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.

Expert Analysis Highlights:

• Study in the prestigious New England Journal of Medicine concluded that early Hospice care (also known as palliative or end-of-life care) led to significant improvements in quality of life and mood
• When a Hospice team is involved there is often better management of patient symptoms such as pain, patients might have less depression, and in some circumstances may even live longer
• Hospice Care should not be instituted during the end stages of death, but much earlier so that patients might preserve their quality of life
• See also:  Study Finds Straight Talk About Dying Improves Patient’s Quality of Life

When lung cancer progresses to advanced stages, patients are destined to die over the ensuing weeks or months. Oftentimes, they suffer from the symptoms of their cancer (such as extreme pain) or the damage of chemotherapy intended to prolong their life. If they fail all treatments, they are oftentimes left to the care of their family. Typically, there are family members with no prior first-hand experience with the dying process.  Oftentimes, Hospice Care services are contacted during the final days to help cope with the terminal stages of death.

I’ve written a number of blogs about the process of death and dying and how this should be approached with both grace and dignity for the patient and their family unit, as well as not abandoning hope for their future even though the goals of their lives may change to short-term goals as their cancer progresses. In the prestigious New England Journal of Medicine (Aug. 19, 2010), a major study (abstract below) was published examining the impact of early palliative care for patients with advanced lung cancer. Such patients have a substantial symptom burden and may receive aggressive care at the end of life.

The authors examined the effect of introducing palliative care early after the diagnosis of advanced lung cancer and compared the results with those who received standard cancer care alone. The results were amazing! Patients assigned to early palliative care had a better quality of life than those assigned to standard care. In addition, patients in the early palliative care had fewer depression symptoms, and they lived longer (!), even though they received less aggressive end of life care. The authors concluded that early palliative care led to significant improvements in quality of life and mood. As compared with patients receiving standard care, patients receiving early palliative treatment had less aggressive care at the end of life, but lived longer.

I found in my oncology practice that patients and their families oftentimes did not want to call in Hospice Care for fear that it would signal that death was imminent. On the other hand, when a Hospice team is involved, there is often better management of patient symptoms, better care of any open wounds or symptoms of pain, and the family is relieved of the terrible emotional toil of solely providing the physical and emotional needs for a dying patient. The nurses, staff and physicians who dedicate their lives to Hospice Care are truly a special group who can bring skills and a sense of hope and dignity to the dying process, both for patients and their families.

This outstanding scientific study clearly demonstrates the value of early intervention that both patients and physicians should take note of. Hospice Care should not be instituted during the end stages of death, but much earlier so that patients might preserve their quality of life, have less depression, and in some circumstances may even live longer. The additional benefit I would also emphasize is the assistance of Hospice Care to the families and caregivers of a dying cancer patient. Usually they are not equipped to handle all the circumstances that can come up at this time and may feel an extreme sense of hopelessness, frustration and inadequacy when confronted with a circumstance that they are trying to navigate themselves.

The abstract of this referenced study is listed below.

Reference: Early palliative care for patients with metastatic non-small cell lung cancer. Temel JS et al. New England Journal of Medicine volume 363, pages 733-742, August 19,2010.

ABSTRACT:

Early Palliative Care for Patients with Metastatic Non–Small-Cell Lung Cancer

Jennifer S. Temel, M.D., et al. N Engl J Med 2010; 363:733-742August 19, 2010

Background: Patients with metastatic non–small-cell lung cancer have a substantial symptom burden and may receive aggressive care at the end of life. We examined the effect of introducing palliative care early after diagnosis on patient-reported outcomes and end-of-life care among ambulatory patients with newly diagnosed disease.

Methods: We randomly assigned patients with newly diagnosed metastatic non–small-cell lung cancer to receive either early palliative care integrated with standard oncologic care or standard oncologic care alone. Quality of life and mood were assessed at baseline and at 12 weeks with the use of the Functional Assessment of Cancer Therapy–Lung (FACT-L) scale and the Hospital Anxiety and Depression Scale, respectively. The primary outcome was the change in the quality of life at 12 weeks. Data on end-of-life care were collected from electronic medical records.

Results: Of the 151 patients who underwent randomization, 27 died by 12 weeks and 107 (86% of the remaining patients) completed assessments. Patients assigned to early palliative care had a better quality of life than did patients assigned to standard care (mean score on the FACT-L scale [in which scores range from 0 to 136, with higher scores indicating better quality of life], 98.0 vs. 91.5; P=0.03). In addition, fewer patients in the palliative care group than in the standard care group had depressive symptoms (16% vs. 38%, P=0.01). Despite the fact that fewer patients in the early palliative care group than in the standard care group received aggressive end-of-life care (33% vs. 54%, P=0.05), median survival was longer among patients receiving early palliative care (11.6 months vs. 8.9 months, P=0.02).

Conclusions: Among patients with metastatic non–small-cell lung cancer, early palliative care led to significant improvements in both quality of life and mood. As compared with patients receiving standard care, patients receiving early palliative care had less aggressive care at the end of life but longer survival. (Funded by an American Society of Clinical Oncology Career Development Award and philanthropic gifts; ClinicalTrials.gov number, NCT01038271.)

NOTE: An accompanying editorial by Drs Kelley and Meier* concluded: “The study by Temel et al. represents an important step in confirming the beneficial outcomes of a simultaneous care model that provides both palliative care and disease-specific therapies beginning at the time of diagnosis. This study is an example of research that shifts a long-held paradigm that has limited access to palliative care to patients who were predictably and clearly dying. The new approach recognizes that life-threatening illness, whether it can be cured or controlled, carries with it significant burdens of suffering for patients and their families and that this suffering can be effectively addressed by modern palliative care teams. Perhaps unsurprisingly, reducing patients’ misery may help them live longer. We now have both the means and the knowledge to make palliative care an essential and routine component of evidence-based, high-quality care for the management of serious illness.”

*N Engl J Med 2010; 363:781-782, August 19, 2010

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:

• While conventionally, radiation treatments for lung cancer were given in 25-35 treatments, stereotactic approaches usually use only 1-5 treatments
• It was in patients with poor lung functions who are not candidates for surgery that stereotactic treatments were first explored
• Largest experiences in using this approach have been for patients with small tumors that are located away from central structures in the chest
• This technology is now becoming more widely adopted

Radiation has been used successfully to treat lung and other cancers for over 50 years.  During this period, there have been numerous technology advances that have allowed for higher dosages of radiation to be selectively delivered to the tumor while sparing dose to the normal tissues.  Most recently, these advances have led to “stereotactic” radiation treatments of lung tumors, which were nicely described in this video.  The goal of this type of treatment is to deliver very high ablative dosages of radiation in a very precise fashion to the tumor.  Multiple sites of beam entrances are used and all these beams then intersect within the tumor in order to provide this very high dose.  While conventionally, radiation treatments for lung cancer were given in 25-35 treatments, stereotactic approaches usually use only 1-5 treatments.

The largest experiences in using this approach have been for patients with small tumors that are located away from central structures in the chest.  Historically, these types of patients have been successfully treated with surgical resection.  Accordingly, it was in patients with poor lung functions who are not candidates for surgery that stereotactic treatments were first explored.  The results from these studies have shown the treatment to be highly effective.  The chance of eradicating the disease without the need for any surgical intervention is very high for appropriately selected patients.  Based on these data, there are now ongoing national/international studies to directly compare this new radiation approach versus surgical resection.

As suggested in the video, stereotactic treatments of lung cancer requires sophisticated technology including methods to manage the tumor motion due to breathing and image guidance to assure that the precise radiation delivery appropriately hits its target.  Equally important to the technology and equipment is the staff and physician experience.  Fortunately, this technology is now becoming more widely adopted and more centers are gaining experience with this new and promising approach.

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.