Raloxifene versus continuous combined estrogen/progestin therapy: densitometric and biochemical effects in healthy postmenopausal Taiwanese women.

We treated 116 healthy postmenopausal women (age 47-66 years, mean 57 years) in Taiwan with either raloxifene (RLX) 60 mg (n = 92) or 0.625 mg conjugated equine estrogen plus 5 mg medroxyprogesterone acetate (CCEP, n = 24) daily for 12 months in a randomized, double-masked, active-controlled fashion. The results showed that both regimens increased bone mineral density (BMD) at hip sites (means: RLX 2.5-4.9%, CCEP 4.6-7.9%, all p<0.005 compared with baseline), and the difference between the two regimens was not significant. The spinal BMD increased significantly in both groups (1.4% with RLX and 6.0% with CCEP, both p<0.01), and more with CCEP (p<0.003). Osteocalcin levels and urinary type I collagen C-telopeptide/creatinine ratios decreased significantly in both regimens, but the decreases were significantly larger with CCEP. Compared with baseline, both RLX and CCEP decreased the total cholesterol (median 4.9% and 8.6% respectively, p<0.001) and LDL-cholesterol (median 11% and 19% respectively, p<0.001), and increased HDL-cholesterol (median 8.6% and 10.7% respectively, p<0.01). Both regimens increased triglyceride levels (median 3.2% and 18.9% respectively, both p<0.05), although to a lesser extent with RLX than with CCEP (p<0.05). Only 3 subjects (3.3%) reported vaginal bleeding in the RLX group, as compared with 31% (7/22) with CCEP (p<0.05). We conclude that in healthy, postmenopausal Taiwanese women, RLX 60 mg given daily has favorable results in BMD, bone turnover and serum lipids, although the dosage we used showed a potency less than that of conventional CCEP.

Effects of alendronate on osteopenic postmenopausal Chinese women.

To evaluate the effects of alendronate on postmenopausal Chinese women with osteopenia, we treated 46 subjects daily with either 10 mg alendronate (N = 24) or placebo plus 500 mg calcium supplement (N = 22), and measured their bone mineral density (BMD) at the lumbar spine and hip, and urinary bone resorption markers before, during, and after the 1 year treatment period. The bone markers included N-telopeptide of type I collagen (NTx) and deoxypyridinoline (Dpd); both were corrected by the concentration of creatinine in the same sample (NTx/Cr and Dpd/Cr). Both NTx/Cr and Dpd/Cr decreased significantly by 44% and 28%, respectively (p < 0.05 for both), in 1 month in the active treatment group but did not change in the placebo group. BMD at the spine, femoral neck, trochanter, and Ward's triangle increased significantly by 6 months and showed a further increase through month 12 at the spine in the alendronate-treated group. Relative to the placebo group, BMD changes at various sites in the alendronate-treated group were higher at 12 months by 6%-11%. Thus, our data suggest that 10 mg alendronate daily resulted in significant increases in spine and hip BMD, and decreases of urinary resorption markers in the osteopenic postmenopausal Chinese women studied. The amplitude of responses was higher than in previous reports in the USA and Europe.

Laparoscopic cystectomy of a twisted, benign, ovarian teratoma in the first trimester of pregnancy.

Adnexal torsion is an unusual, but serious complication in pregnancy. The treatment is surgical, but this may increase the risk of pregnancy loss in the first trimester. The use of laparoscopic surgery, which is less invasive than traditional laparotomy, has been limited by diagnostic and technical difficulties including determination of ovarian tumor nature and spillage of cyst contents intraoperatively. A 25-year-old woman in her 11th week of pregnancy had acute severe left lower-abdominal pain, which was diagnosed as left ovarian teratoma with torsion. She underwent emergency laparoscopic surgery with unwinding of the twisted fallopian tube and ovary and cystectomy of the teratoma. The patient subsequently delivered a full-term baby, without complications. Accurate ultrasound and cytologic diagnoses along with copious intraoperative warm, normal saline irrigation were likely contributing factors to the successful outcome of this case.

Oral contraceptives and breast cancer risk in Taiwan, a country of low incidence of breast cancer and low use of oral contraceptives.

One hundred and seventy four (81% of all) pathologically confirmed new incident cases of female breast cancer identified from a medical center in Taipei from February, 1993 to June, 1994 were selected as the case group. Four hundred and fifty three inpatient controls who were without obstetric-gynecological, breast, or malignant diseases were individually matched for each case by age and date of admission. Information was obtained through direct interview and review of medical records. Conditional logistic regression was used to estimate the effects of each risk factor. After adjusting for education level, body mass index, age at menarche and first full-term pregnancy, parity, menopausal status and age at menopause, lifetime lactation, use of lactation inhibition hormones, and family history of breast cancer, breast cancer risk significantly elevated in use of OC before 25 years old and before 1971. In stratified analysis, significantly higher risk were found in OC use before 25 years old and in duration of use less than one year among post-menopausal subjects. Our results support the notion that OC use in early life for younger women and in early calendar years increase breast cancer risk.

PIP: The effects of oral contraceptive (OC) use on the risk of breast cancer were investigated in a hospital-based case-control study conducted in Taiwan--a country with low use of OCs and a low incidence of breast cancer. 174 consecutive new incident cases of breast cancer diagnosed at National Taiwan University Hospital in Taipei in a 16-month period in 1993-94 and 435 age-matched controls admitted to the same hospital during the study period with nongynecologic, nonmalignant conditions were enrolled. 25 cases (14.4%) and 47 controls (10.4%) had ever used OCs; 9 cases (5.2%) and 15 controls (3.3%) had used the pill for 5 years or more. The risk of breast cancer was moderately elevated in OC users who started pill use before 25 years of age or before 1971, when the hormonal content of OCs was stronger. After adjustment for educational level, body mass index, ages at menarche and first full-term pregnancy, parity, menopausal status and age at menopause, lactation, family history of breast cancer, and use of female sex hormones other than OCs, the adjusted odds ratio (OR) for OC use was 1.7 (95% confidence interval (CI), 0.9-3.2). The adjusted OR for OC use before 25 years of age vs. never use was 3.4 (95% CI, 1.2-9.7). The adjusted OR for OC use before 1971 compared with never use was 3.2 (95% CI, 1.2-8.9). In premenopausal women, the adjusted OR for age at first use under 25 years of age compared with never use was 5.8 (95% CI, 1.5-22.1) and the adjusted OR for duration of OC use of 5 or more years vs. never use was 3.5 (95% CI, 0.9-14.3). For postmenopausal women, the adjusted OR of duration of OC use less than 1 year vs. never use was 7.5 (95% CI, 1.1-50.1).

Prognostic factors of primary adenocarcinoma of the uterine cervix.

OBJECTIVE: To determine which clinicopathological factors influence the prognosis of cervical adenocarcinoma. METHODS: Three hundred and two cases of primary adenocarcinoma of the uterine cervix, treated between 1977 and 1994, were studied retrospectively. Clinical data and pathological findings with respect to primary therapy were reviewed and evaluated. RESULTS: The 5-year survival rates for stages I, II, and III/IV were 75.9, 62.9, and 25.1%, respectively. International Federation of Gynecology and Obstetrics stage (P < 0. 0001), cell type (P = 0.0176), tumor grade (P = 0.023), lymph node status (P = 0.018), and bulky tumor (P = 0.007) were found to be independent factors using the stepwise Cox proportional hazards model. Old age (P = 0.0581), presence of hypertension (P = 0.46), diabetes mellitus (P = 0.18), obesity (P = 0.15), and oral contraceptive use (P = 0.42) were not found to adversely influence survival rates for cervical adenocarcinoma after adjusting for other covariates. Adenosquamous adenocarcinoma had a better prognosis than endocervical columnar cell adenocarcinoma in stages I and II (P = 0. 0235). Also, in cervical adenocarcinoma's early stages, multivariate modeling revealed that chances of survival were significantly better for patients treated by radical surgery than for patients treated by radiation therapy (P < 0.001). CONCLUSIONS: Survival rates for cervical adenocarcinoma were significantly influenced by stage, histologic subtype, tumor grade, the presence of a positive lymph node, and tumor size. Although a randomized prospective study is needed, our data imply that radical surgery may be considered a better primary modality of treatment than radiation therapy for the early stages of cervical adenocarcinoma. Further, the presence of hypertension, diabetes mellitus, or obesity may not adversely influence survival rates.

Independent clinical factors which correlate with failures in diagnosing early cervical cancer.

Our aim was to identify independent factors that correlated with colposcopically directed biopsy's reliability as a method for diagnosing early cervical cancer. One hundred ninety-one of a total of 2265 patients who had colposcopic examinations because of abnormal Papanicolaou smears were included in this study. These patients had all undergone a hysterectomy after being diagnosed as having cervical intraepithelial neoplasia grade III by colposcopically directed biopsy. By univariate analysis, old age (P = 0.0195), achievement of menopausal status (P = 0.0046), large lesion size (P = 0.0021), and unsatisfactory colposcopy (P = 0.0017) were found to be associated with the nondiagnosis of early cervical cancer. However, multivariate analysis using stepwise logistic regression revealed that large lesion size (P = 0.003) and unsatisfactory colposcopy (P = 0.0008) were the only independent factors that correlated with nondiagnosis. Our findings indicate that in order to reach a clear-cut diagnosis, cases with either unsatisfactory colposcopy or satisfactory colposcopy with large lesions (despite a lack of histologic evidence of invasions) should undergo a diagnostic conization.

Measurement of human chorionic gonadotropin by carboxyl terminal peptide assay in patients with cervical neoplasm.

The aim of this study was to investigate whether human chorionic gonadotropin (hCG) is produced by preinvasive cancer and the early stages of invasive cancer. One hundred and fifty-two patients with either various grades of preinvasive cervical carcinoma or microinvasive carcinoma, and 46 normal women used as controls, were enrolled in this study. A carboxyl terminal peptide beta-hCG (CTP-beta-hCG) assay with a sensitivity of 0.2 mIU/mL was used to measure serum levels. The results showed that the serum beta-hCG levels among normal control, preinvasive carcinoma and microinvasive carcinoma patients were not statistically different. Among the factors tested, including the interval since the last menstrual period, age, menopausal status, contraception method and diagnosis, serum hCG levels only correlated with the first factor. Preinvasive cervical carcinoma and microinvasive carcinoma did not result in significantly increased hCG secretion. At present, the CTP-beta-hCG assay is of limited value in the diagnosis of these diseases.

Loop electrosurgical excision procedure for conization of the uterine cervix.

The application of loop electrosurgical excision procedure (LEEP), a new method of conization of the uterine cervix used to diagnose cervical intraepithelial neoplasia (CIN) or cervical cancer is presented herein. A loop electrode consists of a thin wire that allows deep excision of the transformation zone (TZ). The cone-shaped tissue removed can be examined histologically. Over a period of one year, a total of 41 cases underwent LEEP. Without anesthesia, the patients did not have any noticeable pain during the procedure. There were no complications, such as fever, wound infection, massive bleeding or cervical stenosis. In low-grade CIN, follow-up colposcopy and cytology did not show persistence or recurrence. In two cases of high-grade CIN, subsequent hysterectomy revealed residual lesions on hysterectomized specimens. LEEP is a simple and quick procedure of diagnostic conization that can be done at the first visit without major complication. If the histopathology after LEEP is moderate- to high-grade CIN or invasive cancer, the conization cannot be regarded as a sufficient therapeutic procedure, and such a patient needs further treatment.

Secondary ovarian malignancy of extragenital origin: clinical analysis of 42 cases.

Forty-two patients with secondary ovarian cancer from extragenital sites encountered in the past 14 years at the National Taiwan University Hospital were retrospectively analyzed. They accounted for 11.6% (42/362) of all ovarian cancers. The mean age was 43.7 years, and 32 patients were premenopausal. Gastric cancer was the most frequent primary malignancy (50.0%); other sites of extragenital primaries were colon (23.8%), breast (11.9%), rectum (4.8%), and indeterminate (9.5%). Bilateral ovarian involvement was found in 78.6% of patients. The most common presenting symptom was abdominal distension (52%). All patients received surgical intervention as the primary treatment; 30 patients had subsequent chemotherapy and four patients had postoperative radiotherapy. However, the outcome was poor; more than half of the patients died within one year, with a two-year survival rate of 22.5%.

Serum squamous cell carcinoma antigen in gynecologic malignancies with special reference to cervical cancer.

Squamous cell carcinoma (SCC) antigen was measured by double-antibody radioimmunoassay in the sera of 113 patients with gynecologic malignancies and 30 controls. The mean serum SCC antigen level was 9.24 ng/ml in those with cervical squamous cell carcinoma, 2.15 ng/ml in those with other gynecologic malignancies, and 1.25 ng/ml in controls. With a cutoff value of 2.23 ng/ml (2 SD above the mean of the control group), the rate of SCC antigen elevation was 54% in cervical cancer (78), 14% in vulvar or vaginal cancer (7), 22% in ovarian cancer (18), and 10% in endometrial cancer (10). In cervical squamous cell carcinoma, the rates of elevated SCC antigen level increased with disease advancement in stages 0, I, II, III, and IV, by 13, 50, 53, 78, and 100%, respectively. In early-stage cervical squamous cell carcinoma, SCC antigen was not sensitive enough for screening. However, if elevated, serum SCC antigen levels decreased rapidly after successful surgical treatment. One case with a serum SCC antigen level above 65 multiples of the cutoff value had widespread cancer and postoperative recurrence. In the advanced case, the sensitivity was much higher. In the recurrent case, the positive rate was 73%. Serum SCC antigen level is useful in predicting the prognosis and monitoring the course of cervical squamous cell carcinoma, especially in the detection of a recurrence.