Serena Mraz - Academia.edu (original) (raw)

Papers by Serena Mraz

Research paper thumbnail of Efficacy and tolerability of a fixed combination of clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel in moderate or severe acne subpopulations

PubMed, Aug 1, 2009

Background: Oral antibiotics are commonly prescribed for moderate or severe acne, but there may b... more Background: Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitations due to concerns about side effects associated with systemic treatments. Objective: To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations. Methods: Two multicenter, double-blind studies randomized 2,813 subjects with moderate or severe acne to clindamycin-BP 2.5% gel, each active ingredient, or vehicle gel, once daily for 12 weeks. Efficacy evaluations included inflammatory and non-inflammatory lesion counts and evaluator's global severity score at baseline and weeks 4, 8 and 12. Adverse events and subjects' evaluations of product tolerability were also monitored. Subpopulation efficacy and safety analyses by baseline acne severity were performed for the combined data from the two phase 3 studies. Results: Clindamycin-BP 2.5% gel significantly reduced inflammatory, non-inflammatory and total lesions compared with each active ingredient and vehicle in subjects with moderate acne and compared with vehicle in severe acne subjects at week 12. Significant improvements in evaluator's global severity score were evident for subjects with moderate acne in the clindamycin-BP 2.5% group compared with each active ingredient and vehicle and compared with vehicle in subjects with severe acne at week 12. Rates of adverse events were low and similar between treatment groups and baseline acne severity. Conclusion: Clindamycin-BP 2.5% aqueous gel is an effective and safe once-daily treatment for moderate or severe acne.

Research paper thumbnail of Gene Expression Profiles of Cutaneous B Cell Lymphoma

Journal of Investigative Dermatology, May 1, 2003

Research paper thumbnail of Expression of the bcl-6 and MUM1/IRF4 proteins correlate with overall and disease-specific survival in patients with primary cutaneous large B-cell lymphoma: a tissue microarray study

Journal of Cutaneous Pathology, Mar 1, 2005

Systemic B-cell lymphomas have been studied using microarrays, which has led to a better understa... more Systemic B-cell lymphomas have been studied using microarrays, which has led to a better understanding of their molecular characteristics. Initial microarray studies of these lymphomas have implicated several genes as important predictors of outcome. In this study, we used a tissue microarray (TMA) to characterize primary cutaneous large B-cell lymphomas (PCLBCL). We studied 14 patients for whom clinical follow up was available, including four patients whose lesions were limited to the leg on presentation. Immunohistochemical staining with CD20, CD44, CD21, CD5, CD10, bcl-2, bcl-6, Ki67, p53, and multiple myeloma 1 (MUM1) was examined. Our results identify two subgroups of lymphomas. The first group showed staining with bcl-6 and had an overall survival of 176 months (p = 0.003). The majority of this group was negative for MUM1. The second group lacked staining with bcl-6 and had an overall survival of 26 months, with a majority of these cases staining with MUM1. Three of four patients with PCLBCL of the leg showed no staining with bcl-6. Our study demonstrates the utility of TMAs in the analysis of PCLBCL and that expression of bcl-6 and MUM1 correlates with survival.

Research paper thumbnail of Prediction of Sentinel Lymph Node Micrometastasis by Histological Features in Primary Cutaneous Malignant Melanoma

Archives of Dermatology, Aug 1, 1998

To develop a prognostic model, based on clinical and pathological data, to estimate the probabili... more To develop a prognostic model, based on clinical and pathological data, to estimate the probability of micrometastasis in the sentinel lymph node in patients with malignant melanoma. Design: Retrospective analytical study. Setting: University medical center. Patients: Two hundred fifteen patients with American Joint Committee on Cancer stages I and II cutaneous malignant melanoma underwent sentinel lymph node biopsy. Measurements: Presence of microscopic melanoma in the sentinel lymph node(s). Clinical attributes recorded included age, sex, and location of the primary melanoma. Pathological attributes recorded before lymph node evaluation included ulceration, microsatellites, angiolymphatic invasion, mitotic rate, tumor infiltrating lymphocytes, and regression. Results: Forty-six patients (21.4%) overall had a positive sentinel lymph node. Patients with tumor thickness ranging from 3.0 to 3.9 mm had the highest incidence (50%) of nodal involvement, followed by those with tumors 4.0 to 4.9 mm thick (41%). Patients with melanomas measuring greater than 4.9 mm thick and those between 1.0 and 2.9 mm had a similar rate of nodal involvement (16%-17%). Clinical characteristics had minimal correlation with nodal status in multivariate analysis. The total number of histological high-risk features was significantly correlated with sentinel lymph node involvement. Important pathological risk factors included ulceration, high mitotic rate, angiolymphatic invasion, and microsatellites. Patients with tumor thickness greater than 1.0 mm but lacking these features had a 14% risk of occult metastases. Conclusion: Among patients with clinically nodenegative primary melanoma, the presence of 1 or more high-risk histological features significantly increases the incidence of microscopic nodal involvement and can be used to predict the likelihood of a positive sentinel lymph node biopsy.

Research paper thumbnail of Clinical images: Libman-Sacks endocarditis

Arthritis & Rheumatism, 2001

Increased numbers of microchimeric cells of fetal origin are associated with dermal fibrosis in m... more Increased numbers of microchimeric cells of fetal origin are associated with dermal fibrosis in mice following injection of vinyl chloride.

Research paper thumbnail of Treatment of Primary Cutaneous Melanoma

JAMA, Apr 11, 2001

... Matthew H. Kanzler, MD; Serena Mraz-Gernhard, MD. Author Affiliations: Division of Dermatolog... more ... Matthew H. Kanzler, MD; Serena Mraz-Gernhard, MD. Author Affiliations: Division of Dermatology, Santa Clara Valley Medical Center, San Jose, Calif (Dr Kanzler) and Department of Dermatology, Stanford University School of Medicine ... Balch CM, Soong S, Bartolucci AA, et al. ...

Research paper thumbnail of Noninvasive genomic detection of melanoma

British Journal of Dermatology, Mar 25, 2011

Support for this investigation was provided by DermTech International, Inc. (La Jolla, CA, U.S.A.... more Support for this investigation was provided by DermTech International, Inc. (La Jolla, CA, U.S.A.), who also provided the tape strip packets used for sample collection. Conflicts of interest W.W. was a recipient of research support from a UC Discovery award, co-sponsored by the University of California and DermTech International, and is an uncompensated member of the DermTech scientific advisory board; T.P. and S.C. are employees of DermTech and have DermTech stock options; J.Z. owns stock in DermTech; H.R. was an uncompensated member of DermTech's melanoma advisory board, is a member of the scientific advisory board of Mela Sciences, and receives research support from Mela Sciences, Lucid, Spectral Image, Inc. and SciBase AB; D.P. is a member of DermTech's melanoma advisory board; V.M. is a consultant to DermTech.

Research paper thumbnail of Treatment of Primary Cutaneous Melanoma

JAMA, 2001

... Matthew H. Kanzler, MD; Serena Mraz-Gernhard, MD. Author Affiliations: Division of Dermatolog... more ... Matthew H. Kanzler, MD; Serena Mraz-Gernhard, MD. Author Affiliations: Division of Dermatology, Santa Clara Valley Medical Center, San Jose, Calif (Dr Kanzler) and Department of Dermatology, Stanford University School of Medicine ... Balch CM, Soong S, Bartolucci AA, et al. ...

Research paper thumbnail of Subjects Experiencing at Least One Unsolicited or Solicited Adverse Events (FAS, N = 632)

<p>N = number of subjects in the specified group; n = number of subjects in the specified c... more <p>N = number of subjects in the specified group; n = number of subjects in the specified category (with at least one adverse event); % = percentages of n based on N; AD = atopic dermatitis; AE = adverse event; AESI = adverse event of special interest; SAE = serious adverse event; related AE = AE considered by the investigator to have a possible, probable, definite or missing relationship to study medication; Grade ≥ 3 = AE which prevented normal everyday activities or body temperature ≥ 39°C; FAS = full analysis set. P-value is Fisher’s exact test of the differences in proportions between groups.</p><p>Subjects Experiencing at Least One Unsolicited or Solicited Adverse Events (FAS, N = 632).</p

Research paper thumbnail of Seroconversion rates for ELISA and PRNT at all post-baseline visits (FAS, N = 632)

<p>N = number of subjects in the specified group; n = number of subjects who had a titer av... more <p>N = number of subjects in the specified group; n = number of subjects who had a titer available at the specified visit; SC is the number of subjects who had seroconverted.</p><p>Seroconversion rates for ELISA and PRNT at all post-baseline visits (FAS, N = 632).</p

Research paper thumbnail of GMT for ELISA and PRNT at all post-baseline visits (FAS, N = 632)

<p>N = number of subjects in the specified group.</p><p>GMT for ELISA and PRNT ... more <p>N = number of subjects in the specified group.</p><p>GMT for ELISA and PRNT at all post-baseline visits (FAS, N = 632).</p

Research paper thumbnail of Subjects Experiencing at Least One Solicited Systemic Adverse Events (8-Day Follow-Up period After Vaccination, FAS, N = 632)

<p>N = number of subjects in the specified group; n = number of subjects in the specified c... more <p>N = number of subjects in the specified group; n = number of subjects in the specified category (with at least one report of a solicited systemic AE); % = percentages of n based on N; AD = atopic dermatitis; AE = adverse event; Grade ≥ 3 = AE which prevented normal everyday activities or body temperature ≥ 39°C; related AE = AE considered by the investigator to have a possible, probable or definite relationship to study medication.</p><p>Subjects Experiencing at Least One Solicited Systemic Adverse Events (8-Day Follow-Up period After Vaccination, FAS, N = 632).</p

Research paper thumbnail of Numerical Simulations of the Thermodynamic Process of Granite Formation on the Geological Model of in Situ Melting

Research paper thumbnail of Natural Killer/Natural Killer-Like T-Cell Lymphoma, CD56+, Presenting in the Skin: An Increasingly Recognized Entity With an Aggressive Course

Journal of Clinical Oncology, 2001

PURPOSE: To describe and identify the clinical and pathologic features of prognostic significance... more PURPOSE: To describe and identify the clinical and pathologic features of prognostic significance for natural killer (NK) and NK-like T-cell (NK/T-cell) lymphoma presenting in the skin. PATIENTS AND METHODS: This study was a retrospective review of 30 patients with CD56+ lymphomas initially presenting with cutaneous lesions, with analysis of clinical and histopathologic parameters. RESULTS: The median survival for all patients was 15 months. Those with extracutaneous manifestations at presentation (11 patients) had a shorter median survival of 7.6 months as compared with those without extracutaneous involvement (17 patients), who had a more favorable median survival of 44.9 months (P = .0001). Age, gender, extent of cutaneous involvement, and initial response to therapy had no statistically significant effect on survival. Seven patients (24%) had detectable Epstein-Barr virus (EBV) within neoplastic cells. The patients with tumor cells that coexpress CD30 (seven patients) have not y...

Research paper thumbnail of Primary cutaneous malignant melanoma and its precursor lesions: Diagnostic and therapeutic overview

Journal of the American Academy of Dermatology, 2001

W ith a lack of scientific data, the standard of care for treatment of patients with melanoma at ... more W ith a lack of scientific data, the standard of care for treatment of patients with melanoma at the beginning of the twentieth century called for extensive mutilating surgery, local amputation of involved body areas, or both. In the mid-twentieth century, aggressive lymph node dissections were popular in an attempt to control metastatic disease despite the lack of scientific data that such procedures did, indeed, affect the survival of patients with melanoma. The purpose of this review is to present clinicians with an evidencebased summary of the current literature with regard to primary cutaneous melanoma, its diagnosis, precursor lesions, and therapy. All patients cannot be referred to a melanoma center or be enrolled in prospective randomized studies. For the majority of patients who are treated outside these research centers, it is hoped that the following review will allow the clinician to choose diagnostic and therapeutic approaches based on facts as we know them today, rather than making these decisions based on "tradition." PRECURSOR LESIONS Acquired melanocytic nevi Common acquired nevi typically appear after 6 to 12 months of age. These nevi enlarge and increase in number in early childhood and puberty. Most common acquired nevi remain less than 5 mm in diameter. 1 Nevi continue to increase in number through the third and fourth decades, and then slowly disappear with age. Fifty-five per cent of adults have between 10 and 45 nevi greater than 2 mm in diameter. 2 Several studies have been published regarding the prevalence of normal nevi in adults with conflicting results. Whereas Holly et al 3 found at least one nevus in virtually all adults, Swerdlow, English, and MacKie 4 noted that approximately 20% of adult patients have no clinical nevi (>2 mm) whatsoever. Bataille et al 5 found that 21% of adults had more than 50 nevi, whereas Tucker et al 6 found that only 10% of 998 controls had more than 50 nevi.

Research paper thumbnail of Gene Expression Profiles of Cutaneous B Cell Lymphoma

Journal of Investigative Dermatology, 2003

Research paper thumbnail of Expression of the bcl-6 and MUM1/IRF4 proteins correlate with overall and disease-specific survival in patients with primary cutaneous large B-cell lymphoma: a tissue microarray study

Journal of Cutaneous Pathology, 2005

Systemic B-cell lymphomas have been studied using microarrays, which has led to a better understa... more Systemic B-cell lymphomas have been studied using microarrays, which has led to a better understanding of their molecular characteristics. Initial microarray studies of these lymphomas have implicated several genes as important predictors of outcome. In this study, we used a tissue microarray (TMA) to characterize primary cutaneous large B-cell lymphomas (PCLBCL). We studied 14 patients for whom clinical follow up was available, including four patients whose lesions were limited to the leg on presentation. Immunohistochemical staining with CD20, CD44, CD21, CD5, CD10, bcl-2, bcl-6, Ki67, p53, and multiple myeloma 1 (MUM1) was examined. Our results identify two subgroups of lymphomas. The first group showed staining with bcl-6 and had an overall survival of 176 months (p = 0.003). The majority of this group was negative for MUM1. The second group lacked staining with bcl-6 and had an overall survival of 26 months, with a majority of these cases staining with MUM1. Three of four patients with PCLBCL of the leg showed no staining with bcl-6. Our study demonstrates the utility of TMAs in the analysis of PCLBCL and that expression of bcl-6 and MUM1 correlates with survival.

Research paper thumbnail of Clinical images: Libman-Sacks endocarditis

Arthritis & Rheumatism, 2001

Increased numbers of microchimeric cells of fetal origin are associated with dermal fibrosis in m... more Increased numbers of microchimeric cells of fetal origin are associated with dermal fibrosis in mice following injection of vinyl chloride.

Research paper thumbnail of Prediction of Sentinel Lymph Node Micrometastasis by Histological Features in Primary Cutaneous Malignant Melanoma

Archives of Dermatology, 1998

To develop a prognostic model, based on clinical and pathological data, to estimate the probabili... more To develop a prognostic model, based on clinical and pathological data, to estimate the probability of micrometastasis in the sentinel lymph node in patients with malignant melanoma. Design: Retrospective analytical study. Setting: University medical center. Patients: Two hundred fifteen patients with American Joint Committee on Cancer stages I and II cutaneous malignant melanoma underwent sentinel lymph node biopsy. Measurements: Presence of microscopic melanoma in the sentinel lymph node(s). Clinical attributes recorded included age, sex, and location of the primary melanoma. Pathological attributes recorded before lymph node evaluation included ulceration, microsatellites, angiolymphatic invasion, mitotic rate, tumor infiltrating lymphocytes, and regression. Results: Forty-six patients (21.4%) overall had a positive sentinel lymph node. Patients with tumor thickness ranging from 3.0 to 3.9 mm had the highest incidence (50%) of nodal involvement, followed by those with tumors 4.0 to 4.9 mm thick (41%). Patients with melanomas measuring greater than 4.9 mm thick and those between 1.0 and 2.9 mm had a similar rate of nodal involvement (16%-17%). Clinical characteristics had minimal correlation with nodal status in multivariate analysis. The total number of histological high-risk features was significantly correlated with sentinel lymph node involvement. Important pathological risk factors included ulceration, high mitotic rate, angiolymphatic invasion, and microsatellites. Patients with tumor thickness greater than 1.0 mm but lacking these features had a 14% risk of occult metastases. Conclusion: Among patients with clinically nodenegative primary melanoma, the presence of 1 or more high-risk histological features significantly increases the incidence of microscopic nodal involvement and can be used to predict the likelihood of a positive sentinel lymph node biopsy.

Research paper thumbnail of Long-term Outcome of 525 Patients With Mycosis Fungoides and Sézary Syndrome

Archives of Dermatology, 2003

To study and update the clinical characteristics and long-term outcome of our patients with mycos... more To study and update the clinical characteristics and long-term outcome of our patients with mycosis fungoides (MF) and Sézary syndrome (SS), and to identify important clinical factors predictive of survival and disease progression.

Research paper thumbnail of Efficacy and tolerability of a fixed combination of clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel in moderate or severe acne subpopulations

PubMed, Aug 1, 2009

Background: Oral antibiotics are commonly prescribed for moderate or severe acne, but there may b... more Background: Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitations due to concerns about side effects associated with systemic treatments. Objective: To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations. Methods: Two multicenter, double-blind studies randomized 2,813 subjects with moderate or severe acne to clindamycin-BP 2.5% gel, each active ingredient, or vehicle gel, once daily for 12 weeks. Efficacy evaluations included inflammatory and non-inflammatory lesion counts and evaluator's global severity score at baseline and weeks 4, 8 and 12. Adverse events and subjects' evaluations of product tolerability were also monitored. Subpopulation efficacy and safety analyses by baseline acne severity were performed for the combined data from the two phase 3 studies. Results: Clindamycin-BP 2.5% gel significantly reduced inflammatory, non-inflammatory and total lesions compared with each active ingredient and vehicle in subjects with moderate acne and compared with vehicle in severe acne subjects at week 12. Significant improvements in evaluator's global severity score were evident for subjects with moderate acne in the clindamycin-BP 2.5% group compared with each active ingredient and vehicle and compared with vehicle in subjects with severe acne at week 12. Rates of adverse events were low and similar between treatment groups and baseline acne severity. Conclusion: Clindamycin-BP 2.5% aqueous gel is an effective and safe once-daily treatment for moderate or severe acne.

Research paper thumbnail of Gene Expression Profiles of Cutaneous B Cell Lymphoma

Journal of Investigative Dermatology, May 1, 2003

Research paper thumbnail of Expression of the bcl-6 and MUM1/IRF4 proteins correlate with overall and disease-specific survival in patients with primary cutaneous large B-cell lymphoma: a tissue microarray study

Journal of Cutaneous Pathology, Mar 1, 2005

Systemic B-cell lymphomas have been studied using microarrays, which has led to a better understa... more Systemic B-cell lymphomas have been studied using microarrays, which has led to a better understanding of their molecular characteristics. Initial microarray studies of these lymphomas have implicated several genes as important predictors of outcome. In this study, we used a tissue microarray (TMA) to characterize primary cutaneous large B-cell lymphomas (PCLBCL). We studied 14 patients for whom clinical follow up was available, including four patients whose lesions were limited to the leg on presentation. Immunohistochemical staining with CD20, CD44, CD21, CD5, CD10, bcl-2, bcl-6, Ki67, p53, and multiple myeloma 1 (MUM1) was examined. Our results identify two subgroups of lymphomas. The first group showed staining with bcl-6 and had an overall survival of 176 months (p = 0.003). The majority of this group was negative for MUM1. The second group lacked staining with bcl-6 and had an overall survival of 26 months, with a majority of these cases staining with MUM1. Three of four patients with PCLBCL of the leg showed no staining with bcl-6. Our study demonstrates the utility of TMAs in the analysis of PCLBCL and that expression of bcl-6 and MUM1 correlates with survival.

Research paper thumbnail of Prediction of Sentinel Lymph Node Micrometastasis by Histological Features in Primary Cutaneous Malignant Melanoma

Archives of Dermatology, Aug 1, 1998

To develop a prognostic model, based on clinical and pathological data, to estimate the probabili... more To develop a prognostic model, based on clinical and pathological data, to estimate the probability of micrometastasis in the sentinel lymph node in patients with malignant melanoma. Design: Retrospective analytical study. Setting: University medical center. Patients: Two hundred fifteen patients with American Joint Committee on Cancer stages I and II cutaneous malignant melanoma underwent sentinel lymph node biopsy. Measurements: Presence of microscopic melanoma in the sentinel lymph node(s). Clinical attributes recorded included age, sex, and location of the primary melanoma. Pathological attributes recorded before lymph node evaluation included ulceration, microsatellites, angiolymphatic invasion, mitotic rate, tumor infiltrating lymphocytes, and regression. Results: Forty-six patients (21.4%) overall had a positive sentinel lymph node. Patients with tumor thickness ranging from 3.0 to 3.9 mm had the highest incidence (50%) of nodal involvement, followed by those with tumors 4.0 to 4.9 mm thick (41%). Patients with melanomas measuring greater than 4.9 mm thick and those between 1.0 and 2.9 mm had a similar rate of nodal involvement (16%-17%). Clinical characteristics had minimal correlation with nodal status in multivariate analysis. The total number of histological high-risk features was significantly correlated with sentinel lymph node involvement. Important pathological risk factors included ulceration, high mitotic rate, angiolymphatic invasion, and microsatellites. Patients with tumor thickness greater than 1.0 mm but lacking these features had a 14% risk of occult metastases. Conclusion: Among patients with clinically nodenegative primary melanoma, the presence of 1 or more high-risk histological features significantly increases the incidence of microscopic nodal involvement and can be used to predict the likelihood of a positive sentinel lymph node biopsy.

Research paper thumbnail of Clinical images: Libman-Sacks endocarditis

Arthritis & Rheumatism, 2001

Increased numbers of microchimeric cells of fetal origin are associated with dermal fibrosis in m... more Increased numbers of microchimeric cells of fetal origin are associated with dermal fibrosis in mice following injection of vinyl chloride.

Research paper thumbnail of Treatment of Primary Cutaneous Melanoma

JAMA, Apr 11, 2001

... Matthew H. Kanzler, MD; Serena Mraz-Gernhard, MD. Author Affiliations: Division of Dermatolog... more ... Matthew H. Kanzler, MD; Serena Mraz-Gernhard, MD. Author Affiliations: Division of Dermatology, Santa Clara Valley Medical Center, San Jose, Calif (Dr Kanzler) and Department of Dermatology, Stanford University School of Medicine ... Balch CM, Soong S, Bartolucci AA, et al. ...

Research paper thumbnail of Noninvasive genomic detection of melanoma

British Journal of Dermatology, Mar 25, 2011

Support for this investigation was provided by DermTech International, Inc. (La Jolla, CA, U.S.A.... more Support for this investigation was provided by DermTech International, Inc. (La Jolla, CA, U.S.A.), who also provided the tape strip packets used for sample collection. Conflicts of interest W.W. was a recipient of research support from a UC Discovery award, co-sponsored by the University of California and DermTech International, and is an uncompensated member of the DermTech scientific advisory board; T.P. and S.C. are employees of DermTech and have DermTech stock options; J.Z. owns stock in DermTech; H.R. was an uncompensated member of DermTech's melanoma advisory board, is a member of the scientific advisory board of Mela Sciences, and receives research support from Mela Sciences, Lucid, Spectral Image, Inc. and SciBase AB; D.P. is a member of DermTech's melanoma advisory board; V.M. is a consultant to DermTech.

Research paper thumbnail of Treatment of Primary Cutaneous Melanoma

JAMA, 2001

... Matthew H. Kanzler, MD; Serena Mraz-Gernhard, MD. Author Affiliations: Division of Dermatolog... more ... Matthew H. Kanzler, MD; Serena Mraz-Gernhard, MD. Author Affiliations: Division of Dermatology, Santa Clara Valley Medical Center, San Jose, Calif (Dr Kanzler) and Department of Dermatology, Stanford University School of Medicine ... Balch CM, Soong S, Bartolucci AA, et al. ...

Research paper thumbnail of Subjects Experiencing at Least One Unsolicited or Solicited Adverse Events (FAS, N = 632)

<p>N = number of subjects in the specified group; n = number of subjects in the specified c... more <p>N = number of subjects in the specified group; n = number of subjects in the specified category (with at least one adverse event); % = percentages of n based on N; AD = atopic dermatitis; AE = adverse event; AESI = adverse event of special interest; SAE = serious adverse event; related AE = AE considered by the investigator to have a possible, probable, definite or missing relationship to study medication; Grade ≥ 3 = AE which prevented normal everyday activities or body temperature ≥ 39°C; FAS = full analysis set. P-value is Fisher’s exact test of the differences in proportions between groups.</p><p>Subjects Experiencing at Least One Unsolicited or Solicited Adverse Events (FAS, N = 632).</p

Research paper thumbnail of Seroconversion rates for ELISA and PRNT at all post-baseline visits (FAS, N = 632)

<p>N = number of subjects in the specified group; n = number of subjects who had a titer av... more <p>N = number of subjects in the specified group; n = number of subjects who had a titer available at the specified visit; SC is the number of subjects who had seroconverted.</p><p>Seroconversion rates for ELISA and PRNT at all post-baseline visits (FAS, N = 632).</p

Research paper thumbnail of GMT for ELISA and PRNT at all post-baseline visits (FAS, N = 632)

<p>N = number of subjects in the specified group.</p><p>GMT for ELISA and PRNT ... more <p>N = number of subjects in the specified group.</p><p>GMT for ELISA and PRNT at all post-baseline visits (FAS, N = 632).</p

Research paper thumbnail of Subjects Experiencing at Least One Solicited Systemic Adverse Events (8-Day Follow-Up period After Vaccination, FAS, N = 632)

<p>N = number of subjects in the specified group; n = number of subjects in the specified c... more <p>N = number of subjects in the specified group; n = number of subjects in the specified category (with at least one report of a solicited systemic AE); % = percentages of n based on N; AD = atopic dermatitis; AE = adverse event; Grade ≥ 3 = AE which prevented normal everyday activities or body temperature ≥ 39°C; related AE = AE considered by the investigator to have a possible, probable or definite relationship to study medication.</p><p>Subjects Experiencing at Least One Solicited Systemic Adverse Events (8-Day Follow-Up period After Vaccination, FAS, N = 632).</p

Research paper thumbnail of Numerical Simulations of the Thermodynamic Process of Granite Formation on the Geological Model of in Situ Melting

Research paper thumbnail of Natural Killer/Natural Killer-Like T-Cell Lymphoma, CD56+, Presenting in the Skin: An Increasingly Recognized Entity With an Aggressive Course

Journal of Clinical Oncology, 2001

PURPOSE: To describe and identify the clinical and pathologic features of prognostic significance... more PURPOSE: To describe and identify the clinical and pathologic features of prognostic significance for natural killer (NK) and NK-like T-cell (NK/T-cell) lymphoma presenting in the skin. PATIENTS AND METHODS: This study was a retrospective review of 30 patients with CD56+ lymphomas initially presenting with cutaneous lesions, with analysis of clinical and histopathologic parameters. RESULTS: The median survival for all patients was 15 months. Those with extracutaneous manifestations at presentation (11 patients) had a shorter median survival of 7.6 months as compared with those without extracutaneous involvement (17 patients), who had a more favorable median survival of 44.9 months (P = .0001). Age, gender, extent of cutaneous involvement, and initial response to therapy had no statistically significant effect on survival. Seven patients (24%) had detectable Epstein-Barr virus (EBV) within neoplastic cells. The patients with tumor cells that coexpress CD30 (seven patients) have not y...

Research paper thumbnail of Primary cutaneous malignant melanoma and its precursor lesions: Diagnostic and therapeutic overview

Journal of the American Academy of Dermatology, 2001

W ith a lack of scientific data, the standard of care for treatment of patients with melanoma at ... more W ith a lack of scientific data, the standard of care for treatment of patients with melanoma at the beginning of the twentieth century called for extensive mutilating surgery, local amputation of involved body areas, or both. In the mid-twentieth century, aggressive lymph node dissections were popular in an attempt to control metastatic disease despite the lack of scientific data that such procedures did, indeed, affect the survival of patients with melanoma. The purpose of this review is to present clinicians with an evidencebased summary of the current literature with regard to primary cutaneous melanoma, its diagnosis, precursor lesions, and therapy. All patients cannot be referred to a melanoma center or be enrolled in prospective randomized studies. For the majority of patients who are treated outside these research centers, it is hoped that the following review will allow the clinician to choose diagnostic and therapeutic approaches based on facts as we know them today, rather than making these decisions based on "tradition." PRECURSOR LESIONS Acquired melanocytic nevi Common acquired nevi typically appear after 6 to 12 months of age. These nevi enlarge and increase in number in early childhood and puberty. Most common acquired nevi remain less than 5 mm in diameter. 1 Nevi continue to increase in number through the third and fourth decades, and then slowly disappear with age. Fifty-five per cent of adults have between 10 and 45 nevi greater than 2 mm in diameter. 2 Several studies have been published regarding the prevalence of normal nevi in adults with conflicting results. Whereas Holly et al 3 found at least one nevus in virtually all adults, Swerdlow, English, and MacKie 4 noted that approximately 20% of adult patients have no clinical nevi (>2 mm) whatsoever. Bataille et al 5 found that 21% of adults had more than 50 nevi, whereas Tucker et al 6 found that only 10% of 998 controls had more than 50 nevi.

Research paper thumbnail of Gene Expression Profiles of Cutaneous B Cell Lymphoma

Journal of Investigative Dermatology, 2003

Research paper thumbnail of Expression of the bcl-6 and MUM1/IRF4 proteins correlate with overall and disease-specific survival in patients with primary cutaneous large B-cell lymphoma: a tissue microarray study

Journal of Cutaneous Pathology, 2005

Systemic B-cell lymphomas have been studied using microarrays, which has led to a better understa... more Systemic B-cell lymphomas have been studied using microarrays, which has led to a better understanding of their molecular characteristics. Initial microarray studies of these lymphomas have implicated several genes as important predictors of outcome. In this study, we used a tissue microarray (TMA) to characterize primary cutaneous large B-cell lymphomas (PCLBCL). We studied 14 patients for whom clinical follow up was available, including four patients whose lesions were limited to the leg on presentation. Immunohistochemical staining with CD20, CD44, CD21, CD5, CD10, bcl-2, bcl-6, Ki67, p53, and multiple myeloma 1 (MUM1) was examined. Our results identify two subgroups of lymphomas. The first group showed staining with bcl-6 and had an overall survival of 176 months (p = 0.003). The majority of this group was negative for MUM1. The second group lacked staining with bcl-6 and had an overall survival of 26 months, with a majority of these cases staining with MUM1. Three of four patients with PCLBCL of the leg showed no staining with bcl-6. Our study demonstrates the utility of TMAs in the analysis of PCLBCL and that expression of bcl-6 and MUM1 correlates with survival.

Research paper thumbnail of Clinical images: Libman-Sacks endocarditis

Arthritis & Rheumatism, 2001

Increased numbers of microchimeric cells of fetal origin are associated with dermal fibrosis in m... more Increased numbers of microchimeric cells of fetal origin are associated with dermal fibrosis in mice following injection of vinyl chloride.

Research paper thumbnail of Prediction of Sentinel Lymph Node Micrometastasis by Histological Features in Primary Cutaneous Malignant Melanoma

Archives of Dermatology, 1998

To develop a prognostic model, based on clinical and pathological data, to estimate the probabili... more To develop a prognostic model, based on clinical and pathological data, to estimate the probability of micrometastasis in the sentinel lymph node in patients with malignant melanoma. Design: Retrospective analytical study. Setting: University medical center. Patients: Two hundred fifteen patients with American Joint Committee on Cancer stages I and II cutaneous malignant melanoma underwent sentinel lymph node biopsy. Measurements: Presence of microscopic melanoma in the sentinel lymph node(s). Clinical attributes recorded included age, sex, and location of the primary melanoma. Pathological attributes recorded before lymph node evaluation included ulceration, microsatellites, angiolymphatic invasion, mitotic rate, tumor infiltrating lymphocytes, and regression. Results: Forty-six patients (21.4%) overall had a positive sentinel lymph node. Patients with tumor thickness ranging from 3.0 to 3.9 mm had the highest incidence (50%) of nodal involvement, followed by those with tumors 4.0 to 4.9 mm thick (41%). Patients with melanomas measuring greater than 4.9 mm thick and those between 1.0 and 2.9 mm had a similar rate of nodal involvement (16%-17%). Clinical characteristics had minimal correlation with nodal status in multivariate analysis. The total number of histological high-risk features was significantly correlated with sentinel lymph node involvement. Important pathological risk factors included ulceration, high mitotic rate, angiolymphatic invasion, and microsatellites. Patients with tumor thickness greater than 1.0 mm but lacking these features had a 14% risk of occult metastases. Conclusion: Among patients with clinically nodenegative primary melanoma, the presence of 1 or more high-risk histological features significantly increases the incidence of microscopic nodal involvement and can be used to predict the likelihood of a positive sentinel lymph node biopsy.

Research paper thumbnail of Long-term Outcome of 525 Patients With Mycosis Fungoides and Sézary Syndrome

Archives of Dermatology, 2003

To study and update the clinical characteristics and long-term outcome of our patients with mycos... more To study and update the clinical characteristics and long-term outcome of our patients with mycosis fungoides (MF) and Sézary syndrome (SS), and to identify important clinical factors predictive of survival and disease progression.