Self-Examination or no Self-Examination

1. Self-Examination or no Self-Examination? That is the question on this 8th day of January, 2003. Krista Moreno Roybal, MD

2. To Shanghai we must go Randomized Trial of Breast Self-Examination in Shanghai: Final Results David B. Thomas, Dao Li Gao, Roberta M. Ray, Wen Wan Wang, Charlene J. Allison, Fan Liang Chen, Peggy Porter, Yong Wei Hu, Guan Lin Zhao, Lei Da Pan, Wenjin Li, Chunyuan Wu, Zakia Coriaty, Ilonka Evans, Ming Gang Lin, Helge Stalsberg, Steven G. Self Journal of the National Cancer Institute, Vol. 94, No.19, October 2, 2002 The goal: to determine whether Breast Self-Exam (BSE) reduces the # of women dying of breast cancer The real question was whether an INTENSIVE program of INSTUCTION in BSE would reduce the number of women dying from breast cancer. Inherent in the question are intermediary steps: can self breast exam be taught, do women become proficient at performing exam, if they do, does this lead to early detection of breast cancer, if early or not, does this detection lead to a decrease in mortality from the disease The real question was whether an INTENSIVE program of INSTUCTION in BSE would reduce the number of women dying from breast cancer. Inherent in the question are intermediary steps: can self breast exam be taught, do women become proficient at performing exam, if they do, does this lead to early detection of breast cancer, if early or not, does this detection lead to a decrease in mortality from the disease

3. What do the Guidelines and the Women say The U.S. Preventive Health Services Task Force states there is insufficient evidence to recommend for or against Women�s actions speak louder than words The US Preventive health services task force�s guidelines do not include the results of this study, but to date the evidence was inconclusive. In 1983, the World Health Organization recognized the need for randomized trial of BSE. The first randomized trial was intiated in 1985 in Leningrad (now St. Petersburg) �After approx 10 years of follow up, nearly equal numbers of women in the BSE and control groups had died from breast cancer, they were not diagnosed at a smaller size or a less advanced stage Programs to support and encourage monthly BSE in women were first established in Europe, Australia, and North America in the 1950�s. However despite a high level of awareness, many surveys in the 1990�s showed only a small minority of women ever examined their breasts regularly. Rates were low even among women doctors�only 21% of American Female doctors reported examining their breasts monthly.The US Preventive health services task force�s guidelines do not include the results of this study, but to date the evidence was inconclusive. In 1983, the World Health Organization recognized the need for randomized trial of BSE. The first randomized trial was intiated in 1985 in Leningrad (now St. Petersburg) �After approx 10 years of follow up, nearly equal numbers of women in the BSE and control groups had died from breast cancer, they were not diagnosed at a smaller size or a less advanced stage Programs to support and encourage monthly BSE in women were first established in Europe, Australia, and North America in the 1950�s. However despite a high level of awareness, many surveys in the 1990�s showed only a small minority of women ever examined their breasts regularly. Rates were low even among women doctors�only 21% of American Female doctors reported examining their breasts monthly.

4. Study Design: 266, 064 current and retired textile workers, from 519 factories Ages 30-64 Randomized by factory to a group receiving instruction on BSE or control Intervention- intensive instruction both in groups and individually Between the years 1989 and 1991, nearly 267, 000 current and retired 30-64 year old female employees of the Shanghai textile industry bureau, working in 519 different factories, were randomized by factory to a group receiving instruction in self breast exam or to the control group. The intervention included intensive regular instruction both in groups and individually, with multiple reminders to examine their breasts, and reinforcement practice sessions every six months for five years. No breast screening was offered to women in the control groupBetween the years 1989 and 1991, nearly 267, 000 current and retired 30-64 year old female employees of the Shanghai textile industry bureau, working in 519 different factories, were randomized by factory to a group receiving instruction in self breast exam or to the control group. The intervention included intensive regular instruction both in groups and individually, with multiple reminders to examine their breasts, and reinforcement practice sessions every six months for five years. No breast screening was offered to women in the control group

5. Did you get it right? Or are you still around? Approximately 2400 women from each arm of the study, were evaluated for proficiency at six different intervals. The women were given 4 min to palpate three silicone models BSE workers visited each factory every 1-2 months to report on deaths, transfers and retirements All women who reported a suspicious lump were initially evaluated by a factory medical worker, and then referred to a surgeon if the signs and symptoms were compatible with breast CA. The follow up rates were high. The medical records of all women found to have a histologically benign or malignent breast lesion were reviewed by specially trained study personnel for tumor size, spread to regional lymph nodes, and distant metastasis, for the TNM (tumor, node, metastasis) scheme. All histological slides were reviewed for quality, both benign and malignent sections, and pertinent changes made to the numbers in each group. All malignent cancers diagnosed in Shanghai were used, and the suspected missed cancers, originally thought to be benign, were detected through the process of review and used in the data.All women who reported a suspicious lump were initially evaluated by a factory medical worker, and then referred to a surgeon if the signs and symptoms were compatible with breast CA. The follow up rates were high. The medical records of all women found to have a histologically benign or malignent breast lesion were reviewed by specially trained study personnel for tumor size, spread to regional lymph nodes, and distant metastasis, for the TNM (tumor, node, metastasis) scheme. All histological slides were reviewed for quality, both benign and malignent sections, and pertinent changes made to the numbers in each group. All malignent cancers diagnosed in Shanghai were used, and the suspected missed cancers, originally thought to be benign, were detected through the process of review and used in the data.

6. Data processing and Analysis No clustering effect Stratification based on the hospital affiliation of factory Categorical variables were compared using chi-square Women within the same factory or group of factories may have had similar risk factors or type of medical care that could have influenced their breast cancer incidence or mortality. Analysis and stratification was done to secure that this factor was accounted for and that no such clustering effect would affect the final data.Women within the same factory or group of factories may have had similar risk factors or type of medical care that could have influenced their breast cancer incidence or mortality. Analysis and stratification was done to secure that this factor was accounted for and that no such clustering effect would affect the final data.

7. RESULTS RANDOMIZATION The two groups were similar with respect to risk factors for breast cancer and other variables The factories in instruction and control groups were also similar with respect to hospital affiliation, # of employees, time of initiation of trial activities Pg 1450 About 133,000 women in each group and because of this magnitude, no p values were reported. Basically, all the numbers were significant within this randomization which includes age, but overall, lists all the suspected risks of breast cancer Pg 1450 About 133,000 women in each group and because of this magnitude, no p values were reported. Basically, all the numbers were significant within this randomization which includes age, but overall, lists all the suspected risks of breast cancer

8. RESULTS COMPLIANCE Baseline instruction-high attendance- 98.5% Reinforcement sessions � decreasing attendance � Session 1 � 95% Session 2 � 83% P 1451 Supervised BSE sessions total 15 for employed �mean and median number actually attended were 12.3 and 13�and 13 sessions for retired workers, of which the mean and median were 11 and 12 sessions attended. GRAPHP 1451 Supervised BSE sessions total 15 for employed �mean and median number actually attended were 12.3 and 13�and 13 sessions for retired workers, of which the mean and median were 11 and 12 sessions attended. GRAPH

9. RESULTS PROFICIENCY Instruction Group � higher proportion consistently found lumps Lump-detecting ability was greatest immediately after the video, and declined to pre-video proficiency by 1 year later GRAPH, bottom of the page 1451 GRAPH, bottom of the page 1451

10. RESULTS INTERMEDIATE VARIABLES Slightly fewer women in the instruction group were diagnosed with breast cancer, but the difference was not statistically significant (p = .47) Instruction group � 864 Control group - 896 The number of women with benign biopsies was more than double More than double in the instruction group. # of benign biopsies in instruction group � 2761 vs 1505 in the control groupMore than double in the instruction group. # of benign biopsies in instruction group � 2761 vs 1505 in the control group

11. RESULTS DETECTION AND TREATMENT OF How was the Breast Cancer Found? Only 2.7% and 3.6% initially found by CBE 81.9% reportedly found by BSE Comparable information was not ascertained in the control group, 96.4% found them �accidentally� or �by themselves� In regards to treatment, slightly more women in the instruction group had breast-conserving surgery � 4.4% vs 2.7% and slightly fewer had radical mastectomies. Stratification by stage revealed that these differences were not as result of women in the instruction group having been diagnosed at a slightly less advanced stage than women in the control group. All other treatment interventions were the same: nearly equal percentages of each group were treated with radiation, hormones or antihormones,traditional chinese herbal medicines, etc In regards to treatment, slightly more women in the instruction group had breast-conserving surgery � 4.4% vs 2.7% and slightly fewer had radical mastectomies. Stratification by stage revealed that these differences were not as result of women in the instruction group having been diagnosed at a slightly less advanced stage than women in the control group. All other treatment interventions were the same: nearly equal percentages of each group were treated with radiation, hormones or antihormones,traditional chinese herbal medicines, etc

12. RESULTS MORTALITY Instruction group � 4.0% died and 7.4% left the STIB Control group � 4.5% died and 7.5% left the STIB ***0.12% of the women in the instruction and control groups developed Breast CA and Died

13. RESULTS SURVIVAL Eliminated any affect of lead-time bias No difference in survival from breast cancer for women from the two arms of the study They assessed survival in women with breast cancer from the time of entry into the trial to eliminate any effect of lead time bias. There was no difference in survival for women in the two arms of the study�no difference in survival from time of diagnosis, between the two groups, clearly demonstrating no increase in lead-time resulting from teaching BSE. Mortality from breast cancer did not decrease statistically significantly with number of BSE instruction, reinforcement, and supervised BSE sessions attendedThey assessed survival in women with breast cancer from the time of entry into the trial to eliminate any effect of lead time bias. There was no difference in survival for women in the two arms of the study�no difference in survival from time of diagnosis, between the two groups, clearly demonstrating no increase in lead-time resulting from teaching BSE. Mortality from breast cancer did not decrease statistically significantly with number of BSE instruction, reinforcement, and supervised BSE sessions attended

14. Discussion Duration � adequate N-number � large Intervention � appropriate Randomization � well done as well as Exclusions Women worked in factories of equal size, hospital affl, and diagnostic facilities This was a massive effort to teach and encourage 133,000 women to practice BSE and it did not show a reduction in mortality over a 10-11 year period. The trial period was adequate, especially when compared to randomized trials of mammography which show a reduction in mortality rates after about 5 years of follow up. The level of instruction and encourgagement was as high as one could reasonably expect in a mass program directed at a large population. It is unlikely that routine public health programs in developing countries, where mammography may not be available, could achielve this level of intensity, reminders, instruction (group and individual) and encouragment. They achieved a very appropriate level of randomization in this study. The ages were adequately distributed from 30 to 64. But because of the assoc with work/retirement the population was a little on the low side for breast cancer. Older women greater fatty tissue- easier time with detection and higher incidence of breast ca. Exclusions after randomization were three times as high in the instruction group than the control.�presumably b/c they were asked to make a much greater commitment than simply completing a baseline questioniare. It�s virtually impossible that these exclusions could have affected the overall breast cancer mortality rates.This was a massive effort to teach and encourage 133,000 women to practice BSE and it did not show a reduction in mortality over a 10-11 year period. The trial period was adequate, especially when compared to randomized trials of mammography which show a reduction in mortality rates after about 5 years of follow up. The level of instruction and encourgagement was as high as one could reasonably expect in a mass program directed at a large population. It is unlikely that routine public health programs in developing countries, where mammography may not be available, could achielve this level of intensity, reminders, instruction (group and individual) and encouragment. They achieved a very appropriate level of randomization in this study. The ages were adequately distributed from 30 to 64. But because of the assoc with work/retirement the population was a little on the low side for breast cancer. Older women greater fatty tissue- easier time with detection and higher incidence of breast ca. Exclusions after randomization were three times as high in the instruction group than the control.�presumably b/c they were asked to make a much greater commitment than simply completing a baseline questioniare. It�s virtually impossible that these exclusions could have affected the overall breast cancer mortality rates.

15. Blinding Issue Patients and Investigators were not blinded. Effect of behavioral changes on overall decreased mortality in the instruction group Also, more women in the instruction group had breast-conserving surgeries (4.4 vs 2.7%) However, this still did not affect the outcome in a way we would expect � decreasing the mortality from Breast Ca in the instruction group.However, this still did not affect the outcome in a way we would expect � decreasing the mortality from Breast Ca in the instruction group.

16. Conclusions Reasonable YES. All things considered, this study showed that the efficacy of BSE for decreasing breast cancer mortality is UNPROVEN Intensive instruction did not reduce mortality from Breast CA Programs to encourage BSE in absence of mammography would be unlikely to reduce mortality Women who choose to do BSE may have increased chance of having benign biopsy

17. External Validity Is this data �generalizable�? Does this apply to women outside rural China, where there was no access to mammography? Implications unclear in women with routine mammos and who are very motivated and proficient in BSE In countries with access to mammography screening, the results emphasize that BSE is not a substitute for regular mammos. The implications are unclear in women who have regular mammos or who are very motivated and proficient in the practice of BSE. This was a study of TEACHING SBE not on the PRACTICE of proficient SBE�which could presumably be something women practiced in between regularly scheduled mammos�this could enhance the benefit of a screening program In countries with access to mammography screening, the results emphasize that BSE is not a substitute for regular mammos. The implications are unclear in women who have regular mammos or who are very motivated and proficient in the practice of BSE. This was a study of TEACHING SBE not on the PRACTICE of proficient SBE�which could presumably be something women practiced in between regularly scheduled mammos�this could enhance the benefit of a screening program

18. What about CBE? The clinical breast exam is widely recommended and practiced Its effectiveness is dependent on its precision and accuracy On a recent collection of evidence by JAMA, reported in �The Rational-Clinical examination� here is some info on the best technique to use

19. Data Synthesis Indirect evidence supports the effectiveness of CBE, especially when women are screened with both CBE and mammography The proper technique includes Positioning Thoroughness of the search Vertical-strip search pattern Proper position and movement of the fingers CBE duration of at least 3 minutes per breast

20. Positioning Clinical breast exam requires flattening the breast tissue against the patient�s chest The lateral tissue The medial tissue Breast Boundaries-tissue extends laterally toward the axilla and superiorly toward the clavicle

21. Examination PatternThoroughness of the Search Palpation begins in the axilla and extends in a straight line down the midaxillary line to the bra line. The entire breast tissue is covered in this manner, between the clavicle and the bra line in a vertical fashion This technique was found to be more thorough than concentric circles or a radial spoke pattern. In one study, 2/5�s of physicians used no discernable pattern at allThis technique was found to be more thorough than concentric circles or a radial spoke pattern. In one study, 2/5�s of physicians used no discernable pattern at all

22. Proper position and movement of fingers The 3 middle fingers are held together, with the MCP joints slightly flexed. The pads, not tips, of the fingers are the examining surfaces Each area is palpated by making small circles, as if following the edge of dime 3 different pressures-light, med, deep, are used at each spot to ensure palpation at all levels of tissue

23. Duration of exam A careful exam of an average-sized breast takes 3 minutes This is much longer than the 1.8 min most physicians take to exam both breasts and teach SBE

24. Other Issues Palpation of supraclavicular and axillary regions to detect adenopathy is standard though UNTESTED Palpation of nipple should be same. Some texts call for squeezing nipple to express discharge-NOT USEFFUL PROGNOSTIC FACTOR Inspection-Importance UNPROVEN, no adequate data support recommendations

25. Bottom Line Screening CBE�s should be conducted for women at risk for Breast Cancer, women older than 40 years of age A well-conducted CBE can detect 50% of asymptomatic cancers and may contribute to reduction of mortality rate