CTF Structured Abstract: Br Ca Follow-up

Canadian Task Force on Preventive Health Care

Structured Abstract

Please note: In 2003, the CTF updated its Grades of Recommendations to include an "I Recommendation" for situations where insufficient evidence exists to allow a recommendation to be made. (Formerly, these situations were captured under a "C Recommendation".) This change is not retroactive, and all "C Recommendations" made prior to 2003 have not been reevaluated in light of the new "I" recommendation grade. For a discussion of these recommendation grades, please link to the 2003 article in the Canadian Medical Association Journal here.

Preventive Health Care, 1999 Update: Follow-up After Breast Cancer

Prepared by Larissa K.F. Temple, MD, Dept. of Surgery, Mount Sinai Hospital and University of Toronto, Elaine Wang, MDCM, MSc, FRCP (C), Dept. of Pediatrics, The Hospital for Sick Children, Toronto, Ontario, and Robin S. McLeod, MD, FRCS (C), Mount Sinai Hospital Samuel Lunenfeld Research Unit, Toronto, Ontario

These recommendations were finalized by the Task Force in January 1998

Objective
Burden of Suffering
Options
Outcomes

Evidence
Values
Benefits, Harms, and Costs

Recommendations
Validation
Sponsors

Objective

To evaluate the role of breast cancer follow-up in improving quantity and/or quality of life and to establish evidence based guidelines.

Burden of Suffering

Breast cancer is the most common cancer and second most common cause of cancer related mortality in Canadian women. In 1996, 18,600 Canadian women were diagnosed with breast cancer. It is estimated that 30%-40% of these women will eventually die as a result of their disease. Over 5,000 deaths in Canadian women were due to breast cancer in 1996.

Despite earlier detection of breast cancer and and changes in breast cancer therapy, recurrence continues to be problematic. Even with early disease, 30% of women will develop recurrent disease. After an audit and re-analysis, the NSABP-06 trial reported a 10% local recurrence rate in the conserved breast at 12 years. Women continue to be at risk of local recurrence for 20 years and 1%-2% of women every year will develop an ipsilateral recurrence. With mastectomy, local recurrence is less frequent (4%), but distant disease is more frequent. Regardless of local therapy (mastectomy of local excision and radiation), metastatic disease develops in 23% of women with stage I and II breast cancer. In addition to recurrent disease, women who have had breast cancer are at risk of developing cancer in the contralateral breast. After the first breast cancer, the risk of a new primary breast cancer is 3-5 times the risk of women developing a first breast cancer.

Options

Combination of blood tests, bone scans, liver echography and chest radiography for detection of distant disease; physical examination with or without mammography for detection of contralateral breast cancer; and physical examination with or without mammography for detection of ipsilateral recurrent disease after breast-conserving therapy.

Outcomes

Survival, disease recurrence and quality-of-life measures for distant disease, local recurrence of disease and disease in the contralateral breast

Evidence

MEDLINE was searched from 1966 to January 1998 using the MeSH terms "breast neoplasms, neoplasm recurrence (local and distant), local/diagnosis, and mammography" with limits to human and English. Reference lists were reviewed and two breast cancer specialists (PG and DM) were consulted to ensure completeness of the search.

Recommendations were graded as:

A Good evidence to support the recommendation that the condition be specifically considered in a PHE.

B Fair evidence to support the recommendation that the condition be specifically considered in a PHE.

C Poor evidence regarding inclusion or exclusion of the condition in a PHE, but recommendations may be made on other grounds.

D Fair evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE.

E Good evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE.

Quality of evidence was rated according to 5 levels:

I Evidence from at least 1 properly randomized controlled trial (RCT).

II-1 Evidence from well-designed controlled trials without randomization.

II-2 Evidence from well-designed cohort or case-control analytic studies, preferably from more than 1 centre or research group.

II-3 Evidence from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments could also be included here.

III Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees.

Values

The 9-member Task Force of experts in family medicine, geriatric medicine, pediatrics, psychiatry and epidemiology used an evidence-based method for evaluating the effectiveness of preventive health care interventions. Recommendations were not based on cost-effectiveness of options. Patient preferences were not discussed.

Background papers providing critical appraisal of the evidence and tentative recommendations prepared by the chapter author were pre-circulated to the members. Evidence for this topic was presented and deliberated upon in a 2-day meeting in January 1998. Consensus was reached on final recommendations.

Benefits, Harms, and Costs

4 RCTs of single ultrasound examinations were examined. 3 showed no difference in fetal mortality whereas the fourth one did although this difference was no longer significant when the increased number of therapeutic abortions for malformations were considered as deaths. The 4 studies did not differ for Apgar scores or days in the special care nursery. 1 study showed that women who had ultrasound examination had fewer inductions and a slight increase in birth weight (42 g, P = 0.008), and another showed earlier detection of twin pregnancies (100% detected before 21 weeks in the study group vs 76% in the control group).

The 4 studies that assessed multiple ultrasound examinations showed no differences in Apgar scores and perinatal deaths. 1 study showed fewer hospital days and 1 showed more hospital days with ultrasonography.

Systematic reviews showed that a single ultrasound examination was associated with early detection of twin pregnancies, decreased rates of induction, increased birth weight in singleton pregnancies, increased rates of therapeutic abortions because of fetal abnormalities and no differences in perinatal mortality or Apgar scores. Late ultrasound examination showed no differences for mortality, morbidity, or induction of labour. 1 meta-analysis showed decreased perinatal mortality with a single ultrasound examination.

Recommendations

Recommendation grade [A, B, C, D, E] and level of evidence [I, II-1, II-2, II-3, III] are indicated after each recommendation. Citations in support of individual recommendations are identified in the guideline text.

There is good evidence to exclude blood work and diagnostic imaging from screening for distant disease [E, I ]
There is insufficient evidence to include physical examination and/or mammography for the contralateral breast [C, III]. However, there is indirect evidence that it may be beneficial.
There is insufficient evidence to suggest that mammography decreases mortality by detecting ipsilateral disease in the conservatively treated breast [C, III]. However, there is indirect evidence that it may be beneficial.

Validation

This report was externally peer reviewed. Under the auspices of the Italian Ministry of Health and the Italian Research Council, an Italian group of stakeholders met in 1994 and recommended that yearly mammography and physical examination every 3 months be done for the first 2 years, yearly mammography and physical examination every 6 months be done for the next 3 years, and yearly mammography and physical examination be done thereafter. Although the authors acknowledged that their recommendations were extrapolated from findings in the general population, a Canadian consensus document recommended frequent physical examination and yearly mammography, .

A	Good evidence to support the recommendation that the condition be specifically considered in a PHE.
B	Fair evidence to support the recommendation that the condition be specifically considered in a PHE.
C	Poor evidence regarding inclusion or exclusion of the condition in a PHE, but recommendations may be made on other grounds.
D	Fair evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE.
E	Good evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE.

I	Evidence from at least 1 properly randomized controlled trial (RCT).
II-1	Evidence from well-designed controlled trials without randomization.
II-2	Evidence from well-designed cohort or case-control analytic studies, preferably from more than 1 centre or research group.
II-3	Evidence from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments could also be included here.
III	Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees.