Report from ASCO, 2004 By Ann Fonfa This was the 40th annual meeting of the American Society of Clinical Oncology, held in New Orleans, LA. From a statment by ASCO President Margaret Tempero, MD: "The goal of prevention and control reflects ASCO’s conviction that modern society is committed to health and wellness. In the near term, the practice of oncology may be revised in ways that address this aim". On the first full day, Saturday, June 5, 2004, I attended a 7:45 AM- 9:00 meeting on ‘CAM and Palliative Care in Pediatric Oncology’. This meeting focused on two very important topics in a very short time. I would have liked to see palliative care have a separate hour and fifteen minutes (if not more). However Joanne M. Hilden, MD, Chair of Pediatric Oncology at the Children’s Hospital, Cleveland Clinic, Cleveland, OH spoke about the mandate to include palliative and hospice care for children. National organizations have supported a policy statement but she wondered how things would move along when unfunded. In her opening remarks, she mentioned that since the use of CAM (complementary, alternative medicine therapies) is ‘prevalent’ in pediatric oncology, she is often asked to counsel families. She spoke of trials that are beginning. The philosophy of palliative care is that components should be offered at the time of diagnosis and continued throughout the course of treatment, regardless of outcome. That way the patient and the family do not suddenly begin getting counseled when complications or failures occur. (Am Acad Ped 2002). Particularly of note are issues with fatigue, pain, dyspnea (shortness of breath), poor appetite, nausea, vomiting, constipation, etc. (NEJM 342 326, 2000). At this point I fully expected her to ‘integrate’ CAM since there are many acknowledged methods for dealing with almost all of the above, but that did not happen. She did say that a multidisciplinary approach is needed, one that prevents or relieves symptoms produced by a life-threatening medical condition or its treatment. The goal is to help patients and their families live as normally as possible and provide them with timely and accurate information and support in decision-making. She acknowledged that nurses are ‘under the radar’ and provide continuity of care that is missing at other levels. She suggested that a ‘bereavement follow-up plan’ with families is desirable. We have a “ very marginal ability to predict illness trajectory”, but there is a need for anticipatory guidelines at or near the time of death. This concept is of course superceded by the idea of addressing palliative issues from day one and including them in other discussions (see above). Her abstract included the statement: “When it is clear that a child will die/is dying, the involvement of hospice services is the gold standard of excellent care.” Dr. Hilden mentioned an organization called the National Alliance for Children with Life Threatening Conditions, www.nawcltc.org. The next speaker was Javier Kane, MD Department of Pediatrics, University of Texas Health Science Center, San Antonio, TX., “Pediatric Palliative Care: State of the Science.” From his abstract: “The field of palliative care must create a unified evidence-based set of minimum U.S. standards and guidelines for clinical practice and education of health care professionals.” Dr. Kane told the audience that there are indeed efforts underway to achieve the above, such as those of the Center to Advance Palliative Care (www.capc.org) and national consensusproject.org. Also check out epec.org and nhpco.org, and end of life nursing education at aach.nche.edu/elnec. The desired clinical outcomes include: Pain and symptom management – there are some assessment tools and some guidelines already available Psycho-social support – many emotional and social needs, not just family oriented but occurring in the context of meaningful relationships. There is “evidence that better social support is actually life extending.” Bereavement care for family and staff- this is probably an unrecognized need for the staff. Interventions need to be standardized, researched and eligible for reimbursement. Decision-making – relationships, communication, prognosis, goals of care, support, information and illness experience (from the perspectives of the child and the family [which may be different from each other]. He then discussed the question ‘should children participate in clinical research for the benefit of society?’ Should a child’s dissent to participate be honored? NCI holds that this dissent is NOT binding. Children do not have a legal right to refuse consent. Kara Kelly, MD spoke on “Integrating Complementary and Alternative Medicine Therapies in the Care of Children with Cancer: Research and Clinical Practice.” FYI, there were about 75 people in the audience for these presentations which given the introductory remarks confirming that 60-80% of people with cancer, and 90% of children are using some form of CAM therapies, is NOT a good attendance. Two-thirds of Dr. Kelly’s presentation consisted of just about the same set of caveats heard everywhere; St. John’s Wort may interfere with Irinotecan; there may be other herb/chemo interactions of which we are not sure. We currently do not know how often it happens, how much herb or drug is needed to produce a negative reaction, or when it occurs in the time frame… She suggested not using immunostimulants such as mistletoe or mushrooms/herbs “until more data” is in, especially with blood cancers and stem cell treatments. Ann’s NOTE: This creates quite a problem for people with cancer. Waiting for ‘more data’ takes HOW LONG? I have been living with cancer for almost 13 years. For more than twelve of those years I have been asking for studies in this area so that we can KNOW what works, what doesn’t, what interacts positively and what negatively impacts conventional therapy. How LONG? Dr. Kelly pointed out that the use of CAM therapies has grown rapidly. Surveys in 1977-1983 showed less than 20% using them, while in 1994-1998 it increased to 65%. In studies of CAM use from 2000-2003, pediatric patients were up to 90%. She suggested the reasons for this included: try everything possible; reduce stress of illness; improve quality of life; symptom management; and sometimes for cure. (From a perceived effectiveness study at Columbia - 86% of users were satisfied with their results). It is always important to remember that 50% of people using CAM therapies do NOT tell their physicians or nurses about such use. Dr. Kelly listed some of the ongoing trials that fall under CAM: Traumeel (homeopathic) to prevent and treat mucositis (Cooperative Groups) Electroacupuncture for delayed nausea/vomiting from chemo in the pediatric community (solid tumors) (National Cancer Institute) Sylmarin for liver toxicity in all cancers (New York Hospital Coulmbia University) She also told the audience of oncologists, journalists and interested others that Columbia is using massage, yoga, aromatherapy, reiki, acupressure bands, peppermint, ginger, chamomile compress, etc. (All covered on our site under Studies-Non-Toxic…) She offered the website www.integrativetherapiesprogram.org for children with cancer. In one of her final, almost throwaway remarks, she said that children who began treatment for ALL fared better if they had higher levels of antioxidants in their blood. (See the article below from MEDSCAPE on this). Ann’s NOTE: On Friday night there was a Patient Advocate Recognition event which I attended. I spoke with Gabriel Hortobagyi, a very well-known oncologist, about patients’ use of CAM. He said he always asks about it. He turned out to be a very good communicator and quite sensitive to the issues. (He is head of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston). The rest of the Saturday was spent wondering through the extensive exhibit hall which featured some of the most amazing trade booths I have ever seen. Many advocates commented on the amount of money spent on this show. Remember that this is but one disease area for the pharmaceutical community. It is certainly possible that the same huge and expensive booth set-ups are brought to each meeting the company has a presence at. I do not know. But some of them were two stories high, and one featured a waterfall. All had freebies to hand out along with their information. I did take a tape measure from the booth featuring a new type of lymphedema arm/leg treatment. And I took two ‘post-it’ note pads from one of the pharmas. ASCO created a section for advocacy and the booth space was offered at no charge to non profits. Its location was good, right in the front where it is to be hoped many doctors stopped off. Other advocacy groups took paid booth space of their own, including the National Lymphedema Network which was staffed by a massage professional from New Orleans. The ‘Flexitouch’ system suggests it is “like having mild therapy right in your own home.” This is not a pump. The company says it acts to ‘prepare and drain. It is not yet covered by insurance but has been approved by FDA. www.tactilesystems.com (Find more information on lymphedema on our site under Breast Cancer Issues http://annieappleseedproject.org/lymtes.html or Ovarian and Gyn Issues http://annieappleseedproject.org/lymingynmal.html). Sunday featured a presentation on “Implications of the Women’s Health Initiative”. This was a series of discussions on what we now know about hormone replacement therapy. Dr. R. Chenoweth pointed out that as a result of recent trials, 33 million less prescriptions were written for hormones. Negative results included more congestive heart disease, more strokes, and pulmonary emboli. One thing of interest was a statement that the trials did not see more cases of invasive lobular. This had been discussed in the past but is not proving out. Interestingly the risk of breast cancer is decreased almost 40% in the first year of hormone use, down to a 23% reduction in risk in the second year and increased risk from then on. I asked if it would be a useful strategy to take HRT for one year, stop for a while (undefined) and then take it for another year? Of course we do not know the answer. The only strong benefit shown was a reduction in the number of colorectal cancers but the bad news was that the cases that did show up were more likely to have positive nodes and be metastatic (shades of finasteride – more on that later). Overall statement “No indication of chronic disease risk reduction”. There has been so much discussion as to why the whole country jumped on the hormone replacement wagon, and it is a complex discussion. There were observational studies that seemed to indicate a benefit. Certainly too much was made of the idea without any clinical trials. Jennifer Hays from Baylor College of Medicine discussed the Women’s Health Initiative (WHI) study. She told the audience that the participants were informed in April, 2000, of the increased risk of cardiovascular disease during first two years of use. In November, 2001, the women were told that the risk does not disappear after four years and in July, 2002 the trial was stopped. (JAMA, 2000 288) An increase in risk of stroke was shown in the trials, 31% with estrogen/progesterone and 39% with estrogen alone. The only unequivocal benefit was a reduction in hip fractures (after almost seven years). The risk of dementia almost doubled in the estrogen/progesterone group, particularly high among women over age 65. Kathy Pritchard, MD (Toronto) spoke about the HABITS and Stockholm trials (from Sweden), which followed 1300 women for five years. Women with a uterus were given estrogen plus progesterone and those without, just estrogen. There was more local recurrence of breast cancer, more contralateral and more distant mets on the HRT arm versus placebo. There were more serious adverse effects of all kinds with HRT. Dr. Pritchard mentioned that diet and exercise was useful for prevention of heart disease, osteoporosis, and colon cancer. I asked whether we had data on long-term developments of breast or colon cancer or heart disease. The women in the WHI will be followed for five more years so there will be more data forthcoming. One interesting result of stopping the US trial was that all the women stopped on the same day (per a letter of instruction). Thus they are an excellent cohort for follow up. All the women were scheduled for mammograms at the same time as well. Dr. Runowicz suggested that some women would continue to take estrogen given by their own personal physicians, so the group might have some confounding factors. There was a question on vaginal estrogen – ‘estring’. Dr. Pritchard originally thought that it could be used sparingly but some evidence now suggests it may raise lipid profiles. There were two papers with opposite results. Dr. Chenoweth stated women should be told there is uncertainty. Dr. Runowicz suggested that ‘vagifem’ showed higher absorption levels and Dr. Hays said topical estrogens might have less risk. At the end, there was some discussion of sexual satisfaction. Dr. Hays said there would be some data from the analysis of the estrogen and progesterone trial. Dr. Pritchard said the data was limited because the women were not necessarily highly symptomatic. 75% of the women on estrogen/progesterone said their hot flashes improved, while 52% felt that way on placebo. And a final comment said are some studies looking at whether hormone replacement helped skin look better. One of the speakers said that effect might be seen mostly on the back or other areas, rather than the face. |
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