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Manejo práctico de los sofocos
y de las demás toxicidades del
tratamiento hormonal
Dr. José Angel García Sáenz
Effects of estrogen deprivation
Central nervous systemHot flashes
Night sweat
Vagina dryness
Urinary issuesReproductive system
Cardiovascular system
Musculo skeletal system
Hot-flases (vasomotor sympton)
Subjective sensation of sudden heat
Rendering face
Intensive sweating
Palpipations
Anxiety
Night sweats
Detrimental QOL
Baum et al. Cancer 2003BIG 1-98 Collaborative Group NEJM 2009
Smith I et al. SABCS 2017
FACE trial
Letrozol Anastrozol
Hot flushes 33% 32%
ATAC study BIG 1-98 study
Anastrozol Tamoxifen Anastrozol Tamoxifen
Hot flushes 35% 41% 33% 32%
Increased Risk of Recurrence AfterHormone Replacement Therapy in
Breast Cancer Survivors. HABITS study
Holmberg L. JNCI 2008
n= 442•Breast Cancerssurvivors (≈60% ER+ and 30% ER-unknown)*
Hormone Therapy
Symptomatic Treatment
Arms Breast cancerevents/N
5ys cumulativeevents
Hormone Tx 39/221 22%
Control 17/221 8%
33% on adjuvant tamoxifen at randomizationAIs were no allowed; acupunture was allowed
Farmacológicos
Antidepresivos
Antiepilépticos
No farmacológicos
Acupuntura
Yoga
Hipnosis
Clonidina
Meditación
T ocupacional
Act. física
Suplementos nutricionales
Dose comparisons of pharmacologic therapies
Comparisons of different pharmacologic therapies
Comparisons of non-pharmacologic and pharmacologic therapies
Phase III, Placebo-Controlled Trial of Three Doses of Citalopram for the
Treatment of Hot Flashes: NCCTG N05C9
Barton D. JCO 2010
0%
20%
40%
60%
80%
100%
Citalopram10 mg/d
Citalopram20 mg/d
Citalopram30 mg/d
Citalopram is an effective, well-tolerated agent in managing hot flashes… broader helpful effects of the agent appear to be more evident at 20 mg/d.
Venlafaxine in management of hot flashes in survivors of breast cancer: a
randomized controlled trial.
Loprinizi. Lancet 2000
Venlafaxine is an effective non-hormonal treatment for hot flashes, though the efficacy must be balanced against the drug's side-effects.
Gabapentin for hot flashes in 420 womenwith breast cancer: a randomised double-
blind placebo-controlled trial
Pandya. Lancet 2005
Gabapentin is effective in the control of hot flashes in women with breast cancer at dose of 900 mg/day.
Paroxetine is an effective treatment forhot flashes: results from a prospective
randomized clinical trial.
Stearns.JCO 2005
Paroxetine is is an effective treatment for hot flashes in women with prior breast cancer. Women were less likely to discontinue low-dose paroxetine.
▪ Citalopram, Venlafaxina, Gabapentina y
Paroxetina son eficaces y tienen una aceptable
tolerancia.
▪ El beneficio se observa a las 1-2 semanas.
Valorar empezar a dosis bajas, y escalar en norespondedores (salvo Venlafaxina y Paroxetina).
Dose comparisons of pharmacologic therapies
Comparisons of different pharmacologic therapies
Comparisons of non-pharmacologic and pharmacologic therapies
Interventions Hot flashes QOLPatientpreference
Aditional sideeffects
Time to hot flashes improvement
(1)Venlafaxine 75 mg
Clondine 0.1 mg= NA =
Venlafaxine:↓appetite
Favor venlafaxine
(2)
Venlafaxine 75 mg
Gabapentine 900 mg= = Venlafaxine
Venlafaxine↓appetite↑nausea↑constipation
Gabapentine:↑dizzinessNegative mood
=
(3)
Venlafaxine 75 mg
Clondine 0.1 mg= = =
Venlafaxine: ↓appetite↑nausea↑constipation
Clonidine:↑pain↓blood pressure
=
(4)Venlafaxine 75 mg
Clondine 0.15 mgFavor venlafaxine NA NA
Venlafaxine:↑nausea
Favor venlafaxine
(1) Boekho. JCO 2011 (2) Bordeleau. JCO 2010 (3) Bujis. Breast Cancer Res Treat 2009 (4) Loibl. Ann Oncol 2007
Dose comparisons of pharmacologic therapies
Comparisons of different pharmacologic therapies
Comparisons of non-pharmacologic and pharmacologic therapies
Lesi G. JCO 2016
n= 190Breast cancer
patients
Acupuncture + enhanced self-care
Enhanced self-care alone
Acupuncture for the treatment of Hot Flashes in women with Breast Cancer: A Prospective Multicenter Randomized
Controlled Trial (AcCliMaT)
Interventions Hot flashes QOLAditionalside effects
Time tohot-flashes improvement
(1)
Gabapentine
AcupuntureFavor Gabapentine NA
Gabapentine:↑dizziness↑fatigue↑drowsiness
Acupunture:↑bruising
=
(2)
Venlafaxine
Acupunture
= during active treatment
Acupunture with longerdurability of effect
=
Venlafaxine↑nausea↑cheadache↑dizziness
=
(1) Mao. JCO 2015 (2) Walker. JCO 2010
Pharmacologic therapies vs acupunture
Interventions Hot flashes QOLAditional side
effects
Time tohot-flashes
improvement
(1)Gabapentine
Vitamine E
Favor Gabapentine
Favor Gabapentine
Gabapentine:↑sleep quality
Favor Gabapentine
(2)Gabapentine
Hypnosis= NA NA =
(3)Pregabaline
Stellate ganglion block
Favor stellateganglion block =
TransientHorner's Sd.
=
(4) Soy or Red Clover
Placebo
=NA NA =
(1) Biglia . Climateric 2009 (2) Maclaughlan David. BMJ 2013(3) Othan. Pain Med. 2014 (4) Nelson. JAMA 2006
Other non-pharmacologic therapies
Adverse efects of non-hormonal pharmacologicalinterventions in BC survivors suffering hot flashes
Brook Hervik. Breast Cancer Res Treat 2016
HR 95% CI p
High drug doses vs low drug doses 1.67 1.31-2.13 <0.0001
Non-hormonal medication vs placebo 1.51 1.16-1.98 =0.002
Non-hormonal medication vs acupunture 1.75 1.092.75 =0.02
✓Evitar jabones
✓Usar hidratantes y lubricantes.
✓Fisoterapia de suelo pélvico
✓Dilatadores vaginales
✓Infiltración botox
Bone Surveillance in BC survivors
Screening for risk of osteoporosis
Initiante bisphosphonate/denosumab if T-score <2.5
Reassess risk for low-risk patients annually
Optimize cardiovascular risk
Monitor lipid levels, blood presure and providecardiovascular monitoring and treatment
Educate on healthy lifestyle and potential cardiac riskfactors
Cognitive Impairment
Ask patients if they are experiencing cognitivedifficulties
Asses for reversible contributing factors
Refer for neurocognitive assesment and rehabilitation
▪ Antidepresivos (ISRS) y Gabapentina:
eficaces y con aceptable tolerancia.
▪ Venlafaxina es una buena opción como primera
linea para los sofocos en cáncer de mama
▪ Empezar a dosis bajas, y escalar en no
respondedores (salvo Venlafaxina y Paroxetina).
Conclusiones
▪ La acupuntura en pacientes que no deseen más
pastillas, o en los que han fracasado los ttos
farmacológicos.
▪ En resumen, hay medidas no hormonales para
tratar los sofocos y sequedad vaginal, que deben
ser discutidas individualmente
▪ Manejo de la sequedad vaginal, osteoporosis,
riesgo cardiovascular y cognitivo.