CA NEWS&VIEWS. STAR: First-Year Recruitment Efforts Set Brisk Pace for Future. Eligibility Requirements. Developing Safer, More Effective Agents

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1 CA NEWS&VIEWS STAR: First-Year Recruitment Efforts Set Brisk Pace for Future The Study of Tamoxifen and Raloxifene (STAR), a trial being conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and supported by the NationalCancerInstitute, needs to recruit an additional 16,000women. Having enrolled 6,139 postmenopausal subjects in its first year, the landmark study, which was designed to compare the relative efficacies of raloxifene and tamoxifen in lowering breast cancer risk, is seeking thousands of additional subjects throughout the US, Canada, and Puerto Rico. Developing Safer, More Effective Agents "Having shown that the risk of breast cancer can be reduced," explained Robert A. Smith, PhD, director of cancer screening for the American Cancer Society, referring to results of the Breast Cancer Prevention Trial (BCPT), which showed in 1998 that tamoxifen reduced the incidence of breast cancer in higher risk women, "the goal now is to develop safer and more effective agents." Unlike tamoxifen, raloxifene has not been associated with an increased risk of endometrial cancer. It is anticipated that STAR will help further define the risks and benefits of both tamoxifen and raloxifene. Originally studied in a large trial as an osteoporosis-preventing drug, raloxifene was also found to be associated with a reduction in the incidence of breast cancer. Results of that trial led to the current comparative study with tamoxifen. Eligibility Requirements Women are considered at high-risk for developing breast cancer-for the purposes of enrolling in the STAR trial-if their calculated risk is equivalent or higher than that of an average 60-year-old woman. Potential subjects must be postmenopausal, at least age 35, and have an increased risk of breast cancer (based on Fine Needle Aspiration: One Step Closerto Predicting Who Will Develop Breast Cancer A group of researchers from the University of Kansas Medical Center has reported a techniquethat may help predict which high-risk women will actually developbreast cancer. Nowthat chemoprevention with agents such as tamoxifen and raloxifene (see "STAR" story, this page) is rapidly becoming an option for some high-risk women, the ability to identify those at highest risk is particularly critical. These agents,whilerepresenting an exciting opportunity to be proactive with regard to breast cancer prevention, are also associated with a certain degree of risk in terms of side effects. The development of a test that mightpredictwhoismostlikelyto develop breast cancer could help target such Continued on page 272 VOL. 50 NO.5 SEPTEMBER/OCTOBER

2 NEWS & VIEWS STAR-Continued age; family history of breast cancer; personal medical history; age at first period; age at first live birth). Although quite rare, both deep vein thrombosis and pulmonary embolism have been associated with use of tamoxifen and raloxifene, and eligible subjects must be fully informed about such risks before enrolling in the trial. Once a woman decides to participate in the trial, she is randomly assigned to receive either 20 mg of tamoxifen or 60 mg of raloxifene daily for five years. The study protocol includes regular follow-up examinations, including mammograms and gynecologic exams. From BCPT to STAR Women who participated in the BCPT trial and were given placebo are now eli- gible either to receive free tamoxifen from the manufacturer or to enroll in STAR at one of 500 centers. How to Get Information on STAR In the US and Puerto Rico, postmenopausal women may call the NCI's Cancer Information Service at CANCER ( ) for information (English. or Spanish) about participating in STAR. The number for callers with TTY equipment is In Canada, interested women may call the Canadian Cancer Society's Cancer Information Service at for information (English or French). Information on STAR is also available at the NSABP's Web site (nsabp.pitt.edu) or the NCI's clinical trials Web site (cancertrials.nci.nih.gov). FINE NEEDLE-Continued therapies more accurately, and conversely, eliminate the need for unnecessarytherapy in those not at elevated risk. To improve on the Gail model of calculating a woman's risk for breast cancer (based on age at firstperiod; age at firstlive birth; number of breast biopsies; number of first-degree relatives with breast cancer)-which often overestimates risk in young women-carol Fabian, MD, and colleagues used fine-needle aspiration of breast tissue in 480 women to estimate breast cancer risk (J Natl Cancer Inst 2000;92: ). Fine needle aspiration removes fluid, cells,and smallfragments of tissue for subsequent cytologic examination. In the study by Fabian and co-workers, eight to 10 aspirationswere performed on different areas of each breast. Local anesthesia with lidocaine was used, and the procedure caused little discomfort, according to the researchers. The 480women were followedfor up to 10 years for signs of breast cancer. Of the 480 women, 20 developed breast cancer. Of those, 13 had invasivecancer and seven had ductal carcinomain situ. Hyperplasia with Atypia Hyperplasia with atypia was present more often in the samples of women who later developed cancer than in those of women who did not. Women whose aspirates showed hyperplasia with atypia had a fivetimes-higher risk of breast cancer than those without the abnormality. Fabian and colleagues observed that for women with both a higher-than average risk (based on the Gail model) and a 'finding of hyperplasia with atypia (established by fine needle aspiration), 15% developed breast cancer within three years. In contrast, 4% of those with an above-average risk (based on the Gail model) but without hyperplasia with atypia developed breast cancer during the same period. Additionally, the study indicated that none of the women with belowaverage risk estimates developed breast cancer. 272 CA-A CANCER JOURNAL FOR CLINICIANS

3 NEWS BRIEFS Don't Rush Counseling, Say Genetic Testing Experts Cancer survivors are likely to underestimate the degree of distress they might expect to experience in response to hearing that they have a genetic predisposition to cancer, according to researchers at Dana Farber Cancer Institute in Boston. Moreover, although many genetic testing programs allocate an average of 30 minutes for counseling, these investigators advise that several hours of counseling would be more appropriate. The study, which was conducted by Andrea F. Patenaude, PhD, and colleagues (J Clin Oncol2000;18: ), examined the pre- and post-test emotions of 65 people undergoing testing for either a mutation in the p53 gene (implicated in Li-Fraumeni syndrome) or in the BRCAI gene, linked to hereditary breast and ovarian cancers. Seven out of the 65 were cancer survivors; the other subjects had not had a cancer diagnosis, despite their higher risk. Subjectswere asked to rate levels of six different emotions-relief, happiness, sadness, guilt, anger, and worry-before testing and after actual results were reported. When the researchers compared the average levels of anticipated and actual emotional responses, they found that overall, both mutation carriers and noncarriers from the two groups (p53 and BRCAl) were able to accurately predict theiremotionalresponses to test results. Cancer Survivors Angrier, More Worried Subgroup analysis of cancer survivors in the BRCAI group, however, showed that mutation carriers had underestimated their actual reactions more frequently: 43% were more sad, 57% were angrier, and Cancer survivors are affected by a number ofissues raised by a positive test result, such as the possibility ofa cancer recurrence, as well as the knowledge that they may have passed a life-threatening genetic mutation on to their children. 57% were more worried than they had anticipated being when they learned of the positive test result. Overall, 86% of these cancer survivors reported feeling more intense levels of distressthan anticipated. Commenting on these results, Angela Trepanier, MS, a cancer genetic counselor in the division of medical genetics at Emory University in Atlanta, GA, explained that cancer survivors are affected by a number of issues raised by a positive test result, such as the possibility of a cancer recurrence, as well as the knowledge that they may have passed a life-threatening genetic mutation on to their children. The study authors point out that a cancer patientis often the firstmember of a family to undergo genetic testing, and that his or her response may affect the future health of other at-riskfamilymembers. It was recommended that several hours be allocated for counseling of individuals undergoing genetic counseling, and especially for cancer survivors, to have sufficient opportunity to review the information necessary for informed consent; to collect a thorough family and personal medical history; to address the subject's perception of the cancer experience; and to help prepare for a positive test result. VOL 50 NO.5 SEPTEMBERIOCTOBER

4 NEWS & VIEWS PATIENT P AGE. :,;':<FAnGu'Ejs when a persallhas less energy todothe things he orshe.normally does, ':<'Or:Jjal)tS todo;,,;ratigueisthemost~mmonsideeffectofcaocer.treatment.. The.,:i;~;''i'..,.{,f~tigueexPerien~eQ,bya person Wittr~cer isoifferent from the "';fatigue ofe~eryday life.'': '~:'1 7 } ;zc~i'.: r,;". ~ ~ I,;."...,,,,,,,~: >. \\~::;:,~c;: :;f';-;..,,~.>. > cxcp:ne~~:~eat~~nt RELATEiii=Af1GUE"'~appear suddenly arid....:_>-~f: :~:">'_~:';'~:"'_;: '._';:~::.,:,""/".::,,,,:,' -. _,,,' ':; ~i',:,: :. :'>, :::::. /"~_. ',:" '..,....:can6~:overv.'helrt1ing.l~is nofalvfaysreh~vedbyrest. It can last after "'tre~ment:ends\irilmay';p~rsistfor sev~rnlm()iiths.,.,"[;:: Managing Fatigue Related to Cancer Treatment What to Look For Feeling like you have no energy Feeling like you have to sleep more than usual Not wanting to do normal activities Decreased attention to your personal appearance.. Feeling tired, even after sleeping Trouble concentrating What to Do Prioritize your activities to make sure you have energy for important things Schedule activities throughout the day rather than all at once Plan rest periods Get enough rest and sleep but don't overdo (sometimes too much rest can make you feel tired and make it more difficult to sleep) Eat nutritious foods and drink plenty of liquids Let others help you with meals, housework, or errands Restore yourself whenever possible with moderate exercise and pleasant activities, such as listening to music, enjoying nature, visiting with family and friends 274 CA-A CANCER JOURNAL FOR CLIN ICIANS

5 PATIENT P AGE What Causes Cancer-Related Fatigue? Sometimes fatigue is related to the medications you take, either to help treat the cancer or to manage its symptoms, such as pain. Try to keep in mind that the medication is doing an important job and that your fatigue will probably improve gradually once you can stop taking it. Sometimes fatigue is related to depression. If you feel sad, tearful, or hopeless most or all ofthe time, you should talk with your doctor, nurse, or social worker. Ifyou are depressed, talking to someone about how you feel and/or medication can be helpful, and may relieve some of your fatigue. Sometimes fatigue has medical causes, such as dehydration, electrolyte imbalance, breathing problems, or anemia. Don't hesitate to talk with your doctor about being tired. He or she may be able to help you by correcting these conditions. Sometimes people feel more tired if they rest all the time. A professional, such as an occupational or physical therapist, can help you develop an appropriate exercise program that may give you more energy. Sometimes physical barriers or elements in your environment can cause you to waste precious energy. An occupationaltherapist can help you identify these energy-wasters and can suggest ways to streamline your activities. Call the Doctor or Nurse If you have been too tired to get out of bed for more than 24 hours; ifyou feel confused or cannot think clearly; or if you feel that your fatigue has become progressively worse. Where to Go For Information For more information about cancer-treatment related fatigue, call the American Cancer Society at ACS-2345 o'r the National Cancer Institute at CANCER. You may also visit the following helpful Web sites: (ACS); (NCI) or (Oncology Nursing Society). I These pages can be copied and given toyour patients. I VOL. 50 NO.5 SEPTEMBER/OCTOBER