Differentiation of small adnexal masses based on morphologic characteristics of transvaginal sonographic imaging: a multicenter study.

OBJECTIVE: The purpose of this study was to assess the diagnostic accuracy of transvaginal sonographic examination of small adnexal masses by simple descriptive sonographic scoring. METHODS: In a prospective multicenter study, 4 teaching hospitals and 2 regional hospitals with homogeneous standard sonographic equipment and operator experience recruited 677 consecutive patients with small adnexal masses of less than 5 cm. Morphologic scoring was obtained for each mass and recorded. The management of the mass was based on local protocols. The minimal requirement was that surgery had to be performed for complex masses scoring 8 or higher, and follow-up of at least 12 months had to be performed and recorded for patients not admitted to surgery. Sonographic results were compared with pathologic reports and follow-up findings. RESULTS: Fifty-two malignant tumors (19 borderline, 15 stage I-II, 15 stage III-IV, 2 tubal carcinomas, and 1 ovarian lymphoma), 243 benign tumors at pathologic examination, and 382 masses defined as benign according to follow-up findings were observed. Malignant tumors had a significantly higher mean +/- SD morphologic score (11.2 +/- 2.7) than benign masses (6.2 +/- 2.5) (P = .001). No difference was observed in the scoring assignment of malignant masses in different centers (P = .56). With a score of 8 or higher, the likelihood ratio was 3.61 (95% confidence interval, 3.09-4.21); sensitivity, 92%; specificity, 76.9%; and positive predictive value, 25.6%. CONCLUSIONS: Our results provide evidence that descriptive morphologic scoring may overcome the subjectivity of interpretation of morphologic characteristics in small masses, and, at the same time, it can incorporate criteria to avoid simplistic description of a complex mass.

A prospective study of the role of ultrasound in the management of adnexal masses in pregnancy.

OBJECTIVE: To assess the clinical relevance of adnexal masses in pregnancy and the usefulness of ultrasound in their management. DESIGN: A prospective study on pregnancy complicated by adnexal masses. SETTING: Department of Obstetrics and Gynaecology in Italy. POPULATION: 6636 women with pregnancy in utero followed in our clinic from January 1996 to December 1999. METHODS: From 1996 to 1999, all ovarian cysts with a diameter exceeding 3 cm were prospectively recorded and followed. The management was expectant except in case of symptoms or suspected malignant features. Cysts suggestive of borderline tumours were treated expectantly. MAIN OUTCOME MEASURES: Clinical relevance of adnexal masses in pregnancy, the outcome of these pregnancies and the usefulness of ultrasound examination in their management. RESULTS: We detected 82 cysts in 79 of 6636 women (1.2 in 100 term pregnancies). Sixty-eight women were asymptomatic at the time of diagnosis, whereas 11 (13.9%) were diagnosed because of pain. Diagnosis occurred in the first trimester for 57 cases and in the second or third trimester in 22 (27.8%). One-half of the cysts were simple and anechoic at ultrasound. Fifty-seven had a diameter not exceeding 5 cm. Forty-two cyst resolved in pregnancy without treatment. Three cysts required surgery within few days (torsion). One woman required laparotomy at the 37th week of gestation, due to torsion. When one case of termination was excluded, 78 women delivered at term (66 vaginally, 12 by caesarean section). Nineteen women underwent surgery after pregnancy. We recorded three Stage Ia borderline tumours, accounting for 3/82 cysts (3.6%) and 3/30 persisting masses (10%). CONCLUSION: Ultrasound allows definition of ovarian cysts in pregnancy and this positively impacts on management. The incidence of cancer among persistent masses is lower than previously reported. Acute complications in stable cysts are extremely uncommon after the first trimester. An expectant management is successful in the majority of cases and should be considered more often. Routine removal of persistent cysts is not justified.

Impact of adjuvant chemotherapy and surgical staging in early-stage ovarian carcinoma: European Organisation for Research and Treatment of Cancer-Adjuvant ChemoTherapy in Ovarian Neoplasm trial.

BACKGROUND: All randomized trials of adjuvant chemotherapy for early-stage ovarian cancer have lacked the statistical power to show a difference in the effect on survival between adjuvant chemotherapy and no adjuvant chemotherapy. They have also not taken into account the adequacy of surgical staging. We performed a prospective unblinded, randomized phase III trial to test the efficacy of adjuvant chemotherapy in patients with early-stage ovarian cancer, with emphasis on the extent of surgical staging. METHODS: Between November 1990 and January 2000, 448 patients from 40 centers in nine European countries were randomly assigned to either adjuvant platinum-based chemotherapy (n = 224) or observation (n = 224) following surgery. Endpoints were overall survival and recurrence-free survival, and the analysis was on an intention-to-treat basis. The Kaplan-Meier method was used to perform time-to-event analysis, and the log-rank test was used to compare differences between treatment arms. Statistical tests were two-sided. RESULTS: After a median follow-up of 5.5 years, the difference in overall survival between the two trial arms was not statistically significant (hazard ratio [HR] = 0.69, 95% confidence interval [CI] = 0.44 to 1.08; P =.10). Recurrence-free survival, however, was statistically significantly improved in the adjuvant chemotherapy arm (HR = 0.63, 95% CI = 0.43 to 0.92; P =.02). Approximately one-third of patients (n = 151) had been optimally staged and two-thirds (n = 297) had not. Among patients in the observation arm, optimal staging was associated with a statistically significant improvement in overall and recurrence-free survival (HR = 2.31 [95% CI = 1.08 to 4.96]; P =.03 and HR = 1.82 [95% CI = 1.02 to 3.24] P =.04, respectively). No such association was observed in the chemotherapy arm. In the non-optimally staged patients, adjuvant chemotherapy was associated with statistically significant improvements in overall and recurrence-free survival (HR = 1.75 [95% CI = 1.04 to 2.95]; P =.03 and HR = 1.78 [95% CI = 1.15 to 2.77]; P =.009, respectively). In the optimally staged patients, no benefit of adjuvant chemotherapy was seen. CONCLUSION: Adjuvant chemotherapy was associated with statistically significantly improved recurrence-free survival in patients with early-stage ovarian cancer. The benefit of adjuvant chemotherapy appeared to be limited to patients with non-optimal staging, i.e., patients with more risk of unappreciated residual disease.