prostate or pancreas cancer?

The age of the family member at diagnosis as well as their close relation will give a clearer understanding, for example, if your relative has cancer at age 85 it will have a much lower risk than if she were 35.

We have, in the last ten years, identified a subtype of cancer known as triple negative or basal-like cancer, which can often be linked to a genetic mutation known as BRCA1 or BRCA2. These cancers occur in younger persons and have up to 30 percent likelihood of the mutation being present in other family members.

For example, if your mother is 40 years old and has the BRCA gene mutation, all close members of the family including males will be advised to be tested.

You should be tested and have a mammogram by age 30 and consider an MRI of both breasts. If you test positive, then a mastectomy can prevent breast cancer. These mutations also increase risk for ovarian cancer and not uncommonly removal of these ovaries may be recommended if no more pregnancies are planned. These “preventive” surgeries are highly protective in over 90 percent of people.

These mutations rarely increase incidence of prostate and pancreas cancer. Specific recommendations for these are being worked out since these are not common.

A family member having cancers in both breasts is not uncommon, but often signals a mutation such as BRCA.

As one can see, a good history, gene testing when appropriate, imaging with mammograms, and seeing a breast cancer specialist can help you establish your risk as well as allay any anxiety. A wealth of information is now available which can guide you if a family member is diagnosed with breast cancer.

But remember that more than 50 percent of newly diagnosed breast cancers have no family history. n

Jitendra G Gandhi, M.D.

This is often a scary statement to hear after undergoing any test. Despite the fear an abnormal mammogram may evoke, ninety-five percent of them are not breast cancer. Less than one percent of abnormal mammograms detected are early cancer, and early cancer is curable. Questionable abnormalities often require additional evaluation. With further examination, most of these abnormal mammograms are found to be normal breast tissue or benign (non-cancerous) tissue.

The breast is a very complex organ which not only changes with age but also with the time of your monthly cycle. Remember, your body is not symmetrical. Often the asymmetry is ironically just the way you are made and consistent with a healthy breast.

• “This is my first mammogram and it is abnormal.” A careful study of the asymmetry is often checked by an ultrasound to confirm if it is normal tissue, a cyst or a noncancerous fibroadenoma. Asymmetry is part of your normal anatomy. By ordering an ultrasound the same day, the patient does not have to anxiously wait for that phone call of reassurance. Ultrasound also helps to read future mammograms accurately and without apprehension. Ask your physician to show you the images and also get a CD of the mammogram for your records. A digital mammogram gives you a very easy to understand picture and it is worthwhile for future references. Be proactive and stay involved.

• “I had a normal mammogram last year and they have found something this year.” This is not uncommon since various techniques may be used and a different technician may have performed the procedure this year. Before you panic, ask questions. Take your previous CD with you and review it with your physician. If there is a problem, a biopsy or MRI would be ordered to better understand the nature of the abnormality. The breast is a very complex organ but is very easy to study and follow by performing self-exams and imaging studies. Be aware and ask questions.

• “I had a normal mammogram six months ago and I feel something today.” You are the best person to know your body. Don’t ignore it. Call your physician. If you need another test, have it arranged. Ignoring the problem will not make it go away. Remember … early detection is your protection and often leads to cures. Be aggressive and follow-up.

The best opportunity for a positive outcome is early detection. Breast cancer may be curable if detected at an early stage. A screening mammogram is a woman’s first line of defense and can be crucial in detecting cancer. Do your monthly self-exams, see experts, get a mammogram and retain a CD of it. Request that all your tests be done the same day, ask questions, get answers and don’t forget the follow-ups.

Dr. Jitendra Gandhi is Board Certified in Medical Oncology and Internal Medicine and has been practicing in Chattanooga since 1983. He sees patients with lung, prostrate, breast, adult cancers, blood disorders and osteoporosis. Medical memberships include AMA, TMA, ASCO, ASH, SAO, TOPS and Chattanooga-Hamilton County Medical Society. Dr. Gandhi’s Digital Mammo and Osteoporosis Clinic and Medical Oncology office is located at 2205 McCallie Avenue, Suite 502. This Mammo and Osteoporosis Clinic is unique in that it is the only facility in the area that gives immediate testing with immediate answers. For more information or to schedule a mammogram, call (423) 648-8015.

Jitendra G Gandhi, M.D.

Nipple discharge can be quite alarming and often lead to marked anxiety. Ninety-five (95 percent) of nipple discharge is from a non-cancer condition. So, what should you consider before you panic?

• How old are you?
• What is the color of the discharge?
• How frequent is it?
• Is it spontaneous?
• Is it from one or both breasts?
• Is it from one or multiple ducts?

Age is an important predictor of Cancer. In one series, three percent of women under 40, ten percent between age 40 and 60, and thirty-two percent over 60 presented with a nipple discharge as the only symptom of cancer.

The color of the discharge is also a helpful indicator. If it is milky and from both breasts, it often indicates pituitary hormone excess or it is from use of certain drugs. In two out of three women who are not lactating, a small amount of fluid can be expressed from the breast. This is consistent with health and is often white to yellow to green to blue black. This often is not spontaneous and from multiple ducts with each duct discharge having a different color. Since the breast is a special sweat gland, the secretions often resemble sweat. These ducts can be cannulated and the cell can be examined under the microscope to screen women who would be at a high risk.

Papilloma, a benign growth, is the most frequent cause of a bloody or clear discharge. This can be felt as a mass and can sometimes be seen through the nipple if it is close to the skin. The mammogram is often negative. Further a papilloma is NOT precancerous and can be treated by a small surgery to remove the affected duct.

Infrequently, there can be multiple papillomas that often do not have a discharge. It represents a different disorder and even rarely may be cancer. It sounds confusing but these are well-characterized disorders, and an expert can help you sort it out.

When is a nipple discharge associated with Cancer? As a presenting feature, it is present in less than ten percent. These are often non-invasive cancers that generate a negative mammogram but can be treated with breast conserving surgery. With the advent of breast MRI, more high-grade, non-invasive cancers are visualized, when associated with a discharge, which again can be curable.

So, if you have a nipple discharge and it is spontaneous, persistent and/or associated with a mass in one breast, it can be easily treated. It would need further diagnostic testing such as ductoscopy, ductography, mammography, and in rare cases, MRI. It will also need examination by an expert.

For further information, read Diseases of the Breast fourth edition by Harris, Lippman Morrow and Osborne.

Dr. Jitendra Gandhi is Board Certified in Medical Oncology and Internal Medicine and has been practicing in Chattanooga since 1983. He sees patients with lung, prostrate, breast, adult cancers, blood disorders and osteoporosis. Medical memberships include AMA, TMA, ASCO, ASH, SAO, TOPS and Chattanooga-Hamilton County Medical Society. Dr. Gandhi’s Digital Mammo and Osteoporosis Clinic and Medical Oncology office is located at 2205 McCallie Avenue, Suite 502. This Mammo and Osteoporosis Clinic is unique in that it is the only facility in the area that gives immediate testing with immediate answers. For more information or to schedule a mammogram, call (423) 648-8015.

Dr. Gandhi’s Digital Mammo & Osteoporosis Clinic
2205 McCallie Avenue, Suite 502
Chattanooga, TN. 37404
Phone: (423) 622-2337

Jitendra G Gandhi, M.D.

Breast Cancer affects over one in eight women during their lifetime. While it can be cured in a majority of patients if detected early, the questions often asked are:

“What can I do to decrease my risk of getting Breast Cancer?” and “If I get Breast Cancer, what can be done to survive it?” By being aware, YOU can make a difference. Here are some important steps to preventing or decreasing cancer:

1. Breast Self-Exam (BSE). This is a very simple technique that a doctor or a nurse can teach you. It allows you to be involved so you can perceive any minor change in the breast consistency even before a medical person can detect it. There are also numerous sites on the internet where you can buy a video which shows the technique for correct breast self-exam. This is best done after your menstrual cycle. This self-exam can find a problem in 15 percent of all detectable cancer and it costs absolutely nothing.

2. Digital Mammography. This simple test can detect 85 percent of all cancer. New digital mammography equipment takes 10 minutes and is more comfortable than the older Analog equipment. The pressure felt by digital mammography is shorter and it gives “less of a squeeze.” While the images are more distinct in the digital, it is generally accepted that both are equal in detecting problems. It is important to have a mammogram every year after age 40 or sooner, if there is a family history. Insurance companies pay for digital mammography and, if needed, there is financial assistance available.

3. Ultrasound or an MRI in special circumstances. Have your physician discuss this with you and see if this is applicable, especially if you have a worrisome family history of breast or other cancers. In some clinics, these tests can be arranged the same day, even if a biopsy is needed.

4. Exercise. This is appearing to be a major way to prevent and survive breast cancer. Move it “faster and harder” in exercise activities at least five times a week. It seems that uncontrolled insulin production may be a major event in cancer formation and regular exercise will blunt the insulin damage.

5. Alcohol. Consuming even one glass a day can increase the risk for breast cancer.

6. Vitamins and bisphosphonates. There is no proof that taking multivitamins can prevent breast cancer. However, Vitamin D provides protective effect not only in breast cancer but also prostate cancer! Taking medications such as Boniva, Fosomax or Actonel — a class of bisphosphonate drugs — may also decrease incidence of invasive breast cancer.

7. Genetic Testing. If there is a family history of breast cancer, there are numerous tests which can estimate your individual risks such as BRCA1 and BRCA2.
So, no excuses! Protect yourself. Be proactive and don’t be afraid.

Dr. Jitendra Gandhi is Board Certified in Medical Oncology and Internal Medicine and has been practicing in Chattanooga since 1983. He sees patients in lung, prostrate, breast, and adult cancers and blood disorders. Medical memberships include AMA, TMA, ASCO, ASH, SAO, TOPS and Chattanooga-Hamilton County Medical Society. Dr. Gandhi’s Digital Mammo and Osteoporosis Clinic and Medical Oncology office is located at 2205 McCallie Avenue, Suite 502. This Mammo Clinic is unique in that it is the only facility in the area that gives immediate testing with immediate answers.

Dr. Gandhi’s Digital Mammo & Osteoporosis Clinic
2205 McCallie Avenue, Suite 502
Chattanooga, TN.  37404
Phone:  (423) 622-2337

Jitendra G Gandhi, M.D.

Our bones are a vital part of healthy life, just as our other organs such Heart and Brain and Kidneys. They are as important to the body as the steel beams are for a skyscraper. We need to learn to keep healthy bones all our lives and not wait till we are “old”.

Osteoporosis is thinning of bones. The WHO (World Health Organization), devised a system which defines osteoporosis, in mathematical terms, as bone strength compared to a 21 year old woman, when the bone mass is at its peak.

The T score (the number of standard deviations below the average of a young adult at peak bone density) of less than 2.5 is defined as osteoporosis, when tested on a bone density machine, (the DEXA scan).

Dexa scan is a very simple, painless, takes less than ten minutes. The Dexa scan uses special x-rays to measure the amount of calcium in the bones and determine your actual bone mass.  This will help your physician advice you on an appropriate plan to treat and prevent bone aging.

Osteoporosis is painless and can be present for years before the weakened bone fractures and becomes intensely painful. The pain is often life long with premature death common after a hip fracture. A bent spine can affect your breathing capacity and often interfere with sleep.

What are the most common causes ?

• Hereditary can be a factor.
• Women after menopause – and men after age 70; can rapidly loose bone mass.
• Smoking has a profound impact on bone loss and cessation will have the most immediate and positive impact on bone health.
• Celiac Sprue or wheat allergy interferes with absorption of Vitamin D, an important hormone, necessary for bone health. This is present in 16% of the Caucasian population in some studies!
• Inactivity and early childhood diseases which are associated with inactivity, can prevent attaining peak bone mass and can lead to osteoporosis at an early age.

Hemochromotosis, Bone Marrow Disorders, Increased production of Thyroid and Parathyroid production plus a long list of drugs are just a few reasons to cause this silent disease.

What can I do to prevent it?

• Daily ingest calcium of at least 1500 mg and Vitamin D of at least 800 I.U.
• Do weight bearing exercise and get 15 minutes of sun exposure to help convert vitamin D in your skin to its active form.
• Cease smoking.

How is it treated?

There are many good options

• Oral Bisphonates such as Fosomax, Boniva, Actonel
• Intravenous Bisphosphonates, Reclast
• Parathyroid Hormone, Forteo
• Hormone replacement therapy
• Calcitonin
  • A new drug, Denosumab

So, be Aware, stop smoking, daily exercise and Calcium and Vitamin D

Have a Dexa scan if menopausal or have a family history of osteoporosis (men after age 70).Do something about it, for you are only as old as your spine. Keep it young!

Dr. Gandhi’s Digital Mammo & Osteoporosis Clinic
2205 McCallie Avenue, Suite 502
Chattanooga, TN.  37404
Phone:  (423) 622-2337

Jitendra G Gandhi, M.D.

Breast Cancer is not one disease. It can now be analyzed in the lab as many different types and subtypes. This understanding has greatly helped us in treating and possibly leading to curing this disease. Therefore one person’s breast cancer can be very different in its biology, treatment options and prognosis. 15% of newly diagnosed breast cancer fall in this category.
A newly described entity, “Triple Negative”, is being recognized. While these cancers respond to chemotherapy, they often relapse and tend to have a more serious prognosis.

So, what is it?
Whenever a breast cancer is diagnosed, the tissue is analyzed for at least three different markers: Estrogen receptor, progesterone receptor and Her2neu Oncogene. If these are absent, the tumor is termed as “triple negative”. Molecular markers however now classify further subtypes of these tumors. The knowledge of these tumors and their biology is close to being understood, which should help us in treating it better.

So, who gets it?
While anyone can have this type, it is often seen in younger women, women of African American or Jewish heritage. There is often a family history of early breast cancer.
A gene mutation BRCA1 and BRCA2 gene is often present and is a marker for unaffected family members, who could also be at high risk of getting it.

So, what does it mean?
These tumors often have an aggressive nature. They are diagnosed late and may have a decreased survival, when treated with conventional chemotherapy. These tumors can occur in the intervals between mammograms, since they are fast growing. Therefore it is important to mention to your physician, when something new is felt, even if you had a normal study in the last six months.

So, what is new in Treatment for this cancer?
While traditional chemotherapy is still being used such as Adriamycin, Cytoxan, Taxotere, other drugs such as Cisplatinum may be more effective. Other newer agent such as Ixempra is being tested for efficacy. Tumors with BRCA subtype may also be very responsive to a new class of drugs known as PARP inhibitors. Drugs which affect tumor blood vessel growth, such as Bevacizumab, may also be effective in treating these tumors. A recent study suggested that targeted agent against epidermal growth factor receptor (EGFR) showed very promising positive results. In one subtype, “Claudin low”, breast cancer stem cells are being implicated and a totally new design of chemotherapy will have to be devised.  While this disease can be a challenge, understanding its basic biology will help us control and hopefully eventually cure this disease.As one can see now the next step is personalizing treatment for each patient for each cancer is a unique cancer.

Dr. Gandhi’s Digital Mammo & Osteoporosis Clinic
2205 McCallie Avenue, Suite 502
Chattanooga, TN.  37404
Phone:  (423) 622-2337