Adnexal Mass Observation vs Intervention MMohit Gynecologist Oncologist NAIGO ID: 754095
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Slide1
به نام خداوند بخشنده و مهربانSlide2
Adnexal MassObservation vs Intervention
M.Mohit
Gynecologist Oncologist NAIGO,
Bahman
1395Slide3
Ovarian Cancer
Ovarian Cancer is a Major Women's Health Problem
7
th
most common cancer in women in US:
3%
of all female malignancies
About
1/3
of invasive female genital organ cancers
Deadly disease with High morbidity and mortality
4
th
cause of women cancer mortality (
6%)
: 1/ 44 min
Leading cause of death of
gyn
malignancies:
53% death of
gyn
cancersSlide4
Epidemiology
of ovarian cancer
Highest fatality/case ratio of all the gynecologic malignancies
fatality /case:
-
Ovarian ca:
15520
/
21650 ≈
80/100
- Cervical
ca
:
3710 /10500 ≈
37/100
- Endometrial
cancer
:
7310
/40800
≈
16/100
Slide5
Epidemiology of ovarian cancer
- Age
Peak incidence
:
56-60
y/o,
rises from 20-80 ,then decline
Ovarian
mass:
Age < 40
: 1/10 invasive or borderline
Age > 40
: 1/3
invasive or borderline
-
Postmenopause
: 30% of
neoplasms
are malignant
-
Premenopause
: 7% of epithelial
neoplasms
are malignant
Epithelial cancers: the most common ovarian cancer
Ovarian ca before age 20:
1% epithelial, 2/3 germ cell
Slide6
Ovarian Cancer
Greatest
clinical challenge in all gynecologic cancers
Usually
asymptomatic until advanced disease: >
2/3 at diagnosis
M
ajor
surgical challenge, requires intensive
& often
complex therapies,
extreme
demand
in
pt's
psychological &
physical
energy
Appropriate diagnosis & optimal
treatment can improves survival:
- Early stage diagnosis
- Optimal surgery (
gyn
oncologist, High volume surgeons & centers)
-
S
uitable chemotherapy
Slide7
Survival Rates for Ovarian Cancer Need to be Improved
Ovarian Cancer 5-yr Survival Rate by Stage
stage
Stage Distribution
at Diagnosis
Survival Rate
Stage I
20-27%
73-93%
Stage II
5-10%
45-70%
Stage III52-58%21-37%Stage IV11-17%11-25%
Heintz APM, et al. FIGO Annual Report on the Results of Treatment in Gynecologic Cancers. 2000; 24 :107-138.
Holschneider CH, Berek JS.
Semin Surg Oncol
. 2000;19:3-10.Slide8
Surgery can Impact Survival
Surgery
by gynecologic oncologist:12 month survival advantage
Complete surgical staging /
Cytoreductive
surgery
Complete surgical staging
:
to Define
extent
of disease, Determine the need for adjuvant treatment, Provide prognosis, Outline a plan of care
Optimal surgical
debulking
: remove all tumor in advanced tumor by Hysterectomy, removal of ovaries, omentectomy, bowel resection if needed, peritoneal stripping, diaphragmatic stripping, l.n. debulking, …Slide9
Oncology Specialist Most Likely to
Perform Comprehensive Surgery
*Ovarian Cancer Surgery by: Surgeon
Surgeon Specialty
Rate of Comprehensive Surgery
Gynecologic oncologist
75.7%
Obstetrician gynecologist
37.3%
General surgeon
38.5%
Goff BA et al.
Cancer.
2007;109(10):2031-2042.* South Carolina admissionsSlide10
High Volume Surgeons Most Likely to
Perform Comprehensive Surgery
Ovarian Cancer Surgery by: Surgeon
Surgery Volume
Percentage
of Cases
Rate of Comprehensive Surgery
Very Low
1 case/year
25.2%
55.2%
Low / Medium
2-9 cases/year
22.7%65.1%High≥ 10 cases/year52.1%75.2%Goff BA et al. Cancer. 2007;109(10):2031-2042.Slide11
Less than Half of US Ovarian Cancer
Surgery is at
High Volume Hospital
Ovarian Cancer Surgery by: Hospital
Surgery Volume
Percentage
of Cases
Rate of Comprehensive Surgery
Low
1-9 cases/year
33.3%
57.4%
Medium
10-19 cases/year18.1%69.5%High≥ 20 cases/year48.6%73.7%Goff BA et al. Cancer. 2007;109(10):2031-2042.Slide12
Significantly Higher Survival Rates with Oncology Specialists
Type of Surgeon Impacts Survival Rates
Type of Hospital Impacts Survival Rates
Paulsen T et al.
Int J Gynecol Cancer.
2006;16(Suppl 1):11-17.
TH: Teaching hospital
NTH: Nonteaching hospitalSlide13
Adnexal mass
F
requently
found in both symptomatic and asymptomatic
women
F
requency: 7.8
% in reproductive
age, 2.5-18
%
in postmenopausal
Usually detected by gynecologist, most incidentally in pelvic exam or imaging and less commonly present with acute or intermittent pain
Can
have gynecologic or non-gynecologic etiologiesGynecologic: ovarian(benign or malignant), tubal(hydrosalpynx , EP, …), paratubal, uterine( leiomyoma, anomalies, hemato or pyometra,…)Non-Gynecologic: GI, urologic, metastatic, retroperitoneal tumors ( LAP, sarcoma, neurologic tumors),…Slide14
Adnexal mass
The discrimination between benign and malignant adnexal masses is central to clinical management and surgical planning in adnexal mass
Characterizing
ovarian pathology is fundamental to
optimizing management
in both pre- and post-menopausal
women:
- Inappropriate
referral
to oncology services
- Unnecessary surgery
- Overly
radical
interventions compromising fertility in young womenFor adnexal masses highly suspicious for cancer, women should be referred a gynecologic oncologist and facility for optimal care.Failing to recognize cancer significantly impact on prognosisSlide15
Adnexal mass
Main purpose
of the diagnostic evaluation of adnexal tumors is to exclude the possibility of
malignancy
Prediction
of malignancy of an ovarian mass is critical for:
Management ( surgery vs observation)
Choice of surgeon
Center and
Surgical
technique
Accurate preoperative
evaluations are
pivotal for optimal managemenSlide16Slide17Slide18
Evaluation of adnexal mass:
How
to predict the risk of malignancy in
adnexal
mass
?Slide19
Goal of our diagnostic evaluations on a pelvic mass?
prediction of it’s behavior/exclude
malignancy
How
we can exclude malignancy?
Is
there any tool for definite diagnosis?Slide20
-
«در شناختن حق بیشتر خلاف در میان خلق چنین است که همه از وجهی راست گفته باشند و لکن بعضی را ببینند، پندارند که همه را بدیدند ومثال ایشان چون گروهی نابینا باشد که.....»
کیمیای سعادت امام محمد غزالی
پیل
اندر خانه ای تاریک بود
...
در کف هر یک اگر شمعی بدی
اختلاف از گفتشان بیرون شدی
چشم حس همچون کف دست است و بس
نیست کف را بر همه او دسترسSlide21
Evaluation of pelvic masses
Clinical evaluation of patient (patient’s characteristics, risk factors, history and physical examination), imaging results and serum markers help us to separate masses into the categories of “
probably benign
”, “
uncertain
” and “
likely malignant
” which can guide appropriate management.Slide22
Tools
for Assessing
Risk of Ovarian Cancer in
a Mass
Tools as malignancy marker:
Clinical: - History
:
age , menopausal status, family history, Wt loss
,..
-
P/E
:
firm nodular adherent pelvic mass, evidences of advanced tumorParaclinical: - Imaging (Sono, CT and MRI): bilaterality, solid part, large tumor size( >10cm), mural nodules and vegetation, thick wall and septation, detection of omental or peritoneal nodularity and seeding, ascites, lymphadenopathy - Serum tumor markers: CA125, …Combinations of markersSlide23
Clinical evaluation
Risk factors:
Age:
most important independent risk factor of ovarian cancer, about 70% > 55y/o
Menopausal status:
risk of malignancy is much greater than premenopausal
Familial history of breast or ovarian cancer
: most important personal risk factor of ovarian cancer. Different from familial ovarian cancer syndrome
- lifetime probability of general population: 1.6%
- one affected family member: 5%
- woman with BRCA1 mutation: 41-46% by age 70 - woman with BRCA1 mutation: 10-27% by age 70 - woman with Lynch syndrome: 5-10% by age 70 ACOG Practice Bulletin No 174, Nov 2016 Slide24
Clinical evaluation
Detailed history and Symptoms:
Patient may present history and symptoms that can refine the differential diagnosis: genetic/familial high risk assessment, potential of pregnancy, acute onset pain, intermittent acute pain, fever, chills, vaginal discharge, secondary dysmenorrhea, dyspareunia, chronic pelvic pain, AUB, bloating, early satiety,
wt
loss,…
Physical
examination:
irregular, firm, nodular, bilateral mass or associated with ascites are concerning for malignancy
ACOG
Practice Bulletin No 174, Nov
2016Slide25Slide26
Imaging of mass
Ultrasonography:
-
TVS:
most commonly used for evaluation of adnexal mass
-
TAS:
distorted pelvic structures, mass extended beyond the pelvis or when TVS cannot be performed
Color Doppler ultrasonography
CT, MRI, PET:
not recommended for initial evaluation of adnexal massSlide27
TVS
Transvaginal
ultrasound has long been considered the imaging modality of choice for the evaluation of adnexal
masses:
Available,
high quality
images,
detailed descriptions of
macroscopic appearance of
mass,
and
least expensive of all imaging modalities currently
available
Advantage: widespread availability, good pt tolerability, cost effectivenessMain limitation for distinguishing benign from malignant mass: low specificity, low PPV especially in premenopausal womenSlide28
Gray scale TVS
Recommended
modality for suspected adnexal mass
No alternative imaging modality has sufficient superiority to TVS to justify its routine use
High frequency gray scale TVS: high resolution images of mass that approximate it’s gross anatomic appearance
Image quality is operator dependent
High inter-observer agreement among experts
In
premenopause
: expert
sonography
reached the highest discriminative power with PPV of 0.45, and an
NPV of 0.99
.Slide29
MR Imaging
MRI:
limited data
May
have superior ability compared to TVS in correctly classifying malignant masses at the expense of lower detection
rate. Help
clarify malignant potential in patients in whom ultrasonography may be unreliable, MRI is the most appropriate test
Often
helpful in differentiating the origin of pelvic masses that are not of
ovarian origin
,
specially leiomyomaSlide30
CT
CT:
best use of CT is not to detect or characterize pelvic masses but to evaluate:
In cases in which extra-ovarian disease and abdominal metastasis suspected or needs to be ruled out, CT is the most useful technique
To evaluate an alternate primary cancer site when cancer is suspected based on
sono
, P/E or serum markersSlide31
Doppler technology
Doppler technology:
Evaluation of an adnexal mass by Doppler technology alone is not recommended. Doppler technology should be combined with a morphology assessment
Increase
the specificity of two dimensional gray scale
sonography
Overlapping range of values of resistive index,
pulsatility
scale, max systolic velocity between benign and malignant masses
In attempt to overcome this overlap: Three dimensional ultrasound of vasculature of
mass,
better discrimination than Doppler
sonoSlide32
What ultrasound finding suggest malignancy?
Findings should raise concern regarding malignancy are:
- Size: greater than 10 cm
- Papillary or solid component
- Irregularity
- Ascites
- High color Doppler flow
Many
research on different various
ultrasonographic
scoring systems to quantify cancer risk based on
morphology
Generally all
evaluated scoring systems were found to have an acceptable level of sensitivity and specificitySlide33
What ultrasound finding suggest benign disease?
Characteristics of benign masses: simple appearance with
-
Thin smooth walls
- Absence of
septation
, solid component
Absence of internal blood flow in Doppler
Highly likely (almost always) to be benign in any age group regardless of menopausal status and often regress
Malignancy rate in most series: 0-1%Slide34
Cutoff size of need for surgery of simple
masses
Cutoff size of need for
surgery of simple masses:??
Often
≥ 10 cm
Large prospective study: 2763
postmenopause
cystic < 10 cm 2/3 regress, no case of malignancy in 6.3 y mean
f.u
.
Obstet Gynecol 2003;102:594. In 1148 unilocular cyst: 11, 0.96% were malignant (7/11 , sono did not detect macroscopic papillary projection or solid part seen at surgery) Ultrasound Obstet Gynecol 2013;41:80. ACOG Practice Bulletin No 174, Nov 2016 Slide35
Ultrasound finding suggest selected benign masses
Some ultrasound findings may be specific for selected benign masses (level II evidences, small descriptive studies):
Endometrioma
:
specificity 89%, sensitivity 83%, PPV 77%,
NPV
92%
Mature
Teratoma
:
98% accuracy in 155 case of
dermoid specificity 99%, sensitivity 58%Hydrosalpinx: specificity 99%, sensitivity 93%, Slide36
Ultrasonography-based morphology scoring systems
Generally
various models
all are
able
to distinguish
benign from malignant masses
in most instances
2014 systematic review and meta-analysis compared various morphologic (ultrasound scoring) malignancy prediction
models.
Hum
Reprod
Update 2014;20:449-62
Best performing models were: IOTA group logistic regression model 2(LR2): patient age + 5 sono findings: sensitivity 92% , specificity 83%IOTA simple rules model: including 10 ultrasound findings: sensitivity 93% , specificity 81% ACOG Practice Bulletin No 174, Nov 2016 Slide37
Ultrasound
based prediction model (LR2) developed by
the International
Ovarian Tumor Analysis (IOTA) study offers better
diagnostic performance
than CA125 alone.Slide38
Laboratory Testing
To evaluate likelihood of malignancy and need for
surgery of a mass
CBC, pregnancy test, STD, U/A, stool-OB,...
Serum markers:
CA125, HE4, markers of less common ovarian histopathology:
BhCG
, LDH, AFP,
Inhibin
,…
CA125
:
Specificity
and PPV are consistently higher in postmenopausalCutoff : Premenopause: 30 U/ml Postmenopause & hysterectomy: suggested 20 -26 U/ml - Epithelial ovarian cancer: - 83% CA125 ≥ 35 IU/ml - ↑ 50% in stage I - ↑ 90% in more advanced stagesSlide39
CA125
Best known ovarian cancer serum tumor marker
Biomarker
in epithelial ovarian cancer
Overall sensitivity in distinguishing
malig
: 61-90%, spec 71-93%
PPV: 35-91, NPV 67-90%. wide variation
Elevated only in ½ early stage, rarely elevated in germ cell, stromal and mucinous
Positive in many non malignant conditions:
myoma
, PID, ascites of any etiology, endometriosis, IBD, SLE,…Slide40
Limitations :
-
Low
specificity/ PPV in premenopausal years: Elevated levels in
benign
gynecological
diseases
- Low sensitivity/NPV:
in Stage I ovarian cancer 50%. CA 125 alone is not a sensitive marker for screening of pelvic mass - Elevated level in some other cancers - In premenopausal: Using > 35 U/mL as threshold 78% sensitivity and 78% specificityCA125Slide41
CA125
In
premenopause
women:
less
value in prediction, extreme values increase suspicious and concern for
malignancy, even
though benign conditions such as
endometrioma
can have CA125 of 1000 or greater
Threshold: ?, no evidence based threshold is currently available
Prior ACOG guidance used ≥ 200 for referral of
premenopause
Gynecologist should integrate CA125 with other factors in judging the need for referralSlide42
ACOG
2007 simple
Guidelines for
referral
of
ovarian
mass to GYN- Oncologist
Premenopausal
- CA125 > 200
- Ascites
- Evidence of metastasis
Family
history of
breast or ovarian cancerPostmenopausal- CA125 >35- Ascites- Fixed or nodular mass- Evidence of metastasisFamily history of breast or ovarian cancerACOG Practice Bulletin. Obstet Gynecol. 2007;110:201-213.Slide43
CA125
In
postmenopause
:
Both sensitivity and specificity of elevated CA125 for cancer diagnosis in setting of pelvic mass is higher after menopause
Elevated
CA125 + pelvic mass in post menopause: highly suspicious to malignancy & should be referred to
Gyn
Oncologist
In
post menopause: ↑ CA125 without ovarian ca is a risk factor
of
death from other
malignanciesCombinations of expert sonography with CA-125 serum measurement in postmenopause achieved the highest discriminative power: Combination of CA-125 & expert sono: PPV 0.89 and NPV of 0.97 Slide44
Dual Marker
: CA125+ HE4
1997
:
Maggino
et al.
examined
sens
and spec of CA125 at various cutoffs
At cutoff of
35:
sensitivity of
78.3%
, specificity 82%Increasing cutoff to 65: sensitivity decreased to 71.7% and specificity increased to 92.5%20% of EOC express little, if any, CA125In early stage ↑ to 50%So: not sufficient as single markerSlide45
Dual marker: CA125+HE4
2007
: Moore et al.
examined a panel of biomarkers.
Dual
marker of
HE4 + CA125:
highest sensitivity of various combinations, increased sensitivity of CA125 alone
HE4 is elevated in
> 50%
of tumors that do not express CA125
Addition of HE4 to CA125 enables higher detection of malignancies in:
1-
Patients with tumor that do not express CA125 and will be missed by algorithm CA125 alone2- Early stage disease compared with CA125 So it’s addition to CA125: ↑ sensitivity Slide46
Panels of Serum T
umor Markers
Panels of biomarkers:
FDA approved two panel for assessment of risk of malignancy in adult women (>18) with pelvic mass that require surgery:
MIA:
Multivariate Index Assay
(
OVA1
™:
CA125
II+ transferrin+
transthyrenin
+ apolipoprotein A1+ B2 microglobulin)ROMA: Risk Of Ovarian Malignancy Algorithm(CA125 + HE4+ menopausal status) ACOG Practice Bulletin No 174, Nov 2016 Slide47
Role of Serum biomarker panel testing
Alternative to CA125 alone in determining the need for referral or
gyn
oncology consult when a mass need surgery
Note: not recommended for use in initial evaluation of mass
CA125 alone: 65.7% predict ovarian malignancy in early stageSlide48
MIA
Multivariate index assay:
-
Correctly
predict in 91.4%
A
bnl
in 83.3% of malignancies which clinical impression was benign
Abnl
in 70.8% of malignancies with normal CA125
Sens
: 95.3%. more than clinical impression and CA125
Add radiologic finding to MIA: ↑ Sens to 98% ( for TVS) and 97%(for CT) ↑ NPV to 99% ( for TVS) and 94%(for CT)Note: Low risk imaging + low risk MIA: < 1-2% false negativeSlide49
ROMA
Risk of malignancy algorithm (ROMA):
More sensitive and specific than CA125 alone
In cohort of 531 women with
epithelial ovarian
cancer 93.8% of diagnosed as high risk before surgery
Pre-menopause:
sens
92.3% , spec 75%
Post-menopause:
sens
76.5%, spec 74.8%
ROMA compared with MIA, Prospective analysis of 146 cases of malignancy:
MIA was more sensitive than ROMA (97% VS 87%) ROMA was more specific than MIA (83% VS 55%)NPV of both tests were similar(98 vs 96%) ultrasound Obstet Gynecol 2013;42:218.Slide50
Combination of different markers
Sonography
+ CA125:
In postmenopausal
with adnexal mass seems to
improve
sensitivity and specificity of predicting adnexal malignancies. In
contrast
In
premenopausal women
the consideration of CA-125 levels with Doppler
sono
might confuse differential of ovarian massesAs a standalone modality, serum cancer antigen 125 is not recommended for distinguishing between benign and malignant adnexal masses Slide51
Multimodal tests and diagnostic algorithms
Incorporate serum markers, ultrasound findings and clinical informations
RMI
= U x M x serum CA 125 level
Imaging marker:
ultrasound score(
U
=
0,1 or3)
+ Clinical marker:
menopausal status score
( M
= 1 or 3)
+ Serum tumor marker: CA125 levelRMI I: recommended by NIH guideline for ovarian mass evaluationRMI > 200: systematic review, pooled estimated sensitivity 78%, specificity 87%Geomini et al.Obstet Gynecol 2009,113:384-94. ACOG Practice Bulletin No 174, Nov 2016 Slide52
Serum biomarkers and multimodal test results
considered abnormal
Test
Premenopausal
Postmenopausal
CA125
♠
>35
MIA
>5
>4.4
ROMA
>1.31
>2.77RMI>200>200♠: No threshold in premenopausal women, should be integrated with other clinical factors in judging the need for consultation. 2207 ACOGguideline recommended referral of >200 to gyn oncologistACOG Practice Bulletin No 174, Nov 2016Slide53
Serum
markers
of other ovarian tumors
- AFP:
an
oncofetal
glycoprotein
Ag. EST, mixed germ cell
, immature
teratoma
- Lactate
dehydrogenase
(LDH):
dysgerminomas - Human chorionic gonadotropin (hCG): GTT, PSTT, non gestational chorioca, and embryonal ovarian ca- Carcinoembryonic antigen (CEA): epithelial or germ cell tumors- Inhibin and mullerian inhibiting substance (MIS): granulosa-theca cell - Thrombocytosis: may be associated with ovarian malignancies in girls & adolescents. Readily available, useful in emergency evaluation of ovarian torsion suspicion for malignancySlide54Slide55
When observation is recommended for a pelvic mass?Slide56
Observation with repeat imaging is recommended when:
1- Morphology of ultrasonography suggests benign disease
2- Less certain morphology with compelling reason to avoid intervention
3- Asymptomatic women+ normal CA125 + no TVS finding suspicious for ca
4- Simple cysts < 10 cm, likely benign on TVS by expert ( rare exceptions)
5- Suspected
endometrioma
6- Suspected mature
teratoma
7- Suspected
hydrosalpynx
8- Some women with substantial serious multiple comorbidities: repeat
imaging safer than immediate surgical intervention ACOG Practice Bulletin No 174, Nov 2016Slide57
Adnexal mass in postmenopausal patient
The adnexal mass in a postmenopausal patient poses an important diagnostic
and management
dilemma for primary care providers and gynecologists
.
Postmenopausal women
are at a significantly increased risk of gynecologic malignancy; yet
even in
this population the majority of adnexal masses are benign.
Evaluation and management
of these lesions centers on the identification of
malignancy,
while avoiding unnecessary intervention in
patients with benign lesions. Slide58
Repeat Imaging
Is recommended when the diagnosis is uncertain and cancer remains within the differential diagnosis
Ideal interval and duration
of ultra-sound follow: yet to be defined
In one study all monitored masses eventually diagnosed as malignancy: demonstrated growth by 7 m. (level II-III)
Some experts recommend limit observation time to
:(level III
)
- Stable mass without solid component:
1y.
-
S
table mass with solid component: 2y. Such-Burgmann E, Hung YY, Kinney W. Am J Obstet Gynecol 2014;211:623 Such-Burgmann E, Kinney W. Am J Obstet Gynecol 2015;213:816Slide59
What type of surgical intervention is appropriate?Slide60
Presumed benign adnexal masses: minimally invasive procedures are the
preferred route
of surgery
Regardless of size and approach: fertility preservation should be priority in adolescence and women who have not completed child bearing
If suspicious of cancer during endoscopy: conversion to laparotomy 0-1.5%
Rate of cyst rupture: equivalent in laparoscopy and laparotomy
Shortened hospital stay, decreased pain, decreased convalescence time
Conventional Vs robotic assisted: conventional is preferred , shorter operative time
ACOG
Practice Bulletin No 174, Nov 2016Slide61Slide62
Which patient may benefit from referral to a Gynecologic Oncologist?Slide63
Consult or referral to Gyn
oncologist
Consultation or referral is recommended for women with one OR more following criteria:
Postmenopausal:
masses with elevated CA125, ultrasound findings suggestive of malignancy, ascites, nodular or fixed pelvic mass, evidence of abdominal or distant metastasis
Premenopausal:
masses
with elevated CA125, ultrasound findings suggestive of malignancy, ascites, nodular or fixed pelvic mass, evidence of abdominal or distant
metastasis
Pre or postmenopausal:
masses with elevated score on a formal risk assessment test such as RMI, ROMA,IOTA ultrasound-based scoring systems
ACOG Practice Bulletin No 174, Nov 2016
Slide64
ACOG Guidance for operation
Proper staging + aggressive tumor
debulking
: improve survival
Suspicious or persistent complex adnexal mass
should be operated
:
By a physician trained to appropriately stage and
debulking
of ovarian cancer
I
n a hospital facility that has necessary support and consultation services (
eg
. frozen)Discovered malignant tumor incidentally during operation: if possible intraoperative consult to gyn oncologist ACOG Practice Bulletin No 174, Nov 2016 Slide65