Safety and efficacy of vaginal hysterectomy in the large uterus with the LigaSure bipolar diathermy system.

OBJECTIVE: This study was undertaken to assess safety and efficacy of vaginal hysterectomy in case of large uterine size (> or = 250 g) using the LigaSure bipolar diathermy (Valleylab, Boulder, CO). STUDY DESIGN: In a retrospective study, medical records of 102 patients who underwent vaginal hysterectomy and who had uterine weight (evaluated after surgery) 250 g or greater were reviewed. All hysterectomies were performed by using the LigaSure vessel sealing system to secure vascular pedicles (uterosacral-cardinal, uterine and ovarian and round ligaments). RESULTS: Of the 102 vaginal hysterectomies, 99 were successfully performed (97.1%; 95% confidence interval, 91.6-99.4%), whereas a conversion from the vaginal to the abdominal route was required in 3 cases. The median uterine weight was 455 g (range, 241-1913 g). The weight of the largest uterus successfully removed vaginally was 1600 g, without intraoperative and postoperative complications. The median operative time was 50 minutes (range, 25-50 minutes). CONCLUSION: The current study confirms that very large uterine volume does not represent a real obstacle to perform vaginal hysterectomy and that results in a safe and effective technique in cases of uterine weight 250 g or greater

Relationship between CA 15-3 serum levels and disease extent in predicting overall survival of breast cancer patients with newly diagnosed metastatic disease.

In order to study the relationship between circulating levels of CA 15-3 and the disease extent in predicting survival, we prospectively followed 312 breast cancer (BC) patients, from October 1988 to March 1995, from the time of first relapse. CA 15-3 values were assessed before treatment onset. Disease extent was defined as the percentage of liver or lung involvement and the number of bone segments positive at scintigraphy. The covariates were primary tumour characteristics (T, N and hormone receptor status) and patient characteristics at recurrence (menopause, performance status and age). Higher CA 15-3 serum levels were found in patients with visceral metastases or with pleural effusion. A logistic regression model selected disease extent in liver, lung and bone as independent variables for the determination of abnormal CA 15-3 values. Univariate survival analysis confirmed the positive prognostic influence of low CA 15-3 serum levels, absence of visceral metastases and the presence of only one metastatic site. Multivariate Cox's survival analysis selected disease extent in liver, lung, bone and soft tissue but not level of CA 15-3 as prognostic factors. In conclusion, CA 15-3 is not an independent variable in determining survival, its prognostic role being linked to the disease extent. This association suggests that CA 15-3 may be useful in assessing disease extent when this is not easily assessable

Lonidamine significantly increases the activity of epirubicin in patients with advanced breast cancer: results from a multicenter prospective randomized trial.

PURPOSE: Some evidence in vitro and in vivo shows that lonidamine (LND) can positively modulate the activity of doxorubicin and epirubicin (EPI). On this basis, a multicenter prospective randomized trial was performed in patients with advanced breast cancer (BC) to determine if the addition of LND to EPI could increase the response rate of EPI alone. PATIENTS AND METHODS: From May 1991 to May 1993, 207 patients were enrolled onto this study and randomized to receive intravenous (IV) EPI (60 mg/m2 on days 1 and 2) alone or with LND (600 mg orally daily). EPI administration was repeated every 21 days until tumor progression or for a maximum of eight cycles. LND was administered continuously until chemotherapy withdrawal. RESULTS: Response rate was significantly superior for the EPI plus LND scheme compared with the single-agent EPI either considering assessable patients (60.0% v 39.8%; P < .01) or including all registered patients according to an intention-to-treat analysis (55.3% v 37.5%; P < .02). The distribution of the response rate according to the site of disease did not show any significant difference between the treatment arms, except for the patient subgroup with liver metastases in which the combination EPI plus LND resulted in a significant improvement of responses than EPI alone. Toxicity was moderate, and except for myalgia, no adjunctive side effects were observed in the EPI plus LND arm. Overall survival and time to progression were similar in both groups. CONCLUSION: This study confirms in vivo that the administration of EPI is enhanced by the concomitant LND administration