CIHRT Exhibit P-2592 Page 1 APPENDIX. ADAPTE Process for the Treatment of In situ Breast Carcinoma. Eastern Health Breast Disease Site Group

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1 CIHRT Exhibit P-2592 Page 1 APPENDIX ADAPTE Process for the Treatment of In situ Breast Carcinoma Eastern Health Breast Disease Site Group Phase I - Setup The Breast Disease Site Group was formed in the fall of 2006 with representatives from Eastern Health s Cancer Care Program. It is a coalition of health professionals composed of pathologists, radiologists, radiation oncologists, medical oncologists, surgeons, genetics, representatives of the provincial screening program, pharmacists, nursing, and administration. The purpose of the group is to develop evidence-based clinical practice guidelines for diagnosis, care, and treatment of individuals with breast disease in the province of Newfoundland and Labrador. The objectives of the group include: 1. determining priorities for guideline development 2. reviewing national/international guidelines and providing direction for local adaptation 3. approving practice guidelines for local/provincial use 4. providing direction for dissemination and evaluation of guidelines 5. developing strategies for collection and analysis of breast cancer data within Eastern Health. Limited resources were a significant challenge to the objectives of the group though provincial funding had procured a clinical practice guideline coordinator position, while our expert members of other specialties volunteered generously of their time from busy work schedules. Therefore, a small subcommittee or guidelines team was created to oversee the adaptation process where applicable. It consisted of an oncologist, a pharmacist, the guidelines coordinator, and occasionally member(s) of the Disease Site Group with a particular interest in a guideline topic.

2 CIHRT Exhibit P-2592 Page 2 All panel members in the guideline development process have completed declarations of conflict of interest. Authorship of all adapted guidelines will be acknowledged as that of the Eastern Health Breast Disease Site Group. Once the draft guideline (either adapted or de novo) has been developed, it is reviewed at the monthly meeting of the group. Feedback is welcomed, any revisions are carried out and consensus, where possible, is reached. The guideline is then circulated to select target users for feedback, and revisions made accordingly. The guideline is then presented to the administrative body of Eastern Health for approval. Upon said approval, it will be distributed to appropriate health care providers in the province. This guideline will be reviewed and/or updated every 3-5 years, unless new research requires an earlier review.

3 CIHRT Exhibit P-2592 Page 3 Phase II Adaptation Question: What is the optimal post surgical treatment offered women with in situ breast carcinoma? PIPOH Population concerned women who have been diagnosed with in situ carcinoma of the breast (DCIS/LCIS) Interventions of interest use of the SERM, tamoxifen Professions to whom guideline is targeted family doctors, general practitioners, pharmacists, nurses, and other health specialists expected Outcomes decrease in the rate of invasive breast cancer occurrence after a diagnosis of in situ breast carcinoma Health care setting outpatient settings The search for existing guidelines and other relevant documents concerning the medical management of in situ breast carcinoma have revealed the following: 1. Management of ductal carcinoma in situ (DCIS): A Health Canada s Canadian Breast Cancer Initiative steering committee on clinical practice guidelines for the care and treatment of breast cancer. 2001; 2. Standard for the management of ductal carcinoma in situ of the breast (DCIS): A clinical practice guideline of the American Cancer Society. September 2002; 3. In situ disease: A clinical practice guideline from the B.C. Cancer Agency. November 2004;

4 CIHRT Exhibit P-2592 Page 4 4. Management of ductal carcinoma in situ of the breast: A clinical practice guideline. Program in evidence-based care A Cancer Care Ontario Program. September 2006; 5. NCCN clinical practice guidelines in oncology: Breast cancer. January Table for Summarizing Guideline Characteristics Title Publisher Country, Publication End of Comments language date Search date Management of ductal carcinoma in situ (DCIS): A Health Canada s Canadian Breast Cancer Initiative steering committee on clinical practice guidelines for the care and treatment of breast cancer. Canadian Medical Association Journal Canada, English June 2001 April 2001 This is a Canadian guideline, which may elevate it s status but is too old and out-ofdate to be utilized. Standard for the management of ductal carcinoma in situ of the breast (DCIS): A clinical practice guideline of the American Cancer Society CA: A Cancer Journal for Clinicians United States, English September 2002 unknown This guideline too is old and out-ofdate. In situ disease: A clinical practice guideline from the B.C. Cancer Agency. British Columbia Cancer Agency Canada, English November 2004 unknown Canadian study, not a well developed guideline.

5 CIHRT Exhibit P-2592 Page 5 Management of ductal carcinoma in situ of the breast: A clinical practice guideline. Program in evidence-based care A Cancer Care Ontario Program Cancer Care Ontario Canada, English September 2006 March 2006 Canadian guideline, very well developed, adapted by the National Guideline Clearinghouse. NCCN clinical practice guidelines in oncology: Breast Cancer National Comprehensive Cancer Network United States, English January 2008 unknown Most recent. Table for Summarizing Guideline Content What is the optimal post surgical treatment for in situ breast carcinoma? Population Women who have been diagnosed With in situ breast (DCIS/LCIS) Canadian Breast Cancer Initiative CPG 1 American Cancer Society CPG 2 B.C. Cancer Agency CPG 3 Cancer Care Ontario CPG 4 yes yes yes yes yes National Comprehensive Cancer Network CPG 5 Intervention(s) Post surgical management with use of SERM s yes yes yes yes yes Professionals/ Patients Target users are family physicians, general practitioners, other specialists and health care professionals yes yes yes yes yes Outcome Outpatient setting yes yes yes yes yes

6 CIHRT Exhibit P-2592 Page 6 Assess guideline quality Use of the AGREE (Appraisal of Guidelines Research and Evaluation) provides the framework for assessing the quality of clinical practice guidelines. Each of the five selected guidelines were evaluated with the AGREE instrument. Guideline currency Only two of the five identified guidelines, the Cancer Care Ontario and the NCCN guidelines, could be deemed as current. No new evidence for the use of tamoxifen has been presented, but certainly in terms of risk reduction, there has been some progress in recent years of assessing the best candidates to receive it.

7 CIHRT Exhibit P-2592 Page 7 Guideline content A recommendation matrice was created to help assess the content of each of the identified guidelines and compare their recommendations. Recommendation Matrix RECOMMENDATIONS CBCI ACS BCCA CCO NCCN CPG 1 CPG 2 CPG 3 CPG 4 CPG 5 Clinical Trials Reviewed the NSABP B-24 and the metaanalysis (only one avail. at the time) Reviewed the NSABP B-24 trial (only one avail. at the time) Reviewed both the NSABP B-24 and the smaller UKCCCR trials. Did note that the UKCCCR trial, though didn t show a statistical advantage for tamoxifen, did not include patients with margins and few women>50 yrs. A much more detailed review of both trials Has no reviews of either clinical trial. Role of tamoxifen May be a reasonable option, for those who decline mastectomy (esp.if high risk for contralateral breast ca and low risk of side effects). Not mandatory, risk/benefit ratio should be considered. Option for those who ve had breastconservation, premenopausal women and postmenopausal women without a uterus, as well as those at high for local failure. Tamoxifen should be offered if risk warrants (age, margin status and confirmation of ER positivity). Should not be used for bilateral mastectomy, increased risk of endometrial ca, or thromboembolic events, or life expectancy < 10 yrs, or had recently been taking tamoxifen for prevention. Should be informed of the option and potential risks/benefits.most beneficial for those < 50 yrs, positive resection margins and refuse surgery, or decline radiation or have a contraindication to radiation. Some evidence it s effective in reducing risk of ipsilateral recurrence and contralateral incidence, absolute benefit small and evidence conflicting. LCIS suggests counselling on tamoxifen for premenopausal women and tamoxifen or raloxifene for postmenopausal women. DCIS ipsilateral Tamoxifen after breast conservation and radiation, esp. those with ER positive DCIS, and those with excision alone. (Benefit for ER negative DCIS unknown). contralateral counselling for consideration of tamoxifen.

8 CIHRT Exhibit P-2592 Page 8 Guideline consistency Table of Criteria for Assessing the Quality of Study Search and Selection Overall, was the search for evidence comprehensive? The authors had a clearly focused question (population, intervention, outcome) Appropriate databases were searched for source guidelines Internet sites were searched for source guidelines Canadian Breast Cancer Initiative CPG 1 American Cancer Society CPG 2 B.C. Cancer Agency CPG 3 Cancer Care Ontario CPG 4 National Comprehensive Cancer Network CPG 5 Y Unsure N Y Unsure N Y Unsure N Y Unsure N Y Unsure N Years covered in search Languages covered in search Keywords used Combinations of keywords Detailed search strategies are provided with the guideline Snowball methods were used A hand search of the reference lists was completed Local experts and/or societies were asked for guideline recommendations Overall, was bias in the selection of articles avoided? Y Unsure N Y Unsure N Y Unsure N Y Unsure N Y Unsure N Inclusion and exclusion criteria reported The number of persons who selected and analysed the data is documented The procedure to solve disagreement is described

9 CIHRT Exhibit P-2592 Page 9 The number of references analysed is documented The number of excluded references is documented The reasons for excluding references are given The criteria for inclusion and exclusion are clinically and methodologically valid The reasons for exclusion conform to the selection and exclusion criteria The process for selection of evidence is adequately described Table for Recording Evaluations of Consistency between Evidence, it s Interpretation, and Recommendations What is the optimal post surgical treatment for in situ breast carcinoma? Overall, the evidence was valid Given the search strategy, the risk that relevant evidence has been missed is low The criteria for selecting the evidence is explicit Settings and protocols of selected studies fit with the health question Outcomes were clinically sound (e.g. duration of disease-free survival might be considered too weak as evidence compared to overall survival) The criteria used for assessing the quality and validity of the selected studies are adequately reported (type of studies, randomization methods, patient retention in groups etc...) The risk that biased evidence has been reported is low The outcomes were clinically sound (e.g. duration of disease free survival might be considered too weak as evidence compared to overall survival) CBCI CPG 1 ACS CPG 2 BCCA CPG 3 CCO CPG 4 NCCN CPG 5 Y Unsure N Y Unsure N Y Unsure N Y Unsure N Y Unsure N

10 CIHRT Exhibit P-2592 Page 10 When a meta-analysis was performed, statistical analysis were appropriate. Sensitivity analysis and test of heterogeneity was performed Coherence between the evidence and recommendations The evidence was direct. Patients and interventions included in the studies were comparable to those targeted by the recommendation Conclusions were supported by data and/or the analysis; results were consistent from study to study. When inconsistencies existed in data, considered judgement was applied and reported The conclusions are clinically relevant. (Statistical significance is not always equal to clinical significance) The conclusions derived from data point to effectiveness/ineffectiveness of the intervention and the recommendation is written accordingly There is some justification to recommend/not recommend the intervention even though the evidence is weak The hierarchy of strength of evidence is adequately described Overall, the scientific quality of this recommendation does not present risks of bias The strenght of evidence attributed to the recommendation is adequately described and justified Risks and benefits have been weighed

11 CIHRT Exhibit P-2592 Page 11 Acceptability and Applicability of the Recommendations Health Question What is the optimal post surgical treatment for in situ breast carcinoma? Overall, the recommendation CBCI CPG 1 ACS CPG 2 BCCA CPG 3 CCO CPG 4 NCCN CPG 5 Y Unsure N Y Unsure N Y Unsure N Y Unsure N Y Unsure N is acceptable The strength of evidence and the magnitude of effect adequately support the grade of the recommendation There is sufficient benefit of the intervention, compared with other available management The recommendation is compatible with the culture and values in the setting where it is to be used Overall, the recommendation is applicable The intervention is applicable to the patients in the context of use The intervention/equipment is available in the context of use The necessary expertise is available in the context of use There are no constraints, legislation, policies, or resources in the health care setting of use that would impede the implementation of the recommendation Decision and Selection

12 CIHRT Exhibit P-2592 Page 12 Checklist of Adapted Guideline Content Guideline section 1. Overview material Structured abstract including: o Guideline s release date o Status (original, adapted, revised, updated) o Print and electronic sources Adapter and source guideline developer When to be completed/completed 2. Introduction and background 3. Scope and purpose 4. Target audience of the guideline 5. Health questions 6. Recommendations Risks and benefits associated with the recommendations Specific circumstances under which to perform the recommendation Strength of recommendation (if assigned) 7. Supporting evidence and information for the recommendations Panel rational behind the recommendations Presentation of additional evidence How and why existing recommendations were modified 8. External review and consultation process Who was asked to review the guideline What process was followed Discussion of feedback Feedback incorporated into the final document 9. Plan for scheduled review and update 10. Algorithm or summary document 11. Implementation considerations 12. Glossary (for unfamiliar terms) 13. References of all material used in creating the guideline 14. Acknowledgment of source guideline developers and permission granted (where necessary) 15. List of panel members and their credentials, declaration of conflicts of interest 16. List of funding sources 17. Appendix describing adaptation process including: Guideline search and retrieval including list of guidelines and whether they were included/excluded with rationale Guideline assessments including a summary of results for each assessment (including AGREE domain scores) Decision process followed by panel Results and decisions of each evaluation

13 CIHRT Exhibit P-2592 Page 13 Table for Reporting on Results of Update Process Health question Recommendation in original guideline(s) End date of literature search New evidence (references) Final recommendation Comments