Expert Analysis Highlights:

• Mr. Douglas was diagnosed with an advanced stage cancer at the base of the tongue
• Douglas tells Matt Lauer that he feels good now that the treatment is over
• Like many cancer patients I have worked with, he has come to appreciate loved ones with a particularly deep appreciation
• Head and Neck cancers are often caused by tobacco and alcohol use and manifest as a persistent sore throat, difficulty swallowing, or a lump in the neck

Five days-a-week for 7 weeks, Michael Douglas went to a hospital to receive radiation treatments for his throat cancer.  He lost 32 pounds and felt tired frequently, but he kept his spirits high.   Mr. Douglas tells Matt Lauer that he feels good now that the treatment is over.  He looks forward to spending more time with his family.  Most impressive, Mr. Douglas describes what’s truly important in life during this difficult chapter.  Like many cancer patients I have worked with, he has come to appreciate loved ones with a particularly deep appreciation.  I have also heard some of my cancer patients share the wise saying that living like you’re dying is the best way to live.

Head and Neck cancers are often caused by tobacco and alcohol use and manifest as a persistent sore throat, difficulty swallowing, or a lump in the neck.   In his case, Mr. Douglas was diagnosed with an advanced stage cancer at the base of the tongue.  He will now have throat exams and periodic scans every few months to monitor for tumor recurrence.  For now he is not allowing a what is normally a poor prognosis to get in the way of his enjoying life—a model attitude for all cancer patients.

Expert Analysis Highlights:

• There is continued evidence that prophylactic removal of the breast and ovaries decreases mortality rate
• This subject is not without controversy, but results of studies have been impressive
• For example, study demonstrates removal of the ovaries in select groups of mutation carriers can cut the risk of ovarian cancer by 70%
• Visit PatientResource.net for more information about breast and ovarian cancer

For breast cancer women who carry the BRAC-I or BRAC-II mutations, there is continued evidence that prophylactic removal of the breast and ovaries decreases mortality rate.  Prophylactic removal simply refers to surgically removing the breast or ovary that is not known to contain cancer for the purpose of reducing the patient’s risk. For your reference, below are relevant summary abstracts from professional medical journals. This subject is not without controversy. Removing healthy tissue, for example the breast that may otherwise never develop cancerous cells despite having cancer in the opposite breast, is a difficult choice that’s not for everyone. Talk to your doctor about your options.

A recent report from Dr Domchek and colleagues from the University of Pennsylvania in the Journal of American Medical Association showed that prophylactic mastectomy (breast removal) and removal of the ovaries significantly reduce mortality in this select group of women. They examined the survival outcome in a group of 2,482 BRAC-I or BRAC-II mutation carriers identified at 22 medical centers in North America and Europe who were participating in the prospective clinical trial. Approximately 10% of these women underwent prophylactic mastectomies and 40% underwent prophylactic removal of their ovaries.

The results were impressive. No breast cancers developed in mutation carriers who underwent prophylactic mastectomy whereas breast cancer did develop in 7% of those who declined prophylactic mastectomy. The results were even more impressive in preventing ovarian cancer which is much more lethal at the time of diagnosis. Among women who underwent prophylactic removal of their ovaries, only 1% subsequently developed ovarian cancer and only 11% subsequently developed breast cancer. In contrast, among women who declined prophylactic removal of their ovaries, about 6% subsequently developed ovarian cancer and 19% subsequently developed breast cancer. Thus, prophylactic removal of the ovaries in this select group of mutation carriers can cut the risk of ovarian cancer by 70% in those women who did not have prior breast cancer and decrease it even further, by 85%, in those who did have prior breast cancer.

These findings illustrate why breast cancer patients may want to know about their BRCA genetic status even if they have undergone bilateral mastectomy because prophylactic removal of their ovaries, even in this group of patients, may protect them from developing a new primary malignancy. Among women with no prior breast cancer, prophylactic removal of the ovaries reduced the breast cancer by 37% in carriers of the BRCA-I mutation and by 64% in carriers of BRCA-II mutation.

Another related medical study was reported in the November, 2010 issue of the ASCO Post on women who carried the BRCA mutation. This study by Dr Metcalfe and colleagues from the University of Toronto demonstrated that women younger than 50 years with BRCA-mutated breast cancers can have a 38% risk of developing breast cancer in the opposite breast within the next 15 years. In addition, there is a 68% risk in a woman diagnosed before age 50 who chooses to keep her ovaries and has two first degree relatives diagnosed with breast cancer before the age of 50. Thus, women with a younger age at onset of their breast cancer are at significant risk for developing an opposite breast cancer or ovarian cancer during follow-up over the next 10-15 years.

The results in women who are BRCA-mutant carriers who undergo prophylactic removal of their ovaries are similar to the results reported in the previous studies.  In this circumstance the object of the study was to examine the development of opposite breast cancer in mutant carriers who had a diagnosis of cancer in the opposite breast. In this study, women who underwent prophylactic removal of their ovaries and who were younger than 50 years of age at diagnosis have a 60% risk of developing opposite breast cancer within 15 years compared to 20% of those older than 50 years of age. Women younger than 50 who underwent prophylactic removal of their ovaries had a subsequent reduction in their risk for opposite breast cancer by more than one-third. The authors concluded that “women with early-onset breast cancer have the highest risk and get the most protection from prophylactic removal of their ovaries”.

Dr. Metcalfe emphasized how these risk factors can be used in counseling women. For example, while the 15-year risk for a woman diagnosed before age 50 is 37.6% it greatly increases if she decided against prophylactic removal of their ovaries and nearly doubles if she has two or more 1^st degree relatives diagnosed with breast cancer at an early age.

KEY REFERENCES BELOW:

JAMA. 2010 Sep 1;304(9):967-75.

Association of risk-reducing surgery in BRCA1 or BRCA2 mutation carriers with cancer risk and mortality.

Domchek SM, Friebel TM, Singer CF, Evans DG, Lynch HT, Isaacs C, Garber JE, Neuhausen SL, Matloff E, Eeles R, Pichert G, Van t’veer L, Tung N, Weitzel JN, Couch FJ, Rubinstein WS, Ganz PA, Daly MB, Olopade OI, Tomlinson G, Schildkraut J, Blum JL, Rebbeck TR.

Abramson Cancer Center and Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, USA.

Abstract

CONTEXT: Mastectomy and salpingo-oophorectomy are widely used by carriers of BRCA1 or BRCA2 mutations to reduce their risks of breast and ovarian cancer.

OBJECTIVE: To estimate risk and mortality reduction stratified by mutation and prior cancer status.

DESIGN, SETTING, AND PARTICIPANTS: Prospective, multicenter cohort study of 2482 women with BRCA1 or BRCA2 mutations ascertained between 1974 and 2008. The study was conducted at 22 clinical and research genetics centers in Europe and North America to assess the relationship of risk-reducing mastectomy or salpingo-oophorectomy with cancer outcomes. The women were followed up until the end of 2009.

MAIN OUTCOMES MEASURES: Breast and ovarian cancer risk, cancer-specific mortality, and overall mortality.

RESULTS: No breast cancers were diagnosed in the 247 women with risk-reducing mastectomy compared with 98 women of 1372 diagnosed with breast cancer who did not have risk-reducing mastectomy. Compared with women who did not undergo risk-reducing salpingo-oophorectomy, women who underwent salpingo-oophorectomy had a lower risk of ovarian cancer, including those with prior breast cancer (6% vs 1%, respectively; hazard ratio [HR], 0.14; 95% confidence interval [CI], 0.04-0.59) and those without prior breast cancer (6% vs 2%; HR, 0.28 [95% CI, 0.12-0.69]), and a lower risk of first diagnosis of breast cancer in BRCA1 mutation carriers (20% vs 14%; HR, 0.63 [95% CI, 0.41-0.96]) and BRCA2 mutation carriers (23% vs 7%; HR, 0.36 [95% CI, 0.16-0.82]). Compared with women who did not undergo risk-reducing salpingo-oophorectomy, undergoing salpingo-oophorectomy was associated with lower all-cause mortality (10% vs 3%; HR, 0.40 [95% CI, 0.26-0.61]), breast cancer-specific mortality (6% vs 2%; HR, 0.44 [95% CI, 0.26-0.76]), and ovarian cancer-specific mortality (3% vs 0.4%; HR, 0.21 [95% CI, 0.06-0.80]).

CONCLUSIONS: Among a cohort of women with BRCA1 and BRCA2 mutations, the use of risk-reducing mastectomy was associated with a lower risk of breast cancer; risk-reducing salpingo-oophorectomy was associated with a lower risk of ovarian cancer, first diagnosis of breast cancer, all-cause mortality, breast cancer-specific mortality, and ovarian cancer-specific mortality.

J Natl Cancer Inst. 2010 Nov 23. [Epub ahead of print]

Family History of Cancer and Cancer Risks in Women with BRCA1 or BRCA2 Mutations.

Metcalfe K, Lubinski J, Lynch HT, Ghadirian P, Foulkes WD, Kim-Sing C, Neuhausen S, Tung N, Rosen B, Gronwald J, Ainsworth P, Sweet K, Eisen A, Sun P, Narod SA; for the Hereditary Breast Cancer Clinical Study Group.

Affiliations of authors: Women’s College Research Institute, Toronto, ON, Canada (KM, PS, SAN); Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada (KM); Center for Hereditary Breast Cancers, Pomeranian Medical University, Szczecin, Poland (JL, JG); Department of Preventive Medicine and Public Health, Creighton University School of Medicine, Omaha, NE (HTL); Department of Cancer Genetics, Department of Medicine, and Department of Genetics, Epidemiology Research Unit, CHUM Hôtel-Dieu, University of Montreal, Montreal, QC, Canada (PG); Department of Genetics and Department of Medical Oncology, McGill University, Montreal, QC, Canada (WDF); BC Cancer Agency, Vancouver; BC, Canada (CK-S); Department of Population Sciences, City of Hope, Duarte, CA (SN); Beth Israel Deaconess Hospital, Boston, MA (NT); Department of Gynecology Oncology, University Health Network, University of Toronto, Toronto, ON, Canada (BR); London Regional Cancer Program, London, ON, Canada (PA); Department of Medical Genetics, Ohio State University, Columbus, OH (KS); Sunnybrook Regional Cancer Centre, Department of Medical Oncology, Toronto, ON, Canada (AE).

Abstract

Women who carry a deleterious mutation in BRCA1 or BRCA2 have high lifetime risks of breast and ovarian cancers. However, the influence of a family history of these cancers on these risks in women with BRCA mutations is unclear. We calculated cancer incidence rates for a multinational cohort comprising 3011 women with BRCA1 or BRCA2 mutations who were followed up for a mean of 3.9 years, during which time 243 incident breast or ovarian cancers were recorded. The 10-year cumulative risks of breast cancer were 18.1% (95% confidence interval [CI] = 13.3% to 22.8%) for women with a BRCA1 mutation and 15.2% (95% CI = 9.1% to 21.2%) for women with a BRCA2 mutation. Among women with a BRCA1 mutation, the risk of breast cancer increased by 1.2-fold for each first-degree relative with breast cancer before age 50 years (hazard ratio [HR] = 1.21; 95% confidence interval [CI] = 0.94 to 1.57) and the risk of ovarian cancer increased by 1.6 fold for each first- or second-degree relative with ovarian cancer (HR = 1.61; 95% CI = 1.21 to 2.14). Among women with a BRCA2 mutation, the risk of breast cancer increased by 1.7-fold for each first-degree relative younger than 50 years with breast cancer (HR = 1.67; 95% CI = 1.04 to 2.07).

Clin Genet. 2009 Mar;75(3):220-4.

Breast and ovarian cancer risk perception after prophylactic salpingo-oophorectomy due to an inherited mutation in the BRCA1 or BRCA2 gene.

Finch A, Metcalfe K, Lui J, Springate C, Demsky R, Armel S, Rosen B, Murphy J, Elit L, Sun P, Narod S.

Women’s College Research Institute, Toronto, ON, Canada.

Abstract

It is often recommended that women who carry a mutation in the BRCA1 or BRCA2 gene have their ovaries and fallopian tubes removed to reduce their risk of gynecologic cancer. The aim of this study was to evaluate women’s perception of their risk of breast and ovarian cancer before and after prophylactic salpingo-oophorectomy. We surveyed 127 women who carry a BRCA1 or BRCA2 mutation and who underwent prophylactic salpingo-oophorectomy at the University Health Network, Toronto. Subjects were asked to estimate their risks of breast and ovarian cancer before and after surgery. Their perceived risks of cancers were then compared with published risks, based on their mutation status. BRCA1 carriers estimated their risk of breast cancer risk to be, on average, 69% before surgery and 41% after surgery. They estimated their risk of ovarian cancer to be 55% before surgery and 11% after surgery. BRCA2 carriers estimated their risk of breast cancer to be 69% prior to surgery and 45% after surgery and their perceived risk of ovarian cancer to be 43% before surgery and 8% after surgery. Compared with published risk figures, the perceived risk of ovarian cancer before prophylactic salpingo-oophorectomy was overestimated by 47% of BRCA1 mutation carriers and by 61% of BRCA2 mutation carriers. Most women who have undergone genetic counseling and subsequently choose prophylactic salpingo-oophorectomy accurately perceive their risk of breast cancer. However, in this study, many women overestimated their risk of ovarian cancer, particularly women who carry a BRCA2 mutation.

Expert Analysis Highlights:

• There’s a lot of controversy about the effects of Vitamin D on survival outcome for various forms of cancer
• Retrospective studies show “clues” that lower serum Vitamin D levels are associated with lower survival rates
• Still, there is no evidence to date that taking Vitamin D as a treatment intervention improves the survival outcome
• It makes sense to take a regular dose of multivitamin supplementation (but not high doses) as part of good health
• Visit PatientResource.net for specific nutritional information

There’s a lot of controversy about the effects of Vitamin D on survival outcome for various forms of cancer, including breast, prostate and colorectal cancer. Several recent articles associating Vitamin D levels in the serum, as well as several large studies on Vitamin D supplements, have been published recently. Dr. Kathleen Wesa from Memorial Sloan Kettering Comprehensive Cancer Center described the results of a retrospective study that analyzed baseline Vitamin D levels in newly diagnosed Stage IV colorectal cancer to determine if serum levels at diagnosis could predict subsequent survival. The results were reported in Oncology News International (August, 2010). Interestingly, the majority of patients (83%) were Vitamin D deficient. The “take-home message” was that Vitamin D levels were significantly associated with survival and that patients with low Vitamin D levels had survival outcomes that were 1.5 times worse than those with normal levels. The authors concluded that most patients with newly diagnosed Stage IV colorectal cancer are Vitamin D deficient at the time of diagnosis and that higher Vitamin D levels are associated with better survival rates. A similar type of study by Dr. Mezawa and colleagues from Japan in colorectal cancer patients undergoing surgery found that higher Vitamin D levels at surgery were associated with a better survival rate.

What we don’t know from this study is whether an intervention with Vitamin D supplements would improve survival rates in those patients who are Vitamin D deficient. In other words, it’s one thing to find a correlation in the data through studies like the one above, but it’s a completely different reality sometimes when the conclusions we draw from the data are put to the test.  In a study reported in the ASCO Post (October 2010), Dr. Kimmie Ng from the Dana-Farber Cancer Center in Boston reported that multivitamin supplementation during or after adjuvant chemotherapy failed to improve the outcomes in those with Stage III colon cancer who underwent surgical resection. Dr. Ng stated, “To our knowledge, this is the first study to examine the impact of multivitamin use on survival among patients with established colon cancer. No benefit on patient outcome was seen for multivitamin supplementation in this large prospective study of patients with Stage III colon cancer overall.”

But hold on before one makes a totally negative conclusion. In this study, they did identify an interaction between multivitamin use and age. Thus, patients aged 60 or younger appeared to derive benefit from the supplements. Moreover, less fatigue was observed in multivitamin users than in non-users. The interactions of multivitamin D used with younger ages will need to be explored in further studies.

A third large scale European study was reported this year that collected data on Vitamin D serum levels among 52,000 participants in several European countries. One object of the study was to determine whether there was a link between pre-diagnostic circulating Vitamin D levels and the risk for developing colorectal cancer. In a “case-control study”, the authors focused on 1,248 cases of colorectal cancer that developed after enrollment into the study and matched their results to the same number of healthy controls. The investigators found that lower levels of serum Vitamin D were associated with a higher colorectal cancer risk and conversely that higher concentrations of serum Vitamin D were associated with a lower colorectal cancer risk. However… and  this is important … the investigators also found that a higher consumption of dietary Vitamin D was not associated with a reduced risk of colorectal cancer. They concluded that the optimal level of Vitamin D supplementation still needs to be established through clinical trials before any change is made to public health recommendations.

Trying to sort out the impact of a single factor in the survival outcome of a complex disease such as colorectal cancer is difficult. Nevertheless, the current evidence shows some interesting “clues” that patients who are deficient in serum Vitamin D have an increased risk for developing colorectal cancer and a worse outcome if they develop colorectal cancer later on. On the other hand, there is no evidence to date that taking Vitamin D supplementation as a treatment intervention improves the survival outcome.  It would make sense, however, for us to take a regular dose of multivitamin supplementation (but not high doses) as part of good health. I do.

Expert Analysis Highlights:

• Acute Promyelocytic Leukemia (APL) is relatively rare and educational resources are limited; below is information on how to get started
• Our companion website www.patientresource.net launched a new Acute Promyelocytic Leukemia Guide which is FREE to download
• Clinical trial studies below demonstrate improvements in survival
• If your doctor does not ask you about clinical trials, raise the discussion yourself

On our companion website www.patientresource.net, we have just launched a new Patient Resource Cancer Guide on acute promyelocytic leukemia (APL) under the expert direction of our distinguished Advisory Board member, Dr James Armitage from the University Of Nebraska Medical Center.  Here is the link to download this guide for free: Acute Promyelocytic Leukemia Guide. I selected a video story by a patient from South Carolina to include in this article, for Terry Ikner illustrates a realistic hope and optimism about her treatment and her willingness to participate in a clinical trial. I have also referenced two new articles (below) being published in the journal Blood which illustrate the benefit of advancing treatment through clinical trials for this uncommon form of leukemia. Both clinical trials in the articles referenced below demonstrated improvements in survival and both were registered on the website: www.clinicaltrials.gov where all cancer clinical trials are listed. We could not make the advances that are illustrated by these two medical publications without patients volunteering to participate in cancer clinical trials!

As written in the APL Guide for patients: You should learn all you can about APL so that you can better understand how the disease developed and what to expect during treatment and recovery. Because this type of leukemia is relatively rare, educational resources are limited, but some major cancer organizations offer detailed information on APL. Online information about APL is often found in resources on AML or leukemia, but it is important to remember that APL is treated very differently from other subtypes of AML. As with all types of cancer, a clinical trial may offer an opportunity to receive a newer treatment. Clinical trials are a vital part of the cancer research process and are done to determine whether new cancer treatments are more effective than the current standard treatment. Many of today’s standard treatments for cancer are based on the results of earlier clinical trials. Individuals who take part in a clinical trial may receive the standard treatment or be among the first to receive a new treatment.

A clinical trial is an option, and you may decide that standard treatment outside of a trial is the best choice for you. To make an informed decision about volunteering for a clinical trial, learn as much as possible about clinical trials and weigh the advantages and disadvantages of participating. Read about clinical trials in general as well as about specific trials for your type of cancer. Some people may think that a clinical trial is not an option for them because their doctor didn’t recommend it. However, if your doctor does not ask you about clinical trials, you may raise the discussion yourself. Ask your physician and medical team about trials that may be appropriate for you.

One of the most important considerations in deciding whether to volunteer for a clinical trial is to weigh the advantages and disadvantages. Make sure you understand the details of the particular trial you’re considering; asking several questions can help you in this decision-making process. Your physician can tell you about specific benefits and risks that may be associated with the particular trial that he or she recommends. The decision to participate in a clinical trial is a personal one and is yours to make.

Many individuals with APL or other types of cancer have found it helpful to talk about the decision with family members or friends. Ask your physician or a member of your medical team about clinical trial resources available online or in your local community. In addition, a number of government and private organizations provide listings of clinical trials and information about the trials on their Web sites.

As with all cancers, but particularly with the rare or uncommon forms of cancer, it is vitally important to have the correct diagnosis and a treatment plan that brings all the expertise to bear on your situation. Sometimes that means traveling to a specific cancer specialist for a consultation, even if you plan to receive your treatment closer to home. Ask your doctor about whether a second opinion would be of benefit in your situation….and whether there are any clinical trials available for your particular form of cancer.

For more information about clinical trials related to APL, see below.

Arsenic trioxide improves event-free and overall survival for adults with acute promyelocytic leukemia: North American Leukemia Intergroup Study C9710.

Powell BL, Moser B, Stock W, Gallagher RE, Willman CL, Stone RM, Rowe JM, Coutre S, Feusner JH, Gregory J, Couban S, Appelbaum FR, Tallman MS, Larson RA.
Cancer and Leukemia Group B, Chicago IL;

Abstract

Arsenic trioxide (As(2)O(3)) is a highly effective treatment for patients with relapsed acute promyelocytic leukemia (APL); its role as consolidation treatment for patients in first remission has not been defined. We randomized 481 patients (age ≥ 15 years) with untreated APL to either a standard induction regimen of tretinoin, cytarabine, and daunorubicin, followed by 2 courses of consolidation therapy with tretinoin plus daunorubicin, or to the same induction and consolidation regimen plus two 25-day courses of As(2)O(3) consolidation immediately after induction. After consolidation, patients were randomly assigned to one year of maintenance therapy with either tretinoin alone or in combination with methotrexate and mercaptopurine. Ninety percent of patients on each arm achieved remission and were eligible to receive their assigned consolidation therapy. Event-free survival, the primary end point, was significantly better for patients assigned to receive As(2)O(3) consolidation, 80% compared with 63% at 3 years (stratified log-rank test, P < .0001). Survival, a secondary end point, was better in the As(2)O(3) arm, 86% compared with 81% at 3 years (P = .059). Disease-free survival, a secondary end point, was significantly better in the As(2)O(3) arm, 90% compared with 70% at 3 years (P < .0001). The addition of As(2)O(3) consolidation to standard induction and consolidation therapy significantly improves event-free and disease-free survival in adults with newly diagnosed APL. This trial was registered at clinicaltrials.gov (NCT00003934).
PMID: 20705755 [PubMed – in process]
————————————————————————————————-
Blood. 2010 Jun 24;115(25):5137-46. Epub 2010 Apr 14.

Risk-adapted treatment of acute promyelocytic leukemia based on all-trans retinoic acid and anthracycline with addition of cytarabine in consolidation therapy for high-risk patients: further improvements in treatment outcome.

Sanz MA, Montesinos P, Rayón C, Holowiecka A, de la Serna J, Milone G, de Lisa E, Brunet S, Rubio V, Ribera JM, Rivas C, Krsnik I, Bergua J, González J, Díaz-Mediavilla J, Rojas R, Manso F, Ossenkoppele G, González JD, Lowenberg B; PETHEMA and HOVON Groups.
Hospital Universitario La Fe, Valencia, Spain. msanz@uv.es

Abstract

A risk-adapted strategy based on all-trans retinoic acid (ATRA) and anthracycline monochemotherapy (PETHEMA LPA99 trial) has demonstrated a high antileukemic efficacy in acute promyelocytic leukemia. We designed a new trial (LPA2005) with the objective of achieving stepwise improvements in outcome. Between July 2005 and April 2009, low- and intermediate-risk patients (leukocytes < 10 x 10(9)/L) received a reduced dose of mitoxantrone for the second consolidation course, whereas high- risk patients younger than 60 years of age received cytarabine combined with ATRA and idarubicin in the first and third consolidation courses. Of 372 patients attaining complete remission after ATRA plus idarubicin (92.5%), 368 proceeded to consolidation therapy. For low- and intermediate-risk patients, duration of neutropenia and thrombocytopenia and hospital stay were significantly reduced without sacrificing antileukemic efficacy, compared with the previous LPA99 trial. For high-risk patients, the 3-year relapse rate was significantly lower in the LPA2005 trial (11%) than in the LPA99 (26%; P = .03). Overall disease-free survival was also better in the LPA2005 trial (P = .04). In conclusion, the lower dose of mitoxantrone resulted in a significant reduction of toxicity and hospital stay while maintaining the antileukemic activity, and the combination of ATRA, idarubicin, and cytarabine for high-risk acute promyelocytic leukemia significantly reduced the relapse rate in this setting. Registered at http://www.clinicaltrials.gov as NCT00408278.
PMID: 20393132 [PubMed - indexed for MEDLINE]

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.

An ovarian cancer patient in England describes her difficult struggles with chronic pain due to her advancing disease and the side effects of her chemotherapy. In the video, Dr Beverly Collett, Immediate Past President of the British Pain Society describes a survey in Great Britain of advanced cancer patients who responded that about one-third had “intractable pain.” In other words, pain that just would not go away.

No one with cancer should be denied appropriate amounts of pain medicines, including narcotics if necessary (we are not worried about addiction here). Most major cancer centers have pain specialists who can be helpful consultants in this vital subject.

The National Cancer Institute has an informative web section on cancer pain control. Go to http://www.cancer.gov/cancertopics/paincontrol.

Also, a new website was recently launched to help cancer patients find pain relief: Cancer-pain.org.  Some of their website is still “under construction.” It has a very distinguished Advisory Board, including Diane Blum who is on our Patient Resource Cancer Guide Patient Advisory Board. Their news announcement is pasted below:

The Association of Cancer Online Resources (ACOR), the largest online community of cancer patients, announces the launch of a new website, Cancer-pain.org, to provide cancer patients with the education and support they need to obtain effective relief from pain.

“There is always a way to alleviate pain; however, effective treatment of cancer pain has been a problem long acknowledged by the cancer community,” said Gilles Frydman, President of ACOR. “A significant majority of cancer patients suffer pain as their disease progresses, but almost half do not get adequate pain relief. Cancer-pain.org is our commitment to help cancer patients better understand their pain and obtain more effective pain control.” Cancer-pain.org features sections on the causes of pain, breakthrough cancer pain, pain treatment options, and tools to help cancer patients communicate effectively with physicians about their pain. The Web site also has a complete list of medications available to treat pain, information about complementary and alternative methods of pain control, and a section devoted to the special needs and issues of caregivers. In addition, Cancer-pain.org has an interactive section where patients and caregivers can exchange information.

The Web site’s news section provides patients with updates on developments in cancer pain treatments as well as links to other cancer sites, such as the National Cancer Institute (NCI), which enable patients to stay abreast of legislative issues affecting cancer research and treatment. ACOR also has plans to add a “Healthcare Professionals Corner” where professionals can exchange information on effective pain therapies, post relevant journal articles and new clinical research and recruit patients for clinical trials, as well as take accredited CME courses on cancer pain treatment.

“We hope this site helps educate patients about new advances in the understanding and treatment of pain, including breakthrough cancer pain, which can seriously diminish quality of life for cancer patients,” says Mr. Frydman. “Encouraging patients to exchange information about what works and what doesn’t, as well as dispelling the myth of addiction, are two of the reasons we have developed this site to be a resource for patients and caregivers.” Cancer-pain.org is supported through an educational grant from Cephalon, Inc.