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Sponsored by AAGL Advancing Minimally Invasive Gynecology Worldwide Panel Session 2: Hereditary Cancers in Gynecology: What the MIS Surgeon Should Know About Genetic Testing, Screening, and Risk-Reducing Surgery PROGRAM CHAIR Jubilee Brown, MD Lisa Amacker-North, MS Eugenio Solima, MD Yukio Sonoda, MD

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Page 1: Gynecology: What the MIS Surgeon Should Know About Genetic ... · Panel Session 2: Hereditary Cancers in Gynecology: What the MIS Surgeon Should Know About Genetic Testing, Screening,

Sponsored by

AAGLAdvancing Minimally Invasive Gynecology Worldwide

Panel Session 2: Hereditary Cancers in Gynecology: What the MIS Surgeon Should Know About Genetic Testing, Screening, and

Risk-Reducing Surgery

PROGRAM CHAIR

Jubilee Brown, MD

Lisa Amacker-North, MS Eugenio Solima, MD Yukio Sonoda, MD

Page 2: Gynecology: What the MIS Surgeon Should Know About Genetic ... · Panel Session 2: Hereditary Cancers in Gynecology: What the MIS Surgeon Should Know About Genetic Testing, Screening,

Panel Session 2: Hereditary Cancers in Gynecology: What the MIS Surgeon Should Know About Genetic Testing, Screening, and Risk-Reducing Surgery

Jubilee Brown, Chair

Faculty: Lisa Amacker-North, Eugenio Solima, Yukio Sonoda This session provides practical guidance for the gynecologist and gynecologic oncologist on genetic

testing, screening for hereditary gynecologic cancers, interpretation of results, surgical techniques, and

implementation of a successful program. Over ten percent of gynecologic cancers are preventable with

the detection of genetic mutations and timely intervention, which incorporates minimally invasive

surgical techniques. As this topic is increasingly covered in the lay media, patients desire sophisticated

answers to their questions. Who should be screened? What do the results mean? When should

screening and surgery take place? How should surgical techniques be performed and what else must

patients do to protect themselves from related cancers? These topics will be addressed by experts in the

field, along with practical guidelines for providing state-of-the-art care for your patients to eliminate

preventable cancers.

Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Counsel patients on

the most current recommendations for genetic testing, screening, and risk-reducing surgery to prevent

hereditary gynecologic cancers.

Course Outline

12:10 Welcome, Introductions and Course Overview J. Brown

12:15 Impact of Hereditary Cancer Prevention - Essential for Every Practitioner Y. Sonoda

12:20 Genetic Testing, Program Implementation, and Telegenetics L. Amacker-North

12:25 Appropriate Techniques for Risk-Reducing Surgery in Gynecology E. Solima

12:30 Current Recommendations for Screening, Surgery,

and Hormone Replacement Y. Sonoda

12:35 Panel Discussion All Faculty

1:10 Adjourn

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PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop (listed in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* R. Edward Betcher* Amber Bradshaw Speakers Bureau: Myriad Genetics Lab Other: Proctor: Intuitive Surgical Jubilee Brown* Sarah L. Cohen Consultant: Olympus Erica Dun* Joseph (Jay) L. Hudgens Contracted Research: Gynesonics Frank D. Loffer, Medical Director, AAGL* Suketu Mansuria Speakers Bureau: Covidien Linda Michels, Executive Director, AAGL* Karen C. Wang* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Sawsan As-Sanie Consultant: Myriad Genetics Lab Jubilee Brown* Aarathi Cholkeri-Singh Consultant: Smith & Nephew Endoscopy Speakers Bureau: Bayer Healthcare Corp., DySIS Medical, Hologic Other: Advisory Board: Bayer Healthcare Corp., Hologic Jon I. Einarsson* Suketu Mansuria Speakers Bureau: Covidien Andrew I. Sokol* Kevin J.E. Stepp Consultant: CONMED Corporation, Teleflex Stock Ownership: Titan Medical Karen C. Wang* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Lisa Amacker-North* Jubilee Brown* Eugenio Solima* Yukio Sonoda* Content Reviewer has no relationships. Asterisk (*) denotes no financial relationships to disclose.

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Page 4: Gynecology: What the MIS Surgeon Should Know About Genetic ... · Panel Session 2: Hereditary Cancers in Gynecology: What the MIS Surgeon Should Know About Genetic Testing, Screening,

Hereditary Cancers in Gynecologic Oncology:What the MIS Surgeon Should Know About

Genetic Testing, Screening, and Risk Reducing Surgery

Jubilee Brown, M.D.Professor and Associate DirectorDepartment of Gynecologic OncologyLevine Cancer InstituteCarolinas HealthCare SystemCharlotte, NC

Disclosures

• I have no financial relationships to disclose

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Objective

• Participants will be able to counsel patients on the most current recommendations for genetic testing, screening, and risk-reducing surgery to prevent hereditary gynecologic cancers

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The Panel

4

• Yukio Sonoda, MD

Surgeon, Gynecology Service

Memorial Sloan-Kettering Cancer Center

The Panel

5

• Lisa Amacker-North

Senior Genetic Counselor

Levine Cancer Institute, Carolinas HealthCare System

The Panel

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• Eugenio Solima, MD

Surgeon, Gynecologic Oncology

Fatebenefratelli-Macedonio Melloni Hospital, Milan, Italy

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The Line-Up

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• WHY?

Impact of Hereditary Cancer Prevention - Essential for Every

Practitioner

• WHAT?

Genetic Testing, Program Implementation, and Telegenetics

• HOW?

Appropriate Techniques for Risk-Reducing Surgery in

Gynecology

• WHO and WHEN?

Current Recommendations for Screening, Surgery, and

Hormone Replacement

• Panel Discussion

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Page 6: Gynecology: What the MIS Surgeon Should Know About Genetic ... · Panel Session 2: Hereditary Cancers in Gynecology: What the MIS Surgeon Should Know About Genetic Testing, Screening,

Impact of Hereditary Cancer Prevention - Essential for Every Practitioner

Yukio Sonoda, MD, FACOG, FACS

Attending Surgeon

Gynecology Service

Department of Surgery

Memorial Sloan Kettering Cancer Center

Disclosures

• I have no financial relationships to disclose

Objective

• Discuss effectiveness of early identification and prevention of gynecologic cancers, including family history assessment and risk reducing surgery.

Gynecologic Cancers – United States

Estimated New Cases in 2016

12%

57%

21% 6% 4%

Uterine Cervix Uterine Corpus Ovary Vulva Vagina

Uterine Cervix 12,990                  Uterine Corpus 60,050Ovary 22,280Vulva 5,950Vagina and other 4,620

Siegel R, et al. CA Cancer J Clin. 2016;66(1):7‐30

Gynecologic Cancer – United States

Estimated Deaths in 2016

13%

34% 46%

4% 3% Uterine Cervix Uterine Corpus Ovary Vulva Vagina

Uterine Cervix 4,120Uterine Corpus 10,470Ovary 14,240Vulva 1,110Vagina and other 950

Siegel R, et al. CA Cancer J Clin. 2016;66(1):7‐30

Causes of Hereditary Susceptibility to Ovarian Cancer

Hereditary(~10-20%)

Sporadic

BRCA1 (~70-75%)

Other single genes (<5%) BRCA2 (~20%)HNPCC (~2%)

~4200 cases of ovarian  cancer could be prevented if we could identify all predisposing mutations 

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Lynch Syndrome(Hereditary Non‐Polyposis Colorectal Cancer)

• Lynch (HNPCC) syndrome is the most common form of both hereditary endometrial and hereditary colon cancer accounting for approximately 5% of each of these diseases.

• It is vastly under recognized.

• Identification of individuals at risk allows application of proven risk‐reduction strategies for synchronous/metachronous cancers in probands as well as family members.

• ~3,000 cases of uterine  cancer could be prevented if we could identify predisposing mutations associated with Lynch Syndrome

Assessing Family History

• Family history screen for first visit:

– “Does anyone in your family; parents, grandparents, siblings, aunts, uncles or first cousins; have breast, ovary, uterine or colon cancer?”

• Family history screen for subsequent visits:

• Details

– Lineage

– Age of onset• Red Flags:

– Ovarian cancer

– Uterine Cancer

– Colon Cancer

– Early onset breast cancer

– Male breast cancer

– Multiple primary (ex bilateral) breast cancer

– Many relatives affected over multiple generations

– Breast and ovarian cancers

– Ashkenazi descent 

Risk‐Reducing Salpingo‐Oophorectomy

Kauff ND, et al. NEJM. 2002; 346:1609‐15

Risk-Reducing Salpingo-Oophorectomy

Study DesignN

(RRSO)Ovarian Cancer

Breast Cancer HR

Kauff, et al.NEJM 2002

Prospective 98HR = 0.15

(95% CI: 0.02-1.31)HR = 0.32

(95% CI: 0.08-1.20)

Rebbeck, et al.NEJM 2002

Retrospective 259HR = 0.04

(95% CI: 0.01-0.16)HR = 0.53

(95% CI: 0.33-0.84)

Finch, et al.JAMA 2006

Combined 1045HR = 0.20

(95% CI: 0.07-0.58)

Kauff, et al.JCO 2008

Prospective 881HR = 0.12

(95% CI: 0.03-0.41)HR = 0.53

(95% CI: 0.29-0.96)

Prophylactic Hysterectomy/BSO in Lynch

• Schmeler KM, et al. NEJM 2006; 354:261-9

– Retrospective case-control study of documented MMR mutation carriers

• No endometrial cancers in 61 women following hysterectomy vs. 69 endometrial cancers in 210 women who did not undergo hysterectomy.

– 3 unsuspected endometrial cancers detected at surgery

• No ovarian cancers in 47 women following BSO vs. 12 ovarian cancers in 223 women who did not undergo BSO.

Impact of Risk‐Reducing Hysterectomy in Lynch

Schmeler KM, et al. N Engl J Med. 2006; 354:261‐9

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Conclusions

• A significant number of gynecologic cancers can be prevented if these patients can be identified early.

• Hereditary cancer prevention starts with family history assessment.

• Risk reducing surgery is effective.

References

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan‐Feb;66(1):7‐30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.

• Kauff ND, Satagopan JM, Robson ME, Scheuer L, Hensley M, Hudis CA, Ellis NA, Boyd J, Borgen PI, Barakat RR, Norton L, Castiel M, Nafa K, Offit K. Risk‐reducing salpingo‐oophorectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med. 2002 May 23;346(21):1609‐15. Epub 2002 May 20.

• Rebbeck TR, Lynch HT, Neuhausen SL, Narod SA, Van't Veer L, Garber JE, Evans G, Isaacs C, Daly MB, Matloff E, et al. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med. 2002 May 23; 346(21):1616‐22. Epub 2002 May 20.

• Finch A, Beiner M, Lubinski J, Lynch HT, Moller P, Rosen B, Murphy J, Ghadirian P, Friedman E, FoulkesWD, Kim‐Sing C, Wagner T, Tung N, Couch F, Stoppa‐Lyonnet D, Ainsworth P, Daly M, Pasini B, Gershoni‐Baruch R, Eng C, Olopade OI, McLennan J, Karlan B, Weitzel J, Sun P, Narod SA; Hereditary Ovarian Cancer Clinical Study Group. Salpingo‐oophorectomy and the risk of ovarian, fallopian tube, and peritoneal cancers in women with a BRCA1 or BRCA2 Mutation. JAMA. 2006 Jul 12;296(2):185‐92.

• Kauff ND, Domchek SM, Friebel TM, Robson ME, Lee J, Garber JE, Isaacs C, Evans DG, Lynch H, EelesRA, Neuhausen SL, Daly MB, Matloff E, Blum JL, Sabbatini P, Barakat RR, Hudis C, Norton L, Offit K, Rebbeck TR. Risk‐reducing salpingo‐oophorectomy for the prevention of BRCA1‐ and BRCA2‐associated breast and gynecologic cancer: a multicenter, prospective study. J Clin Oncol. 2008 Mar 10;26(8):1331‐7. doi: 10.1200/JCO.2007.13.9626. Epub 2008 Feb 11.

• Schmeler KM, Lynch HT, Chen LM, Munsell MF, Soliman PT, Clark MB, Daniels MS, White KG, Boyd‐Rogers SG, Conrad PG, Yang KY, Rubin MM, Sun CC, Slomovitz BM, Gershenson DM, Lu KH. Prophylactic surgery to reduce the risk of gynecologic cancers in the Lynch syndrome. N Engl J Med. 2006 Jan 19;354(3):261‐9.

Thank You

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Genetic Testing, Program Implementation, and Telegenetics

Lisa Amacker North, MS, CGCLevine Cancer Institute

Charlotte, NC

Disclosures

I have no financial relationships to disclose.

Objective

Counsel patients on current recommendations for genetic testing

SGO Clinical Practice Statements

Genetic Testing for Ovarian Cancer, October 2014

• Women diagnosed with epithelial ovarian, tubal, and peritoneal cancers should receive genetic counseling and be offered genetic testing, even in the absence of a family history.

Screening for Lynch Syndrome in Endometrial Cancer, March 2014

• All women diagnosed with endometrial carcinoma should undergo systematic clinical screening (review of personal and family history) and/or molecular screening for Lynch syndrome, a hereditary cancer syndrome.

• Endometrial carcinomas can be screened for Lynch syndrome using immunohistochemistry (IHC) for the four mismatch repair proteins (MLH1, MSH2, MSH6, PMS2), microsatellite instability (MSI) analysis, and MLH1 hypermethylation testing.

3

Germline vs. Somatic Testing

Multiple tumor typing tests are available (i.e. Caris, FoundationOne, etc.)

MSI/IHC screening of Colon and Endometrial tumors fall in this category

These tests look for alterations within the TUMOR DNA, not the GERMLINE DNA to help determine which, if any, chemotherapy will be effective.

These results are NOT representative of the patient’s GERMLINE DNA.

• Can sometimes detect germline mutations, but these would need to be confirmed through additional genetic testing.

4

Cancer Germline Testing History

1994/1995 BRCA1/2 – 30% +variant rate in 90’s, now 3%

2007 BART – BRCA large rearrangement test (also called Del/Dup)

May 2013- US Supreme Court overturned Myriad Patent of BRCA1/2 genes

Next Gen Sequencing panels 2016 # oncology genes

• Ambry – January 2013 55

• GeneDX – August 2013 61

• Myriad – November 2013 28

• Invitae - 2014 94

Future: Whole exome (Now Pediatrics) Whole genome (2-5 years)

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Program Implementation

CoC Standard 2.3: Cancer risk assessment, genetic counseling, and genetic testing services are provided to patients either on-site or by referral to a qualified genetics professional.

LCI approach: Increase Genetic Counselors from 1 to 8, offer services regionally via 6 in-person clinics and by telemedicine at 5 sites.

Impact: increase referrals of women with ovarian cancer to genetics from 40% to 96% with 19% of those tested having germline mutations identified.

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References

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Appropriate techniques for Risk-Reducing Surgery in Gynecology

Eugenio Solima, MDGynecology Oncology DirectorObstetrics and Gynecology DeptUniversity of MilanMilan Italy

Disclosure

I have no financial relationships to disclose

• Assess the best approach to RRS

• Explain rationale for different surgical techniques

• Improve patient counseling

ObjectivesProphylactic salpingo oophorectomy:

The most proven method for the prevention of ovarian cancer in BRCA

mutation Carriers

70-85% reduction in ovarian cancer

Reduction in cancer-related mortality and overall mortality

Domchek jama 2010

Risk-Reducing Surgery

Salpingo-OophorectomyLaparoscopic ApproachInspection of all peritoneal surfacesCytology collectionResection of entire ovary (retroperitoneal in case of adhesions) resection of tube as close as possible to uterus, Lap bag

Alternative RR surgery in BRCA mutation carriers:Salpingectomy after childbearing complection

Preserve IP and UO ligamentsResection of yhe tubes at the uterusRemove all fimbriae Wedge of ov capsula where fimbiae are attachedSpecimen removal through lap sac

Subsequent ovariectomy+/-hysterectomy

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Bilateral salpingo-oophorectomy offers the greatest risk reduction for breast and ovarian cancer among BRCA mutation carriers. However, when considering quality-adjusted life expectancy, bilateral salpingectomy with delayed oophorectomy is a cost-effective strategy and may be an acceptable alternative for those unwilling to undergo bilateral salpingo-oophorectomy

Concerns

No study has currently shown the impact of salpingectomy in brca mutation carriers

No randomized study of RRS Vs RRSO No data for a 2-stage procedure Women undergoing interval

salpingectomy may will never decide to undergo oophorectomy

References Domchek SM, Friebel TM, Singer CF, Evans DG,

Lynch HT, Isaacs C, Garber JE,Neuhausen SL, Matloff E, Eeles R, Pichert G, Van t'veer L, Tung N, Weitzel JN,Couch FJ, Rubinstein WS, Ganz PA, Daly MB, Olopade OI, Tomlinson G, SchildkrautJ, Blum JL, Rebbeck TR. Association of risk-reducing surgery in BRCA1 or BRCA2mutation carriers with cancer risk and mortality. JAMA. 2010 Sep 1;304(9):967-75

Kwon JS(1), Tinker A, Pansegrau G, McAlpine J, Housty M, McCullum M, Gilks CB Prophylactic salpingectomy and delayed oophorectomy as an alternative for BRCA mutation carriers. Obstet Gynecol. 2013 Jan;121(1):14-24

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Current Recommendations for Screening, Surgery, and Hormone Replacement

Yukio Sonoda, MD, FACOG, FACS

Attending Surgeon

Gynecology Service

Department of Surgery

Memorial Sloan Kettering Cancer Center

Disclosures

• I have no financial relationships to disclose

Objectives

• Discuss current recommendations for screening, surgery, and hormone replacement therapy

UKCTOCS Trial

• Randomized trial to establish the effect of early detection by screening on ovarian cancer mortaily

• 202,638 women, June 2001‐Oct 2005, aged 50‐74

– Multimodal screening (MMS) vs annual TV US (USS) vs no screening

– Died from Ovarian Cancer

• MMS: 0.29%

• USS: 0.6%

• NS: 0.6%

• No significant mortality reduction

Jacobs et al. Lancet 2006

• Randomized trial, age 55‐75 yo, from 1993‐2001• 39,105 (Annual TVUS and Ca 125) vs 39,111 Usual Care• Median f/u: 14.7yrs• Deaths from Ovarian Cancer

• 187 (screened) vs 176 (usual care)• Rate Ratio 1.06 (95% CI: 0.86‐1.31)

• Conclusion: Extended f/u did not reveal a mortality benefit

Screening for Ovarian Cancer

• High risk women have traditionally been recommended to undergo TVUS and serum CA125 measurements q6 months starting ~age 30

• FDA Statement 9/7/2016

– Recommendation AGAINST using currently offered tests to screen for ovarian cancer for all women, including those at increased risk: 

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Efficacy of Endometrial Biopsies for Endometrial Cancer Screening in Women with Lynch

• Renkonen‐Sinisalo et al. Int J Cancer 2007

– 175 documented mutation carriers followed for 4.3 years.

– 503 Surveillance visits during 759 person‐years at risk

• TV Ultrasound – 94% of visits

• Endometrial Biopsy – 74% of visits

– 11 of 14 endometrial cancers diagnosed by surveillance

• 9 diagnosed by endo bx (2 with abnormal u/s, 6 with normal u/s, 1 u/s not done)

• 2 diagnosed by u/s (1 with normal endo biopsy, 1 biopsy not done)

– 14 (8%) of women had endometrial hyperplasia detected 

Lynch Syndrome Screening

www.NCCN.org

Risk of Breast and Ovarian Cancer with BRCA 1&2

Antoniou et al. am J Hum Genet 2003 

Breast

Ovarian

Breast

Ovarian

BRCA 1

BRCA 2

Sentinel Cancer in Women with HNPCC (N = 101 excluding synchronous cases)

Lu KH, et al. Obstet Gynecol. 2005; 105:569-74

Risk Reducing Surgery for HNPCC

www.NCCN.org

HRT following Risk‐Reducing Salpingo‐Oophorectomy

• Increase in endocrine and sexual symptomatology is common following RRSO.1

• Sexual symptomatology is the single biggest predictor of satisfaction with RRSO.2

• RRSO with short term HRT was still associated with a profound reduction in breast cancer risk in carriers of BRCA1 and BRCA2 mutations.

– HR = 0.37 (95% CI, 0.14-0.96)

1 Madalinska JB, Hollenstein J, et al. J Clin Oncol. 20052 Robson M, Hensley M, et al. Gynecol Oncol. 20033Rebbeck TR, et al. J Clin Oncol 2005

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Conclusions

• No apparent role for Ovarian Cancer Screening

• Annual Endometrial Bx may be considered for HNPCC patients

• Prophylactic surgery involves a long discussion

• Short term HRT seems reasonable

References• Jacobs I et al. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening 

(UKCTOCS): a randomised controlled trial. Lancet. 2016 Mar 5;387(10022):945‐56. doi: 10.1016/S0140‐6736(15)01224‐6. Epub 2015 Dec 17. Erratum in: Lancet. 2016 Mar 5;387(10022):944.

• Pinsky PF, Yu K, Kramer BS, Black A, Buys SS, Partridge E, Gohagan J, Berg CD, Prorok PC. Extended mortality results for ovarian cancer screening in the PLCO trial with median 15years follow‐up. GynecolOncol. 2016 Sep 8. 

• Renkonen‐Sinisalo L, BützowR, LeminenA, Lehtovirta P, Mecklin JP, JärvinenHJ. Surveillance for endometrial cancer in hereditary nonpolyposis colorectal cancer syndrome. Int J Cancer. 2007 Feb 15;120(4):821‐4.

• Lu KH, DinhM, KohlmannW, Watson P, Green J, Syngal S, Bandipalliam P, Chen LM, Allen B, Conrad P, Terdiman J, Sun C, Daniels M, Burke T, Gershenson DM, Lynch H, Lynch P, Broaddus RR. Gynecologic cancer as a "sentinel cancer" for women with hereditary nonpolyposis colorectal cancer syndrome. Obstet Gynecol. 2005 Mar;105(3):569‐74.

• Madalinska JB, Hollenstein J, Bleiker E, van BeurdenM, Valdimarsdottir HB, Massuger LF, GaarenstroomKN, MouritsMJ, VerheijenRH, van Dorst EB, van der Putten H, van der VeldenK, BoonstraH, Aaronson NK. Quality‐of‐life effects of prophylactic salpingo‐oophorectomy versus gynecologic screening among women at increased risk of hereditary ovarian cancer. J ClinOncol. 2005 Oct 1;23(28):6890‐8. Epub 2005 Aug 29.

• Robson M, Hensley M, Barakat R, Brown C, Chi D, Poynor E, Offit K. Quality of life in women at risk for ovarian cancer who have undergone risk‐reducing oophorectomy.GynecolOncol. 2003 May;89(2):281‐7.

• RebbeckTR, FriebelT, Wagner T, Lynch HT, Garber JE, Daly MB, Isaacs C, OlopadeOI, Neuhausen SL, van 't Veer L, Eeles R, Evans DG, Tomlinson G, Matloff E, NarodSA, EisenA, DomchekS, Armstrong K, Weber BL; PROSE Study Group. Effect of short‐term hormone replacement therapy on breast cancer risk reduction after bilateral prophylactic oophorectomy in BRCA1 and BRCA2 mutation carriers: the PROSE Study Group. J Clin Oncol. 2005 Nov 1;23(31):7804‐10. Epub 2005 Oct 11.

Thank You

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Page 16: Gynecology: What the MIS Surgeon Should Know About Genetic ... · Panel Session 2: Hereditary Cancers in Gynecology: What the MIS Surgeon Should Know About Genetic Testing, Screening,

CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

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