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N8, Canada. 3Child Health Evaluative Services, The Hospital for Sick Children, Toronto, Ontario, Canada. Correspondence to: A B Miller ab. Women aged 4. 0- 4. Main outcome measure Deaths from breast cancer. Results During the five year screening period, 6. The overall hazard ratio for death from breast cancer diagnosed during the screening period associated with mammography was 1. The findings for women aged 4. During the entire study period, 3. Thus the cumulative mortality from breast cancer was similar between women in the mammography arm and in the control arm (hazard ratio 0. After 1. 5 years of follow- up a residual excess of 1. Conclusion Annual mammography in women aged 4. Overall, 2. 2% (1. Introduction. Regular mammography screening is done to reduce mortality from breast cancer. Mammogram detected non- palpable breast cancers are smaller on average than clinically palpable breast cancers. Small breast cancers confer a better prognosis than large ones. However, survival in the context of a screening programme is not predictive of reduced mortality because of lead time bias, length bias, or over- diagnosis. Thus the benefit of mammography screening must be evaluated in randomised screening trials, with breast cancer mortality as the endpoint. Over- diagnosis refers to the possibility that a screen detected cancer might not otherwise become clinically apparent during the lifetime of the woman. Over- diagnosis can be estimated in a randomised screening trial when a sufficiently long period has elapsed from the cessation of screening—that is, when all cancers should have become clinically apparent in both trial arms. In 1. 98. 0 a randomised controlled trial of screening mammography and physical examination of breasts in 8. Canada, the Canadian National Breast Screening Study. It was designed to tackle research questions that arose from a review of mammography screening in Canada. US Breast Cancer Detection and Demonstration projects. At that time the only breast screening trial that had reported results was that conducted within the Health Insurance Plan of Greater New York. Benefit from combined mammography and breast physical examination screening was found in women aged 5. Therefore the Canadian National Breast Screening Study was designed to evaluate the benefit of screening women aged 4. It was not deemed ethical to include a no screening arm for women aged 5. We have now followed the study participants for a mean of 2. Previously the trial was reported in two components, women aged 4. As the results from the mammography and control arms were similar in both age groups, we have combined the age groups and compare breast cancer incidence and mortality rates up to 2. Methods. Participants were recruited to the study by a general publicity campaign, by reviewing population lists and sending personal invitation letters, by group mailings, and through family doctors. Women were eligible if they were aged 4. Recruitment was planned to enrol 5. Before randomisation, the women who volunteered to participate signed an informed consent form approved by the University of Toronto’s Human Experimentation Committee. The study was conducted in 1. Canadian provinces (Nova Scotia, Quebec, Ontario, Manitoba, Alberta, and British Columbia). All screening centres were located in teaching hospitals or in cancer centres. The central coordinating centre was at the University of Toronto. Participants then had a physical (clinical) breast examination and were taught breast self examination by trained nurses, or in the province of Quebec, by doctors (fig 1. The examiners had no role in the randomisation that followed; this was performed by the study coordinators in each centre. Randomisation was individual and stratified by centre and five year age group. Irrespective of the findings on physical examination, women aged 4. Those allocated to mammography were offered another four rounds of annual mammography and physical examination, those allocated to no mammography were told to remain under the care of their family doctor, thus receiving usual care in the community, although they were asked to complete four annual follow- up questionnaires. Women aged 5. 0- 5. Fig 1 Process of randomisation and initial screening (screen 1). Breast examination was carried out by nurses unless stated otherwise (+ve indicates abnormality found by examiner, - ve no abnormality found). MA=mammography (+ve indicates abnormality found by radiologist, - ve no abnormality found). Study surgeon could order diagnostic mammography or consult with the study radiologist if necessary before sending recommendations to family doctors. Bracketed interventions indicate protocol at subsequent screens. For those women enrolled in the final year of recruitment, a total of four annual screens were offered. The screening period was defined as the first five years from randomisation for each woman and the follow- up period as years 6 to 2. As previously reported,4. In addition a small proportion (up to 3%) of the women attended and accepted breast examination but refused mammography. Of the women who failed to attend 3% to 7% submitted questionnaires. Over 9. 3% of participants in the control arm aged 4. Women with abnormal findings either on physical examination or on mammography were referred to a special review clinic directed by the surgeon affiliated with the study centre. If indicated, diagnostic mammography was performed. If further diagnostic investigation such as a biopsy was required, the woman was referred to a specialist chosen by her family doctor. Women for whom these investigations did not result in a diagnosis of breast cancer resumed their normal participation in the trial; women with a diagnosis of breast cancer were treated by specialists selected by the woman’s family doctor and were followed by us through annual communication with the selected surgeon until 3. June 1. 99. 6. During the screening period, centre coordinators collected surgical and pathology reports for all diagnostic and therapeutic procedures, including those for women aged 4. A pathologist affiliated with the Canadian National Breast Screening Study obtained and reviewed representative slides of all biopsy samples. Cancer treatment was arranged through the participant’s doctor and was not influenced by the study team. Canada has a universal healthcare system. No financial barrier exists to accessing appropriate diagnostic investigation or treatment. Throughout the study two view film screen mammography was used. In accordance with standard practice in North America, craniocaudal and mediolateral views were used until 1. Thereafter craniocaudal and mediolateral oblique views were used. Facilities and equipment for modern film screen mammography were prerequisites. Quality control procedures were established for radiation physics and mammography interpretation. Breast examiners received a month of training by the centre surgeon before conducting examinations in the study. In the remainder of this report we refer to the mammography plus breast physical examination arm in both age groups as the mammography arm, and the no mammography arms (usual care for women aged 4. Follow- up. The screening centres closed in 1. Thereafter the Canadian National Breast Screening Study coordinating centre continued to follow the women with a diagnosis of breast cancer in the screening period through their treating surgeon until 3. June 1. 99. 6. 6. To determine the underlying cause of death for those women with breast cancer who died, expert oncologists blind as to allocation obtained and reviewed detailed documentation on the terminal illness. Subsequent to 3. 0 June 1. The cut- off date for passive follow- up was 3. December 2. 00. 5. Using linkage to the Canadian Cancer Registry and the Canadian national mortality database, maintained by Statistics Canada in Ottawa, we ascertained all dates of breast cancer diagnoses and all dates of death from breast cancer that occurred before the cut- off date. The study investigators received reports on all deaths, with the certified underlying cause of death as coded within Statistics Canada. The denominators for the breast cancer incidence and mortality rates reported were all women randomised to the two arms of the trial. Statistical analysis. Tumour characteristics—We collected data on tumour size, lymph node status, and tumour palpability (yes or no) for women with a diagnosis of breast cancer in the screening period. For this analysis, we considered only invasive cancers as events. We also obtained similar data for 6. Cancers in the mammography and control arms (including interval cancers) were compared for these three characteristics and the . We also conducted analyses assuming the screening period to be six years and seven years. Survival was estimated from time of diagnosis to time of death from breast cancer, death from another cause, or date last known to be alive. Women not known to be dead were assumed to be alive on 3. December 2. 00. 5. We carried out subanalyses, stratifying the participants by tumour size (cm), nodal status, palpability of tumour, and mammography and control arms. Mortality rates—Participants were followed for death from breast cancer from the date of randomisation until 3. December 2. 00. 5. Women who died from another cause were censored at the date of death. The primary analysis included only deaths from invasive breast cancers diagnosed during the screening period. We carried out subanalyses on deaths from prevalent cancers (cancers detected at the first screening round) and deaths from incident cancers (cancers detected at screening rounds 2 to 5) plus cancers detected between screening rounds and cancers detected within one year of the last screen (interval cancers). We used Cox proportional hazards model to calculate hazard ratios with 9. A P value of 0. 0. All analyses were conducted using SAS. Results. Breast cancer occurrence. The 8. 9 8. 35 women were followed for incident breast cancers for up to 2. A total of 1. 19. Of the 6. 66 cancers detected in the mammography arm during the screening period, 4. Table 1 Number of breast cancers diagnosed in mammography arm and control arm, by study year. During the screening period the mean size of the cancers diagnosed in the mammography arm was 1. P=0. 0. 1) (table 2. In the mammography arm, 3. In the control arm, 3. P=0. 5. 3 for difference) and all were palpable. Overall, 4. 54 palpable cancers were detected in the mammography arm and 5. On average, palpable cancers were larger than cancers that were detected only by mammography (2. P< 0. 0. 01) and were more likely to be node positive (3. P< 0. 0. 01) (table 2). Table 2 Comparison of breast cancers detected during screening phase (years 1 to 5) in mammography arm versus control arm. Values are numbers (percentages) unless stated otherwise. Breast cancer survival. Overall, 1. 00. 5 women died from breast cancer during the 2. The 2. 5 year survival was 7. P< 0. 0. 01). The 2. P=0. 0. 2). The 2. The 2. 5 year survival of women with breast cancer diagnosed by mammography only (non- palpable) was 7. In the mammography arm, the survival of women with a non- palpable cancer was much longer than that of women with a palpable cancer (0. P< 1. 0. The 2. Overall, 1. 00. 5 deaths occurred from breast cancer. The 2. 5 year cumulative mortality from breast cancer was similar between women in the mammography arm and control arm (fig 2) (0. P=0. 8. 7). Fig 2 All cause mortality, by assignment to mammography or control arms (all participants)During the screening period, 3. Overall, the 2. 5 year cumulative mortality from breast cancers diagnosed during the screening period was similar between women in the mammography and control arms (fig 3. The hazard ratio remained similar if the screening period was extended to six years (1. P=0. 5. 5) or seven years (1. P=0. 4. 6). For women aged 4. P=0. 5. 8) and for women aged 5. P=0. 8. 8). The hazard ratio for 2. P=0. 0. 4), and the hazard ratio for deaths from incident cancers (those diagnosed in years 2 to 5) was 0. P=0. 4. 0). Table 3 Deaths from breast cancer to 3. December 2. 00. 5, by study arm and year of diagnosis. Values are numbers (percentages) unless stated otherwise. Fig 3 Breast cancer specific mortality, by assignment to mammography or control arms (all participants)Over- diagnosis. At the end of the screening period, an excess of 1. Fifteen years after enrolment, the excess became constant at 1. This excess represents 2. Fig 4 Breast cancer specific mortality from cancers diagnosed in screening period, by assignment to mammography or control arms. Discussion. In this analysis of findings from the Canadian National Breast Screening Study, we have extended the previously reported follow- up at 1. We still found no reduction in breast cancer mortality from mammography screening in a programme offering five annual screens, neither in women aged 4. Although the difference in survival after a diagnosis of breast cancer was significant between those cancers diagnosed by mammography alone and those diagnosed by physical examination screening, this is due to lead time, length time bias, and over- diagnosis. At the end of the screening period, an excess of 1. This implies that 2. This represents one over- diagnosed breast cancer for every 4. Assuming that nearly all over- diagnosed cancers in the Canadian National Breast Screening Study were non- palpable, 5. Strengths and limitations of this study. We believe that the lack of an impact of mammography screening on mortality from breast cancer in this study cannot be explained by design issues, lack of statistical power, or poor quality mammography. It has been suggested that women with a positive physical examination before randomisation were preferentially assigned to the mammography arm. If this were so, the bias would only impact on the results from breast cancers diagnosed during the first round of screening (women retained their group assignment throughout the study). However, after excluding the prevalent breast cancers from the mortality analysis, the data do not support a benefit for mammography screening (hazard ratio 0. It has also been suggested that women in the screening group might have been at higher a priori risk of developing breast cancer than women in the control group. After the screening period ended, however, breast cancer was diagnosed in 5. P=0. 8. 0), showing that the risk of breast cancer was identical between the compared groups. It has also been suggested that the lack of benefit from mammography screening found in the study could have been due to mammography screening ongoing in the community. We tackled this issue for women aged 4. Mammography screening programmes fall under provincial jurisdiction and were not introduced in Canada until after screening ceased in the Canadian National Breast Screening Study, initially in British Columbia in 1. Ontario and Alberta in 1. Nova Scotia in 1. Manitoba in 1. 99. Quebec in 1. 99. 8. We do not have data on the participation of the participants in these programmes, but we have no reason to suspect it was differential between the two arms of the Canadian National Breast Screening Study. These programmes did not necessarily include breast examination and most excluded women in their 4. In our analyses we included deaths of any woman with breast cancer detected by these programmes. Long term follow- up was conducted passively on participants, by record linkage to national databases. This allowed us to capture incident cancers and deaths for women who moved within the country, and for Canadian women who died in the United States, as death certificates on such women are forwarded to Statistics Canada. An occupational cohort study estimated that record linkage to the Canadian national death index was at least 9. We have shown that the sensitivity of the mammography employed in the screening centres was representative of the quality of the technology delivered at cancer centres and teaching hospitals and that the screening examination was properly conducted. Of the 6. 66 breast cancers diagnosed in the mammography arm during the screening period, 2. Cancers detected in the mammography arm were significantly smaller than cancers detected in the control arm (1. Furthermore, during the screening period 7. Some of this difference may be due to random fluctuation, but this may also be the consequence of shifting 7. Our study is strengthened by the long follow- up period and the acquisition of information on incident cancers that occurred beyond the screening period. The interpretation of our results is aided by additional data we acquired on tumour size, nodal status, mammographic detection, and palpability of tumours. In particular, during the screening period we detected 5. Within the screening arm, 4. Screening was annual, and therefore it is to be expected that in programmes with less frequent screening (for example, every two or three years) the proportion of invasive cancers detected in the mammography arm that would be palpable would be even higher. From this we infer that if there is benefit from a mammography only screening programme, it is derived through cancers detectable by a thorough breast physical examination. Comparison with other studies. Our long term result differs from the finding of the 2. Swedish Two- County Trial, which reported a 3. The analysis of the Swedish trial was based on invitation to screen (rather than actual screening), informed consent was not implemented, randomisation was at the county level (not individually), and screening was done every 2. The persisting divergence of breast cancer mortality with time suggests an initial imbalance of the compared groups, not a benefit of screening mammography. Of note, 6. 8% of the cancers in the screening arm in the Swedish trial were detected through screening, compared with 7. Canadian National Breast Screening Study. Tumours in the control group of the Swedish Two- County study were on average 2. The mean size of the tumours in our control group was relatively small (2. The difference in mortality associated with tumours less than 2 cm compared with larger tumours is substantial. Our estimate of over- diagnosis is smaller than that of a review of data from the Surveillance, Epidemiology, and End Results programme from 1. However, the reviewers considered a wider age range than in the Canadian National Breast Screening Study, and it is likely that over- diagnosis is greater at older than younger ages, as competing causes of death are more common. Other studies that resulted in lower estimates of over- diagnosis were based on indirect observations of the numbers of cancers detected in a population, before and after the introduction of screening programmes, and the extent of over- diagnosis was probably underestimated. Conclusions and policy implications. The results of the present study may not be generalisable to all countries. Early detection could be of greater benefit in communities where most cancers that present clinically are larger and a higher proportion are node positive. However, in technically advanced countries, our results support the views of some commentators that the rationale for screening by mammography should be urgently reassessed by policy makers. 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