A breakthrough treatment for lymphoma was announced at the American Society of Hematology meeting today. The treatment, Kte-C19 (generic name axicabtagene ciloleucel), is exciting not only because it works, but especially exciting because it is likely to be approved by the FDA within the year.
Why "Star Wars Medicine?" Because it uses modern, state-of-the art molecular engineering to convert our own white blood cells into killer cells that specifically attack cancer cells--and only cancer cells. In other words, the bland droids in our blood are engineered to become Starfighters that go directly to the cancer.
Converting these cells requires extremely sophisticated biology. In brief, a patient's white blood cells are collected, similar to donating blood for a blood drive. Then, the white cells are separated out, while the red blood is given back to the patient. Those white cells are then re-programmed so they will home in and destroy any cells that have the CD-19 protein, which is present on lymphoma cells.
The amazing thing is that the entire process, from cell collection to molecular re-programming, can be done in only 17 days. During that time, the patient is treated with low-dose chemotherapy to ready their body for the infusion.
What is so exciting about fast-track FDA approval? FDA approval means that any cancer doctor will have the ability to order the treatment, without having to send the patient to a clinical trial, available at only one or two medical centers. And if the drug is FDA approved, then insurance will cover it.
That means that the 30% of patients who currently have lymphoma today who fail chemotherapy or relapse early will be able to get this drug in another year or two, when they will need it.
In the meantime, it is likely that clinical trials will also be studying whether this drug works for the initial treatment of lymphoma. We are looking at a potential future in which newly diagnosed lymphoma patients can finish their treatment in 3 to 4 weeks with only minimal inconvenience, without the months of chemotherapy, with its discomfort and side effects.
Kite Pharma, the company that makes Kte-C19, reported the results of their clinical trials, treating patients with aggressive lymphoma who had not previously responded to chemotherapy, or relapsed soon after treatment. In spite of their poor track record with chemo, 3/4 of them responded to the Kte-C19 treatment, and almost one half had complete disappearance of disease!!
A similar cell-based treatment, CTL019 (generic name tisagenlecleucel-T), made by Novartis, is being used for the treatment of acute lymphoblastic leukemia (ALL) in children.
This type of treatment will soon be studied in other cancers. Will this be the treatment of the future for all cancers?
I've had several questions about using alternative cancer treatments, such as laetrile, and it's time I addressed them here.
"Alternative treatments" are untested, unlicensed or unproven treatments given with hope that they will eradicate cancer. These herbal or holistic treatments are not part of conventional medical treatment because there is no rigorous proof that they work, and that is why the FDA has not approved them, and insurance will not pay for them. Standard chemotherapy is often derived from natural substances such as these, but the anti-cancer activity of these drugs was then confirmed by rigorous testing on thousands of patients which showed that they were effective in slowing cancer growth, extending life or relieving symptoms.
There are many reports and testimonials in the literature and online about new treatments associated with cancer cure. When (or if) these are taken to the next step, many fail to demonstrate their activity on other patients when subjected to the rigor and discipline of testing that is required for scientists, doctors, and the FDA to confirm activity. In the US they cannot be sold or used as cancer treatment, but may be given or sold as "dietary supplements" or used as complementary support for cancer patients. Outside of the US, though, many countries allow clinics and retailers to make unwarranted claims, and give alternative treatments or sell them online. Offshore clinics usually have no regulatory oversight. In the US, alternative clinics always offer conventional treatment as well as their unproven modality so they could legitimately claim to offer cancer treatment. Such businesses prey on the vulnerable.
Yet some people will try anything because they are desperate. If you do, know the risks:
1. Most herbal remedies do not have enough active ingredients to have any effects, but others can be harmful. For example, laetrile, also called "vitamin" B12 (it's not a vitamin), has contains enough cyanide to kill you if given in large doses. It was long discredited as a cancer treatment in clinical trials, but its popularity continues as a folk remedy.
2. Many patients look to alternative treatments in order to avoid the side effects of chemotherapy, even though some can have have toxic and unpleasant side effects.
3. Some treatments may be harmless on their own, but can have serious interactions with conventional chemotherapy or radiation. Tell your doctor if you are taking any of these while you are on active treatment.
4. Delaying standard medical care to try alternative remedies may allow a curable, Stage I cancer to progress to an incurable Stage 4.
5. Alternative remedies can drain your resources, especially if they involve going out of the country, or checking into a "clinic." This can easily drain your savings, leaving no resources for you or your family to deal with the costs and complications of advanced cancer.
Alternative treatments are not ignored by the medical community. This segment of treatment is under study by the National Institutes of Health, through the National Center for Complementary and Alternative Medicine (NCCAM). Accredited cancer centers may even have ongoing clinical trials testing supplements or procedures. The NCCAM web site is a valuable resource for people interested in complementary medicine. But be warned you are unlikely to fight your cancer if you treat yourself without the addition of conventional therapies.
What is a carcinogen? Does a carcinogen always cause cancer? How worried do I have to be if I've been exposed to one?
The feeling that random contact with a normal, everyday substance might lead to cancer can be frightening. Yet, most people don't have a clear understanding of what it means, and whether or not they are going to get cancer.
I've had two recent questions about exposure to carcinogens. To address them we need to understand what we are talking about with carcinogens.
Nikhil Khanna posted this question: " Today we had some fried snacks which were wrapped in a newspaper... we noticed that the ink from the newspaper print was getting leached onto the snacks... I read on the Internet that newspaper print ink causes cancer and I got really worried... Will we get cancer because of this?"
A Facebook reader posted: "Today I bought around 7 strips of medicines (capsules and tablets) for my son that was packed in blister plastic packs and...they were exposed to the sunlight for around 2 hours. Should my son take those medicines, as I am scared of the blister plastic leaching harmful chemicals?"
First of all, a carcinogen does not cause cancer; cancer is caused by DNA mutations. It's a matter of random chance whether or not DNA damage occurs, and whether those mutations turn the cell into a cancer. A carcinogen can increase that chance of mutation and cancer initiation.
A person's risk of developing a cancer, then, depends on carcinogen, the type and amount of exposure, and their own genetic susceptibility (which you can't control).
There are only a few very strong carcinogens, and only a few exposures raise your cancer risk significantly. These include some chemicals and radioactive substances taken internally or breathed in, such as I131 exposure with nuclear fallout or nuclear testing. Even then, most people exposed do not get cancer. For example, it was estimated people exposed to the Chernobyl nuclear plant disaster had an estimated 3 to 4% above normal cancer levels. Other carcinogens are very strong -- such as the tars in cigarette smoke -- whereas other are very weak. Ingesting some substances are more likely to make you sick from toxicity or poisoning than getting cancer from it (such as arsenic, a strong carcinogen). The type of carcinogen impacts on kind of cancer that is at risk. For example, I131 from Chernobyl causes thyroid cancer since it is concentrated in the thyroid, whereas the tars found in cigarettes cause lung cancer.
A chance encounter on the skin or a very tiny amount ingested by accident is not likely to cause much harm. What is important, though, is repeated exposure to the chemical, such as in the workplace or in daily life. There are workplace guidelines. National Institute for Occupational Safety, NIOSH, and the Food and Drug Administration (FDA) may comment on exposure to a substance can increase cancer, and limit exposure to acceptable levels.
If you know a substance increases cancer risk, then you will want to avoid excessive exposure, or at least weight your risks. Exposure does not guarantee you will get cancer--not every smoker gets lung cancer, but smokers are 23 times more likely to get cancer. The choice will be up to you.
That of course brings up the question of what is a carcinogen, and how strong is it. Just because a compound is a "chemical" does not mean it is a carcinogen--even safe, natural substances such as vitamins have chemical structure that look like they should be unsafe--such as Vitamin B12--but in fact they are necessary for life! The IARC -- International Agency for Research on Cancer, a part of the World Health Organization--keeps details lists of carcinogenic compounds, classifying them from "known" to "possibly" to "probably not." For many substances there is no hard data, and you can't really know--you can't test it on people, and testing on animals does not always give the same results. So a lot of things are classified as probably possibly unknown.
We are continuously exposed to things that can slightly increase our risk of cancer, and it is impossible to avoid them all or we wouldn't be able to eat or breathe. All in all, most cancers arise from random mutational events, not from carcinogens. There are many other things to be more worried about than getting cancer from your surroundings.
To answer Nikhil Khan, most newspaper inks are now soy based and non-toxic. In they past, newspaper inks contained heavy metals, which are both toxic and mildly carcinogenic; some glossy magazines still require these inks. Even if these were toxic inks, the level of exposure you might have had is so minimal I would not worry about it. I would, however, ask the food vendor to use plain paper because the ink on food is unsightly and spoils your appetite.
To the Facebook reader, I wrote that I would be more concerned that the medicine itself was deteriorating due to the exposure, and it might not maintain its potency. But still 2 hourse is hardly enough time for any significant breakdown to occur, and it takes a lot of PVC to even slight increase the risk of cancer (most pill blister packs are made of PVC).
How long have I got, Doc? Am I going to die? How much is it going to cost to treat this cancer? Should I get a second opinion? These are among the many questions that you were afraid to ask your oncologist, or asked and did not receive a direct answer. Why is it that you can't get a straight answer from your oncologist? Here are six reasons why, and what to do about it.
1. Your doctor does not have enough time to sit and talk to you
Oncologists today rarely have the chance to take off their white coats, sit back, and have a heart-to-heart chat with a patient. I consider these moments a privilege; they are all about what it means to be a doctor. If I stop to listen to what a patient is saying I can better serve his needs. We long-time practitioners struggle to free up time for these lengthy but valuable patient sessions. Sadly, the next generation of doctors may never have this privilege. Why? Talking to patients takes up time, and in today's medical practice, time is too valuable to spend on patients. Oncology practices are structured to use the doctor's time to make as much money as possible for their employers--and the oncologist has little say in the matter since he is no longer in charge. At risk of losing her job, a specialist may be required to see sixteen to twenty patients in a day, with an average visit of 15 minutes or less. Worse yet, much of this time is used by a nurse specialist or Physician Assistant, with only a cursory visit from the doctor. The practice administrator knows that more income is generated by giving chemo than by charging for face-to-face time.That is why an oncologist is under tremendous pressure to spend a little time as possible with a patient. Lengthy phone calls, emails, and family conferences also take up time that could be better used to see more patients (according to the practice manager). Doctors who don't play along can lose their jobs, if they don't quit first. This unfortunate situation is unlikely to be rectified until the entire medical system is overhauled.
What to do about it: Ask for more time. Tell your doctor that you have serious issues to discus, and request an additional clinic visit just for a family conference with the doctor--not with a nurse, PA, or social worker.
2. Your doctor doesn't understand what you are really asking
You may be too embarrassed to ask your doctor directly, or feel you can't handle the terminology, or may not even realize that you have a question. A very perceptive physician can tell that there is something on your mind and draw it out of you-- for example, your jokes about virility may indicate a concern for chemo effects on your sex life, or references to retirement could reflect concerns about your ability to work after treatment. But a busy doctor, or one who has no rapport with you, may not recognize that you have unanswered questions.
What to do about it: Think carefully about burning issues on your mind before you go to your clinic visit, and jot down a few notes to bring along. Sometimes it's easier to mention problems to the nurse first, who is more used to discussing medical issues with patients using lay language, and ask him or her to bring it up to the doctor.
3. You didn't understand your doctor's answer
There is a lot of jargon that an average patient does not understand as he makes their way through a system of baffling complexity. Patients are afraid, or intimidated, or forget their questions, or don't want to reveal that they don't understand a word of what was said. Studies have shown that misunderstanding can be so extreme that a person's perception of what the doctor said may be the exact opposite of what was meant! Some misperceptions are based on anxiety, others on medical ignorance—and at other times the patient only heard what he wanted to hear.
What to do about it: Take notes at every clinic visit, use a voice recorder, or bring another person with you to listen and compare notes. This is especially important at visits that discuss test results or treatment decisions. Your health portal (electronic chart) may give you the opportunity to contact your doctor and clarify the answer. Take advantage of it.
4. Your doctor thought she answered your question when she said, "because that's the way we do things."
At times you may not be satisfied with your doctor's answer. Perhaps you feel there are other answers or other alternatives. Perhaps you don't trust your doctor. Maybe you understand the correct answer, but don't like your doctor's attitude. And sometimes you just don't get along. Although your doctor may be the top in her field, and her answer was correct "by the book," the personality clashes may lead to a loss of trust, which in turn may interfere with your ability to be a good patient, and to receive good care.
What to do about it: If personality issues are interfering with your medical care, consider getting a second opinion or even changing doctors. The easiest way to do this is to ask to make an appointment with another physician in the practice. Alternatively, you can easily find a new physician in another clinic and request a second opinion. Changing providers is your right as a patient, and your clinic is obliged to provide copies of your records. Insurance will usually pay for a second opinion about treatment, diagnosis or surgery. Don't worry about hurting your doctor's feeling--your first priority is your own survival. You doctor will handle this professionally, and may be happy to give you up if you both don't get along.
5. Your doctor doesn't like giving bad news and avoids it as much as possible.
The relationship that a doctor has with a patient is delicately balanced, and it's an important part of the healing process. A doctor know he is not only providing medicine—he is providing comfort, relief, encouragement, trust, and . . . hope. At times an oncologist will downplay the bad news or side effects he wants to avoid undue concern for the patient or family members. This may appear to be evasive.
One reason doctors don't talk to their patients is that they don't like to give bad news--we are only human in this regard. Patients don't want to hear that they are dying, and doctors don't want to tell them. Recent studies have shown that most cancer doctors avoid discussing end of life care and death until it is too late to make realistic plans for advanced directives, hospice and terminal care. Professional societies like the American Society of Clinical Oncology have begun to take steps to help doctors and patients face these issues together, developing guidelines for care planning and encouraging more open discussion. But there is a long way to go.
What to do about it: If you think your doctor is avoiding bad news, request to have a few minutes alone with the doctor, without anyone else present. This will allow the doc to speak freely. One way to broach a difficult subject is to bring it up neutrally, saying, for example, "May I speak with you alone about my end-of-life and living will documents?" Doc will get the hint.
6. Your doctor doesn't know the answer
Yes, medical science does not know everything! Far from it--there is so much yet to be learned. And of course, yours might not have the details at hand. A good doctor will answer, "That's a good question and I don't know the answer, but I will look into it and get back to you by email or at our next visit."
The other reason you doctor does not know the answer is that your "doctor" is really not a doctor, but a mid-level provider who doesn't have the knowledge or experience to answer your question. Of course they care about you, and do the best they can, but a few years of Nurse-Specialist or Physician Assistant courses cannot compare with 4 years of med school, 3 years of residency, and 3 years of medical oncology training and years of practice.
What to do about it: If you are looking for more answers, then consider getting a second opinion, see #4 above. If you want to see more of your doctor and less of your alternative provider, then ask specifically to see the doctor. Be insistent, and talk to the clinic administrator if necessary. If you are still frustrated by the lack of a physician input, then consider making a permanent change to another practice, and make your displeasure known on the patient rating sites and on the clinic surveys that are sent to you.
(Excerpted and revised from the book, Ask An Oncologist: Honest Answers to Your Cancer Questions)