Breast Cancer Screening Pros and Cons Dr Khaled

Breast Cancer Screening…. Pros and Cons Dr. Khaled Abulkhair MSc, Ph. D clinical Oncology, Mansoura University Medical Oncology SCE, Royal College, UK Ass. Professor of Clinical Oncology, Mansoura University, Egypt

Questions • Would you follow the current Guidelines ordering Mammographic screening for breast cancer for average risk lady aged 40 years or more? • What is the ultimate goal of screening? • How frequent you will do MAM?

FACTS: • Cancer develops in the body very silently. • Cancer is the cause of 12% of all deaths. • Until it comes to a certain stage patients lead a normal life without any complaints. • Initially it produces mild symptoms as found in other diseases. • Cancer detected at early stage produces better results on treatment and even cure. • Advanced disease leads to financial and psychological burden.

How To Detect Cancer Early As simple as…. . The Seven Danger Signals The American Cancer Society uses the word C-A-U-T-I-O-N to help recognize the seven early signs of cancer: 1. Change in bowel or bladder habits. 2. A sore that does not heal. 3. Unusual bleeding or discharge. 4. Thickening or lump in the breast, testicles, or elsewhere. 5. Indigestion or difficulty swallowing. 6. Obvious change in the size, color, shape, or thickness of a wart, mole, or mouth sore. 7. Nagging cough or hoarseness. These signs don't necessarily mean you have cancer, but it's important to have them checked out

Do we trust the public to catch upon these signals? We need a test …. many theories, questions and plans: • What we will call it? Screening…. . • Did we make a mistake replacing the concept of early detection by Screening ? ? ? • Why we are doing it? To help the public’s fight against cancer • Did the test really help the public? ? ? After 20 years of screening we are still not sure!

Questions? • Is early detection of cancer an easy job? • Is early detection equals screening? • What are the needed requirements for effective screening? • Cost / Benefits? • Do we need to import recommendations from other countries or carefully select what is suitable for our community?

He is not a woman!

Yes Non Conclusive False Positive

Screening • Screening refers to the use of simple tests across a healthy population in order to identify individuals who have disease, but do not yet have symptoms. • Examples include breast cancer screening using mammography and cervical cancer screening using cytology screening methods, Prostate cancer and PSA, Lung cancer and CT etc. • Based on the existing evidence, mass population screening can be advocated only for breast and cervical cancer, using mammography screening and cytology screening, in countries where resources are available for wide coverage of the population.

Definitions in simple Screening MAM is usually studied in comparison to the gold standard for diagnosing cancer (Biopsy). 1. High Sensitivity: to be sure that as few as possible with cancer get through undetected. 2. High Specificity: to be sure that as few as possible without cancer are subject to further diagnostic tests 3. Positive predictive value: the portion turned out to have cancer in those who give a positive test result. 4. Negative predictive value: the portion turned out to be free of cancer in those who give a negative test result. 5. Prevalence: If the prevalence of the disease is very low, even the best screening test will not be an effective public health programs. 6. Acceptability: the extent to which those for whom the test is designed agree to be tested.

Requirements for effective screening as per WHO: • Screening programs should be undertaken only when their effectiveness has been demonstrated. • Screening tests should fulfill the following criteria: i. ii. The screening test should meet acceptable levels of accuracy and cost. The screening test and follow-up requirements should be acceptable to individuals at risk and to their health-care providers. • when resources (personnel, equipment, etc. ) are sufficient to cover nearly all of the target group. • when facilities exist for confirming diagnoses and for treatment and follow-up of those with abnormal results. • And when prevalence of the disease is high enough to justify the efforts and costs of screening.

Basically…… • A disease of a relatively high prevalence and constitutes a major health problem e. g. Breast Cancer. • Organizational body to review the cost benefits, requirements and evaluate the program under utilization. • A good screening Test:

Perfect Screening Test Simple Cheap cost /benefit Non invasive and widely accepted • High sensitivity /specificity • Low false positive /false negative • •

GOOD AND BAD • Major financial burden on mass application • False negative! • False positive! Anxiety • Over diagnosis • Over treatment • Etc.

Breast Cancer Screening Using Mammography

What are the benefits of screening mammograms? • Early detection of breast cancer with screening mammography means that treatment can be started earlier in the course of the disease, possibly before it has spread! Remember this point • Results from randomized clinical trials and other studies show that screening mammography can help reduce the number of deaths from breast cancer among women ages 40 to 70, especially for those over age 50. • However, studies to date have not shown a benefit from regular screening mammography in women under age 40 or from baseline screening mammograms (mammograms used for comparison) taken before age 40.

USA: The American Cancer Society recommends that annual screening begin at age 40 for women at average risk

Who is offered breast screening/how often? We currently invite all women between 50 - 70 years old for breast screening. We offer breast screening every three years

Nordic Countries Including: (Denmark, Finland, Iceland, Norway and Sweden) § The recommendations is that screening begin at age 50 with two year intervals for subsequent exams. § Each Country adopts its own guidelines!

Inconsistency Among Different Guidelines § Which Guidelines Should We follow? § Is There A Strong Evidence Behind these Guidelines? If so……. . § Why there is a great difference between different guidelines? § How come UK doctors are sure they will not miss cancer cases by long interval Q 3 years? § Are there any harms behind screening mammogram? ?

The potential Harms Of Mammogram? • Finding cancer early does not always reduce a woman’s chance of dying from breast cancer. • False-negative results. Overall, screening mammograms miss about 20 % of breast cancers that are present at the time of screening e. g. dense breasts. Remember it depends up on “what the picture shows”. • False-positive results occur when radiologists decide mammograms are abnormal but ultimately no cancer is actually present……Anxiety till Cancer excluded

Continued……. . • Over-diagnosis: Can find very early indolent cancers especially in elderly and cases of DCIS that may never cause symptoms or threaten a woman’s life, leading to “over-diagnosis” of breast cancer. • Over-treatment: Treatment of these indolent cancers and cases of DCIS is not needed and leads to “overtreatment. ” This exposes women unnecessarily to the adverse effects associated with cancer therapy. • For every 14, 000 women screened regularly for 10 years, one woman may develop breast cancer she will die from because of the radiation from the mammograms (NHS). • QUALY? COST?

Methods: • Quality adjusted life years (QALYs), combining life years gained from screening with losses of quality of life from false positive diagnoses and surgery. The setting was England. • The outcomes of 100 000 women aged 50 were modelled in two cohorts, one screened the other not. • The outcome measures were deaths from breast cancer, deaths from all other causes, and the number of women having false positive diagnoses and surgery, which they combined into the main outcome—quality adjusted life years (QALYs).

They concluded that… • What is already known on this topic: Ø Mammographic screening for breast cancer saves lives but also imposes losses in quality of life from false positive results and unnecessary treatment. Ø It has been suggested that the harms outweigh the benefits, but this has not been quantified. • What this study adds: Ø By combining the life years saved with the quality of life losses in quality adjusted life years QALYs, this study combined the benefits and harms into a single measure. Ø Overall, their study supports the suggestion by Gøtzsche and Nielsen, 2009 that mammographic breast cancer screening could be causing more harm than good after 10 years.

• Methods: 8 Randomised trials comparing mammographic screening with no mammographic screening. They included 600, 000 women in the analyses. • Conclusions: 1. Screening is likely to reduce breast cancer mortality. A reasonable estimate is a 15% reduction corresponding to an absolute risk reduction of 0. 05%. 2. Screening led to 30% overdiagnosis and overtreatment, or an absolute risk increase of 0. 5%. 3. For every 2000 women invited for screening throughout 10 years, one will have her life prolonged and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. 4. Furthermore, more than 200 women will experience important psychological distress for many months because of false positive findings.

U. K: NHS • From NHS For every 400 women screened regularly for 10 years, one less will die from breast cancer i. e. one life saved! • Cost of a screening mammogram range from € 80 -120. • Simple Calculation: 400 x 100 € x 4 (times of screening over 10 years) = € 160. 000 to save one life! • Cost would be in billions of Euros if a significant number of women complied. • Around one in 20 women are called back because their mammograms show that more tests are needed (False Positive). • For each 1000 screened women; 8 will be diagnosed with breast cancer. Two of them will have DCIS (potential over diagnosis / over treatment).

• On 29 Oct 2012 Professor Sir Mike Richards, the NHS's National Cancer Director, initiated the review last year due to a number of academic reports which suggested the benefits of screening programs were being oversold and the harms underplayed. • While the panel concluded that the £ 96 million campaign does save lives, they said it caused significant harm too. • After looking at 10 trials involving almost 600, 000 women, they estimated the NHS program saves 1, 300 lives a year. • However, they also calculated it resulted in another 4, 000 receiving treatment for early-stage cancers that would never spread and cause them a problem.

Conclusions: The contrast between the time differences in implementation of mammography screening and the similarity in reductions in mortality between the country pairs suggest that screening did not play a direct part in the reductions in breast cancer mortality.

The benefit of screening is still highly criticized in countries with high Prevalence e. g. USA, UK and Nordic countries This criticism involved not only the clinical outcome but also the cost. • What about our countries? • What would be the real benefit? • What would be the cost?

Again…. Simple Calculations! • With our current incidence in Middle east Countries of about 1/2 - 1/3 that of western countries: • I assume that we may need to spend 2 -3 folds to save the same one life i. e. • Saving one Life = € 160. 000 x 2 = € 320, 000 = 3, 200, 000 L. E

Saving a single life worth Billions to us! But Do We really want to save lives? !!! • What vision they are talking about? It is a blind world! • During the 60 mint of this activity… 300 child will die in hunger!!!! • FAO ( Food Agriculture Organization) stated that Every day 925 millions worldwide experience hunger • € 160, 000/1. 600, 000!!!! • How many thousands of lives they can save? • A real Hypocrisy in medicine!

What Age Should We Start Screening At? • If we start at 40 years following NCCN guidelines…the median age of diagnosis of breast cancer in U. S. A is about 60 years i. e. they start about 15 - 20 years earlier. • Other countries start at 50 i. e. 10 years earlier. • Median Age of Breast Cancer in the middle east is around 45 years! DATA FROM K. S. A

Data on female patients with invasive breast carcinoma reported from different regions in Saudi Arabia show that most patients are in the age group of 40 - 50 years and were predominantly premenopausal.

Continued…. • The only available screening program is established in Al-Qaseem, Saudi Arabia, run by the local health department in cooperation with the King Abdulaziz Women’s Charity Committee. • This program employed a mobile mammography van to reach remote areas in the province. • Results of this ongoing screening program are not yet available. However, they will be important as the program is the first in the world to screen a population under the age of 40. • They invited women aged 35 -65 years for screening. • Very good BUT… What about the efficacy of MAM under 40 years!

WHO Statements: 1. Policies on early cancer detection will differ markedly between countries. 2. An industrialized country may conduct screening programs for cervical and breast cancer. Such programs are not, however, recommended in the least developed countries in which there is a low prevalence of cancer and a weak health care infrastructure. 3. The recommended early detection strategies for low- and middle-income countries are awareness of early signs and symptoms and screening by clinical breast examination in demonstration areas. 4. Mammography screening is very costly and is recommended for countries with good health infrastructure that can afford a long-term programs. 5. Further, only organized screening programs are likely to be fully successful as a means of reaching a high proportion of the at-risk population.

My Point Of View: 1. I am not against screening but against imposing the “high technology” of the developed world on countries that: • Lack resources / Lack Awareness To achieve adequate coverage of the population. • Having lower incidence. • Different disease characteristics.

2. Major success improving mortality in cancer patients were mainly achieved in cancers with fast growing nature where screening does not help! Ø Decreasing mortality: How can we separate the effect of screening from the effect of improving treatment strategy in breast cancer over the last 20 years? 3. A necessary condition for benefit by early detection requires that the disease tends to be diagnosed in an earlier stage (we still have ≥ 70% of breast cancer patients diagnosed at advanced stages). Awareness may be more needed than Screening? 4. The general consensus is that randomized clinical trials are the only way to evaluate screening programs for potential benefit. Do We Have Such Trials? 5. Important factor to consider is the efficacy of MAM in young population below 40 years as with our patient. No benefit for western population. What about ours?

Important Points To Remember • • Not all cancers can be screened for. Screening tests are not perfect. Early detection is not an easy job. It is becoming more difficult every day to justify MAM screening. It is based on “what the picture shows” thus it misses 20% of cancer! False Negative

• Easily, you can find data just saying the opposite of what I presented. • However, till we have our own data I do not believe adopting mass screening MAM is the best way for our countries. • I believe Screening is not an equal term for early detection! • CBE is still a valid option by WHO & NCCN guidelines. • Knowing your body well is still a very important and valid option. • Talk to your doctor if having new findings; which may not be anything to worry about, in which case you’ll lose nothing. But if it’s something serious, you could have everything to gain. • Breast awareness can not be over emphasized!

Wherever You Find Young People Fighting For A Better Life Help Them As Much As You Can…. If You Cannot Help…. . Please Do Not Be an Obstacle In Their Way