Expert Analysis Highlights:

• Clinical trials serve two purposes: Offering patients the newest treatment options and advancing scientific knowledge for future patients
• Below are some useful questions you should ask when deciding whether or not to participate in a clinical trial
• To find out if there is a trial in the area you need treatment, check out clinicaltrials.gov where all trials are registered
• For more information about clinical trials, click on the following link to patientresource.net

The phrase “Clinical Trials” means one of two things to most people: An opportunity to get the latest and greatest new treatment, or a futile human experiment with no major benefit to them.  The truth is somewhere in between.  The bottom line is that it depends on the trial and its design.

To review, a clinical trial is a program offered by some hospitals which assigns you randomly to receive standard treatment or a new treatment for which the potential benefit is not yet proven.  Some trials have 3 “arms” or treatment paths.  The key to a good research study from a design standpoint is that patients are randomly assigned to a treatment path and then the outcomes are compared.  This is the most scientifically valid way of assessing how good the treatments work.

Here are some useful questions you should ask when deciding whether or not to participate in a clinical trial:

• What is the benefit seen in previous studies of the new treatment being studied in the trial?
• Does the new treatment being studied work by a different mechanism (i.e. a novel treatment) compared to the standard treatment?
• Where did the idea for the clinical trial come from?
• What are the quality of life and survival differences likely if I do not participate in the trial?

For some trials the new treatment may be very promising, while for other trials, the benefit may be marginal or even negligible based on prior studies.

For your protection, all clinical trials are governed by rules which hospitals are ethically and legally obliged to follow.  The rules are: 1) If the benefit of one of the treatment options is clearly apparent during the course of the study, the study must be ended early so that the results can be disseminated and patients do not have to continue a course of treatment which is known to be inferior, 2) You must be informed of every aspect of the design of the study, 3) You can opt out of the trial at any time, and 4) You are entitled to see the results of the study once completed.

Clinical trials serve two purposes: Offering patients the newest treatment options and advancing scientific knowledge for future patients.  Consider it not just a way of getting a new treatment, but also a way of helping inform future patients with a similar cancer.  In general, clinical trials provide hope for patients whose treatment options might otherwise be limited.  Many trials are managed on a multi-institution level, making the trials available on a local level for many patients.

To find out if there is a trial in the area you need treatment, check out clinical trials.gov where all trials are registered.  There you will be able to find out what the treatment arms are, whether the trial is open of closed to new patients, and where to go to see if you’re a candidate.

Expert Analysis Highlights:

• Below are a few basic principles that will allow you to know your rights and get the records you need
• The most critical medical records in your cancer care are usually your CT scan (a.k.a. your ‘CAT scan’)
• To get a copy of your CT, MRI, or PET scan on CD-ROM, find out where your hospitals “Radiology Customer Service” counter is located
• Pathology slides can be obtained by calling the pathology department and asking them to have them ready for you to pick up

Getting your medical records can be a huge barrier to getting a second opinion. Trying to figure out our complex healthcare system on the fly can be a daunting task. Here are a few basic principles that will allow you to know your rights and get the records you need to get a second opinion quickly.

The most critical medical records in your cancer care are usually your CT scan (a.k.a. your ‘CAT scan’) and your pathology slides if a biopsy or surgery was performed.

The most important thing to remember is that your CT or MRI or PET scan is yours. You have a right to have a copy no matter what anyone tells you. The two ways a hospital typically provides you with a copy of your CT scan is 1) to provide a report or 2) to provide you with a CD-ROM copy of the actually pictures. In my experience, the report is not very helpful, and I never trust it in giving a second opinion. The actual CD-ROM is what a consulting doctor will insist on. In many instances, it’s the only thing needed to render an opinion about surgical respectability. In fact, as a routine practice, my office insists that a CD-ROM of a CT scan be mailed ahead of time to determine if an appointment is warranted. If it was never done, we simply get one done at our hospital prior to the appointment.

To get a copy of your CT, MRI, or PET scan on CD-ROM, find out where your hospitals “Radiology Customer Service” counter is located and what their hours of operation are. You can usually find this out by calling the hospital’s operator or your doctor’s office. There is sometimes a $10-15 fee for the CD-ROM although many hospitals offer the service for free. Also, when traveling to another hospital, its a good idea to bring a second copy with you to your consultation visit.

There are also times when an outside CT is not readable on the computers of another hospital. Until President Obama’s national health electronic record is standard practice, then we will have to continue to hope that hospital computers can open outside CD-ROM’s. Luckily, hospitals can open more than half of outside CT’s using their software.

Pathology slides can be obtained by calling the pathology department and asking them to have them ready for you to pick up. Alternatively, many hospitals have a system to send pathology slides directly from one hospital’s pathology dept to another. Of course this relies on them to not drop the ball so I recommend picking up the slides to ensure that the review is not delayed and things don’t fall through the cracks.

Despite the many advances in cancer treatments at major cancer centers, the answer to this question can be ‘no’.  You should consider traveling far away to get chemotherapy or radiation therapy when there is a clinical trial you would like to participate in.  Consider the marginal benefit and how innovative the treatment is at a center far away.  In the case of having surgery, traveling far to get an experienced surgeon makes sense if there is not one close to home.  But if the chemo or radiation you would be get at a hospital far away is the same chemo or radiation you would get close to home (i.e. same medication, same dose, same length… or at least very similar), then consider enjoying the comfort of home.

Family support is an important part of your cancer care, and when a recommended chemo or radiation regimen is one that you can have close to home, many oncologists will suggest having it done at a cancer center close to your family and support network.   Chemo and radiation can require frequent trips to the hospital (sometimes as many as 3-5 appointments per week).  In addition these treatments can sometimes be tiring.  Family and friend support can be helpful and sometimes critical.  This includes everything from rides to the hospital to verbal encouragement.  When getting a second opinion at a major cancer center far away from home, ask the oncologist if the recommended chemo or radiation regimen is the same or similar to what you can get closer to home.  Most importantly, consider the importance of your support network.

Expert Analysis Highlights:

• Lay media does a poor job of keeping a balanced perspective when reporting cancer information
• Study found that 95% reported exclusively on aggressive and expensive treatments such as chemotherapy, while only 13% mentioned that these treatments can fail
• Less than a third put their article in a balanced perspective by including a description of the adverse side effects and cost of cancer treatments; Only 8% mentioned the possibility that people die of their cancer
• Researcher from the study concludes, media “…play to this fear (of dying) by reassuring us that there are treatments that work, and that there are cures that are effective. That is, they tell us what we want to hear”
• That is why we are working to empower patients with accurate and straight-forward information on our site and our companion site www.patientresource.net

How well does the media do in reporting to you about the “hope” of cancer advances, while keeping a perspective that this is still a life-threatening disease that kills over a half million people each year?

Not very well, according to a study published in the Annals of Internal Medicine in March, 2010 by Drs  Fishman, Ten and Casarett from the University of Pennsylvania. They examined over 400 articles published in the lay press (i.e.: a public audience, not a medical journal) and found that a whopping 95% reported exclusively on aggressive and expensive  treatments –such as chemotherapy, bone marrow transplantation and radiation therapy—while only 13% mentioned that these treatments can fail. Moreover, less than a third put their article in a balanced perspective by including a description of the adverse side effects and cost of cancer treatments.

Please understand that I am not against the reporting of promising advances and the progress we are making, but I do think the media can do a better job. For example, I was recently interviewed on a new drug advance for melanoma, and was quoted (appropriately) that this was “ a single, not a home run”, meaning that is one of the first survival advances in the treatment of advanced melanoma, but probably won’t be used as a single agent to increase cure rates of melanoma. It was not reported that the drug can have serious side effects and that some patients died as a result of the treatment! On the one hand, if you are a patient for whom all other treatments have failed and you are facing the prospects of dying in the coming months, then getting a powerful drug with serious, sometimes life-threatening side effects may be your only choice. Or, if you have had potentially curative surgery but still have a risk of relapsing later on, you might have some pause about taking a drug that may interrupt or halt your present quality of life or even shorten your life. Doctors and cancer patients make these kinds of decisions every day based upon estimating the probability of success or failures among groups of patients. However, at the level of an individual patient, we don’t have a crystal ball! Some patients do better than expected and other do worse. We all have to make our best decision about the whether the benefits of a particular treatment outweigh the potential risks and complications and then accept the outcome as we go forward.

I’ll quote from a blog by Dr Casarett, one of the researchers on this study. “Of course, it’s not such a terrible thing if we can’t find what we need about cancer in newspapers and magazines. These are just one source of information that’s available to us. If we don’t find what we are looking for in one of these articles, we can look somewhere else. That’s why the real problem with these articles is not the information that’s missing from them, but rather the biased picture that they give of what it’s like to have cancer…..The most worrisome thing we found in these articles, though, was the way they carefully avoid mentioning death and dying. In fact, only 8% mentioned the possibility that people die of their cancer….So these articles play to this fear (of dying) by reassuring us that there are treatments that work, and that there are cures that are effective. That is, they tell us what we want to hear.” The full blog story can be found at www.huffingtonpost.com/david-casarett-md/cancer-news-offers-reader_b_499540.html.

Of course, this desire–indeed our passion– is to inform and educate cancer patients so they can learn about what they need to know, not just the things we want to hear. That is why we started Patient Resource Cancer Guides and its website www.patientresource.net and www.mycanceradvisor.com, so that cancer patients could learn about all aspects of the cancer journey, including the more difficult issues of pain management, treatment options and their complications, and the process of death and dying. We hope that empowering patients with accurate and straight-forward information will make a difference in their lives and the lives of their loved ones.

The abstract of the publication cited above is:

Fishman J, Ten Have T, Casarett D. Arch Intern Med. 2010 Mar 22;170(6):515-8.

Cancer and the media: how does the news report on treatment and outcomes?

BACKGROUND: Cancer receives a great deal of news media attention. Although approximately half of all US patients with cancer die of their illness or of related complications, it is unknown whether reports in the news media reflect this reality. METHODS: To determine how cancer news coverage reports about cancer care and outcomes, we conducted a content analysis of US cancer news reporting in 8 large-readership newspapers and 5 national magazines. Trained coders determined the proportion of articles reporting about cancer survival, cancer death and dying, aggressive cancer treatment, cancer treatment failure, adverse events of cancer treatment, and end-of-life palliative or hospice care. RESULTS: Of 436 articles about cancer, 140 (32.1%; 95% confidence interval [CI], 28%-37%) focused on survival and only 33 (7.6 %; 5%-10%) focused on death and dying (P < .001, chi(2) test). Only 57 articles (13.1%; 10%-17%) reported that aggressive cancer treatments can fail, and 131 (30.0%; 26%-35%) reported that aggressive treatments can result in adverse events. Although most articles (249 of 436 [57.1%]; 95% CI, 52%-62%) discussed aggressive treatments exclusively, almost none (2 of 436; [0.5%]; 0%-2%) discussed end-of-life palliative or hospice care exclusively (P < .001, chi(2) test), and only a few (11 of 436 [2.5%]; 1%-6%) discussed aggressive treatment and end-of-life care. CONCLUSIONS: News reports about cancer frequently discuss aggressive treatment and survival but rarely discuss treatment failure, adverse events, end-of-life care, or death. These portrayals of cancer care in the news media may give patients an inappropriately optimistic view of cancer treatment, outcomes, and prognosis.

Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, 19104, USA. fishman1@mail.med.upenn.edu

Expert Analysis Highlights:

• Radiation and surgery components of treatment for pancreatic cancer are highly complex
• Data indicate that rates of postoperative mortality are directly related to the surgical volume of the treatment team and medical facility
• It is my recommendation that patients with pancreatic cancer seek out major institutions of excellence for their treatment
• Here is a comprehensive list of all cancer treatment centers in your state from  our companion site patientresource.net

Pancreatic cancer remains one of the most difficult to treat and deadliest forms of cancer. This blog highlights the value of an aggressive approach that combines preoperative proton radiation with chemotherapy followed by an aggressive resection known as a “Whipple” procedure. For selected patients who present with the disease still localized within the pancreas, this approach represents the best chance for cure.

The radiation and surgery components of treatment for pancreatic cancer are highly complex. The video describes using a highly specialized form of radiation called proton therapy. Proton radiation differs from conventional X-ray radiation in the way the radiation dose is deposited. With proton radiation, the dose increases to a peak and then rapidly falls off. The goal of the protocol study described is to uses these physical properties of protons to limit the dose to the very sensitive normal structures just adjacent to pancreatic tumors. These structures include the liver, stomach, and small intestine.

The surgery for localized pancreatic cancer is equally complex. Studies have clearly indicated that these types of complex operations are best handled by experienced surgeons. Data indicate that rates of postoperative mortality are directly related to the surgical volume of the treatment team and medical facility. Therefore, it is my recommendation that patients with pancreatic cancer seek out major institutions of excellence for their treatment.

Expert Analysis Highlights:

• This video provides patients with the chance to see what actually happens during the course of radiation treatment
• On a daily bases there is no pain or discomfort with the treatment
• Treatment course can extend anywhere from 2-8 weeks
• Side effects are highly dependent on the region of the body being treated and the total dose

Radiation treatments are used in the majority of patients with cancer, and yet most patients have little idea of what to expect. This video is helpful in showing what happens during the course of a single radiation treatment. Some take home messages include that the technology has become relatively sophisticated, that the treatment has to be precisely delivered to one defined area of the body, and that on a daily bases there is no pain or discomfort with the treatment.

Prior to this patient’s treatments, a series of events had already taken place. You can see in the video that the patient’s head is immobilized by plastic mask that is fastened onto the table. The purpose of this and other forms of immobilization is to assure that the carefully planned treatment is able to be reproduced each day when the patient comes for their daily treatment. Treatment course can extend anywhere from 2-8 weeks and the ability of the treatment to hit its target is highly dependent on the ability to precisely reproduce the position of the patient each day. Also prior to the treatment, a CAT scan of the patient while he was immobilized in his mask was obtained. This information is transferred to treatment planning computers and the doctor outlines the targeted region and the normal tissues to avoid. Working with his team, the doctor then helps determine the optimal angle of beam entrance and exit and the shape and intensity of each field. In the video, four fields were used: one from the front, one from the back and one from each side. These four beams will have a mutual intersection point at the targeted region where the addition from each beam will result in a selectively high dose to this region. Within the treatment head of the machine are a collimation system that can shape the beam edges into almost any shape which further adds to the precision of the dose delivery.

Radiation treatments are a scary endeavor for any patient and the treatment can cause some side effects that are highly dependent on the region of the body being treated and the total dose. What I liked about the video is that it provides patients with the chance to see what actually happens within the treatment room. In doing so, I hope you were left with the impression that it’s not that bad and when it is warranted it can provide a great service to cancer patients.

Expert Analysis Highlights:

• Day before surgery can be an intimidating and confusing time
• Patients who do well the day before surgery describe being active with others
• Contrary to popular opinion, the days before surgery should be an active time with good hearty meals
• Exercising beforehand can set back atrophy by not allowing it to get a head start
• Remember the details of your instructions before surgery

The day before surgery can be an intimidating and confusing time. Anxiety about the outcome of the operation and long-term survival can be alleviated by knowing facts about surgery and tips patients have found useful in preparing.

First, stay active and eat well right up until the night before surgery. Unless you’re having colon surgery which often requires a bowel prep and an extra day of a restricted diet before surgery, go ahead and beef up! Contrary to popular opinion, the days before surgery should be an active time with good hearty meals. I tell many patients to treat themselves to a delicious meal in the days leading up to surgery and, depending on the operation, even the night before surgery. You won’t be eating much after the operation for a couple days at least, so to minimize the period of going without nutrition, its good to get some good calories in the system. Nutrition is also known to strengthen your immune system, which sometimes needs to work well during your recovery.

Along the same lines, stay fit. Go ahead and go to the gym and get some good exercise before surgery. The days after surgery are like being an astronaut in that your muscles get weak from lack of use (called atrophy). Exercising beforehand can set back atrophy by not allowing it to get a head start.

Here are some more facts that are good to ease fears. The data on surgery demonstrate that the operation itself is very standardized. In my field of pancreas surgery for example, nearly every experienced pancreas surgeon in the world performs essentially the same operation with minimal variation. Many patients are also worried about general anesthesia, perhaps based on scary movies or public legends of the olden days, but general anesthesia today has a major complication rate of only about 1 in 100,000. Anesthesia is very safe in the modern era, and its safety profile in medicine is among the best of any medical intervention.

Patients who do well the day before surgery describe being active with others. As a general note on patients that I see who are depressed and anxious, the more someone has a community, the less likely they are to experience depression or anxiety. Movies, performances, getting together with friends, and family gatherings are some of the activities patients find helpful in making the day before surgery a pleasant experience. Often times patients describe a great experience surrounding themselves with positive friends—people who are optimistic and enjoy life.

Finally, remember the details of your instructions before surgery: Nothing to eat or drink by mouth 8 hours before your scheduled surgery time, and bring your most recent CAT scan with you if your surgeon does not already have it.