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PubMed1998

Some scale estimators and lack-of-fit tests for the censored two-sample accelerated life model.

Some new scale estimators for the censored two-sample accelerated life model are introduced. They are zeros of some integrated weighted difference between the two cumulative hazard estimators. These estimators are asymptotically normal. The weight is chosen to result in estimators whose asymptotic variances do not involve the destiny functions and can be easily estimated. This provides a fast and simple means of statistical inference in the censored two-sample accelerated life model. Through investigating the asymptotic relative efficiency at some important censoring submodels and the finite example behaviors in various numerical studies, we obtain some estimators with very competitive performance. From the new class of scale estimators, some lack-of-fit tests for the accelerated life model are also derived. These tests are related to Gill-Schumacher type tests and require little extra computing time once the estimator is obtained. The estimators and tests are illustrated in two applications. For a vaginal cancer data set for rats, the effect of pretreatment regime was found to be well described by the two-sample accelerated life model. For a data set on progression of ovarian cancer, it was found that the effect of grade of disease could not be described either by the two-sample proportional hazards model or the two-sample accelerated life model.

9,10-Dimethyl-1,2-benzanthracene↗
PubMed2002

[A case of metastatic vaginal tumor of rectal cancer].

The majority of vaginal metastases from extra-genital tumors are from colorectal cancer. A case of metastases to the vagina from a huge rectal carcinoma is described. A 55-year-old woman was admitted to the hospital because of a barium ileus after upper GI. Further examination revealed that she had a huge rectal carcinoma. Hartmann's operation combined with resection of the right ureter, posterior wall of the uterus and left ovary was performed. Postoperative chemoradiotherapy was performed with 60 Gy of irradiation to the small pelvis with 500 mg/day continuous infusion of 5-FU. After 18 months, she had genital bleeding. Digital examination revealed a vaginal tumor and metastasis of the rectal carcinoma to the vagina was confirmed histologically. Abdominoperineal resection of the rectum and vagina combined with simple total hysterectomy and bilateral salpingo-oophorectomy was performed. Thirty-three months after operation, there is no sign of recurrence.

Adenocarcinoma↗
PubMed1987

Clear-cell adenocarcinoma of the lower genital tract: Memorial Hospital 1974-1984.

Seventeen previously unreported cases of clear-cell adenocarcinoma originating in the vagina (13) and cervix (four) are presented. The mean age of the patients was 23.6 years. Four patients with cervical tumors and four patients with vaginal tumors underwent radical hysterectomy, bilateral pelvic lymphadenectomy, and partial vaginectomy. A total vaginectomy, with replacement of the excised vagina with a split-thickness skin graft or a segment of sigmoid colon, was added to the above procedure in five patients with vaginal cancer. In four patients, definitive treatment was radiation. All of the patients in the present series are without evidence of disease, with follow-up ranging from 21 months to more than ten years.

Adenocarcinoma↗
PubMed2002

[Topical 5-fluorouracil for treatment of vaginal intraepithelial neoplasms].

OBJECTIVE: Our purpose was to determine the effectiveness of 5-fluorouracil (5-FU) in the treatment of vaginal intraepithelial neoplasia (VAIN). MATERIALS AND METHODS: The study was performed in 30 patients with a mean age of 54 years and previous diagnoses from reviewed records and histopathology slides selected from a group of 65 patients with VAIN from 1980 to 1998. Patients received intravaginal treatment with 5-FU, 1.5 g once weekly for 10 weeks and all patients were followed up for at least 2-years. Papanicolaou smear and colposcopy were performed, as was biopsy when indicated. RESULTS: Twenty eight (93%) patients with VAIN had prior or concurrent anogenital squamous neoplasia, including 5 with invasive cervical carcinoma and 23 with cervical intraepithelial neoplasia. In 23 of 30 treated patients (77%), VAIN went into remission after a single treatment; in 3, (10%), it went into remission after two treatment; 3 (10%) had recurrent VAIN 3; and in 1 (3%) it progressed to invasive vaginal cancer. The treatment was well tolerated. CONCLUSIONS: The 5-FU is an option choice for VAIN treatment. It is effective, with minimal slide effects. Its use should be confined to treating extensive or multifocal high-grade VAIN.

Adult↗
PubMed1989

Primary vaginal squamous cell carcinoma in the young patient.

This report, prompted by the recent observation of three cases of primary squamous cell carcinoma in relatively young patients, reviews the English-language literature in search of information on age-related incidence for this tumor in the below-40 age group. From those series providing data, it was found that only 10% of these tumors occur in patients less than 40 years old. No authentic squamous cell vaginal cancer could be found in patients less than 10 years of age, and only five such well-documented cases were found in the age group 11-20. The incidence of this tumor then rises abruptly to 60 patients in the age group 21-30 and to 160 patients in the age group 31-40. The rarity of the tumor, particularly with regard to the anatomical location, is impressive as well as enigmatic.

Adult↗
PubMedDate not supplied

In utero exposure to low doses of bisphenol A lead to long-term deleterious effects in the vagina.

The origins of the "endocrine disrupter hypothesis" may be traced to reports on adolescent daughters born to women who had taken the highly potent synthetic estrogen, diethylstilbestrol, while pregnant, and who developed a rare form of vaginal cancer and adenocarcinoma. Bisphenol A (BPA) is an estrogenic chemical that is highly employed in the manufacture of a wide range of consumer products. Some observational studies have suggested that the amounts of BPA to which we are exposed could alter the reproductive organs of developing rodents. We examined the influence of BPA at low doses to address the questions of (a) whether in utero exposure affects the vagina of the offspring and (b) which mechanisms cause the toxic effects. Gravid Sprague-Dawley dams were administered either 0.1 (low dose) or 50 mg/kg per day BPA, the no observed effect level, or 0.2 mg/kg per day 17 alpha-ethinyl estradiol by gavage. Striking morphological changes were observed in the vagina of postpubertal offspring leading us to examine vaginal estrogen receptor (ER) expression because BPA binds to the ER alpha, which is important for growth of the vaginal epithelium. We show that the full-length ER alpha is not expressed during estrus in the vagina of female offspring exposed to either dose of BPA when compared to the control group, whereas ER alpha expression does not differ from the control group during the diestrus stage. ER alpha downregulation seems to be responsible for the observed altered vaginal morphology.

Animals↗
PubMed2000

Primary carcinoma of the vagina: Tata Memorial Hospital experience.

PURPOSE: Carcinoma of the vagina is a rare gynecological malignancy comprising approximately 2% of all the gynecological malignancies. We have analyzed the treatment outcome of the patients treated at the Tata Memorial Hospital from January 1984 to December 1993. METHODS AND MATERIALS: In this 10-year period, 134 patients of primary vaginal cancers were registered at our hospital. Of these, 75 patients received complete treatment and are analyzed. RESULTS: Disease-free survival (DFS) for the whole group is 50%, and overall survival (OAS) is 60%. Most locoregional recurrences and distant failures are noted in the 2 years following treatment. DFS at 5 years is as follows: Stage I (5 patients), Stage IIA (37 patients), Stage IIB (15 patients), Stage III (14 patients), and Stage IV (4 patients); are 40%, 55%, 60%, 50%, and 25%, respectively. The DFS for patients with complete response (42 patients) to external radiation at 5 years is 68%, with partial response (25 patients) is 35%, and with poor or no response (6 patients) is 18% (p = 0.0000). We observed that brachytherapy was an important part of the treatment, and patients who received brachytherapy (59 patients), either with a vaginal intracavitary applicator (30 patients) or interstitial implant (29 patients) had a DFS of 53% and 56%, respectively, while 15 patients who received external radiation alone had a DFS of 30%. Patients receiving brachytherapy within 4 weeks of external radiation had a DFS of 60% as compared to 30% when the interval was more than 4 weeks. CONCLUSION: The factors indicating prognosis are: site and extent of involvement, presence of lymph nodes at presentation, technique of brachytherapy, and interval between external radiation and brachytherapy.

Adolescent↗
PubMed2006

Vaginal vault smears after hysterectomy for reasons other than malignancy: a systematic review of the literature.

BACKGROUND: Vaginal vault smears are used to detect persisting neoplasia of the lower genital tract after hysterectomy. Recent data suggest both widespread use and uncertain evidence of their effectiveness. OBJECTIVES: To identify and synthesise evidence on the use and effectiveness of vaginal vault smears and to assess the quality. SEARCH STRATEGY 'vault smear' OR 'vaginal vault smear' OR 'cervical vault smear' OR ('Hysterectomy') AND ('Follow up' OR 'Smear'). SELECTION CRITERIA Primary research, women who had a hysterectomy and were followed up by vault cytology. DATA COLLECTION AND ANALYSIS: Systematic search (eight electronic databases), supplemented by contact with experts and review of bibliographies. Two independent reviewers determined eligibility/validity and extracted data concerning test performance characteristics. Quality was assessed according to the established criteria. RESULTS: Of 441 unique references, only 19 were suitable. Quality of studies varied considerably and few were of 'high' methodological quality. Studies were geographically diverse, and were published over more than 40 years in 16 journals. From the higher scoring papers, there were 11 659 hysterectomies [6546, benign; 76, cervical intraepithelial neoplasia (CIN) I/CIN II; 5037, CIN III]. Proportions of abnormal vault smears and abnormal biopsies during follow up increased with worsening histology at hysterectomy (P < 0.0001 and P = 0.0001). There was only one report of vaginal cancer subsequent to hysterectomy for CIN and insufficient data to allow for reliable meta-analysis. CONCLUSIONS: Vault smears cause anxiety, consume resources and their value is largely unproven. Inconsistency of study design and limited methodological quality means that the value of vault smears could not be established. High-quality research is required to ensure that the guidelines are evidence based.

Female↗
PubMed2005

Definitive radiation therapy for squamous cell carcinoma of the vagina.

PURPOSE: To evaluate outcome and describe clinical treatment guidelines for patients with primary squamous cell carcinoma of the vagina treated with definitive radiation therapy. METHODS AND MATERIALS: Between 1970 and 2000, a total of 193 patients were treated with definitive radiation therapy for squamous cell carcinoma of the vagina at The University of Texas M. D. Anderson Cancer Center. The patients' medical records were reviewed to obtain information about patient, tumor, and treatment characteristics, as well as outcome and patterns of recurrence. Surviving patients were followed for a median of 137 months. Survival rates were calculated using the Kaplan-Meier method, with differences assessed using log-rank tests. RESULTS: Disease-specific survival (DSS) and pelvic disease control rates correlated with International Federation of Gynecology and Obstetrics (FIGO) stage and tumor size. At 5 years, DSS rates were 85% for the 50 patients with Stage I, 78% for the 97 patients with Stage II, and 58% for the 46 patients with Stage III-IVA disease (p = 0.0013). Five-year DSS rates were 82% and 60% for patients with tumors < or =4 cm or >4 cm, respectively (p = 0.0001). At 5 years, pelvic disease control rates were 86% for Stage I, 84% for Stage II, and 71% for Stage III-IVA (p = 0.027). The predominant mode of relapse after definitive radiation therapy was local-regional (68% and 83%, respectively, for patients with stages I-II or III-IVA disease). The incidence of major complications was correlated with FIGO stage; at 5 years, the rates of major complications were 4% for Stage I, 9% for Stage II, and 21% for Stage III-IVA (p < 0.01). CONCLUSIONS: Excellent outcomes can be achieved with definitive radiation therapy for invasive squamous cell carcinoma of the vagina. However, to achieve these results, treatment must be individualized according to the site and size of the tumor at presentation and the response to initial external-beam radiation therapy. Brachytherapy plays an important role in the treatment of many vaginal cancers but should be carefully selected and applied to obtain optimal coverage of the target volume.

Adult↗
PubMed1986

Improved control of primary vaginal tumours by combined external-beam and interstitial radiotherapy.

In 20 years we have seen only 78 cases of primary vaginal cancer. 61 patients had squamous carcinoma, three had adenocarcinoma, 10 had clear-cell carcinoma, four of which may have been metastatic from carcinoma of the kidney, and four had malignant melanoma. The actuarial 5-year survival of patients with squamous cancer was: Stage I, 68%; Stage II, 34%; Stage III, 29% and Stage IV, 14%. Patients treated by combined external and intracavitary or interstitial radiotherapy had increased local control and superior survival to those treated by interstitial methods alone. The improved tumour control offered by combination treatment may be due to the elimination of small tumour deposits in lymph nodes within the treated volume and the sterilisation of carcinoma in situ in the vagina some distance from obvious tumour.

Adenocarcinoma↗
PubMed2006

High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up.

Human papillomavirus (HPV) causes cervical, vulvar, and vaginal cancers, precancerous dysplasia, and genital warts. We report data for the longest efficacy evaluation to date of a prophylactic HPV vaccine. In total, 552 women (16-23 years) were enrolled in a randomised, placebo-controlled study of a quadrivalent HPV 6/11/16/18 L1 virus-like-particle vaccine with vaccination at months 0, 2, and 6. At regular intervals through 3 years, subjects underwent gynaecologic examination, cervicovaginal sampling for HPV DNA, serum anti-HPV testing, and Pap testing, with follow-up biopsy as indicated. A subset of 241 subjects underwent two further years of follow-up. At 5 years post enrollment, the combined incidence of HPV 6/11/16/18-related persistent infection or disease was reduced in vaccine-recipients by 96% (two cases vaccine versus 46 placebo). There were no cases of HPV 6/11/16/18-related precancerous cervical dysplasia or genital warts in vaccine recipients, and six cases in placebo recipients (efficacy = 100%; 95% CI:12-100%). Through 5 years, vaccine-induced anti-HPV geometric mean titres remained at or above those following natural infection. In conclusion, a prophylactic quadrivalent HPV vaccine was effective through 5 years for prevention of persistent infection and disease caused by HPV 6/11/16/18. This duration supports vaccination of adolescents and young adults, which is expected to greatly reduce the burden of cervical and genital cancers, precancerous dysplasia, and genital warts.

Adolescent↗
PubMed1998

Liposuction-assisted nerve-sparing extended radical hysterectomy: oncologic rationale, surgical anatomy, and feasibility study.

OBJECTIVE: Our purpose was to improve the therapeutic index of radical hysterectomy by extending the resection of parametrial tissue without further impairing pelvic autonomic nerve functions. STUDY DESIGN: We studied the topographic anatomy of the parametrial tissue with high-resolution magnetic resonance imaging and by dissection of fresh human cadavers. We then performed a clinical feasibility study of the liposuction-assisted nerve-sparing extended radical hysterectomy. RESULTS: Magnetic resonance imaging demonstrated that the perispinous adipose tissue is retained after type III radical hysterectomy and is a frequent site of tumor recurrence. The perispinous adipose tissue contains the pelvic plexus, the pelvic splanchnic nerves, small blood vessels, and lymphatic tissue. We developed the liposuction-assisted nerve-sparing extended radical hysterectomy and applied it to seven consecutive patients with cervical or vaginal cancer. No intraoperative or postoperative complications occurred. Postoperative magnetic resonance imaging assured us that perispinous adipose tissue was cleared in all cases. A metastatic lymph node was found in the perispinous adipose tissue removed by liposuction from one patient. Suprapubic cystostomies could be removed after a median period of 12 days. CONCLUSION: The nerve-sparing removal of perispinous adipose tissue by liposuction is a feasible addition to wide en bloc parametrectomy in anatomically defined planes.

Adipose Tissue↗
PubMed1994

Effect of recombinant human interleukin-3 (rhIL-3) on persisting chemotherapy-induced thrombocytopenia.

A 57 year old woman with heavily pretreated advanced vaginal cancer (FIGO III) developed severe thrombocytopenia (7000/microliter) with bleedings after chemotherapy. This patient was treated with recombinant human interleukin-3 (rhIL-3) after 26 platelet transfusions (25 pooled transfusions and one HLA-matched platelet transfusion) had not been effective. Increase of thrombocyte counts began 2 days after rhIL-3 therapy. Side-effects due to rhIL-3 administration (flu-like symptoms) were mild and could be treated effectively with paracetamol and clemastin. These data support first evidence for efficacy of rhIL-3 in chemotherapy-induced thrombocytopenia and may open new perspectives for its clinical application.

Antineoplastic Agents↗
PubMed2001

Clinical features and risk of recurrence among patients with vaginal intraepithelial neoplasia.

OBJECTIVE: The best treatment modality and factors affecting recurrence among women with vaginal intraepithelial neoplasia (VAIN) are yet to be determined. The aims of the current study were to describe the clinical features, results of treatment, and factors affecting recurrence among patients with VAIN. METHODS: We conducted a retrospective review of 121 women with VAIN after confirming the histologic diagnosis. Patient demographics, clinical features, and results of therapy were recorded. Factors affecting recurrence were assessed using the odds ratio and the 95% confidence intervals among patients who were followed up for 7 months or more and had at least one posttreatment Papanicolaou smear. Significant univariate odds ratios were assessed jointly in a multivariate model with a stratified analysis. RESULTS: The mean age of the patients was 35.0 (+/-17), 41% of the patients smoked, 39% had a history of human papillomavirus infection, 27% had history of sexually transmitted diseases, 22% had history of surgery for cervical intraepithelial neoplasia (CIN), and 23% had total hysterectomy. The upper third of the vagina was the most common site of VAIN and 61% of the lesions were multifocal. Associated cervical and vulvar intraepithelial neoplasia (VIN) were present in 65 and 10%, respectively. Recurrences of VAIN and progression to invasive vaginal cancer occurred in 33 and 2%, respectively. Recurrences following partial vaginectomy, laser, and 5-fluorouracil were 0, 38, and 59%, respectively (P = 0.0001). Multifocality and method of treatment were significant independent predictors of VAIN recurrences (odds ratio 3.3, 95% CI 1.2, 9.2, P = 0.02, and 22.4, 95% CI 1.3, 393.6, P = 0.001, respectively), with no interaction, based on a stratified analysis. CONCLUSIONS: VAIN occurs most often among women with CIN or VIN, commonly involves the upper third of the vagina, and is often multifocal. Partial vaginectomy provides the highest cure rate and multifocality is a risk factor for recurrence.

Adolescent↗
PubMed1997

A simple, inexpensive applicator for irradiation of localized areas of the vagina with intracavitary brachytherapy.

PURPOSE: To describe the construction of a simple, inexpensive applicator for irradiation of localized areas of the vagina with intracavitary brachytherapy. METHODS AND MATERIALS: It was desirable to avoid an interstitial implant in an elderly patient with a stage T2 vaginal cancer. The final phase of radiation therapy was delivered with a custom made intracavitary cylinder that allowed the high-dose area to be limited to the portion of the vagina at high risk for residual disease. The applicator was fabricated from a clear cast acrylic (Lucite) rod with dimensions 3.5 cm diameter x 5.0 cm long. The applicator contained 11 parallel grooves, each 1.8 mm deep x 2.2 mm wide, machined along the surface of the cylinder parallel its long axis at 1.0 cm increments. Plastic needles (15 gauge) were inserted into the grooves along the surface of the acrylic cylinder and held in place with heat shrink tubing. The applicator was easily inserted and positioned without anesthesia. Standard low dose rate 192Ir ribbons were inserted into the plastic needles after positioning the applicator in the vagina. RESULTS: Construction of this applicator system requires a few weeks notice and approximately $150. Fabrication of the grooved cylinder is a routine task for a workshop with a milling machine. A step-by-step description of how to construct and use the applicator is provided along with the telephone numbers of commercial vendors to call to order all necessary materials. CONCLUSION: This article describes a simple, inexpensive method for constructing a customized vaginal applicator that can be used to treat a limited area of the vagina with intracavitary brachytherapy.

Aged↗
PubMed1991

Perioperative morbidity and mortality of gynecologic brachytherapy.

The incidence and nature of perioperative complications associated with gynecologic brachytherapy applications were determined in 462 implants performed on 327 patients with cervical, endometrial, or vaginal cancer from 1986 to 1988. Twenty-one patients (6.4%) had life-threatening complications, including cardiac (16 patients), thromboembolic (4 patients), and pulmonary (1 patient) events. Three complications (0.9%) were fatal within the first 30 days, and two patients died of delayed sequelae of perioperative complications; thus, there was an overall 1.5% mortality rate. Patients experiencing life-threatening complications tended to be older (P = 0.0002), and to have a history of cardiac disease (P = 0.0002) and an increased American Society of Anesthesiology (ASA) score (P = 0.003). Logistic analysis demonstrated that a history of cardiac disease and increased age were independent predictors of life-threatening complications (P = 0.01). Careful patient selection and intensive perioperative care of the high-risk patient may prove to substantially diminish these complications.

Adult↗
PubMed1976

Epidemiological studies related to the use of hormonal agents in animal production.

The principal types of hormonal agents used in the production of meat for human consumption are estrogens, progestagens, and androgens. Only the last class is truly anabolic. Each type of compound named above has fairly characteristic toxic effects after prolonged intake. In this review, an attempt will be made to relate available information from experience with the administration of these three types of hormones to humans to the question whether sufficient amounts of these chemicals can remain in meat cut from carcasses of animals administered hormones during finishing to have deletarious effects on human ingesters. Present indications are that administration of stilbestrol to pregnant women may result in a somewhat increased incidence of cervical and vaginal cancers in their daughters; such administration appears to have no effect on the incidence of cancers in sons and only slight, if any, effect on that in the mothers. Other estrogens seem to have no specific effects on the incidence of cancer. Progestagens also are not known to induce any specific lesions. Although many androgens are known to produce edema, fever, and jaundice, they have not been found to cause specific lesions to any significant extent. With reference to stilbestrol, the doses given to the mothers of affected children have ranged between 5 and 125 mg/day. Because muscle, liver, and kidney from steers treated with stilbestrol in the usual way (s. c. implantation of a pellet at the base of an ear) have been found to contain less than 0.5 ppb of stilbestrol one month after implantation of the pellet, it is obvious that, to approach even the lowest clinically used dose of stilbestrol, a person would have to eat daily a quantity of such animal products that would be impossible to ingest. The findings that a mean of 26.4% of an oral dose of stilbestrol is excreted within 24 hours and that 99.5% is excreted within a week indicate that cumulation of this chemical within the body from the low level of intake provided by meats is not likely to reach a significant level. This would be so even though the animal product contained more than the 0.5 ppb mentioned above.

Abnormalities, Drug-Induced↗
PubMed2006

Clomiphene and hypospadias on a detailed level: signal or chance?

BACKGROUND: Clomiphene, a drug used to induce ovulation, is chemically related to diethylstilbestrol (DES). DES is associated with vaginal cancer and infertility among daughters and with hypospadias among second-generation male offspring. Because clomiphene has a long half-life and metabolites have been found in feces up to 6 weeks after administration, fetal exposure is possible if the mother took this drug prior to becoming pregnant. METHODS: Case-control analyses were performed to investigate the association between clomiphene exposure and hypospadias. Cases were all male subjects registered in the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) Northern Netherlands registry for congenital anomalies with nonsyndromal hypospadias. Controls were all male children born without hypospadias, including those with chromosomal and monogenic defects. Logistic regression analyses were performed to calculate odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Of 392 cases, 7 (1.8%) were exposed to clomiphene compared with 64 of 4538 controls (1.4%). For penoscrotal hypospadias, we found that the OR was significantly increased (6.08; 95% CI, 1.40-26.33); for the mild and moderate forms of hypospadias, the ORs were not increased. CONCLUSIONS: Because penoscrotal hypospadias is rare, the effect is diluted when all forms of hypospadias are studied as a group. Therefore, our study stresses the importance of studying birth defects on as detailed a level as possible. Other studies should be conducted to confirm our findings.

Abortion, Induced↗