2001 Consensus guidelines for the management of women with cervical intraepithelial neoplasia

Division of Gynecologic Oncology, University of South Florida, Tampa, Florida, United States
American Journal of Obstetrics and Gynecology (Impact Factor: 4.7). 10/2004; 191(3):1049. DOI: 10.1016/j.ajog.2004.04.046
Source: PubMed
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    ABSTRACT: The anogenital human papillomavirus (HPV) is estimated to be the most commonly occurring sexually transmitted infection in the US. Comprehensive estimates of the annual economic burden associated with the prevention and treatment of anogenital HPV-related disease in the US population are currently unavailable. The purpose of this paper is to (i) outline an analytic framework from which to estimate the annual economic burden of preventing and treating anogenital HPV-related disease in the US; (ii) review available US literature concerning the annual economic burden of HPV; and (iii) highlight gaps in current knowledge where further study is particularly warranted. Among eight US studies identified that describe the annual economic burden pertaining to one or more aspects of anogenital HPV-related disease, three met the review eligibility criteria (published between 1990 and 2004, examined multiple facets of annual anogenital HPV-related economic burden, and clearly articulated the data and methods used in the estimation process). All costs were adjusted to 2004 US dollars. Estimates of the annual direct medical costs associated with cervical cancer were comparable across studies (range 300-400 million US dollars). In contrast, there was a wide range across studies for estimates of the annual direct medical costs associated with cervical intraepithelial neoplasia (range 700 million US dollars-2.3 billion US dollars). Only one study reported direct medical costs for anogenital warts (200 million US dollars) and routine cervical cancer screening (2.3 billion US dollars). No studies examined direct medical costs attributable to HPV-related anal, penile, vaginal or vulvar cancers, or the work and productivity losses resulting from time spent receiving medical care, morbidity or mortality. Current economic burden estimates would suggest annual direct medical costs associated with the prevention and treatment of anogenital warts and cervical HPV-related disease of at least 4 billion US dollars. This figure would likely rise to at least 5 billion US dollars per year if direct medical costs associated with other disease entities caused by the sexual transmission of HPV were included, with further additions to the economic burden totalling in the billions of dollars if work and productivity losses were incorporated, a research priority for future studies.
    PharmacoEconomics 02/2005; 23(11):1107-22. DOI:10.2165/00019053-200523110-00004 · 2.45 Impact Factor
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    ABSTRACT: Standard surgical treatment for CIN may impair fertility generating a need for alternative treatment options. We tested the efficacy and toxicity of oral DIM in the treatment of CIN 2 or 3 lesions. Patients with biopsy-proven cervical intraepithelial neoplasia (CIN) 2 or 3 scheduled for loop electrosurgical excision procedure (LEEP) were randomized 2:1 to receive diindolylmethane (DIM) (BioResponse-DIM, BioResponse, Boulder, CO) orally at approximately 2 mg/kg/day for 12 weeks or placebo (defatted rice bran, BioResponse). Subjects were evaluated every 3-4 months for 1 year. Analysis of data up to 1 year was assessed including Pap smear, HPV, colposcopy, biopsy and physical examination were performed at follow-up. Central pathology review confirmed all histology diagnoses. To date, 64 subjects (mean age 28 years, range 18-61) have been enrolled (45 in the DIM arm, 19 in the placebo arm), with 60 available for analysis. Average follow-up was 6 months. At enrollment, 58% were diagnosed with CIN 2 and 42% with CIN 3, 57% of subjects were Caucasian, 15% African American, 12% Hispanic and 17% Asian. During treatment 2 subjects (3%) complained of nausea (grade 2) at the 3- to 4-month visit. No systemic toxicities were observed (normal CBC, LFTs, comprehensive metabolic). Forty-six subjects had biopsies at first follow-up (77%). Twenty-one subjects (47%) in the DIM group had improved CIN with a decrease by 1-2 grades or a normal result. Median time to improvement was 5 months. Improved Pap smear was seen in 49% (22/45) with either a less severe abnormality or normal result. Colposcopy improved in twenty-five subjects in the DIM group (56%). Of these 25 subjects, 21 (84%) had improved colposcopic impression, 13 (52%) had a decrease in involved quadrants and 18 (72%) had a decrease in lesion number. Complete colposcopic response was observed in 4 subjects (9%). Stratifying by level of dysplasia, age, race, HPV status, tobacco use, contraceptive used did not alter the results. At median follow-up of 6 months, 85% of subjects have not required LEEP based on routine clinical triage of improving global assessment. There was no statistically significant difference in any outcome between the DIM and placebo group. Oral DIM at 2 mg/kg/day is well tolerated with no significant toxicity. We observed a high rate of clinically significant improvement in confirmed CIN 2 or 3 lesions among both treatment groups in this randomized clinical trial.
    Gynecologic Oncology 11/2009; 116(3):464-7. DOI:10.1016/j.ygyno.2009.10.060 · 3.77 Impact Factor
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    ABSTRACT: To compare large loop excision of the transformation zone (LLETZ) with contour-loop excision of the transformation zone (C-LETZ) in management of cervical intraepithelial neoplasia (CIN) with respect to number of specimens obtained, weight of specimen, surgical margin, treatment time, and morbidity associated with those procedures. Women were randomly allocated to receive LLETZ or C-LETZ. Inclusion criteria were the following circumstances: (1) presence of biopsy-proved CIN 2/3, (2) persistent biopsy-proved CIN 1, (3) discrepancy between cytology and histology, or 4) an endocervical curettage was positive. Ninety-eight women were eligible for the study. Mean weight of specimens in C-LETZ group was significantly more than LLETZ group (4.35 ± 1.39 vs. 3.55 ± 1.48 g, p = 0.007). Duration of treatment were similar in both groups (p = 0.39). After multiple logistic regressions were analyzed, C-LETZ was more likely to result in a single pathologic specimen (76 vs. 29.16 %, p < 0.001; adjusted RR 8.33, CI 3.23-21.47). There was no statistical significant difference in the frequency of positive margins between the groups (40 vs. 39.5 %, p = 0.64; adjusted RR 1.27, CI 0.46-3.50). The morbidity associated with those procedures was not different between the two groups. C-LETZ has a clear clinical benefit in term of a higher rate of a single pathologic specimen. It removes more cervical tissue than LLETZ. The incidence of incomplete excision and complication seem to be similar in both groups.
    Archives of Gynecology 06/2012; 286(5):1173-9. DOI:10.1007/s00404-012-2420-5 · 1.36 Impact Factor