Bjørn Hagen

Evaluation of a risk of malignancy index based on serum CA125, ultrasound findings and menopausal status in the pre-operative diagnosis of pelvic masses

Objective To evaluate the ability of a risk of malignancy index (RMI), based on a serum CA125 level, ultrasound findings and menopausal status, to discriminate a benign from a malignant pelvic mass and to discriminate early stage (Figo Stage I) from Stages II, III and IV of ovarian cancer.

Long-Term Effectiveness Of The Burch Colposuspension In Female Urinary Stress Incontinence

Of 91 women who underwent Burch colposuspension, 86 were available for clinical, urodynamic and isotope renographic follow‐up examinations 5 years after surgery for evaluation of late complications and long‐term effectiveness in urinary stress incontinence. A repeat urodynamic examination was accepted by 76 patients. Stress incontinence was cured in 71 % of the patients with a stable bladder preoperatively, and in 57% with stress incontinence and detrusor instability (non‐significant difference). Cure rate was not significantly related to age, hormonal status or previous anterior vaginal repair. The urodynamic measurements at follow‐up showed a significant increase in the functional urethral length in the cured group, as compared with the improved group. The mean maximum urethral closure pressure was reduced in both groups. Symptomatic detrusor instability was found in 18% of the preoperative stable bladders, while 67% of the unstable bladders had become stable. Only 29% of the patients with a preoperative unstable bladder had a normal lower urinary tract function at follow‐up. Late voiding difficulties were observed in 3% of the study group; enterocele, requiring surgical repair, developed in 7%. One patient suffered a damaged kidney due to undetected ureteral obstruction after surgery. Irritative bladder symptoms such as urgency, frequency, stranguria and nocturia represent a long‐term problem after colposuspension. At the 5‐year follow‐up, only 52% of the study group were completely dry and free of complications, and about 30% needed further incontinence therapy. This may be due to some neurogenic factor which is not corrected by surgery.

Survival and prognostic factors in patients with ovarian cancer.

OBJECTIVE To assess incidence during a 10-year study period and to identify and discuss clinical relevance for prognostic factors of survival within a cohort of Norwegian ovarian cancer patients. METHODS Incidence and prognostic factors of survival within a population-based cohort of ovarian cancer patients from one health region in Norway were examined over the 10-year period 1987 through 1996. A total of 571 histologically verified cases of primary ovarian cancer originally registered either in the Cancer Registry of Norway or in the hospitals discharge registers were included in the study. Pearson χ2 test was used in univariate analyses of cofactors by 5-year survival, and Kaplan-Meier survival curves were computed and tested statistically by the log rank test. A multivariable proportional hazard model (Cox) was applied to assess the prognostic significance of the different covariates. RESULTS The incidence and crude 5-year survival remained stable over the 10-year study period. The standardized incidence rate for the time periods 1987–1991 and 1992–1996 was 11.9/100,000 and 12.5/100,000, respectively. The crude 5-year survival rate for the cohort was 39%, whereas median survival was 32 months. Cox multivariable regression analysis showed that the only independent significant prognostic factors were International Federation of Gynecology and Obstetrics stage (P < .001), size of residual tumor at the end of primary surgery (P < .001), and age at diagnosis (P < .01). Variables such as time period, histologic type and grade, treating hospital, comorbidity, or CA 125 were insignificant in predicting 5-year survival. CONCLUSION The results underline the importance of improved surgical management of ovarian cancer, as residual tumor is the only prognostic factor achievable.

The effect of centralization of primary surgery on survival in ovarian cancer patients.

OBJECTIVE To examine the effect of centralized surgery on overall survival in patients with ovarian cancer and, in particular, patients with advanced disease (stage III/IV). METHODS In a historical prospective study design, patients referred from community hospitals to a teaching hospital for primary surgery during the 2-year period, 1995–1997, were included as cases. For each referred case, two controls, matched for International Federation of Gynecology and Obstetrics (FIGO) stage and age, were selected among patients who had had primary surgery at the referral hospitals (nonteaching) in the years, 1992–1995. Kaplan–Meier survival curves were computed and tested statistically by the log rank test. Cox proportional hazard model was applied for estimation of prognostic factors of survival. RESULTS There was no difference in postoperative mortality for stage I/II patients by level of care (community hospitals versus teaching hospital). However, for advanced stage disease (III + IV), the controls had significantly shorter crude survival than patients who had been operated on at the teaching hospital (5-year survival: 4% versus 26%; median survival: 12 months versus 21 months) (P = .01). Multivariable analyses showed that completed chemotherapy and size of residual tumor after primary surgery were independent prognostic factors of survival. Patients optimally operated on at the teaching hospital had significantly lower risk of death compared with all other groups, independently of chemotherapy. This indicates that the extent of cytoreductive surgery and the overall management undertaken in the teaching hospital are significant predictors of improved survival. CONCLUSION Centralization of primary ovarian cancer surgery in one health region in Norway has improved survival for patients with advanced disease. Patients with apparent advanced ovarian cancer should be referred to a subspecialty unit for primary surgery, and every effort should be made to attain as complete cytoreduction as possible.

The risk-of-malignancy index to evaluate potential ovarian cancers in local hospitals.

OBJECTIVE To assess the risk-of-malignancy index (a scoring system based on menopausal status, ultrasound features, and serum CA 125) at district hospitals for referral of women with suspected malignant pelvic masses for primary surgery at a central gynecologic oncology unit. METHODS All seven hospitals in Health Region IV, Norway, agreed to refer women with pelvic masses and risk-of-malignancy indices of 200 or more for centralized primary surgery. In total, 365 women 30 years of age or older, admitted consecutively at the local hospitals, were enrolled in the study from February 1, 1995, to January 31, 1997. RESULTS Compliance with the study was satisfactory; 84% (65 of 77) of women with risk-of-malignancy indices of at least 200 were referred for centralized primary surgery. Sensitivity and specificity to malignancy were 71% and 92%, respectively, which is in agreement with previous validation of the risk-of-malignancy index in teaching hospital settings. False negatives were due mainly to stage Ia (18 of 24) ovarian cancer, whereas 27 of 28 stage II-IV ovarian cancer cases were identified correctly. CONCLUSION The risk-of-malignancy index identified women with malignant pelvic masses efficiently. Our study showed the risk-of-malignancy index strategy in a practical setting to be able to centralize primary surgery for advanced ovarian cancer from local hospitals to a subspecialty unit. We recommend the risk-of-malignancy index for detection of patients with advanced ovarian cancer for centralized primary surgery.

Randomized study on adjuvant chemotherapy in stage I high-risk ovarian cancer with evaluation of DNA-ploidy as prognostic instrument

Summary Purpose: Adjuvant chemotherapy versus observation and chemotherapy at progression was evaluated in 162 patients in a prospective randomized multicenter study. We also evaluated DNA-measurements as an additional prognostic factor. Patients and methods: Patients received adjuvant carboplatin AUC 7 every 28 days for six courses (n - 81) or no adjuvant treatment (n = 81). Eligibility included surgically staged and treated patients with FIGO stage I disease, grade 1 aneuploid or grade 2 or 3 non-clear cell carcinomas or clear cell carcinomas. Disease-free (DFS) and disease-specific (DSS) survival were end-points. Results: Median follow-up time was 46 months and progression was observed in 20 patients in the treatment group and 19 in the control group. Estimated five-year DFS and DSS were 70% and 86% in the treatment group and 71% and 85% in the control group. The hazard ratio was 0.98 (95% confidence interval (95% CI): 0.52-1.83) regarding DFS and 0.94 (95% CI: 0.37-2.36) regarding DSS. No significant differences in DFS or DSS could be seen when the log-rank test was stratified for prognostic variables. Therefore, data from both groups were pooled for the analysis of prognostic factors. DNAploidy (P = 0.003), extracapsular growth (P = 0.005), tumor rupture (P = 0.04), and WHO histologic grade (P = 0.04) were significant independent prognostic factors for DFS with P < 0.0001 for the model in the multivariate Cox analysis. FIGO substage (P = 0.01), DNA ploidy (P < 0.05), and histologic grade (P = 0.05) were prognostic for DSS with a P-value for the model < 0.0001. Conclusions: Due to the small number of patients the study was inconclusive as regards the question of adjuvant chemotherapy. The survival curves were superimposable, but with wide confidence intervals. DNA-ploidy adds objective independent prognostic information regarding both DFS and DSS in early ovarian cancer.

The outcome of pregnancy after CO2 laser conisation of the cervix

Objective To investigate the effect of laser conisation of the cervix on the outcome of subsequent pregnancy.

Completeness and accuracy of registration of ovarian cancer in the cancer registry of Norway.

Completeness of reporting and accuracy of the diagnosis of ovarian cancer from one health region in Norway to the Cancer Registry were examined. Data kept by the Cancer Registry were evaluated against discharge diagnosis data from all 8 hospitals in the health region during the period of 1987–1996. The assessment of the accuracy of the diagnosis recorded in the Cancer Registry was based on review of all medical records in the hospital setting and on slide review of all histologic diagnoses. The overall completeness of reporting ovarian cancer to the Cancer Registry was 99.6%. The organ specific completeness of registration of histologic verified ovarian cancer within the Cancer Registry was 95.3%; 0.9% was erroneously coded and 3.5% had their diagnosis changed to ovarian cancer at re‐evaluation. Of all ovarian cancer cases registered at the Cancer Registry, 91% had a primary histologic diagnosis. Among 591 cases identified with a histologic diagnosis in the Cancer Registry, the accuracy of the diagnosis was estimated at 92%. Coding errors were found in 2% of these cases, while in 6% of the cases it was not possible to reproduce the original diagnosis of ovarian cancer at re‐evaluation. In order to provide data of high quality for cancer surveillance a cancer registry needs several data providers, such as histopathologic laboratory reports and clinical reports. In addition, assessment of reported data through stringent quality assurance procedures within the registry are necessary for reaching a nearly 100% completeness of registration as found for ovarian cancer in the Cancer Registry of Norway.

Prospectively detected cancer in familial breast/ovarian cancer screening

BACKGROUND Early diagnosis and treatment are shown to improve survival of breast and ovarian cancer. Identification and medical follow-up of high-risk groups may be important for early diagnosis. METHODS A prospective study of 845 women from breast/ovarian- and ovarian cancer kindreds who were classified according to pre-set inclusion criteria (Table I), were offered genetic counseling and annual medical examinations of breasts and ovaries. The material consisted of three series: 1) 754 unaffected women, 2) 49 women with breast cancer, and 3) 42 women with ovarian cancer. RESULTS In series 1) nine ovarian cancers and 20 breast cancers, in series 2) seven ovarian cancers, and in series 3) three breast cancers were found. All but one of the ovarian cancers were 40 years or older, and 4/16 (25%) were Borderline cancer. All breast cancers were 30 years or older, and 89% were detected before spread. CONCLUSIONS This is to our knowledge the first prospective report of the combined breast/ovarian cancer findings in breast/ovarian cancer kindreds. A woman with both breast and ovarian cancer is the hallmark of inherited breast/ovarian cancer, and 50% of the ovarian cancers were detected in these families. Borderline ovarian cancer may represent a manifestation of this syndrome. If prophylactic oophorectomy prevents ovarian cancer, oophorectomy at age 45 would have prevented 75% of such cancers. Based on these results we revised our protocol for annual follow-up in these kindreds: 1) clinical breast examination and mammography (ultrasound/cytology if indicated) from 30 years of age, 2) gynecologic examination (including vaginal ultrasound, serum-CA125) from 35 years of age, and 3) discuss oophorectomy at 45 years of age.

Randomised controlled trial of LigaSure versus conventional suture ligature for abdominal hysterectomy

Objective  To compare the use of LigaSure with conventional suture ligature in abdominal hysterectomy.