Examples: Basic: mastectomy, requires single interaction and done; Limited: Tamoxifen, AC, requires multiple interactions and follow-up; Enhanced: Aromatase Inhibitors, taxanes, (radiation therapy) requires interactions and followup and provides multiple options of therapy ; Maximal: Growth Factors, all targeted therapies, guidelines assume unlimited resources
ABC1: Advanced Breast Cancer 1 1st Consensus Conference November 3-5, 2011, Lisbon, PortugalManaging Breast Cancer in Low and Middle Income countriesNagi S. El Saghir, MD, FACP Professor & Director, Breast Center of Excellence NK Basile Cancer Institute American University of Beirut, Beirut, Lebanon
Beirut Marathon November 7, 2010Coming up : Beirut Marathon November 27, 2011
Breast Cancer Incidence Rates Worldwide and in LMC• Incidence is declining in many parts of USA and Europe (with variations according to state, socio-economic status, race)• Estimated Incidence (& Prevalence) is rising in most Low- & Middle- Income Countries (Lack of widespread Regional and/or National cancer registries)
USA: Trends in Breast Cancer Incidence Rates Drop seen till 2004, stabilization since then Desantis C, Siegel R, Bandi P, Jemal A. CA Cancer J Clin 2011 Oct 3, Epub
Estimated age-standardized incidence rates: ASR /100,000 women /year for breast cancer: GLOBOCAN 2008 Ferlay J, Shin JR, Bray F, et al. Int. J. Cancer: 127, 2893–2917 (2010)
Breast Cancer in LMCs• Global number of new breast cancer cases in 2008: ~ 1.38 Million• LMCs account for 45% of new breast cancer cases worldwide; expected to make 70% of cases by 2020• 54% of annual breast cancer deaths occur in LMC• Nearly 50% increase in breast cancer global incidence and mortality is expected 2002-2020 Lingwood RJ, Boyle P, Milburn A, et al. Nat Rev Cancer 2008; 8: 398–403. Anderson BO, Cazap E, El Saghir NS, et al. Lancet Oncol. 2011 Apr;12(4):387-98
Increased incidence & worse survivals in LMCsFactors associated with increased incidence:• Change in reproductive patterns• increased life expectancy• Changing lifestyle characteristicsFactors associated with worsened cancer survival:• largely attributable to late stage presentation: - In India, 50-70% of cases have locally advanced disease at diagnosis - In Arab countries, 60-80% had LABC and MBC Chopra R. The Indian scene. J Clin Oncol 2001; 19 (suppl 18): 106S–11S El Saghir N, Khalil M, Eid T et al, Intl J Surg. 2007 Aug;5(4):225-33
WHO Definitions: Income-status & effects on health care • The lower the income status: Lesser average life expectancy Lower public funding of health Higher out-of-pocket health expenditure Anderson BO, Cazap E, El Saghir NS, et al. Lancet Oncol. 2011 Apr;12(4):387-98
Survival by stage vs status of health services of countries Sankaranarayanan R, Swaminathan R, Brenner H, et al. Lancet Oncol 2010; 11: 165–73 Anderson BO, Cazap E, El Saghir NS, et al. Lancet Oncol. 2011 Apr;12(4):387-98
Breast Cancer Survival vs Race/Ethnicity (USA) Race/Ethnicity Breast Cancer-specific survival 2001-2007 Non-Hispanic White 88.8% African American 77.5% Asian American/Pacific Islander 90.3% American Indian/Alska Native 85.6% Hispanic/Latina 83.8% • Survival Rates are lowest in African American • Decline of Mortality rates is slower in poorer areas DeSantis C, Siegel R, Bandi P, Jemal A. CA Cancer J Clin 2011 Oct 3, Epub
Breast Health Global Initiative BHGI a Guideline and Project-Development group BHGI Resource Stratification (Anderson BO, Carlson R, Eniu A. 2006) Basic level: Core resources or fundamental services necessary for any breast health care system to function. Limited level: Second-tier resources or services that produce major improvements in outcome such as survival. Enhanced level: Third-tier resources or services that are optional but important, because they increase the number and quality of therapeutic options and patient choice. Maximal level: Highest-level resources or services used in some high resource countries that have lower priority on the basis of extreme cost and/or impracticality.
BHGI GUIDLINES for management of breast cancer according to levels of resources Anderson BO, Carlson R, Eniu A, et al. Cancer 2008;113:2221-2243 •HEALTH CARE SYSTEMS •EARLY DETECTION •DIAGNOSIS•STAGE I •STAGE II •LOCALLY ADVANCED •METASTATIC
BHGI: Guidelines Implementation Optimization of management & care deliveryLancet Oncology 2011; The Breast (suppl) 2011• Anderson BO, Cazap E, El Saghir NS, Yip CH, Khaled HM, Otero IV, Adebamowo CA, Badwe RA, Harford JB. Optimisation of breast cancer management in low-resource and middle-resource countries: executive summary of the Breast Health Global Initiative consensus, 2010. Lancet Oncol. 2011 Apr;12(4):387-98• El Saghir NS, Adebamowo, CA, Anderson, BO, Carlson RW, Bird PA, Corbex M, Badwe RA, Bushnaq MA, Eniu A, Gralow JR, Harness JK, Masetti R, Perry F, Samiei M, Thomas DB, Wiafe-Addai B, Cazap E. Breast cancer management in low resource countries (LRCs): Consensus statement from the Breast Health Global Initiative. The Breast 20 (2011) S3 - S11• Yip CH, Cazap E, Anderson BO, Bright KL, Caleffi M, Cardoso F, Elzawawy AM, Harford JB, Krygier GD, Masood S, Murillo R, Muse IM, Otero IV, Passman LJ, Santini LA, da Silva RC, Thomas DB, Torres S, Zheng Y, Khaled HM. Breast cancer management in middle-resource countries (MRCs): consensus statement from the Breast Health Global Initiative. Breast. 2011 Apr;20 Suppl 2:S12-9.
LMCs: Resources & Treatment Limitations• Mastectomy remains the most common surgical procedure• Radiation therapy, where available, is more often used only for palliative care than treatment• Systemic chemotherapy is not always administered by trained medical oncologists whose numbers are few anyway• Proper choices of therapy require good quality pathology laboratories and reliable determination of ER, PR and HER2 that are not always available• Palliative care remains very fragmented Anderson BO, Cazap E, El Saghir NS, et al. Lancet Oncol. 2011 Apr;12(4):387-98
LMCs: Recommendations by the BHGI 2010• Public awareness and Early Detection programs: Reduces taboos and excessive fears• Clinical breast examination should be promoted as a necessary method for clinical diagnosis of breast abnormalities• Need to optimize tissue sampling and pathology services• More early detection, and more Radiation Therapy centers reduce mastectomy rates• Need for Integration of services within multidisciplinary settings• Reduce barriers to access of cancer treatment and drugs Anderson BO, Cazap E, El Saghir NS, et al. Lancet Oncol. 2011 Apr;12(4):387-98
BHGI, Guidelines for stage IVAnderson, BO, Carlson R, Eniu A. et al. Cancer 2008;113:2221-2243
Treatment of patients with Metastatic Breast Cancer in LMCs• Cytotoxic chemotherapy: CMF, anthracyclines provide good short-term palliation• Training of health care professionals (Oncologists and others) to deliver chemotherapy & monitor side effects• Targeted therapy, ex. trastuzumab, along with chemo, is highly active against HER2-overexpressive breast cancer but remains too expensive to be available for patients in LMCs Anderson BO, Cazap E, El Saghir NS, et al. Lancet Oncol. 2011 Apr;12(4):387-98
New Therapies: Access and costs in LMCs• High costs, usually given for long terms• Anti-HER2 therapy Anti-HER2 therapy beyond progression Anti-HER2 therapy beyond response Other targeted therapies Anti-angiogenic therapy, …• The issue of “Statistically significant “ results vs “clinically meaningful “ results is very relevant in LMCs!• Costs and accessibilty: Major problems
New Therapies: access and costs in LMCs• Generics are Good options:• However, Many physicians in LMCs remain uncomfortable prescribing generics, either - because of poor quality control on manufacturing of generics - because of strong “big pharmaceuticals”’ lobbying - “Copies” (Illegal) of drugs are promoted as “Generics” and authorized in many countries!
Training & “Brain drain”from Low-resource to high resource countries• Health care workers providing anticancer therapy need good education and proper training• Training in countries with enhanced resources is a very common and beneficial practice, but carries risk of having trained people stay in high-income countries• Most LMC have graduates and trainees pursue higher education and training in countries with enhanced resources suffer from the Brain Drain phenomenon Anderson BO, Cazap E, El Saghir NS, et al. Lancet Oncol. 2011 Apr;12(4):387-98
Suggested solutions for “Brain drain”: Onsite training / Improve local conditions• On-site training by International Experts (of physicians, medical oncologists, radiologists, pathologists, nurses, nurse practitioners, pharmacists and all health care providers)• Short-term stays overseas reduce chances of staying there• Encourage commitment of traveling trainees to returning back home• Improve local facilities and working environments• Increase local supporting staff• Better compensation in their homeland• And, of course: Socio-economic and political reforms! Anderson BO, Cazap E, El Saghir NS, et al. Lancet Oncol. 2011 Apr;12(4):387-98
BHGI LEARNING LABORATORY:On-Site Training at Ghana Breast Cancer “Specialty Training Course series 2010”
Promoting multidisciplinary management of patients with breast cancer in LMCs• Care for patients with breast cancer is best delivered through multidisciplinary teams. - “Breast Units” - “Breast Centers of Excellence”• Improves standards of care• Sets up models for the rest of the country or region where they are created• Communications with physicians in rural areas help to improve care in the whole country Anderson BO, Cazap E, El Saghir NS, et al. Lancet Oncol. 2011 Apr;12(4):387-98
Multi-Disciplinary Management in LMCs338 Physicians in Arab countries survey: 72% hold TUMOR BOARDSOnly 52% hold it weekly57% attend Tumor Boards at Neighboring Hospitals93% agree it should become mandatory100% agree to have at least a MINI-TUMOR BOARD meeting with whoever is available! (Ex: Surgeon +Radiologist +/- Oncologist +/- Pathologist, …, ) El Saghir NS, El-Asmar N, Hajj C. et al. The Breast 20 (2011) S70 - S74
Down-staging of breast cancer in LMCs• A priority goal of Cancer Control Programs that countries with low and middle income:• Community awareness• Early detection Downstaging and Prevention of LABC and MBC Improvement of outcome and quality of life
Awareness campaigns help downstage breast cancer at presentationEarly detection saves breasts, saves lives, and saves families!
Awareness Campaigns help downstage breast cancer: Ex.: in Lebanon and other Arab countries• Young age at presentation: 50% are below the age of 50y (not changed)• Patient advocates: Sporadic, still not organized• High proportion of Locally advanced and metastatic diseases at presentation: 60-80%: presently decreasing• High rates of Mastectomy: 88-60%: presently decreasing, down to 50% or less in many centers• Low percentages of in-situ disease: <5% (presently increasing in some areas, due to use screening mammography!) Adapted from El Saghir N, Khalil M, Eid T et al, Intl J Surg. 2007 Aug;5(4):225-33
Regulatory Agencies & Guidelines in LMCs• Absence of reliable Local Regulatory Agencies in most countries• Reliance on International regulatory agencies: FDA & EMEA, NICE, others• International Guidelines remain essential; however, Guidelines often assume unlimited resources!• Adaptation of guidelines to local areas: ex.: NCCN-MENA (Abulkhair O, Saghir N, Sedky L, et al. JNCCN 2010 Jul;8 Suppl 3:S8-S15): have had limited success & utilization• BHGI Guidelines• ABC1 has adopted a great initiative of addressing the issue of resources• Prices are hoped to go down to make drugs accessible for women worldwide: … Imaginable ?!!!!!!!! … Why not ?!!!!!!!
Thank you for your attention! Raouche Twin Rocks, Beirut, Lebanon