[Show abstract][Hide abstract] ABSTRACT: Lymph node pathologic status is the most important prognostic factor in vulvar cancer; however, complete inguinofemoral node dissection is associated with significant morbidity. Lymphoscintigraphy associated with gamma-probe guided surgery reliably detects sentinel nodes in melanoma and breast cancer patients. This study evaluates the feasibility of the surgical identification of sentinel groin nodes using lymphoscintigraphy and a gamma-detecting probe in patients with early vulvar cancer. Technetium-99m-labelled colloid human albumin was administered perilesionally in 37 patients with invasive epidermoid vulvar cancer (T1-T2) and lymphoscintigraphy performed the day before surgery. An intraoperative gamma-detecting probe was used to identify sentinel nodes during surgery. A complete inguinofemoral node dissection was then performed. Sentinel nodes were submitted separately to pathologic evaluation. A total of 55 groins were dissected in 37 patients. Localization of the SN was successful in all cases. Eight cases had positive nodes: in all the sentinel node was positive; the sentinel node was the only positive node in five cases. Twenty-nine patients showed negative sentinel nodes: all of them were negative for lymph node metastases. Lymphoscintigraphy and sentinel-node biopsy under gamma-detecting probe guidance proved to be an easy and reliable method for the detection of sentinel node in early vulvar cancer. This technique may represent a true advance in the direction of less aggressive treatments in patients with vulvar cancer.
British Journal of Cancer 02/2000; 82(2):295-9. · 5.08 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Despite improvements seen in median and overall survival using a combination of platinum-compounds and paclitaxel (PTX), long-term survival rates for patients with advanced epithelial ovarian carcinoma remain disappointing and ongoing efforts have aimed to develop more effective primary therapy. In the early 1990Os the drug PTX was first tested in ovarian cancer. In the Gynaecological Oncology Group (GOG) trial 111 the cisplatin (CP)+PTX regimen was judged to be superior compared to the platinum-based control arm with an improvement of overall response rate, median progression-free interval and overall median survival. These favourable data were confirmed by a European-Canadian Intergroup trial (OV10). In contrast, in a further GOG trial (GOG132) there was no difference in survival between CP alone and the combination of PTX and CP. The International Collaborative Ovarian Neoplasm Study (ICON)3 is the first and only trial comparing PTX plus carboplatin against carboplatin alone or a (non-taxane) CP-based control arm. The last analysis performed with a total of 1,293 events showed an estimated absolute difference in one-year progression-free survival of 1% and in two-year overall survival of 2% both in favour of PTX plus carboplatin. The results of ICON3, in accordance with GOG132 study, appear to contradict the earlier positive results seen for PTX and CP in the GOG-111 and OV10 trials and suggested that single agent carboplatin, CY-adriamycin-CP are safe and effective first-line treatments for women requiring chemotherapy for ovarian cancer. A meta-analysis with individual patient data is warranted to better clarify the issue of PTX in the front line therapy of advanced ovarian cancer. Salvage chemotherapy is often utilised in patients with advanced ovarian cancer, due to the high frequency of recurrent disease even after a clinical or pathological complete response after primary chemotherapy. Main objectives of salvage chemotherapy include: i. improvement in quality of life and symptoms; ii. tumour load reduction and survival advantage; iii. evaluation of potentially active new drugs to be included in first-line. Since the goal is palliation in most cases, monotherapy is generally indicated. However, the chances of response are directly related to the treatment-free interval, with a response rate nearly equivalent to that of primary chemotherapy when the treatment-free interval exceeds 24 months. Extension of the platinum-free interval before re-treatment with platinum or taxanes may allow partial reversal of resistance to these agents which can therefore still show significant activity in relapsing patients. Unfortunately, durable response to salvage chemotherapy is rare and cure is almost impossible. The sequential use of the agents currently available for salvage treatment in monotherapy may transform ovarian cancer into a chronic disease and confers long survival to the patients. Perhaps, the most interesting role of second-line chemotherapy is to identify new potentially active drugs, which can be moved up-front. Most of the compounds used in second line (gemcitabine, topotecan, liposomal doxorubicin) are in fact under investigation to develop alternative schedules and sequences of drug administration. A new phase III multi-national randomised study for patients with advanced stage epithelial ovarian or primary periperitoneal carcinoma will evaluate the impact of incorporating a new drug within either a platinum-based triplet (new drug + platinum + PTX) or a sequential-doublet (new drug + platinum followed by platinum + PTX) in order to identify one or more experimental regimens able to improve long-term survival with acceptable toxicity.
[Show abstract][Hide abstract] ABSTRACT: Pathologic lymph node status is the most important prognostic factor in vulvar cancer; however, complete inguinofemoral node dissection is associated with significant morbidity. Intraoperative lymphoscintigraphy associated with gamma detecting probe-guided surgery has proved to be reliable in the detection of sentinel node (SN) involvement in melanoma and breast cancer patients. The present study evaluates the feasibility of the surgical identification of inguinal sentinel nodes using lymphoscintigraphy and a gamma detecting probe in patients with early vulvar cancer.
Technetium-99-labeled colloid human albumin was administered perilesionally in 44 patients. Twenty patients had T1 and 23 had T2 invasive epidermoid vulvar cancer; one patient had a lower-third vaginal cancer. An intraoperative gamma detecting probe was used to identify SNs during surgery. Complete inguinofemoral node dissection was subsequently performed. SNs underwent separate pathologic evaluation.
A total of 77 groins were dissected in 44 patients. SNs were identified in all the studied groins. Thirteen cases had positive nodes: the SN was positive in all of them; in 10 cases the SN was the only positive node. Thirty-one patients showed negative SNs: all of them were negative for lymph node metastasis.
Lymphoscintigraphy and SN biopsy under gamma detecting probe guidance proved to be an easy and reliable method for detection of SNs in early vulvar cancer. If these preliminary data will be confirmed, the technique would represent a real progress towards less aggressive treatment in patients with vulvar cancer.
[Show abstract][Hide abstract] ABSTRACT: The sensitivity of the Pap smear (PAP) continues to be the subject of debate. During the past several years, cervicography (CER) and HPV DNA testing have been suggested as optional tools in the screening of cervical cancer precursors.
The performance characteristics of PAP, CER and HPV DNA testing (hybrid capture test [HCT]) in all potential combinations were evaluated in a series of 1,030 women (aged 16-70, median, 33), subjected to colposcopy (COLPO) as the reference tool.
Of the 992 evaluable cases, 402/992 (41%) had positive COLPO (i.e., an abnormal transformation zone). Of them, 298 women underwent directed punch biopsy, while of the COLPO negative patients, 18/93 positive by at least one of the three tests had endocervical curettage. Of the 402 COLPO positive women, 146 (36%) remained negative on all tests, whereas 256 (64%) had at least one positive test. There were 84 cervical intraepithelial neoplasia (CIN) 2 and 3 lesions and 6 invasive carcinomas. Of the former, 10 were detected by PAP alone, 4 by CER alone and 3 by HCT alone. Three of the 6 carcinomas were HCT negative. The predictive value (PPV) of a positive test was 45% for PAP, 51% for CER and 48% for HCT. The combinations of PAP with CER (for PAP negative cases) and PAP with HCT were more sensitive for CIN 2 and 3 (95% and 94%, respectively) as compared with PAP alone but were associated with a significant decrease in specificity (44% and 46% vs. 57%, respectively). However, both combinations retained a PPV (43%) similar to that of PAP alone (45%).
The potential combinations of PAP with CER and with HCT were more sensitive in detecting CIN 2 and 3 as compared with PAP alone and retained a PPV similar to that of PAP.
[Show abstract][Hide abstract] ABSTRACT: Our objective was to evaluate the results of laser surgery in patients with vulvar intraepithelial neoplasia (VIN).
From January 1990 to December 1996, 52 patients with histologically proven VIN were treated with CO(2) laser vaporization or laser excision. The analysis included anamnestic characteristics, clinical aspects, types of treatment, correlation of the preoperative biopsy with the excised pathologic specimen, and follow-up results.
Fourteen women underwent laser vaporization, and 38, laser excision. Of the patients submitted to vaporization, 11 were cured in one session (75%), 1 required two procedures, and 2 other patients, who underwent more treatments, eventually developed invasive squamous cell cancer 5 and 7 years from the initial treatment. The cure rate for laser excision was better, as a single session of treatment was curative in 33 of 38 patients (87%). In 3 cases the pathology report on the excised specimen showed an unrecognized invasive lesion (12%) and the women underwent radical surgery. The 2 remaining patients, both affected by multifocal disease, experienced recurrences and were treated with laser excision 2 and 3 years after the primary treatment, respectively. Symptom relief was obtained in all patients studied with both laser vaporization and excision.
Excisional laser surgery is an effective treatment for patients with VIN. In addition, CO(2) laser excision allows evaluation of the operative specimen and detection of occult early invasion with good preservation of vulvar morphology; laser vaporization, while retaining good cosmetic results, is less effective in VIN treatment and does not allow evaluation of the surgical specimen.
[Show abstract][Hide abstract] ABSTRACT: The objective of this study was to compare the use of molecular hybridization by hybrid capture methodology for human papillomavirus (HPV) with the use of demographic and lifestyle variables as intermediate triage in patients with cytological mild dyskaryosis. The study was designed as a prospective study using regression tree analysis of demographic data in consecutive patients who were subjected to colposcopic evaluation at the colposcopy clinic at the First Department of Obstetrics and Gynaecology, University of Milan (Milan, Italy). A total of 177 women were subjected to colposcopy because of a single routine Pap smear showing mild dyskaryosis. A structured interview, sampling for HPV testing for the detection of viral DNA by hybrid capture methodology, and colposcopic evaluation with cervical biopsies were performed for each subject. The accuracies of molecular hybridization for HPV and of the classification model based on the demographic and lifestyle variables in predicting patients with histologically high-grade cervical intraepithelial lesions were measured. The classification model based on the demographic and lifestyle variables showed comparable results with molecular hybridization for HPV (specificity, 0.75 versus 0.73; sensitivity, 0.61 versus 0.67, respectively). The use of demographic and lifestyle variables appears to be a simple and economic possibility for triaging patients with mild dyskaryotic smears in a screening program.
[Show abstract][Hide abstract] ABSTRACT: The treatment of vulvar lichen sclerosus has greatly improved in recent years, with the introduction of new pharmacological approaches and reconsideration of the traditional ones. Oxatomide is a molecule with both antihistamine and inhibiting activities for the inflammatory response, which may have potential use against this disease.
We enrolled 22 patients affected by vulvar lichen sclerosus in a double-blind, cross-over, controlled trial. They were administered a 5% oxatomide-based gel formulation and a placebo (petrolatum ointment) topically. At the beginning and the end of the investigation the severity and duration of symptoms, clinical appearance and tolerability were recorded. Statistical analysis of data was performed by Fisher's exact test and the Student-Newman-Keuls test.
The results indicate that both regimens are significantly correlated with vulvar pruritus improvement and that 5% oxatomide gel has better anti-itching effects compared to the placebo. Other symptoms responded poorly to the treatment. The rate of complete-partial regression of pruritus was significantly higher (P < 0.05) in the oxatomide group than in controls, while no significant improvement was obtained neither with oxatomide or with placebo in terms of clinical appearance.
These results, adequately confirmed, could suggest the introduction of oxatomide, in selected patients, as an alternative for the treatment of vulvar lichen sclerosus.
International Journal of Gynecology & Obstetrics 12/1996; 55(3):259-64. · 1.84 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To determine interoperator variability in the colposcopic evaluation of patients with mild dysplastic smears, retrospective comparison of colposcopy and biopsy results in 856 patients examined by 11 colposcopists in the Outpatient Colposcopy Clinic of "L. Mangiagalli" Institute, Milano, was performed.
The patients underwent a complete colposcopic assessment and target biopsy on suspect areas if a screening smear showed mild dysplasia. Colposcopic findings and disease detection rate for each operator were compared.
There was no significant (P > 0.05) difference in the recording of abnormal colposcopic findings. Significant differences were found, however, in abnormal transformation zone grading (P < 0.001), biopsy rate (P < 0.05), and squamocolumnar junction visualization (P < 0.005). There was no significant difference in overall disease detection (P > 0.5) but there was a statistically significant, inverse relation (r = -0.6, P < 0.01) between the high grade (cervical intraepithelial neoplasia grades 2 and 3) and low grade (human papillomavirus/cervical intraepithelial neoplasia grade 1) detection rate for each operator.
High grade disease detection in patients with mild dysplastic smears is influenced the subjectivity of the colposcopic examination. This should be considered when planning optimal management for patients with mild dysplasia.
Cancer 12/1995; 76(9):1601-5. · 5.20 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To identify the epidemiologic characteristics of women who have mild dyskaryosis on cervical smear but cervical intraepithelial neoplasia (CIN) grade II or III at biopsy.
We analyzed information from 291 women (median age 33 years, range 17-69) observed for the first time with a single smear test showing mild dyskaryosis. All subjects underwent colposcopy, and histologic confirmation was obtained by biopsy. We compared the characteristics of women who had CIN I or no evidence of CIN with those of women with CIN II or III at biopsy.
Twenty-eight women (10%) had CIN I at biopsy, 46 (15%) CIN II, and 23 (8%) CIN III. The frequency of CIN II or III tended to decrease with increasing education; compared with women reporting 11 or fewer years of education, the multivariate odds ratios (OR) of CIN II or III lesions was 0.5 (95% confidence interval [CI] 0.3-0.9) in those reporting 11 years of education or more. Compared with nulliparas, the OR of CIN II or III was 1.8 (95% CI 1.1-3.5) for parous women. Furthermore, compared with never-smokers, the OR of CIN II or III was 2.3 (95% CI 1.0-5.4) for current smokers. Ex-smokers were at increased risk, too; the estimated multivariate OR was 3.8 (95% CI 1.9-7.6). Compared with women reporting one sexual partner, the multivariate ORs of CIN II or III were 1.4 and 2.3 for women reporting two to three or four or more sexual partners, respectively (chi 2(1) trend = 6.65, P < .05).
Our results show that smoking is a risk indicator of CIN II or III in women with a single smear showing mild dyskaryosis. Parous women, those of low social standing, and those reporting multiple sexual partners also are at increased risk of CIN II or III.
Obstetrics and Gynecology 11/1995; 86(5):754-7. · 4.80 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The authors present a comparison between 2 percent testosterone propionate and petrolatum ointment in the treatment of vulvar lichen sclerosus in a randomized, double-blind, controlled clinical study. Fifty-eight consecutive patients with histologically confirmed vulvar lichen sclerosus were enrolled. They underwent a 1-year period of topical treatment with either medication, with clinical evaluations of symptoms and gross appearance at 2-month intervals, followed by histological evaluation at the end of the treatment period. The mean age of the patients studied was 56.5 years, ranging from 35 to 83 years. Thirty women (51.7 percent) were postmenopausal. The symptomatology had been present for 12 months or less in 33 patients (56.9 percent), for 1 to 5 years in 14 patients (24.2 percent) and for more than 5 years in 11 patients (18.9 percent). Table 1 summarizes the results of the two regimens of topical treatment. Table 1. Results of testosterone and placebo therapy in 58 patients with vulvar lichen sclerosus. P = NS After 1 year of therapy 20 patients (66.6 percent) in the testosterone group reported a considerable improvement in symptoms or were symptom-free, six patients (20 percent) were unchanged and four patients (13.4 percent) worsened. In the great majority of cases pruritus vulvae was the symptom reported to have improved most, compared
Obstetrical and Gynecological Survey 03/1995; 50(3):197-198. · 2.51 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Comparison between 2% testosterone propionate and petrolatum ointment in the treatment of vulvar lichen sclerosus in a randomized, double-blind, controlled clinical study.
Fifty-eight consecutive patients with histologically confirmed vulvar lichen sclerosus were enrolled. They underwent a 1-year period of topical treatment with either medication, with clinical evaluations of symptoms and gross appearance at 2-month intervals, followed by histological evaluation at the end of the treatment period. Statistical analysis was performed according to the chi-squared test and the Student-Newman-Keuls test.
A substantial improvement in symptoms was achieved in 20 (66.6%) patients in the testosterone group and in 21 (75%) patients in the placebo group. No statistical differences were observed between the two groups. Gross changes were observed in a few cases and no case demonstrated histologic modifications.
Petrolatum ointment is as effective as 2% testosterone in the treatment of vulvar lichen sclerosus.
International Journal of Gynecology & Obstetrics 08/1994; 46(1):53-6. · 1.84 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Correct methods of sampling are essential for obtaining adequate smears for cytological diagnosis of cervicovaginal abnormalities. In this paper we report on 3 methods of sampling, Ayre spatula, cotton swab and cytobrush on 89 patients who underwent repeat smear and colposcopic examinations because of abnormal screening smears. The cytobrush device was better than Ayre spatula or cotton in collecting both endocervical and neoplastic cells. However, the combination of spatula and cotton was almost the same as spatula and cytobrush in recovering neoplastic cells. Therefore the rate of cervical intraepithelial neoplasia (CIN) diagnosis is more influenced by an adequate sampling of the endocervix than by the type of endocervical device.
European journal of gynaecological oncology 02/1993; 14(3):234-6. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Risk factors for vulvar cancer have been evaluated in a case-control study conducted between 1987 and 1990 in northern Italy on 73 women with histologically confirmed invasive vulvar cancer and 572 control subjects in hospital for acute nongynecological, nonneoplastic non-hormone-related conditions. The risk of vulvar cancer was inversely related to education level: with reference to women reporting less than 7 years of schooling, the relative risk estimates were 0.6 and 0.4, respectively, in those reporting 7 to 11 and 12 or more years of schooling (chi 2(1) trend = 4.91 P = 0.03). No relationship emerged between number of births and spontaneous or induced abortions. Parous women reporting late first birth tended to be at lower risk (relative risk = 0.5, 95% confidence interval 0.3 to 1.1 for < 25 vs > or = 25 years at first birth), but there was no evidence of the risk to decrease with increasing age at first birth. The risk of vulvar cancer increased with body mass index, but the trend in risk was not significant after taking into account potential confounders in the multivariate analysis. No association emerged with indicators of sexual habits, menstrual history, and smoking. The risk of the disease was lower in women reporting Pap smears during their life and diminished with increasing number of cervical smears and decreasing recency of last Pap: compared to women reporting no Pap screening, it was 0.5 in those who reported one smear and 0.3 in those with two or more.