This study aimed to predict the risk of malignancy in women with adnexal masses using preoperative factors. The researchers analyzed 395 patients and found:
1) Tumor morphology on ultrasound, elevated serum CA 125 levels, presence of ascites, and older age were associated with higher risk of malignancy.
2) Patients with solid or complex masses and CA 125 > 35 U/mL had a positive predictive value of 84.7% for malignancy.
3) Purely cystic masses had a 100% negative predictive value for ruling out malignancy.
4) The combination of complex/solid mass and elevated CA 125 best defined patients at high risk of ovarian cancer.
2. investigation was undertaken to estimate the accuracy tional Federation of Gynecology and Obstetrics sys-
of a combination of patient demographics, ultrasono- tem. Data were entered into a MEDLOG database
graphically generated tumor morphology, and serum (MEDLOG Systems, Crystal Bay, NV) and exported
CA 125 values in predicting risk of malignancy in into an Excel (Microsoft Corp., Redmond, WA)
adnexal masses. spreadsheet for analysis using WinSTAT (R. Fitch
Software, Bad Krozingen, Germany), SPSS (SPSS,
MATERIALS AND METHODS Inc., Chicago, IL), and PC-SAS with the Enterprise
This investigation was undertaken after approval Miner statistical software (SAS Institute, Inc., Cary, NC).
from the University of Kentucky Human Subjects Proportions were compared using 2 statistics or
Institutional Review Board. Study participants were Fisher exact tests. Means were compared using two-
women referred to the University of Kentucky–Mar- sample t tests. Statistical significance was determined
key Women’s Cancer Center with a diagnosis of an at the .05 level. Multivariable analyses used the
adnexal mass on pelvic examination who underwent classification and regression tree procedure, a non-
surgery at this institution from 2001 to 2008. parametric method that defines or accepts cut points
The following demographic data were obtained and uses training and validation sets to optimize rules
for all study patients: age, height, weight, gravidity, for the analysis.9 The training set is formed by split-
family history of breast or ovarian cancer, personal ting the entire sample in half after stratification for
history of cancer, and menopausal status. Postmeno- malignant cases and benign controls.
pausal was defined as the absence of menses for a
minimum of 12 months. Family history was consid- RESULTS
ered positive if the patient had a first-degree relative Between July 2001 and December 2008, 399 patients
(ie, mother, sister, or daughter) or a second-degree referred to the outpatient clinic of the University of
relative (ie, grandmother, granddaughter, aunt, or Kentucky–Markey Women’s Cancer Center for eval-
niece) with documented ovarian or breast cancer. All uation of an adnexal mass on pelvic examination
women underwent pelvic examination, transvaginal
ultrasonography, and serum CA 125 determination
within 2 weeks before surgery. Transvaginal ultra- Table 1. Patient Demographics, Tumor Variables,
sonography was performed using General Electric and Biomarker Profiles in Patients
(Milwaukee, WI) Logic 400 or Voluson ProV ultra- Studied (N)593؍
sound units with a 5-mHz vaginal probe as described Mean Range
previously.8 Tumor dimensions from ultrasono-
graphic images were recorded, and tumor morphol- Age (y) 51.6 (Ϯ0.8) 10–86
ogy was classified as cystic, solid, or complex (con- Height (in) 64 (Ϯ0.02) 55–72
Weight (lb) 173 (Ϯ2.8) 78–384
taining both solid and cystic components). All Gravidity 2.4 (Ϯ0.1) 0–21
ultrasonograms were reviewed by at least one of the Family history
authors. All tumors classified as cystic were unilocu- Ovarian cancer 48 (12)
lar, whereas cystic tumors with septations were in- Breast cancer 64 (16)
cluded in the complex group. Ascites was defined as Menopausal status
Premenopausal 176 (45)
free fluid more than 60 mL in the abdomen/pelvis Postmenopausal 219 (55)
confirmed by ultrasonography. Serum CA 125 deter- Tumor morphology
minations were performed using a two-site sandwich Cystic 123 (31)
paramagnetic particle chemiluminescent immunoen- Complex 236 (60)
zymatic assay with a normal value less than 35 Solid 36 (9)
Tumor diameter
units/mL. Serum samples with values exceeding 10 cm or less 291 (74)
5,000 units/mL were diluted to end point for a final More than 10 cm 104 (26)
result. Ascites
After surgical removal, the dimensions of each Present 54 (14)
tumor were recorded, and frozen section histologic Absent 341 (86)
CA 125 (units/mL)
evaluation was performed. Tumors were classified Less than 35 247 (62)
histologically according to the World Health Organi- 35–59 38 (10)
zation system. Patients with a histologic diagnosis of 60–120 23 (6)
ovarian malignancy underwent immediate tumor de- More than 120 87 (22)
bulking and surgical staging according to the Interna- Data are mean (Ϯstandard deviation) or n (%).
688 McDonald et al Risk of Malignancy in an Adnexal Mass OBSTETRICS & GYNECOLOGY
3. were included in this investigation. Four patients had followed by serous cystadenocarcinoma, mucinous
their first CA 125 determination after surgery and cystadenocarcinoma, and clear-cell carcinoma.
were excluded from further evaluation. Demographic The relationship of demographic, biomarker, and
data, biomarker profiles, and tumor characteristics of tumor variables to risk of malignancy in patients with
the patients evaluated are listed in Table 1. Fifty-five an adnexal mass is presented in Table 2. Variables
percent of patients were postmenopausal and 40% statistically related to risk of malignancy were tumor
were aged 55 years or older. Sixty-four patients (16%) morphology, ascites, serum CA 125 level, tumor size,
had a family history of breast cancer, 48 patients tumor bilaterality, menopausal status, and age.
(12%) had a family history of ovarian cancer, and one Tumor morphology from ultrasonographically
patient was BRCA1 positive. Two hundred thirty-six generated images was related directly to risk of ma-
masses (60%) were ultrasonographically complex lignancy. There were 236 complex adnexal masses,
(Fig. 1A), 123 (31%) were cystic (Fig. 1B), and 36 (9%) and 120 (51%) were malignant. None of the five
were solid (Fig. 1C). Five of the 236 complex adnexal complex masses with septal morphology without solid
masses (2.1%) were cystic ovarian tumors with thick areas were malignant. There were 36 solid adnexal
septa but no solid areas. Radiologic evidence of masses, and 11 (32%) were malignant. In contrast,
ascites was present in 54 patients (14%). Serum CA there were 123 cystic adnexal masses, and none were
125 level was elevated (more than 35 units/mL) in ovarian tumors of borderline malignancy or invasive
148 patients (38%) and was more than 120 units/mL ovarian cancers (PϽ.001). The finding of purely cystic
in 87 patients (22%). morphology in an adnexal mass was associated with a
At the time of surgery, 264 patients (67%) were negative predictive value (NPV) for malignancy of 100%.
found to have benign ovarian tumors, 118 patients Fifty-four patients with an adnexal mass had
(30%) had ovarian cancer, and 13 patients (3%) had radiologically confirmed ascites, and all of these pa-
ovarian tumors of borderline malignancy. The stage tients had invasive epithelial ovarian cancer (stage IC,
distribution of the patients with ovarian tumors of nϭ2; stage IIC, nϭ1; stage IIIC, nϭ49; and stage IV,
borderline malignancy and ovarian cancer was as nϭ2). Therefore, the finding of documented ascites
follows: stage I, nϭ38; stage II, nϭ17; stage III, in a patient with a complex or solid adnexal mass
nϭ74; and stage IV, nϭ2. The most common cell had a positive predictive value (PPV) for malig-
types of ovarian malignancy were adenocarcinoma, nancy of 100%.
Fig. 1. Patterns of adnexal mor-
phology. A. Complex adnexal
mass, 12 cm in diameter; the cys-
tic periphery is marked with clear
arrows and the internal solid
component is marked with solid
arrows (histology: clear-cell carci-
noma). B. Cystic adnexal mass,
9.4 cm in diameter, periphery is
marked with clear arrows (histol-
ogy: ovarian serous cystade-
noma). C. Solid adnexal mass, 5
cm in diameter; the periphery is
marked with clear arrows (histol-
ogy: ovarian adenocarcinoma).
McDonald. Risk of Malignancy in an
Adnexal Mass. Obstet Gynecol
2010.
VOL. 115, NO. 4, APRIL 2010 McDonald et al Risk of Malignancy in an Adnexal Mass 689
4. Table 2. Demographic, Tumor, and Biomarker patients with complex and solid adnexal masses are
Variables Related to Risk of Malignancy listed in Table 3. The only benign histologic finding
(N)593؍ consistently associated with an elevated serum CA
Variable Total Malignant P 125 value was ovarian endometriosis. Thirteen (48%)
of 27 women with an ovarian endometrioma had an
Age (y) elevated serum CA 125 value (more than 35 units/
55 or younger 239 58 (24.3) Ͻ.001
Older than 55 156 73 (46.8)
mL), and 5 (18%) had a serum CA 125 value more
Gravidity than 60 units/mL. There were 114 women with other
1 or less 125 41 (32.8) .92 benign complex or solid adnexal masses, and only 1
More than 1 270 90 (33.3) patient (with an ovarian fibroma) had a CA 125 level
Menopausal status more than 60 units/mL. As expected, serum CA 125
Premenopausal 176 43 (24.4) Ͻ.001
Postmenopausal 219 88 (40.2)
values were related directly to stage of disease in
Weight (lb) patients with ovarian malignancies. Serum CA 125
200 or less 314 116 (36.9) Ͻ.02 values were elevated (more than 35 units/mL) in
More than 200 81 15 (18.5) 30.7% of patients with an ovarian tumor of borderline
Family history of ovarian malignancy, 77.2% of patients with stage I and stage II
cancer
Yes 48 16 (33.3) .98
ovarian cancer, and 98.6% of patients with stage IIIC
No 347 115 (33.1) and IV ovarian cancer. All 54 patients with ascites
Family history of breast had an elevated (more than 35 units/mL) serum CA
cancer 125 level, and 52 (96.2%) had a CA 125 level more
Yes 64 20 (31.3) .72 than 60 units/mL.
No 331 111 (33.5)
Tumor morphology
Risk of malignancy in an adnexal mass was signif-
Cystic 123 0 (0) Ͻ.001* icantly higher in women older than 55 years than in
Complex 236 120 (50.8) younger women (PϽ.001), in postmenopausal women
Solid 36 11 (30.6) compared with premenopausal women (PϽ.001), in
Ascites women with bilateral compared with unilateral ovarian
Negative 341 77 (22.6) Ͻ.001
Positive 54 54 (100)
tumors (PϽ.01), and in women whose adnexal masses
Tumor laterality were more than 10 cm in diameter compared with
Unilateral 375 119 (22.6) Ͻ.01 smaller tumors (PϽ.001). A family history of ovarian
Bilateral 20 12 (60) cancer or breast cancer in a woman with an adnexal
Tumor diameter mass was not associated statistically with an increased
10 cm or less 291 67 (23) Ͻ.001
More than 10 cm 104 64 (61.5)
risk of malignancy in the population studied.
CA 125 (units/mL) Although many variables were correlated with ma-
Ͻ.001 lignancy, only a small number had acceptable positive
†
Less than 35 247 19 (7.7)
35–59 38 13 (34.2) or NPVs (Table 4). Classification and regression tree
60–120 23 17 (73.9) multivariable analysis considered age, gravidity, post-
More than 120 87 82 (94.2)
menopausal status, weight, family history of ovarian
Data are n or n (%). cancer or breast cancer, tumor morphology, ascites,
* Cystic compared with complex or solid tumor morphology.
†
CA 125 less than 35 units/mL compared with 35–59, 60 –120, tumor bilaterality, maximum tumor diameter, and CA
or more than 120 units/mL. 125 value. This analysis found the most accurate signif-
icance of interactions to declare a high risk of malig-
nancy if a patient had an adnexal mass with complex or
Serum CA 125 values were related directly to risk solid morphology and a serum CA 125 value more than
of malignancy in women with an adnexal mass. Only 35 units/mL. The statistics for the training and validation
19 (7.7%) of 247 patients with a normal serum CA 125 sets indicated uniformly high performances for sensitiv-
value (less than 35 units/mL) had ovarian cancer. ity, specificity, and predictive values across both the
Conversely, 13 of 83 patients (34.2%) with a serum training and validation sets.
CA 125 value of 35–59 units/mL, 17 of 23 patients Statistical parameters associated with the high-risk
(73.9%) with a serum CA 125 value of 60 –120 definition are listed in Table 5. Using the stated high-risk
units/mL, and 82 of 87 patients (86.8%) with a CA 125 parameters resulted in a sensitivity of 30.8% for ovarian
value more than 120 units/mL had borderline or tumors of borderline malignancy, 77.3% for early
malignant ovarian tumors (PϽ.001). Serum CA 125 stage (I and II) ovarian cancer, and 98.6% for ad-
values related to specific histologic diagnoses in all vanced stage (III and IV) ovarian cancer. Increasing
690 McDonald et al Risk of Malignancy in an Adnexal Mass OBSTETRICS & GYNECOLOGY
5. Table 3. CA 125 Related to Histology in Ultrasonographically Complex or Solid Adnexal Tumors
(n)272؍
CA 125
Less Than 35–59 60–120 More Than
Histology n 35 Units/mL Units/mL Units/mL 120 Units/mL
Fibroma 15 12 2 1 0
Cystadenofibroma 27 25 2 0 0
Endometrioma 27 14 8 1 4
Serous cystadenoma 22 22 0 0 0
Cystic teratoma 20 20 0 0 0
Mucinous cystadenoma 15 15 0 0 0
Granulosa cell tumor 4 3 1 0 0
Pedunculated myoma 7 6 1 0 0
Sertoli-Leydig cell tumor 1 0 1 0 0
Brenner tumor 3 3 0 0 0
Mucinous LMP 5 3 1 0 1
Serous LMP 8 5 1 1 0
Clear-cell carcinoma 8 3 2 3 0
Carcinosarcoma 4 0 0 0 4
Mucinous cystadenocarcinoma 5 2 0 1 1
Serous cystadenocarcinoma 8 1 0 0 7
Adenocarcinoma 93 5 8 12 68
LMP, low malignant potential.
Data are n.
the cutoff value of CA 125 from 35 units/mL to 60 tumor morphology obtained from ultrasonographic
units/mL and keeping the other parts of the definition images, and serum CA 125 levels is useful in estimat-
the same increased specificity from 92.4% to 96.6% ing the risk of malignancy in women with an adnexal
but lowered sensitivity from 84.7% to 80.9% and mass. For example, the risk of neoplasia in unilocular
missed 13 patients with stage I or stage II ovarian cystic ovarian tumors is very low. This morphologic
cancer. Therefore, a cutoff value of 35 units/mL for pattern was present in 123 (31%) of 395 adnexal
CA 125 was used in the final high-risk definition. This tumors, and no patient had either a borderline or an
definition correctly identified 34 of 44 patients with invasive ovarian malignancy. This confirms the ob-
stage I and stage II ovarian cancer and 93 of 94 servation by Roman and colleagues10 who, in a sum-
patients with stage III and stage IV ovarian cancer. mary of the literature, reported a 0.7% rate of malig-
Also, it correctly excluded 244 of the 264 patients nancy in 569 unilocular cystic ovarian tumors 10 cm
with benign ovarian tumors. or less in diameter. Similarly, Modesitt and col-
leagues11 followed more than 3,200 women with
DISCUSSION unilocular cystic ovarian tumors less than 10 cm in
The observation that the occurrence of certain symp- diameter for an average of 6 years without operative
toms may precede the clinical diagnosis of ovarian intervention. No patient developed ovarian cancer,
cancer has resulted in the recommendation that and 69% of these tumors resolved spontaneously over
women experiencing the recent onset of bloating, the period of observation. There is no doubt that
pelvic/abdominal pain, feeling full quickly after eat- some unilocular cystic ovarian tumors grow to signif-
ing, or urinary urgency/frequency should consult a icant size and require surgical removal. However, the
physician and undergo a complete physical examina- risk of malignancy even in larger cystic lesions is low,
tion. Women having a clinically palpable abnormality particularly in women with a normal CA 125 level. In
in the pelvis or those with persisting symptoms in the the present study, there were 27 unilocular cystic
presence of a normal pelvic examination are advised ovarian tumors more than 10 cm diameter, and all
to undergo transvaginal ultrasonography and CA 125 were benign.
testing. In contrast, adnexal masses with complex or solid
The findings of this investigation indicate that morphology are associated with a significant risk of
analysis of data concerning patient demographics, malignancy. There were 272 patients with a complex
VOL. 115, NO. 4, APRIL 2010 McDonald et al Risk of Malignancy in an Adnexal Mass 691
6. Table 4. Sensitivity, Specificity, Positive and Negative Predictive Values, and 95% Confidence Limits of
Each Variable Identifying or Ruling Out Ovarian Malignancy
Sensitivity Specificity
(95% CL) (95% CL)
Variable Sensitivity Lower Upper Specificity Lower Upper
Age older than 55 y 55.7 47.2 64.2 68.6 63.0 74.2
Gravidity more than 1 68.7 60.8 76.6 31.8 26.2 37.4
Postmenopausal 67.2 59.1 75.2 50.4 44.3 56.4
Weight more than 200 lb 11.5 6.0 16.9 75.0 69.8 80.2
Family history
Ovarian cancer 12.2 6.6 17.8 87.9 83.9 91.8
Breast cancer 15.3 9.1 21.4 83.3 78.8 87.8
Tumor morphology
Cystic 100.0 97.7 100.0 46.6 40.6 52.6
Complex 91.6 86.9 96.4 56.1 50.1 62.0
Ascites 41.2 32.8 49.7 100.0 98.9 100.0
Tumor bilaterality 9.2 4.2 14.1 97.0 94.9 99.0
Tumor diameter
More than 10 cm 48.9 40.3 57.4 84.8 80.5 89.2
CA 125 level more than 35 units/mL 85.5 79.5 91.5 86.4 82.2 90.5
CL, confidence limit; PPV, positive predictive value; NPV, negative predictive value.
or solid adnexal mass, and 131 (48%) had an ovarian tricians and Gynecologists and the Society of Gyne-
malignancy. These women form the basis of a high- cologic Oncologists.13 This report stated that 69.8% of
risk group for ovarian cancer. In the present investi- postmenopausal women with an adnexal mass and a
gation, documented ascites in a woman with a com- serum CA 125 value more than 35 units/mL had an
plex or solid adnexal mass was uniformly predictive ovarian malignancy and that an elevated serum CA
of ovarian cancer. There were 54 patients with this 125 value in a patient with a clinically detectable
finding, and all had epithelial ovarian cancer. These pelvic mass could be used as one indication for
results are consistent with the findings of Im and patient referral for subspecialty care. In the present
colleagues12 who, in a multiinstitutional review, re- investigation, more than three fourths of women with
ported that 79% of postmenopausal women with a a complex or solid adnexal mass and a CA 125 value
clinically detectable pelvic mass and ascites had an more than 35 units/mL had either borderline or
ovarian malignancy. invasive ovarian cancer.
The use of serum CA 125 as a method of When evaluating a number of variables, includ-
predicting risk of malignancy in patients with a clin- ing patient demographics, tumor morphology, and
ically detectable pelvic mass was suggested in 2002 by CA 125 levels, as predictors of malignancy, multiva-
a joint publication of the American College of Obste- riable classification and regression tree analysis de-
Table 5. Statistical Parameters Associated with a High-Risk* Group for Ovarian Cancer as Defined by
Multivariable Classification and Regression Tree Analysis
Criteria TP FP TN FN PPV NPV Sensitivity† Specificity‡
Total malignancies (nϭ131) 111 20 244 20 0.847 0.924 0.847§ 0.924§
Borderline malignancy (nϭ13) 4 20 244 9 0.167 0.964 0.308 0.924
Stages I and II ovarian 34 20 244 10 0.630 0.961 0.773 0.924
malignancy (nϭ44)
Stages III and IV ovarian 73 20 244 1 0.785 0.996 0.986 0.924
malignancy (nϭ74)
TP, true positive; FP, false positive; TN, true negative; FN, false negative; PPV, positive predictive value (TP/TPϩFP); NPV, negative
predictive value (TN/TNϩFN).
* High-risk defined as a complex or solid adnexal mass with a CA 125 value more than 35 units/mL.
†
Sensitivity, (TP/TPϩFN).
‡
Specificity, (TN/TNϩFN).
§
These figures vary within 1 standard error (Ϯ3.1% for sensitivity and Ϯ1.6% for specificity) when the sample is randomly split into
training and validation sets.
692 McDonald et al Risk of Malignancy in an Adnexal Mass OBSTETRICS & GYNECOLOGY
7. PPV PPV
(95% CL) (95% CL)
PPV Lower Upper NPV Lower Upper
46.8 39.0 54.6 75.7 70.3 81.2
33.3 27.7 39.0 67.2 59.0 75.4
40.2 33.7 46.7 75.6 69.2 81.9
18.5 10.1 27.0 63.1 57.7 68.4
33.3 20.0 46.7 66.9 61.9 71.8
31.3 19.9 42.6 66.5 61.4 71.6
48.2 42.2 54.1 100.0 97.6 100.0
50.8 44.5 57.2 93.1 89.1 97.0
100.0 94.4 100.0 77.4 73.0 81.9
60.0 38.5 81.5 68.3 63.6 73.0
61.5 52.2 70.9 77.0 72.1 81.8
75.7 68.8 82.6 92.3 89.0 95.6
fined high risk as women with a complex or solid netic testing,17 and this information should be taken into
adnexal mass and a serum CA 125 value of more than consideration in determining optimal treatment for a
35 units/mL. In the population studied, this definition patient with an adnexal mass.
of high risk was associated with a PPV of 84.7% and As an increasing number of women who have
a NPV of 92.4% and correctly identified 34 (77.3%) of symptoms suggestive of ovarian cancer are evaluated,
44 patients with stage I or stage II ovarian cancer as clinicians will be asked to determine which patients
well as 73 of 74 patients (98.6%) with stage III or stage are at significant risk for ovarian cancer. Data from
IV ovarian cancer. Thus, including tumor morphol- the present investigation suggest that the combination
ogy significantly increases predictive values beyond of ultrasonographic tumor morphology and serum
the PPV of 24.3% for stage I or II ovarian cancer and CA 125 value improves the discrimination of women
56.8% for stage III or IV ovarian cancer associated at risk of ovarian cancer from those with benign
with the original American College of Obstetricians adnexal lesions. These findings should be helpful in
and Gynecologists/Society of Gynecologic Oncolo- determining which patients can be followed without
gists high-risk criteria.14 In the present study, raising surgery, which patients are likely to have a benign
the cutoff value of CA 125 from 35 units/mL to 60 ovarian tumor, and which patients are at high risk of
units/mL in the definition of high risk would have ovarian malignancy and should be referred for sub-
increased specificity for identifying ovarian cancer specialty care.
cases but would have lowered sensitivity and resulted
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