Measurement of vaginal length: Reliability of the vaginal sound--a Gynecologic Oncology Group study.

A decrease in vaginal length associated with treatments for gynecological malignancies, particularly pelvic radiotherapy, negatively impacts sexuality. Research into this important problem has been hampered by a lack of instrumentation to measure vaginal length. The Gynecologic Oncology Group recently evaluated the reliability of an instrument, the "vaginal sound," designed to measure vaginal length. Eighty-eight physicians and nurses attended a training session in the use of the vaginal sound that included a clinical practicum with live models. Reliability was assessed at the time of the practicum. The instrument performed well, with vaginal lengths in models without cancer in the upper range of normal as documented by Masters and Johnson. The vaginal sound also appeared to be sensitive to hypothesized changes in vaginal length. Interrater reliability was high with intraclass correlation coefficients of 0.88 among instructors and 0.76 among trainees. In conclusion, the vaginal sound is a simple, yet reproducible measure and adds methodologic rigor to studies of vaginal length.

Recurrent ascites and pleural effusions after surgery for early-stage endometrial adenocarcinoma.

A case of massive postoperative ascites in a woman treated for endometrial cancer is reported. A workup for typical causes of ascites yielded negative results, prompting a more detailed analysis of the patient's condition. Hypothyroidism was discovered. After correction of the hypothyroidism, the ascites slowly resolved. Since myxedema is an uncommon cause of ascites, this is usually a diagnosis of exclusion. However, hypothyroidism must be ruled out to prevent unnecessary and possibly inappropriate treatments for ascites.

Does the presence of thrombus seen on a coronary angiogram affect the outcome after percutaneous coronary angioplasty? An Angiographic Trials Pool data experience.

OBJECTIVES: This study aimed to determine whether pre-existing angiographic thrombus was associated with adverse in-hospital and six-month outcomes after percutaneous coronary interventions. BACKGROUND: There are conflicting data about whether pre-existing thrombus is an independent predictor of adverse in-hospital and short-term outcome after coronary interventions. METHODS: The Angiographic Trials Pool, a data set derived from eight prospective randomized trials, was analyzed. The study population consisted of 7,917 patients who underwent coronary interventions between 1986 and 1995. Two trials were excluded because they did not collect information regarding thrombus. Patients from the other six trials were divided on the basis of the presence or absence of thrombus. RESULTS: In patients with (n = 2,752) and without (5,165) thrombus, in-hospital mortality following angioplasty was low (0.8 vs. 0.6%, p = 0.207). Several adverse outcomes were higher in patients with thrombus: death/myocardial infarction (8.4 vs. 5.5%, p < or = 0.001), in-hospital abrupt closure (5.9 vs. 3.9%, p < or = 0.001) and an in-hospital composite of death, myocardial infarction and/or repeat revascularization (15.4 vs. 11.2%, p < or = 0.001). Six-month mortality was low and comparable between the two groups (2.1 vs. 1.8%, p = 0.34), but the incidence of six-month death/myocardial infarction was higher in patients with thrombus (11.7 vs. 8.7%, p < or = 0.0001). CONCLUSIONS: Percutaneous coronary angioplasty can be performed with low mortality in patients with pre-existing thrombus, although these patients are at higher risk of in-hospital and six-month death/myocardial infarction. Continued efforts are required to optimize the outcome in these high risk patients.

A comprehensive approach to compliance training in a pharmaceutical manufacturing facility.

A healthcare manufacturer seeking to ensure that dollars invested in training return value in performance improvements will want to consider each of these elements and develop a written training plan. Companies who have created a training plan to meet their business objectives are already reaping benefits of reduced turnover and increased productivity.

Preoperative chemoradiation for advanced vulvar cancer: a phase II study of the Gynecologic Oncology Group.

PURPOSE: To determine the feasibility of using preoperative chemoradiotherapy to avert the need for more radical surgery for patients with T3 primary tumors, or the need for pelvic exenteration for patients with T4 primary tumors, not amenable to resection by standard radical vulvectomy. METHODS AND MATERIALS: Seventy-three evaluable patients with clinical Stage III-IV squamous cell vulvar carcinoma were enrolled in this prospective, multi-institutional trial. Treatment consisted of a planned split course of concurrent cisplatin/5-fluorouracil and radiation therapy followed by surgical excision of the residual primary tumor plus bilateral inguinal-femoral lymph node dissection. Radiation therapy was delivered to the primary tumor volume via anterior-posterior-posterior-anterior (AP-PA) fields in 170-cGy fractions to a dose of 4760 cGy. Patients with inoperable groin nodes received chemoradiation to the primary vulvar tumor, inguinal-femoral and lower pelvic lymph nodes. RESULTS: Seven patients did not undergo a post-treatment surgical procedure: deteriorating medical condition (2 patients); other medical condition (1 patient); unresectable residual tumor (2 patients); patient refusal (2 patients). Following chemoradiotherapy, 33/71 (46.5%) patients had no visible vulvar cancer at the time of planned surgery and 38/71 (53.5%) had gross residual cancer at the time of operation. Five of the latter 38 patients had positive resection margins and underwent: further radiation therapy to the vulva (3 patients); wide local excision and vaginectomy necessitating colostomy (1 patient); no further therapy (1 patient). Using this strategy of preoperative, split-course, twice-daily radiation combined with cisplatin plus 5-fluorouracil chemotherapy, only 2/71 (2.8%) had residual unresectable disease. In only three patients was it not possible to preserve urinary and/or gastrointestinal continence. Toxicity was acceptable, with acute cutaneous reactions to chemoradiotherapy and surgical wound complications being the most common adverse effects. CONCLUSION: Preoperative chemoradiotherapy in advanced squamous cell carcinoma of the vulva is feasible, and may reduce the need for more radical surgery including primary pelvic exenteration.

Management of the adnexal mass in the 1990s.

BACKGROUND: Ovarian carcinoma is the leading cause of deaths from female genital cancers in the United States. During the last three decades, advances in diagnostic techniques, surgical techniques, and adjuvant chemotherapy have led to improved survival in some patients who have an adnexal mass that is later diagnosed as malignant. METHODS: A review of the current technique, compiled with our changing management, was done to help identify possible pitfalls in the initial management of the adnexal mass in specific age groups. The expensive and controversial issues such as screening, management of patients with a genetic history, and management with laparoscopy were reviewed. RESULTS: Appropriate initial surgery improves survival in patients with adnexal masses, later determined to be malignant, particularly when adjuvant, modern combination chemotherapy is used. Laparoscopy for suspicious adnexal masses cannot be condoned, unless immediate appropriate surgical staging can be done. CONCLUSIONS: Awareness and implementation of current diagnostic and treatment modalities can improve survival in the patient with an adnexal mass that is later found to be malignant.

An update on the diagnosis and treatment of common malignant ovarian tumors.

Malignant ovarian tumors are the second most common female type of genital tract cancers, and they are the leading cause of death of women with such malignancies. Over the last 2 decades, advances in epidemiology, diagnostic techniques, and treatment have led to earlier diagnoses and to improved survival, particularly for patients with germ cell tumors. The purpose of this review is to acquaint practicing physicians with the advantages and pitfalls of 1990's diagnostic techniques and to guide them on when to refer. Emphasis will be given to performing the appropriate operation the first time. Adjuvant chemotherapy with newer combined regimens may improve survival in some patients with epithelial ovarian cancer and has been shown to improve survival in patients with germ cell tumors.

Characteristics of patients with rapidly growing cervical cancer.

Between April 1983 and December 1990, 387 newly diagnosed cervical cancer cases were managed at our institution. We retrospectively reviewed 59 of those cases, which were identified as having developed within 3 years of the patients' last normal Pap smear. Squamous cell carcinoma was found in 45 patients, and 33 had poorly differentiated lesions. Six cases had typical histology. However, 27 cases (82%) had distinctive histologic features that have not been previously described in rapidly progressive cervical cancer. Thirty-seven patients had surgical treatment; 7 (19%) died of disease. Twenty-two patients had radiation; 10 (45%) died of disease. Patients who have invasive cervical cancer after a recent normal Pap smear may have unusual histologic types, and some with early-stage disease may have better outcome if treated with radical surgery.

Parents of adults with mental retardation living in-home and out-of-home: caregiving burdens and gratifications.

Interviews with parents of adult children with mental retardation were conducted to identify differences in caregiver burdens and gratifications, based on in-home and out-of-home placement. Parental responses indicate that caretakers of adult children with mental retardation are worried and feel responsibility for their care regardless of residential placement of the adult child.

Human chorionic gonadotrophin-beta gene sequences in women with disorders of HCG production.

Women with recurrent abortion, primary unexplained infertility, and gestational trophoblastic neoplasia (GTN) manifest disordered human chorionic gonadotrophin (HCG) secretion. Mutations in the HCG beta/luteinizing hormone (LH) beta gene complex could cause aberrant HCG production in these disorders. The purpose of this study was to determine whether HCG beta gene deletions occur in women with recurrent abortion or primary unexplained infertility, and whether HCG beta gene duplications are present in women with GTN. DNA was extracted from 10 patients with unexplained recurrent abortion, 10 patients with unexplained primary infertility, 12 patients with GTN, three partners of women with GTN, and 30 controls. Southern blots were constructed and hybridized with DNA probes for HCG beta-5 and the LH beta gene. No gene deletions were identified in patients with recurrent abortion or primary unexplained infertility. Likewise, no gene duplications were identified in women with GTN. A previously described Mbol restriction fragment length polymorphism (RFLP) was identified in both patients and controls. A new Pstl RFLP was also characterized, but was present in patients and controls. Deletion/duplication mutations in the HCG beta/LH beta gene complex do not appear to be common causes of aberrant HCG production in humans with these disorders.

A phase II trial of 5-fluorouracil and high-dose leucovorin in patients with recurrent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study.

The addition of leucovorin to 5-fluorouracil (5-FU) has been shown to improve the response rate in recurrent colon cancer. The combination of low-dose leucovorin and 5-FU was previously tested by the Gynecologic Oncology Group (GOG) and did not produce response rates greater than rates using 5-FU alone. From June 1990 to April 1992, 55 patients with unresectable recurrent squamous cervical cancer received high-dose leucovorin at 200 mg/m2 i.v. bolus, followed by 5-FU at 370 mg/m2 i.v. bolus daily for 5 days every 4 weeks for the first two courses. Subsequent courses were given every 5 weeks. The median number of courses delivered was two (range 1-15). Fifty patients were evaluable for toxicity and 45 for response. Prior radiotherapy had been given to 43 patients and prior chemotherapy to 38. The overall response rate was 8.8% (95% confidence interval, 2.5-21.2%). There were two complete responses (4.4%) and two partial responses (4.4%). One response was in the pelvis and three were outside the pelvis. None of the extrapelvic responses had received irradiation at the site of measurable disease. The major adverse effect was granulocytopenia, with 15/50 (30%) experiencing GOG grade 3 or 4 granulocytopenia. The median white blood count for patients experiencing leukopenia was 2,000 (range 400-3,800). Grade 3 or 4 gastrointestinal toxicity was seen in 12 patients (24%). In this pretreated population, patients receiving high-dose leucovorin with 5-FU had moderate toxicity but only minimal activity.

Use of a subcutaneous closed drainage system and antibiotics in obese gynecologic patients.

OBJECTIVE: The purpose of this study was to evaluate the effect of subcutaneous closed drainage systems and prophylactic antibiotics on the wound breakdown rate in obese patients undergoing gynecologic surgery. STUDY DESIGN: A prospective study was performed on 197 obese patients who were randomly selected to have a subcutaneous drain. Incision closure technique was standardized. Antibiotic usage was not randomized. Demographic data, perioperative data, and postoperative complications were noted and analyzed by X2 test and 2 x 2 contingency tables. RESULTS: The overall complication rate was 25%, with 20% (22/109) among the group receiving a drain versus 31% (27/88) without a drain. Seventeen patients (8.6%) had wound breakdowns: 7 of 109 (6.4%) with drains and 10 of 88 (11.4%) without drains. Prophylactic antibiotics were given to 46% (50/109) in the drain group and 51% (45/88) without a drain. Fewer patients (2%) with a drain receiving antibiotics had wound breakdowns. The group with the most breakdowns had neither a drain nor antibiotics (14%). CONCLUSION: We suggest the use of subcutaneous drains plus prophylactic antibiotics may decrease morbidity when operating on obese gynecologic patients.

Mitotic count, nuclear atypia, and immunohistochemical determination of Ki-67, c-myc, p21-ras, c-erbB2, and p53 expression in granulosa cell tumors of the ovary: mitotic count and Ki-67 are indicators of poor prognosis.

In spite of extensive research, the behavior of granulosa cell ovarian tumors remains unpredictable and is complicated by the lack of prognostic factors in early-stage disease. Forty patients with granulosa cell tumors were identified from tumor registries and data were analyzed for patient outcome. Mitotic count and nuclear atypia were determined at time of histological review. Paraffin-embedded archival tumor tissues from 32 of 40 patients were available, and immunohistochemical testing for Ki-67, c-myc, p21-ras, c-erbB2, and p53 was performed on archival tissues. Results were correlated with patients' outcome. Mitotic count and Ki-67 were found to be negatively associated with survival in granulosa cell tumors. Nuclear atypia, c-myc, p21-ras, c-erbB2, and p53 were not found to be of prognostic significance.

Carcinoma of the vulva in young women.

OBJECTIVE: To determine if young women with carcinoma of the vulva have a different risk factor history and outcome compared with older women. METHODS: We conducted a retrospective review of the medical records of 78 women treated at the Medical College of Georgia for squamous carcinoma of the vulva during 1979-1993. Women younger than 45 years were compared with those 45 and over for historic risk factors, treatment modality, and outcome. RESULTS: Over the study interval, the average presenting age of these patients decreased from 69 to 55 years. Women under 45 were found to have a stronger history of condyloma (P < .001, 95% confidence interval [CI] 3.69-87.96). There was no significant difference by age in the duration of symptoms before presentation, smoking history, or tumor size. Women 45 and over were more likely to have advanced-stage disease (International Federation of Gynecology and Obstetrics [FIGO] stage III or IV) (P = .03, 95% CI 0.43-0.91). Treatment did not differ significantly with age. In a univariate analysis, advanced FIGO stage, presence of metastases, and tumor size were associated with shorter survival. There was no detected difference in survival for women in either age group. CONCLUSION: There appears to be a trend in our patient population toward younger women presenting with squamous carcinoma of the vulva. Human papillomavirus infection appears to be more common in younger women with vulvar carcinoma. There may be a difference in the etiologies producing squamous carcinomas of the vulva. Education encouraging the early detection and prevention of sexually transmitted diseases might alter the rising incidence of this disease in younger women.

Phase II trial of mitomycin-C in squamous cell carcinoma of the uterine cervix: a Gynecologic Oncology Group study.

Fifty-six patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix not previously exposed to cytotoxic drugs, other than as radiosensitizers, were entered into a study of single-agent 20 mg/m2 mitomycin-C every 6 weeks. The overall response rate among the 52 patients evaluable for response was 12% (three complete and three partial responses). Median response duration was 7.3 months. For the entire population, median progression-free interval was 3.0 months, and median survival was 4.9 months. Among 27 patients with pelvic disease only in previously radiated fields, two responses were observed (7%), whereas four responses were observed among 25 patients with extrapelvic disease in nonradiated fields (16%). The most frequent and severe adverse effects were the result of myelosuppression. Based on the modest level of activity observed, no further study of mitomycin-C in squamous cell carcinoma of the cervix is planned.