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Precancer or intraepithelial neoplasia (IEN) is a noninvasive lesion that has genetic abnormalities, loss of cellular control functions, and some phenotypic characteristics of invasive cancer and that predicts for a substantial likelihood of developing invasive cancer. The AACR Task Force on the Treatment and prevention of IEN has delineated the relationship between IEN and cancer risk as well as the clinical benefit that can be derived from reducing IEN burden. Although several effective endoscopic and surgical treatments for IEN have become standard medical practice, these interventions can confer morbidity and do not treat the entire epithelial field at risk. The incidence of many epithelial cancers is continuing to rise, the number of individuals at risk is increasing with the aging population, and the rapid advancement of imaging and molecular diagnostics is bringing to light precancers that were heretofore clinically silent. There is therefore an urgent need to rapidly develop new treatment and prevention agents for IEN. The AACR IEN Task Force recommends focusing on established precancers as the target for new agent development because of the close association between dysplasia and invasive cancer and because a convincing reduction in IEN burden provides patient benefit by reducing cancer risk and/or by decreasing the need for invasive interventions. The IEN Task Force proposes several clinical trial designs that provide practical and feasible approaches to the rapid development of new agents to treat and prevent precancer.

Precancer or intraepithelial neoplasia (IEN) is a noninvasive lesion that has genetic abnormalities, loss of cellular control functions, and some phenotypic characteristics of invasive cancer and that predicts for a substantial likelihood of developing invasive cancer. The AACR Task Force on the Treatment and prevention of IEN has delineated the relationship between IEN and cancer risk as well as the clinical benefit that can be derived from reducing IEN burden. Although several effective endoscopic and surgical treatments for IEN have become standard medical practice, these interventions can confer morbidity and do not treat the entire epithelial field at risk. The incidence of many epithelial cancers is continuing to rise, the number of individuals at risk is increasing with the aging population, and the rapid advancement of imaging and molecular diagnostics is bringing to light precancers that were heretofore clinically silent. There is therefore an urgent need to rapidly develop new treatment and prevention agents for IEN. The AACR IEN Task Force recommends focusing on established precancers as the target for new agent development because of the close association between dysplasia and invasive cancer and because a convincing reduction in IEN burden provides patient benefit by reducing cancer risk and/or by decreasing the need for invasive interventions. The IEN Task Force proposes several clinical trial designs that provide practical and feasible approaches to the rapid development of new agents to treat and prevent precancer.

OBJECTIVE: We evaluated the performance of the Papanicolaou smear in screening and diagnostic settings. STUDY DESIGN: We analyzed Papanicolaou smear results of 1,850 women recruited into a clinical trial to evaluate an emerging technology for the detection of cervical cancer. Screening and diagnosis groups were based on the history of previous Papanicolaou smear results. We calculated sensitivities, specificities, positive and negative likelihood ratios (LR+ and LR-), receiver operating characteristic curves, and areas under the receiver operating characteristic curve (AUC). RESULTS: In the screening group, by defining disease as cervical intraepithelial neoplasia (CIN) 2,3/cancer or worse and using high-grade squamous intraepithelial lesion (HSIL) as the test cutpoint, the AUC was 0.689, and the LR+ and LR- were 39.25 and 0.67, respectively. In the diagnosis group, the AUC was 0.764, and the LR+ and LR- were 3.79 and 0.56, respectively. By defining disease as human papillomavirus/CIN 1 or worse and HSIL as the test cutpoint, the AUC was 0.586, and the LR+ and LR- were 17.01 and 0.92 in the screening group; in the diagnosis group, the AUC was 0.686, and the LR+ and LR- were 2.77 and 0.75, respectively. CONCLUSIONS: In a screening setting, a Papanicolaou smear result of HSIL or worse is 39 times more likely in a patient with CIN 2,3/cancer than in a patient without it. This compares to 4 times more likely in the diagnostic setting. The magnitude of the positive likelihood ratio observed in the screening group indicated that abnormal Papanicolaou smear results obtained in the screening setting should have more impact on clinical decision making than those from results obtained in the diagnostic setting. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We describe the content of providers' postcolposcopy consultations and women's perceptions of consultations and their conditions. MATERIALS AND METHODS: Consultations (n = 47) were audiotaped, transcribed, and analyzed. Women were interviewed immediately after consultations. RESULTS: Providers often named or described the diagnosis (n = 46), suggested a return appointment date (n = 41), and asked if women understood the diagnosis or had any questions (n = 40). Risk factors and causes of cervical cancer, including human papillomavirus infection, smoking, and sexual activity, were rarely discussed (n = 5). The majority (n = 40) of women were asked if they understood the provider's explanation or had any questions. Women rated quality of their provider's explanation as high and the severity of and worry about their condition as moderate. CONCLUSIONS: Postcolposcopy consultations focused on follow-up screening and treatment. Risk factors and causes of cervical cancer were discussed infrequently. [ABSTRACT FROM AUTHOR]

In a see-and-treat protocol, patients referred for colposcopy because of an abnormal Pap smear in cervical-cancer screening can be treated by loop excision, without biopsy, during one visit to the clinic. However, overtreatment in the see-and-treat strategy has been reported to be 1.2-83.3% for low-grade squamous intraepithelial lesions (SIL) and to be 13.3-83.3% for high-grade SIL. Range of overtreatment narrowed to 4.0-23.5% for those with normal pathology and to 18.0-29.4% for those with normal or low-grade pathology when calculation of overtreatment was restricted to patients diagnosed with high-grade SIL on colposcopy and referral Pap smear. Most common treatment complications are bleeding and infection. Nonetheless, the strategy has become accepted internationally: low costs, decreased patient anxiety, and increased compliance make it appealing, especially in settings with limited health resources, and for patients at risk of not being treated in a timely manner or of not returning for a second appointment. Mathematical modelling may give information about the appropriateness and usefulness of this treatment while the results of long-term clinical trials are awaited. [ABSTRACT FROM AUTHOR]

While colposcopy remains an essential diagnostic tool in the hands of an experienced clinician, the five new technologies outlined here may eventually replace or at least supplement this important procedure. [ABSTRACT FROM AUTHOR]

Objectives: The use of high-resolution in vivo confocal imaging may offer a clinically useful adjunct to standard methods for the diagnosis and screening of epithelial precancers. This study assesses the feasibility of real-time confocal reflectance imaging of cervical tissue and the use of acetic acid as a contrast agent to increase visualization of cell nuclei.Study Design: A confocal microscope was used to image cervical cells and colposcopically normal and abnormal cervical biopsy specimens. Images were obtained before and after the application of 6% acetic acid.Results: The confocal imaging system resolved subcellular detail throughout the entire epithelial thickness. Normal and abnormal tissues were clearly able to be differentiated. Addition of acetic acid enhanced nuclear signal in all acquired images.Conclusion: High-contrast reflected light images of cervical tissue are attainable in near real time. Acetic acid significantly increases light scattering from cell nuclei, which may partially explain why acetowhitening occurs. [ABSTRACT FROM AUTHOR]

Small bowel dysfunction is an important problem in patients undergoing radiotherapy for cervical cancer and may take many forms. The spectrum of small bowel dysfunction includes subtle findings such as malabsorption and more obvious complications such as obstruction and fistula formation. Predicting who will experience small bowel dysfunction is important so that prospective studies of these compications can be planned. We undertook a controlled retrospective review of patients with stage IB cervical carcinoma looking for parameters of small bowel dysfunction and their predictors to help in the design of a prospective study. This analysis suggests that the interval to development is long. The best predictor of diarrhea requiring medication was the number of laparotomies. A large sample size of stage IB patients would be necessary to prospectively study small bowel dysfunction in this population. [ABSTRACT FROM AUTHOR]