Searched for: person:ark3
Phase IIb randomized clinical chemoprevention trial of a soybean-derived compound (Bowman-Birk inhibitor concentrate) for oral leukoplakia
Meyskens F.L.; Taylor T.; Armstrong W.; Kong L.; Gu M.; Gonzalez R.; Villa M.; Wong V.; Garcia A.; Perloff M.; Kennedy A.; Wan S.; Ware J.H.; Messadi D.; Lorch J.; Wirth L.; Jaffe Z.; Goodwin W.J.; Civantos F.; Sullivan M.; Reid M.; Merciznu M.; Jayaprakash V.; Kerr A.R.; Le A.
Introduction: Epidemiologic observations have suggested a protective effect of soybeans against a number of epithelial cancers including oral malignancies and by inference precursor lesions such as leukoplakia. Several compounds in soybeans have shown activity in preclinical models; we have focused our studies on BBI (Bowman-Birk inhibitor), which is active against the protease chymotrypsin. Our phase I trial demonstrated a very low toxicity profile and a 31% response rate in a 1-month nonrandomized study that was associated with favorable modulation of protease activity and neu oncogene in exfoliated buccal mucosal cells (EBMC). Methods: An intent-to-treat(ITT) randomized placebo (Quaker mass harina, a corn flour)-controlled, double-blind clinical trial of a soybean concentrate (C) of BBI (600 C.I. units) was performed in a multinstitutional investigation (7 sites). The study duration was 6 months and included pre/interim/postevaluation of lesions sizes and pre/post photographic assessments and oral mucosa biopsies(with post central pathology review) of the involved area(s). Intermediate biomarkers (IBM) included serial measurements of EBMC neu protein (ng/mg) and protease (Delrfu/min/ug protein) and serum neu protein (ng/ml). 325 patients underwent preliminary screening and 148 per protocol eligible were enrolled. Of these, 132 were randomized and 105 completed 6 months on study. All data on lesion sizes, photo judgments, and pathology indications of degree of abnormality or change in abnormality were entered into SAS datasets and subjected to 100% verification against the crf forms by the statistician. The several IBM measurements were converted from the original Microsoft Excel sheets into SAS data sets, and subject to spot checks against the original spreadsheets. Similarly, host-factor information from the questionnaires was spot checked against the original records. In all cases, the primary, per-protocol analyses was ITT. The per-protocol, intent-to-treat cohort, and all other categorizations of study participants will also be described with appropriate descriptive summary measures. Results: The ITT data set is composed of all those with valid, two-dimensional measurements on all lesions observed at both the randomization and 6-month visit. 89 evaluable patients met these criteria: 43 in the treatment and 46 in the placebo group. For the BBIC group, the mean relative percent change in total lesion area was -20.6% and for the placebo group -17.1%. Clinical responses for the 89 patients were: four showed a complete response (4.5%), 22 showed a partial response (25%), 53 showed stable disease (60%), and 10 showed disease progression (11.2%). For the drug group the CR+PR(>50% change) was 27.91% and for placebo group 30.43%. Neither the lesion size nor response comparisons demonstrated differences between the two groups that were significantly different (p>0.05). Photos of the same lesion at baseline and at the 6-month exam were available for 91 participants. Five qualified reviewers made judgments of the degree of change in abnormality on a seven-point scale, blinded to study arm and timepoint of photos. For mean comparison scores, 1 was substantial improvement over time, 4 indicated no change and 7 meaning much worse decline over time. Preliminary assessments of 77% of the patients having pre/post photos indicates that there were no significant differences between the placebo and treatment groups. Conclusion: BBIC is not effective as a chemoprevention agent for the management of oral leukoplakia. Central pathology review by two reviewers is near completion, but is unlikely to affect this conclusion. Final measurements of the three biomarkers should be available by the time of presentation and subanalysis will be presented for the two groups and for the patients who seemed to have had a clinical response
EMBASE:70524061
ISSN: 1940-6207
CID: 155354
Tongue Lipomatosis: A Case Report [Meeting Abstract]
Kerr, A. R.; Shah, S.
ISI:000281287500253
ISSN: 1354-523x
CID: 155176
Long-standing oral ulcers: proposal for a new 'S-C-D classification system'
Compilato, D; Cirillo, N; Termine, N; Kerr, A R; Paderni, C; Ciavarella, D; Campisi, G
Persistent oral ulcers and erosions can be the final common manifestation, sometimes clinically indistinguishable, of a diverse spectrum of conditions ranging from traumatic lesions, infectious diseases, systemic and local immune-mediated lesions up to neoplasms. The process of making correct diagnosis for persistent oral ulcers still represents a challenge to clinicians. Major diagnostic criteria should include the clinical appearance of both ulcer and surrounding non-ulcerated mucosa, together with the evaluation of associated signs and symptoms, such as: number (single or multiple), shape, severity of the ulcer(s), conditions of remaining mucosa (white, red or with vesiculo-bullous lesions) and systemic involvement (e.g. fever, lymphadenopathy or evaluation of haematological changes). The aim of this paper was to review the literature relating to persistent oral ulcers and provide a helpful, clinical-based diagnostic tool for recognising long-standing ulcers in clinical dental practice. The authors, therefore, suggest distinguishing simple, complex and destroying (S-C-D system) ulcerations, as each requires different diagnostic evaluations and management. This classification has arisen from studying the current English literature relating to this topic, performed using MEDLINE / PubMed / Ovid databases.
PMID: 19141062
ISSN: 0904-2512
CID: 866552
White sponge nevus [Case Report]
Dadlani, Chicky; Mengden, Stephanie; Kerr, A Ross
A 33-year-old-man presented with a 13-year history of asymptomatic, white, folded, soft, poorly-demarcated, diffuse plaques bilaterally on his buccal mucosae and lateral surfaces of his tongue. There is no family history of similar lesions. The physical examination and histopathologic findings were consistent with a diagnosis of white sponge nevus. This rare disorder is typically inherited; however, as in this case, there have been a few other cases reported without a familial background.
PMID: 18627752
ISSN: 1087-2108
CID: 427092
Adjunctive techniques for oral cancer examination and lesion diagnosis: a systematic review of the literature
Patton, Lauren L; Epstein, Joel B; Kerr, A Ross
BACKGROUND: Adjunctive techniques that may facilitate the early detection of oral premalignant and malignant lesions (OPML) have emerged in the past decades. METHODS: The authors undertook a systematic review of the English-language literature to evaluate the effectiveness of toluidine blue (TB), ViziLite Plus with TBlue (Zila Pharmaceuticals, Phoenix), ViziLite (Zila Pharmaceuticals), Microlux DL (AdDent, Danbury, Conn.), Orascoptic DK (Orascoptic, a Kerr Company, Middleton, Wis.), VELscope (LED Dental, White Rock, British Columbia, Canada) and OralCDx (Oral CDx Laboratories, Suffern, N.Y.) brush biopsy. They abstracted data relating to study design, sampling and characteristics of the study group, interventions, reported outcomes and diagnostic accuracy of adjunctive aids from 23 articles meeting inclusion and exclusion criteria, including availability of histologic outcomes. RESULTS: The largest evidence base was for TB. A limited number of studies was available for ViziLite, ViziLite Plus with TBlue and OralCDx. Studies of VELscope have been conducted primarily to assess the margins of lesions in known OPML. The authors identified no studies of Microlux DL or Orascoptic DK. Study designs had various limitations in applicability to the general practice setting, including use of higher-risk populations and expert examiners. CONCLUSIONS: There is evidence that TB is effective as a diagnostic adjunct for use in high-risk populations and suspicious mucosal lesions. OralCDx is useful in assessment of dysplastic changes in clinically suspicious lesions; however, there are insufficient data meeting the inclusion criteria to assess usefulness in innocuous mucosal lesions. Overall, there is insufficient evidence to support or refute the use of visually based examination adjuncts. Practical Implications. Given the lack of data on the effectiveness of adjunctive cancer detection techniques in general dental practice settings, clinicians must rely on a thorough oral mucosal examination supported by specialty referral and/or tissue biopsy for OPML diagnosis.
PMID: 18594075
ISSN: 0002-8177
CID: 427102
Improving oral health in women: nurses' call to action
Clemmens, Donna A; Kerr, A Ross
The purpose of this article is to discuss the most significant oral health and related problems experienced by women, and to provide a Nurse's Plan of Action to respond to these largely preventable diseases. Oral health is integral to women's overall health and well-being, with poor oral health being associated with cancer, heart disease, diabetes, depression, and the birth of preterm, low-birthweight babies. Poor nutrition and lifestyle, principally tobacco and heavy alcohol use, can further increase the risk for oral diseases. Disparities are evident in women's reported poor access of regular dental care related to lack of dental insurance and low income. These facts are disturbing because most oral diseases are preventable. The Surgeon General's report on oral health in America (U.S. Department of Health and Human Services, 2000) and, more recently, the 'National Call to Action to Promote Oral Health' (U.S. Department of Health and Human Services, 2003) emphasized the need for partnerships of key stakeholders, including nurses, to get involved in oral disease prevention. Nurses are in an ideal position to provide health promotion education and screening across the multitude of settings in which they work regarding oral health and risk factors for oral disease. Nursing interventions aimed at promoting healthy outcomes and preventing disease should include a focus on oral health
PMID: 18158520
ISSN: 0361-929x
CID: 151116
CANCER SCREENING Response [Letter]
Patton, LL; Epstein, JB; Kerr, AR
ISI:000260100100007
ISSN: 0002-8177
CID: 153621
ORAL CANCER EXAMINATION Response [Letter]
Patton, LL; Epstein, JB; Kerr, AR
ISI:000260886500003
ISSN: 0002-8177
CID: 153616
Eating disorders: a threat for women's health. Oral manifestations in a comprehensive overview
Lo Muzio, L; Lo Russo, L; Massaccesi, C; Rappelli, G; Panzarella, V; Di Fede, O; Kerr, A R; Campisi, G
The incidence of eating disorders has progressively increased over the last several years, mainly affecting both the health and quality of life of young women. Such disorders are primarily an outlet for manifest psychic suffering and secondarily, they jeopardize the integrity and function of multiple organ systems resulting in significant morbidity and sometimes, life-threatening outcomes. The complex emerging interplay of etiopathogenetic factors poses many challenges in their prevention and management, which is further complicated by a reluctance by patients with eating disorders to seek medical evaluation and treatment. Recognition of the oral manifestations is important because these signs and symptoms can provide insights about disease progression and parallel general health and psychic status. Oral health care providers may be one of the few providers contacted by this patient population seeking recall prophylaxis or urgent dental care. Thus, improving understanding and knowledge of both general medical aspects of eating disorders and their oral manifestations could be of great impact in elevating the attention of health providers towards this group of very debilitating disorders and, consequently, improving their overall prognosis. In this paper we will review and discuss all these aspects.
PMID: 17529915
ISSN: 0026-4970
CID: 866602
Ploidy Analysis on Brush Biopsy Samples [Meeting Abstract]
Peng, W.; Sirois, D.A.; Sacks, P.G.; Kerr, A.R.
DOSS:25181834
ISSN: 1079-2104
CID: 275942