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Francisco Quereda Seguí. Alicante Gabriel Fiol Ruiz. Almería

ENCUENTRO CON LOS EXPERTOS: Manejo de la superviviente al cáncer de mama

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Francisco Quereda Seguí. Alicante Gabriel Fiol Ruiz. Almería

  1. 1. Dr. Francisco Quereda y Dr. Gabriel Fiol TRATAMIENTO DE LA AVV EN SUPERVIVIENTES DE CÁNCER DE MAMA Profesor Titular / Jefe de Servicio de Ginecología Universidad Miguel Hernández / Hospital Universitario de San Juan de Alicante Ginecólogo Adjunto / Hospital Universitario Torrecardenas de Almeria / Alborán, Centro Médico de la Mujer
  2. 2. ESTA PRESENTACIÓN TIENE UN OBJETIVO EXCLUSIVAMENTE INFORMATIVO Y HA SIDO CONCEBIDO COMO UN SERVICIO A LA PROFESIÓN MÉDICA. SU CONTENIDO REFLEJA ÚNICA Y EXCLUSIVAMENTE LAS OPINIONES, CRITERIOS, CONCLUSIONES Y/O HALLAZGOS PROPIOS DE SU AUTOR O AUTORES, QUE PUEDEN NO COINCIDIR NECESARIAMENTE CON LA OPINIÓN DE LOS LABORATORIOS PROPIETARIOS/COMERCIALIZADORES DE LAS MOLÉCULAS/MEDICAMENTOS MENCIONADAS EN LA PRESENTACIÓN. SE HA SOLICITADO A SU AUTOR QUE EL CONTENIDO DE LA PRESENTACIÓN SEA EN SU TOTALIDAD VERAZ, PRECISO, EQUILIBRADO, LO SUFICIENTEMENTE COMPLETO, Y NO ENGAÑOSO, Y QUE SE BASE EN TODO MOMENTO EN LA LITERATURA Y DATOS CIENTÍFICOS RELEVANTES. LA INFORMACIÓN PRESENTADA EN LA MISMA ES ACORDE EN SU TOTALIDAD CON LAS FICHAS TÉCNICAS AUTORIZADAS POR LAS AUTORIDADES SANITARIAS COMPETENTES PARA LOS FÁRMACOS QUE SE MENCIONAN EN LA MISMA. ESTA PRESENTACIÓN ES PARA USO Y DIFUSIÓN EXCLUSIVOS EN EL PRESENTE EVENTO, POR LO QUE SE HA SOLICITADO A SU AUTOR QUE NO REPRODUZCA SU CONTENIDO EN CONTEXTOS DIFERENTES AL DEL PRESENTE EVENTO, Y, EN PARTICULAR, EN DECLARACIONES ANTE LOS MEDIOS DE COMUNICACIÓN O EN LAS REDES SOCIALES. SE SOLICITA A LOS ASISTENTES, ASIMISMO, QUE NO PROCEDAN A REPRODUCIR EL CONTENIDO DE LA PRESENTACIÓN DE FORMA ÍNTEGRA O PARCIAL. EL PONENTE DECLARA QUE HA RECIBIDO HONORARIOS DE SHIONOGI, DE ACUERDO CON EL VALOR DE MERCADO DE ESTE TIPO DE SERVICIOS, PARA LA PREPARACIÓN Y REALIZACIÓN DE LA PRESENTACIÓN.
  3. 3. El cáncer de mama Problema relevante y frecuente - 24-26.000 nuevos casos de cáncer de mama y - 6.000-6.300 fallecimientos (España INE). - Incidencia en aumento. - El 29% de cánceres de la mujer - 18% de las muertes por cáncer (7.000/año, edad media 66) - 1/3 de ellas antes de los 50 años - Supervivencia media 15 años. - Aproximadamente 350.000 mujeres en España (1/10-12 mujeres climatéricas). PSICOONCOLOGÍA. Vol. 4, Núm. 2-3, 2007, pp. 231-248 Correspondencia: Marina Pollán Santamaría Área de Epidemiología Ambiental y Cáncer. Centro Nacional de Epidemiología. Instituto de Salud Carlos III. C/Sinesio Delgado, 6. 28029 Madrid. E-mail: mpollan@isciii.es SITUACIÓN EPIDEMIOLÓGICA DEL CÁNCER DE MAMA EN ESPAÑA Marina Pollán
  4. 4. El cáncer de mama Cancer Survival and Incidence from the Surveillance, Epidemiology, and End Results (SEER) Program Lynn A. Gloeckler Ries, doi: 10.1634/theoncologist.8-6-541 The Oncologist December 2003 vol. 8 no. 6 541-552
  5. 5. Cancer Survival and Incidence from the Surveillance, Epidemiology, and End Results (SEER) Program Lynn A. Gloeckler Ries, doi: 10.1634/theoncologist.8-6-541 The Oncologist December 2003 vol. 8 no. 6 541-552 SEER cancer statistics review, 1975-2005 Author(s) Ries, LAG; Year 2008 Publisher U.S. National Institutes of Health, National Cancer Institute Location Bethesda, MD Number of Page 907 http://seer.cancer.gov/csr/1975_2005
  6. 6. Impact of age, intrinsic subtype and local treatment on long-term local-regional recurrence and breast cancer mortality among low-risk breast cancer patients. Laurberg et al. Acta Oncol. 2017 Jan;56(1):59-67. doi: 10.1080/0284186X.2016.1246803. Epub 2016 Nov 16
  7. 7. - Percepción de riesgo vital - Cambio de imagen corporal y autoestima - Efectos indeseables y adversos del tratamiento adyuvante - Menopausia precoz o temprana - Impacto en sexualidad
  8. 8. Atención a la mujer tras cáncer de mama: Objetivos - Detección precoz de recidiva - Prevención y/o diagnóstico de nuevos tumores - Evaluación y prevención del riesgo óseo - Atención a síntomas climatéricos y problemas de calidad de vida
  9. 9. Perfil general de la atención al climaterio de la mujer con cáncer de mama - Necesidades de cualquier mujer - Necesidades específicas - Limitaciones para su manejo
  10. 10. Atrofia vulvovaginal Johnston, S. (2002) The Recognition and Management of Atrophic Vaginitis. Geriatrics/Aging, 5, 9-15.
  11. 11. Repercusiones genitourinarias de la menopausia Sintomatología vaginal Sensación de sequedad Prurito Dispareunia Coitorragia ocasional Sintomatología urinaria Nicturia Urgencia miccional Disuria Infecciones recidivantes Disfunción sexual Reducción del deseo sexual Evitación de actividad Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014 Oct;21(10):1063-8. doi: 10.1097/GME.0000000000000329
  12. 12. Impacto de la AVV en la sexualidad (FSFI). EVES cohorte española Palacios S, González SP, Fernández-Abellán M, et al. Impact of Vulvovaginal Atrophy of Menopause in Spanish Women: Prevalence and Symptoms According to the EVES Study. Sex Med 2019 Jun; 7(2): 207–216.
  13. 13. Aspectos de la vida de la mujer interferidos por la AVV. S. Palacios, et al. (2017): Vulvar and vaginal atrophy as viewed by the Spanish REVIVE participants: symptoms, management and treatment perceptions. Climacteric. 2017;20:55-61. S. Palacios, M. J. Cancelo, C. Castelo Branco, P. Llaneza, F. Molero & R. Sanchez Borrego (2017): Vulvar and vaginal atrophy as viewed by the Spanish REVIVE participants: symptoms, management and treatment perceptions. Climacteric. 2017;20:55-61.
  14. 14. Impacto de la AVV y patologías relevantes en la CV Depresión Fibromialgia Dolor Artritis SVM moderados/severos AVV moderada/severa EPOC Asma Vejiga hiperactiva Migraña Angina S. intestino irritable Condiciones con peor calidad de vida Scores EQ-5D de calidad de vida DiBonaventura M. Journal of womens health. 2015;24:713-72. The association between vulvovaginal atrophy symptoms and quality of life among postmenopausal women in the united states and western europe. DOI 10.1089/jwh.2014.5177 Vol 24 N 9, 2015
  15. 15. Montazeri A et al, J Exp Clin Cancer Res 2008 Quality of life in patients with breast cancer before and after diagnosis: an eighteen months follow-up study BMC Cancer volume 8, Article number: 330 Revisiones sistemáticas sobre CV en pacientes con cáncer de mama Autores Año Objetivo principal Conclusiones - Existe repercusión negativa en diferentes áreas de la CV, por el tratamiento quirúrgico y tratamientos adyuvantes - La mayoría se normalizan después del tratamiento adyuvante - No se identifican efectos negativos a largo plazo excepto por los síntomas vasomotores y disfunción sexual
  16. 16. Requisitos que un tratamiento para la AVV debe cumplir Síndrome genitourinario de la menopausia: recomendaciones de la Sociedad Española de Ginecología y Obstetricia Genitourinary syndrome of menopause: Recommendations from the Spanish Society of Obstetrics and Gynecology Santiago Palacios, Mª Jesús Cancelo Hidalgo. Prog Obstet Ginecol 2019;62(2):141-148
  17. 17. ¿Qué podemos hacer con la atrofia vulvovaginal de estas mujeres y su síndrome genitourinario relacionado?
  18. 18. Article AtrophicVaginitisin Breast Cancer Survivors: A Difficult Survivorship Issue JoanneLester 1,2,3, *, Gaurav Pahouja 4 , Barbara Andersen 2,3 and Maryam Lustberg3,5,6 1 Clinical Research Nurse Practitioner, Division of Surgical Oncology, The Ohio State University, Columbus, OH 43210, USA 2 Department of Psychology, The Ohio State University, Columbus, OH 43210, USA; E-Mail: andersen.1@osu.edu 3 Comprehensive Cancer Center, Arthur G. James Comprehensive Cancer Hospital and Richard J. Solove Research Institute, Columbus, OH 43210, USA; E-Mail: Maryam.lustberg@osumc.edu 4 Northeast Ohio Medical University, Rootstown, OH 44272, USA; E-Mail: gpahouja@kent.edu 5 Division of Medical Oncology, The Ohio State University, Columbus, OH 43210, USA 6 Stefanie Spielman Comprehensive Breast Center, 1145 Olentangy River Rd, Columbus, OH 43212, USA * Author to whom correspondence should be addressed; E-Mail: joanne.lester@osumc.edu; Tel.: +1-614-519-8995. Academic Editor: Jane Armer Received: 21 January 2015 / Accepted: 13 March 2015 / Published: 25 March 2015 Abstract: Management of breast cancer includes systematic therapies including chemotherapy and endocrine therapy can lead to a variety of symptoms that can impair the quality of life of many breast cancer survivors. Atrophic vaginitis, caused by decreased levels of circulating estrogen to urinary and vaginal receptors, is commonly experienced by this group. Chemotherapy induced ovarian failure and endocrine therapies including aromatase inhibitors and selective estrogen receptor modulators can trigger the onset of atrophic vaginitis or exacerbate existing symptoms. Symptoms of atrophic vaginitis include vaginal dryness, - Modificaciones del estilo de vida - Hidratantes vaginales - Lubricantes vaginales - Láser. Terapia estrogénica - Estrógenos sistémicos - Estrógenos locales - Otros: prasterona - Ospemifeno J Pers Med. 2015 Mar 25;5(2):50-66. doi: 10.3390/jpm5020050. Atrophic vaginitis in breast cancer survivors: a difficult survivorship issue. Lester J
  19. 19. Eur Rev Med Pharmacol Sci. 2016 Oct;20(20):4190-4195. Postmenopausal vulvovaginal atrophy (VVA) is positively improved by topical hyaluronic acid application. A prospective, observational study. Origoni M1 Int J Community Based Nurs Midwifery. 2016 Jan;4(1):69-78. Comparison of the Hyaluronic Acid Vaginal Cream and Conjugated Estrogen Used in Treatment of Vaginal Atrophy of Menopause Women: A Randomized Controlled Clinical Trial. Jokar A
  20. 20. © 2017Arroyo.ThisworkispublishedandlicensedbyDoveMedical PressLimited. Thefull termsof thislicenseareavailableat https://www.dovepress.com/terms.php International Journal of Women’s Health 2017:9 591–595 International Journal of W omen’sHealth Dovepress submit your manuscript | www.dovepress.com Dovepress 591 O R I G I N A L R E S E A R C H open access to scientifi c and medical research Open Access Full Text Article Fractional CO2 laser treatment for vulvovaginal atrophy symptoms and vaginal rejuvenation in perimenopausal women César Arroyo HM Montepríncipe University Hospital Laser Unit, Madrid, Spain Background:This study investigated a novel fractional carbon dioxide (CO2 ) laser for treatment of symptoms associated with vulvovaginal atrophy (VVA) in perimenopausal women. Methods: The study included 21 perimenopausal women (mean age 45 7 years) treated three times by CO2 laser resurfacing and coagulation of the vaginal canal tissue and mucosal tissue of the introitus. Vaginal health index (VHI) scores were computed by the investigator at baseline and follow-ups. Subjects reported on sexual function, satisfaction, and improvement with treat- ment. A visual analog scale was used to measure discomfort with treatment. Results:Vaginal health and subject assessment of vaginal symptoms improved with successive treatments. At 12 weeks following the third treatment, 82% of the patients showed a statistically significant improvement in VHI (P 0.05). Additionally, 81% of subjects reported improve- ment in sexual gratification, 94% reported improvement in vaginal rejuvenation, and 100% reported satisfaction with treatment. VHI improvement remained significant at 6–8 months after treatments (P 0.01). Most patients (97%) reported no to mild discomfort with treatment. Responses were mild and transient following treatment, with itching being the most commonly reported (20%) side effect. Conclusion: In this study, fractional CO2 laser treatment was associated with improvement of vaginal health and amelioration of symptoms of VVA, resulting in improved sexual function in perimenopausal women. Treatment time was quick, and there was minimal discomfort associated with treatment. Investigation of clinical outcome in a larger study population is warranted. Keywords: genitourinary syndrome of menopause, vaginal rejuvenation, stress urinary incontinence, collagen remodeling, sexual dysfunction, vulvovaginal atrophy Introduction Although the prevalence varies in early premenopausal to late postmenopausal women, vulvovaginal atrophy (VVA) is considered to be a common and underre- ported condition, with nearly 50% of postmenopausal women reporting symptoms.1 Self-reported genital symptoms include dryness, irritation, soreness, and associated dyspareunia.1–3 According to the Vulvovaginal Atrophy Terminology Consensus Conference Panel, genitourinary syndrome of menopause (GSM) is a more medically accurate term for VVA and includes genital symptoms, as well as sexual symptoms of lack of lubrication, discomfort or pain, and impaired function and urinary symptoms of urgency, dysuria, and recurrent urinary tract infections.4 Clinical findings include the presence of pale and dry vulvovaginal mucosa with petechiae. Thinning of the epithelial lining and loss of lubrication during intercourse contribute to dyspareunia and can have a detrimental effect on sexual gratification. As sexual Correspondence: César Arroyo HM Montepríncipe University Hospital Laser Unit, C/Senda del Infante 28, 28035 Madrid, Spain Email carroyoromo@gmail.com Journal name: International Journal of Women’s Health Article Designation: Original Research Year: 2017 Volume: 9 Running head verso: Arroyo Running head recto: CO2 laser treatment of VVA DOI: http://dx.doi.org/10.2147/IJWH.S136857 Number of times this ar ticle has been viewed This article was published in the f ollowing Dove Press journal: International Journal of Women’s Health 28 August 2017 International Journal of W omen’sHealth Dovepress O R I G I N A L R E S E A R C H open access to scientific and medical research Open Access Full Text Article Fractional CO2 laser treatment for vulvovaginal atrophy symptoms and vaginal rejuvenation in perimenopausal women César Arroyo HM Montepríncipe University Hospital Laser Unit, Madrid, Spain Background:Thisstudyinvestigatedanovelfractionalcarbondioxide(CO2 )laser for treatment of symptoms associated with vulvovaginal atrophy (VVA) in perimenopausal women. Methods: The study included 21 perimenopausal women (mean age 45 7 years) treated three times by CO2 laser resurfacing and coagulation of the vaginal canal tissue and mucosal tissue of the introitus. Vaginal health index (VHI) scores were computed by the investigator at baseline and follow-ups. Subjects reported on sexual function, satisfaction, and improvement with treat- ment. A visual analog scale was used to measure discomfort with treatment. Results:Vaginal health andsubject assessment of vaginal symptoms improved with successive treatments. At 12 weeks following the third treatment, 82%of the patients showed a statistically significant improvement in VHI (P 0.05). Additionally, 81% of subjects reported improve- ment in sexual gratification, 94% reported improvement in vaginal rejuvenation, and 100% reported satisfaction with treatment. VHI improvement remained significant at 6–8 months after treatments (P 0.01). Most patients (97%) reported no to mild discomfort with treatment. Responses were mild and transient following treatment, with itching being the most commonly reported (20%) side effect. Conclusion: In this study, fractional CO2 laser treatment was associated with improvement of vaginal health and amelioration of symptoms of VVA, resulting in improved sexual function in perimenopausalwomen. Treatmenttimewasquick,andtherewasminimal discomfortassociated with treatment. Investigation of clinical outcome in a larger study population is warranted. Keywords: genitourinary syndrome of menopause, vaginal rejuvenation, stress urinary Journal Article Year: 20 Volume Runnin Runnin DOI: ht Number of times this ar ticle has been viewed This article was published in the f ollowing Dove Press journal: International Journal of Women’s Health 28 August 2017 © 2017Arroyo.ThisworkispublishedandlicensedbyDoveMedical PressLimited. Thefull termsof thislicenseareavailableat https://www.dovepress.com/terms.php andincorporatetheCreativeCommonsAttribution– NonCommercial (unported,v3.0) License(http://creativecommons.org/licenses/by-nc/3.0/).Byaccessingtheworkyou herebyaccept theTerms.Non-commercial usesof theworkarepermittedwithout anyfurther permissionfromDoveMedical PressLimited,providedtheworkisproperlyattributed.For permission for commercial useof thiswork,pleaseseeparagraphs4.2and5of our Terms(https://www.dovepress.com/terms.php). International Journal of Women’s Health 2017:9 591–595ss.com 591 7 reported (20%) side effect. Conclusion: In this study, fractional CO2 laser treatment was associated with improvement of vaginal health and amelioration of symptoms of VVA, resulting in improved sexual function in perimenopausalwomen. Treatmenttimewasquick,andtherewasminimaldiscomfortassociated with treatment. Investigation of clinical outcome in a larger study population is warranted. Keywords: genitourinary syndrome of menopause, vaginal rejuvenation, stress urinary incontinence, collagen remodeling, sexual dysfunction, vulvovaginal atrophy Introduction Although the prevalence varies in early premenopausal to late postmenopausal women, vulvovaginal atrophy (VVA) is considered to be a common and underre- ported condition, with nearly 50% of postmenopausal women reporting symptoms.1 Self-reported genital symptoms include dryness, irritation, soreness, and associated dyspareunia.1–3 According to the Vulvovaginal Atrophy Terminology Consensus Conference Panel, genitourinary syndrome of menopause (GSM) is a more medically accurate termfor VVAand includes genital symptoms, as well as sexual symptoms of lack of lubrication, discomfort or pain, and impaired function and urinary symptoms of urgency, dysuria, and recurrent urinary tract infections.4 Clinical findings include the presence of pale and dry vulvovaginal mucosa with petechiae. Thinningoftheepithelial liningandlossoflubricationduringintercoursecontribute to dyspareunia and can have a detrimental effect on sexual gratification. As sexual rroyo ity Hospital ante 28, 28035 .com Láser Vaginal CO2 laser for the treatment of vulvovaginal atrophy in women with breast cancer: LAAVA pilot study. Breast Cancer. Res Treat 2019(3) doi:10.1007/s10549-019-05384-9 Pearson A, Booker A, Tio M, Marx G. Int J Womens Health. 2017 Aug 28;9:591-595. doi: 10.2147/IJWH.S136857. eCollection 2017. Fractional CO2 laser treatment for vulvovaginal atrophy symptoms and vaginal rejuvenation in perimenopausal women. Arroyo C Laser Ther. 2018 Mar 31;27(1):41-47. doi: 10.5978/islsm.18-OR-04. Early effect of fractional CO2 laser treatment in Post-menopausal women with vaginal atrophy. Eder SE
  21. 21. - Apoya el uso de estrógenos vaginales en mujeres RE/RP negativas - No hay datos específicos para grupos separados ER+EP+ o ER-EP- en términos de efectividad y seguridad en estos grupos Posicionamiento de la NAMS 2013: CONTRAINDICADOS Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society.
  22. 22. https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on- Gynecologic-Practice/The-Use-of-Vaginal-Estrogen-in-Women-With-a-History-of-Estrogen-Dependent- Breast-Cancer?IsMobileSet=false ACOG American College of Obstetricians and Gynecologists. Obstet Gynecol 2016;127:e93–6. committee opinion Number 659, March 2016 (Reaffirmed 2018) The Use of Vaginal Estrogen in Women With a History of Estrogen-Dependent Breast Cancer
  23. 23. Labrie F, Archer DF, Martel C, et al. Combined data of intravaginal prasterone against vulvovaginal atrophy of menopause. Menopause. 2017 Nov;24(11):1246-1256. Sequedad vaginal Prasterona Su Ficha Técnica contraindica su uso en pacientes con "Diagnóstico actual, antecedentes o sospecha de cáncer de mama"
  24. 24. Estrógenos + + + + + Del Pup et al. Eur Rev Med Pharmacol Sci 2016; 20: 3934-3944
  25. 25. Mejoría sintomática con ospemifeno Goldstein 2014:CLIMACTERIC 2014;17:173–182
  26. 26. Evidence overview No diferencias en marcadores de resorción ni formación ósea entre ospemifeno y raloxifeno en mujeres no osteoporóticas a las 12 semanas de tratamiento Adapted from: Komi J, et al. J Bone Miner Metab 2006; 24: 314-8. NTX: N-terminal cross-linking telopeptide of type I collagen; CTX: C-terminal cross-linking telopeptide of type I collagen. Marcadores resorción Sample Ospemifene 60mg Raloxifene 60mg NTX (normal range, 5- 65nmol/mmol creatinine) Before 75.0 ± 43.6 56.3 ± 29.4 Absolute change -20.2 ± 43.4 -10.2 ± 28.0 Percent change -10.2 ± 69.4 -7.9 ± 35.1 Post study 59.3 ± 21.2 49.5 ± 20.7 CTX (normal range, 40- 680µg/mmol creatinine) Before 417.3 ± 209.4 304.0 ± 168.5 Absolute change -56.6 ± 118.6 -4.6 ± 137.4 Percent change -9.8 ± 31.5 17.1 ± 93.4 Post study 424.0 ± 230.6 318.8 ± 134.0 Marcadores formación Sample Ospemifene 60mg Raloxifene 60mg Bone ALP (normal range, 3.0–14µg/l) Before 9.9 ± 3.1 9.5 ± 4.5 Absolute change 0.3 ± 2.1 0.6 ± 1.5 Percent change 5.8 ± 19.7 7.4 ± 16.4 Post study 10.6 ± 2.8 10.3 ± 4.2 Osteocalcin (normal range, 3.8– 30µg/l) Before 30.0 ± 11.1 26.9 ± 11.4 Absolute change -1.9 ± 7.9 -0.5 ± 6.7 Percent change -0.7 ± 27.1 4.0 ± 27.8 Post study 32.1 ± 8.7 30.8 ± 9.8 PINP (normal range, 19– 84µg/l) Before 51.1 ± 23.2 45.5 ± 24.8 Absolute change -2.2 ± 16.3 4.6 ± 15.6 Percent change 3.8 ± 35.2 21.3 ± 42.9 Post study 54.2 ± 18.2 52.4 ± 24.4 PICP (normal range, 50– 170µg/l) Before 125.0 ± 35.6 129.2 ± 35.7 Absolute change 0.5 ± 30.5 11.0 ± 36.6 Percent change 3.3 ± 22.1 10.1 ± 27.0 Post study 136.8 ± 31.6 147.6 ± 49.8 Bone ALP: bone-specific alkaline phosphatase; PINP: pro-collagen type I N propeptide; PICP: pro-collagen type I C propeptide.
  27. 27. Martino S, et al. J Natl Cancer Inst 2004;96:1751-1761 Incidencia de cáncer de mama invasivo RE+ y RE- 8 años de MORE y CORE (N=7705) 0 0,5 1 1,5 2 2,5 3 3,5 4 Placebo (N=2.576) Raloxifeno (N=5.129) RP 0,24 (95% IC = 0,15 - 0,40) P <0,001 RP 1,06 (95% IC 0,43 - 2,59) P = 0,90 Incidencia/1.000mujeres-años RE+ (n=66) RE- (n=22) *Las mujeres en la división de Raloxifeno recibieron Rlx 60 ó 120 mg/d en MORE y rlx 60 mg/d en CORE
  28. 28. - Una mujer del grupo placebo discontinuó por diagnóstico de cáncer de mama. - Otra mujer del grupo placebo presentó un carcinoma in situ Ningún cáncer de mama en mujeres con ospemifeno
  29. 29. Incidence of Breast Cancer in Vulvar and Vaginal Atrophy (VVA) Patients Treated With Ospemifene and Those Without any VVA-Related Treatments From US Real World Data B. Cai1, S. Djumaeva2, H. Kanakamedala3, M. Particco2, C. Altomare1 1 Shionogi Inc., Florham Park, NJ, USA; 2 Shionogi Limited, London, UK; 3 Genesis Research LLC, Hoboken, NJ, USA EMAS 2019, Berlin, Germany, May 15–17, 2019 Ospemifene Group (N=2,528) Untreated Group (N=118,623) Incidence Rate Ratio (95% CI) Total number of patients with breast cancer diagnosis any time after index date 7 927 Total number of follow-up years between index date and enrollment end date 5,560 322,300 Rate of breast cancer per 1000 patients per follow-up year (95% CI) 1.3 (0.5; 2.6) 2.9 (2.7; 3.1) 0.45 (0.19; 0.84) Incidence Rate of Breast Cancer Ospemifene Group (N=2,005) Untreated Group (N=4,010) Incidence Rate Ratio (95% CI) Number of breast cancer incidence case 4 14 Total person-year (between index date and enrollment end date) 4,386 8,774 Incidence rate per 1,000 person-year (95% CI) 0.9 (0.2; 2.3) 1.6 (0.9; 2.7) 0.56 (0.22; 0.85) Incidence Rate of Breast Cancer
  30. 30. RESULTADOS EFICACIA Mujeres que mostraron reducción en la severidad de su SMM en la semana 12 OSP PBO Población general 74,90% 61,80% Con historia de Cáncer de Mama 66,70% 50,00% Sin historia de Cáncer de Mama 75,00% 61,90% Mejoras comparables en los pacientes con OSP tanto CON (n=11) como SIN (n= 1091) historia de cáncer de mama o Bruyniks N, Del Pup L, Biglia N. Safety and Efficacy of Ospemifene in Women with A History of Breast Cancer. J Gynecol Women’s Health. 2019: 13(5): 555871. Research Article Volume 13 Issue 5 - January 2019 DOI: 10.19080/JGWH.2019.13.555871 J Gynecol Women’s Health Copyright © All rights are reserved by Nico Bruyniks J Gynecol Women’s Health 13(5): JGWH.MS.ID.555871 (2019) 001 Journal of Gynecology and Women’s Health ISSN 2474-7602 Safety and Efficacy of Ospemifene in Women with A History of Breast Cancer Nico Bruyniks1 *, Lino Del Pup2 and Nicoletta Biglia3 1 BrInPhar Ltd, Iver Heath, Buckinghamshire, United Kingdom 2 Centro di Riferimento Oncologico, National Cancer Institue, Italy 3 Department of Oncological Gynaecology, University of Turin, Italy Submission: December 21, 2017; Published: January 08, 2019 *Corresponding author: Nico Bruyniks, BrInPhar Ltd, Iver Heath, Buckinghamshire, United Kingdom Background Vulvar and vaginal atrophy (VVA) is a chronic, progressive postmenopausal condition characterized by dyspareunia, vaginal dryness and vaginal irritation, which are a consequence of a decline in endogenous estrogen production [1]. It has previously been shown that women with a history of breast cancer are more likely to have moderate or severe symptoms and signs of VVA than women without breast cancer, particularly if treated with aromatase inhibitors [2] or tamoxifen after high-dose chemotherapy [3]. Due to the risk of breast cancer recurrence if exposed to estrogen [4], all estrogens (even low-dose vaginal estrogens) are contra-indicated in women with known, past, or suspected breast cancer [5]. Ospemifene is an oral non-estrogen treatment that has been approved for the treatment of moderate to severe symptomatic VVA in post-menopausal women who are not candidates for local vaginal estrogen therapy [5,6]. It belongs to the selective estrogen receptor modulator (SERM) class, which also includes treatments indicated for the treatment and/or prevention of certain breast cancers [7-10]. Ospemifene binds selectively to estrogen receptors to exert a tissue-specific effect [11]. In the breast, there are two estrogen receptors (ERα and ERβ), which can bind estrogen or a SERM [12,13]. Preclinical animal data suggest that ospemifene inhibits malignant breast tissue growth [14-18]. In addition, data from the ospemifene clinical Abstract Background: This post-hoc analysis compares the efficacy and safety data from women with or without a history of breast cancer who had been enrolled in the ospemifene clinical trial program. Methods: Efficacy was assessed by the co-primary endpoints of most bothersome symptom (MBS; pooled data from two studies) and mean baseline to Week 12 change in vaginal pH and maturation index (pooled data from three studies). Safety was assessed using pooled data from all three studies. Comparisons were made between ospemifene-treated women with a history of breast cancer (≥10 years prior to enrolment; n=11) versus those without (n=1091). Result: There were no differences in ospemifene-related improvements in symptoms of vulvar and vaginal atrophy (percentage whose MBS severity improved by ≥1 point on the 4-point severity scale) and in physiological parameters (vaginal pH, parabasal cells, and superficial cells) in women with versus without a history of breast cancer. Treatment-emergent adverse events and adverse drug reactions were comparable in the women using ospemifene who had a previous history of breast cancer (64% and 36%, respectively) compared with those that who did not (69% and 47%, respectively). Conclusion: In this small post-hoc analysis, previous history of breast cancer did not appear to affect the efficacy or safety of ospemifene. Trial registration numbers NCT01585558, NCT01586364, NCT00729469 and NCT00566982. Keywords: Breast cancer; Dyspareunia; Estrogen agonist/antagonist; Ospemifene; Postmenopausal; Safety; Selective estrogen receptor modulator; Vulvar and vaginal atrophy Abbreviatations: ADR: Adverse Drug Reaction; ER: Estrogen Receptor; EU: European Union; FDA: Food and Drug Administration; MBS: Most Bothersome Symptom; SD: Standard Deviation; SERM: Selective Estrogen Receptor Modulator; TEAE: Treatment-Emergent Adverse Event; VVA: Vulvar and Vaginal Atrophy
  31. 31. Parámetros fisiológicos: pH, % células parabasales y superficiales en mujeres tratadas con OSPEMIFENO Parámetro Historia de cáncer de mama Sí (n=11) No (n=1091) pH Media de baseline ± DE 6,2±0,7 6,3±0,8 Cambio medio a la semana 12 ± DE -0,8±1,4 -1,0±1,0 Células parabasales (%) Media de baseline ± DE 71,4±31,0 47,8±40,1 Cambio medio a la semana 12 ± DE -58,8±34,3 -38,1±39,9 Células superficiales (%) Media de baseline ± DE 0,4±0,8 0,9±2,3 Cambio medio a la semana 12 ± DE 13,5±15,8 11,3±14,4 Las diferencias no fueron significativas por el bajo número de pacientes con historia de cáncer de mama DE: Desviación estándar RESULTADOS EFICACIA Research Article Volume 13 Issue 5 - January 2019 DOI: 10.19080/JGWH.2019.13.555871 J Gynecol Women’s Health Copyright © All rights are reserved by Nico Bruyniks J Gynecol Women’s Health 13(5): JGWH.MS.ID.555871 (2019) 001 Journal of Gynecology and Women’s Health ISSN 2474-7602 Safety and Efficacy of Ospemifene in Women with A History of Breast Cancer Nico Bruyniks1 *, Lino Del Pup2 and Nicoletta Biglia3 1 BrInPhar Ltd, Iver Heath, Buckinghamshire, United Kingdom 2 Centro di Riferimento Oncologico, National Cancer Institue, Italy 3 Department of Oncological Gynaecology, University of Turin, Italy Submission: December 21, 2017; Published: January 08, 2019 *Corresponding author: Nico Bruyniks, BrInPhar Ltd, Iver Heath, Buckinghamshire, United Kingdom Background Vulvar and vaginal atrophy (VVA) is a chronic, progressive postmenopausal condition characterized by dyspareunia, vaginal dryness and vaginal irritation, which are a consequence of a decline in endogenous estrogen production [1]. It has previously been shown that women with a history of breast cancer are more likely to have moderate or severe symptoms and signs of VVA than women without breast cancer, particularly if treated with aromatase inhibitors [2] or tamoxifen after high-dose chemotherapy [3]. Due to the risk of breast cancer recurrence if exposed to estrogen [4], all estrogens (even low-dose vaginal estrogens) are contra-indicated in women with known, past, or suspected breast cancer [5]. Ospemifene is an oral non-estrogen treatment that has been approved for the treatment of moderate to severe symptomatic VVA in post-menopausal women who are not candidates for local vaginal estrogen therapy [5,6]. It belongs to the selective estrogen receptor modulator (SERM) class, which also includes treatments indicated for the treatment and/or prevention of certain breast cancers [7-10]. Ospemifene binds selectively to estrogen receptors to exert a tissue-specific effect [11]. In the breast, there are two estrogen receptors (ERα and ERβ), which can bind estrogen or a SERM [12,13]. Preclinical animal data suggest that ospemifene inhibits malignant breast tissue growth [14-18]. In addition, data from the ospemifene clinical Abstract Background: This post-hoc analysis compares the efficacy and safety data from women with or without a history of breast cancer who had been enrolled in the ospemifene clinical trial program. Methods: Efficacy was assessed by the co-primary endpoints of most bothersome symptom (MBS; pooled data from two studies) and mean baseline to Week 12 change in vaginal pH and maturation index (pooled data from three studies). Safety was assessed using pooled data from all three studies. Comparisons were made between ospemifene-treated women with a history of breast cancer (≥10 years prior to enrolment; n=11) versus those without (n=1091). Result: There were no differences in ospemifene-related improvements in symptoms of vulvar and vaginal atrophy (percentage whose MBS severity improved by ≥1 point on the 4-point severity scale) and in physiological parameters (vaginal pH, parabasal cells, and superficial cells) in women with versus without a history of breast cancer. Treatment-emergent adverse events and adverse drug reactions were comparable in the women using ospemifene who had a previous history of breast cancer (64% and 36%, respectively) compared with those that who did not (69% and 47%, respectively). Conclusion: In this small post-hoc analysis, previous history of breast cancer did not appear to affect the efficacy or safety of ospemifene. Trial registration numbers NCT01585558, NCT01586364, NCT00729469 and NCT00566982. Keywords: Breast cancer; Dyspareunia; Estrogen agonist/antagonist; Ospemifene; Postmenopausal; Safety; Selective estrogen receptor modulator; Vulvar and vaginal atrophy Abbreviatations: ADR: Adverse Drug Reaction; ER: Estrogen Receptor; EU: European Union; FDA: Food and Drug Administration; MBS: Most Bothersome Symptom; SD: Standard Deviation; SERM: Selective Estrogen Receptor Modulator; TEAE: Treatment-Emergent Adverse Event; VVA: Vulvar and Vaginal Atrophy o Bruyniks N, Del Pup L, Biglia N. Safety and Efficacy of Ospemifene in Women with A History of Breast Cancer. J Gynecol Women’s Health. 2019: 13(5): 555871.
  32. 32. Estrógenos + + + + + Del Pup et al. Eur Rev Med Pharmacol Sci 2016; 20: 3934-3944
  33. 33. Ospemifeno es seguro y efectivo para mejoría salud vaginal Senshio Ficha Técnica; European Medicines Agency. Senshio Public Assessment Report, 2015
  34. 34. Ospemifeno Seguridad cardiovascular Ficha técnica de Ospemifeno: La información detallada de este medicamento está disponible en la página web de la Agencia Europea de Medicamentos http://www.emea.europa.eu Constantine et al. Menopause 2015:Menopause: The Journal of The North American Menopause Society Vol. 22, No. 1, pp. 36/43
  35. 35. 2019;62(2):141-148
  36. 36. - Menopausia (natural o post-quimioterapia) - Antecedentes de Cirugía del cáncer de mama - Antecedentes de Cáncer estrógeno-dependiente tratado con hormonoterapia - Antecedentes de Cáncer no hormono-dependiente Deseo de mejorar calidad de vida (incluyendo sexo y masa ósea)Clinical profile of women with VVA who are not candidates for local vaginal oestrogen therapy Nappi RE et al. Minerva Ginecol 2017. 69(4):370-380. Mujeres Postmenopáusicas con AVV, con antecedentes de cáncer de mama que hayan terminado su tratamiento, incluyendo el tratamiento adyuvante:
  37. 37. - Climaterio de difícil manejo - Cuestión muy pertinente y no bien resuelta - Alternativas eficaces disponibles - Formación e implicación del/la profesional y la mujer Manejo de la superviviente al cáncer de mama

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