Realhand high dexterity instruments for the treatment of stage I uterine malignancy.

BACKGROUND: The purpose of this pilot study was to evaluate the impact of RealHand instruments on laparoscopic-assisted vaginal hysterectomy (LAVH) for the treatment of stage I uterine cancer. METHODS: This was a single-center, nonrandomized, consecutive patient pilot study. Patient status was evaluated in terms of operative morbidity, length of surgery, anesthesia time, body mass index (BMI), estimated blood loss, uterine weight, and hospital stay. RESULTS: In the group of 10 patients, mean operative time was 1.7 hours, and anesthesia time was 2.3 hours. Mean estimated blood loss was 70mL, and patient hospital stay was 31.8 hours. No intra- or postoperative complications occurred. Blood loss, anesthesia time, BMI, and uterine weight were significant predictors of operative time. In one patient, LAVH using the RealHand instruments was canceled because of deep pelvic visualization difficulties, resulting in a conversion to laparotomy. CONCLUSION: We present the first reported individual physician LAVH experience using RealHand instruments for the treatment of clinical stage I uterine cancer. The reported operative time, reasonable patient complication rates, and acceptable postoperative stay suggest that these innovative surgical instruments may have significant promise in the treatment of patients diagnosed with this gynecologic disease.

New perspectives in clinical research: the Women's Cancer Research Foundation's experience.

The number of physicians involved in clinical research continues to decline. Financial and administrative barriers appear to be primarily responsible, although inadequate community-based infrastructure has also contributed significantly to this troubling phenomenon. Therefore, novel physician-friendly research models amenable to conducting efficient clinical research are necessary. The physicians from the Women's Cancer Research Foundation have developed such a paradigm over the past 23 years, which has proven to increase research productivity above and beyond the traditional academic model.

Laser ablation of surgical margins after excisional partial vulvectomy for VIN: Effect on recurrence.

OBJECTIVE: To determine the recurrence rates in patients who underwent different surgical treatments for vulvar intraepithelial neoplasia (VIN) 2 and 3. STUDY DESIGN: Data on every patient who underwent surgical treatment for VIN 2 or 3 between January 1994 and December 2002 by a single gynecologic oncologist were retrospectively reviewed. The recurrence rates for 3 different surgical therapies were analyzed using Fischer's exact test. RESULTS: Thirty-three patients, who had a median age of 46 years (range, 31-80), were identified. The preoperative biopsy demonstrated VIN 2 or 3 in 9.1% and 90.9% of the patients, respectively. The following primary surgical procedures were employed: 16 patients (48.4%) underwent excisional partial vulvectomy with CO2 laser ablation of the margins, 10 patients (30.3%) had CO2 laser ablation alone, 6 patients (18.2%) had an excisional partial vulvectomy, and 1 patient (3.0%) was. treated with the ultrasonic surgical aspirator. No patient had invasive disease. Recurrent disease was seen in 7 patients (70.0%) treated by laser alone, 3 patients (50.0%) who had an excisional partial vulvectomy and 1 patient (6.25%) who underwent a combined laser and excisional partial vulvectomy (p = 0.0016). CONCLUSION: The results of this small study suggest that laser and excisional partial vulvectomy for the treatment of VIN 2 and 3 may be associated with a lower recurrence rate than either modality alone. A larger study will be needed to confirm these results.

Three-consecutive-day topotecan is an active regimen for recurrent epithelial ovarian cancer.

OBJECTIVE: The aim was to determine the response rate and toxicity of topotecan administered Days 1-3 every 21 days for recurrent epithelial cancers of the ovary, peritoneum, or fallopian tube. A 3-day regimen may be more convenient and less expensive than a 5-day schedule. METHODS: Patients with recurrent epithelial cancer of the ovary, peritoneum, or fallopian tube who had adequate hepatic, renal, and hematologic function were eligible for participation. Topotecan (2 mg/m(2)) was administered for 3 consecutive days every 21 days. Response was measured clinically and serologically. Granulocyte colony stimulating factors (GCSF) were not utilized prophylactically, but could be added under specific conditions. RESULTS: Thirty-one patients with recurrent ovarian cancer whose median age was 63 (range 32-84) received 165 cycles of topotecan (median = 6; range 2-8) and are evaluable for toxicity. The median number of prior regimens was 1. Topotecan was administered on schedule in 96.6% of cycles. Grade 3/4 neutropenia was seen in 29.1 and 23.6% of courses, respectively; but only 3.4% of cycles required GCSF support (6 cycles for 2 patients). Grade 4 thrombocytopenia was rare (1% of cycles). Nonhematologic toxicity was mild. The response rate for 28 evaluable patients was 32.1% (10.7% complete response (CR) and 21.4% partial response (PR)); stable disease was seen in 17.9% of patients. The median progression-free interval (PFI) for all patients was 15.5 weeks (range 5-40). Eighteen platinum-sensitive patients demonstrated a 43.4% response rate (12.5% CR and 31.3% PR); stable disease was documented in 18.8%. The median PFI for platinum-sensitive patients was 18.5 weeks (range 5-40). CONCLUSION: Topotecan is an effective regimen with acceptable toxicity for recurrent ovarian cancer when administered for 3 consecutive days (2 mg/m(2)) every 21 days. It can be delivered on schedule without GCSF support in the vast majority of patients.