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1.
Br J Surg ; 95(11): 1401-7, 2008 Nov.
Article in English | MEDLINE | ID: mdl-18844268

ABSTRACT

BACKGROUND: Existing follow-up guidelines after treatment for melanoma are based largely on dated literature and historical precedent. This study aimed to calculate recurrence rates and establish prognostic factors for recurrence to help redesign a follow-up schedule. METHODS: Data were retrieved from the Sydney Melanoma Unit database for all patients with a single primary melanoma and American Joint Committee on Cancer (AJCC) stage I-II disease, who had received their first treatment between 1959 and 2002. Recurrence rates, timing and survival were recorded by substage, and predictive factors were analysed. RESULTS: Recurrence occurred in 18.9 per cent (895 of 4748) of patients overall, 5.2 per cent (95 of 1822) of those with stage IA disease, 18.4 per cent (264 of 1436) with IB, 28.7 per cent (215 of 750) with IIA, 40.6 per cent (213 of 524) with IIB and 44.3 per cent (86 of 194) with IIC disease. Overall, the median disease-free survival time was 2.6 years, but there were marked differences between AJCC subgroups. Primary tumour thickness, ulceration and tumour mitotic rate were important predictors of recurrence. CONCLUSION: A new follow-up schedule was proposed: stage I annually, stage IIA 6-monthly for 2 years and then annually, stage IIB-IIC 4-monthly for 2 years, 6-monthly in the third year and annually thereafter.


Subject(s)
Melanoma/epidemiology , Neoplasm Recurrence, Local/epidemiology , Practice Guidelines as Topic , Skin Neoplasms/epidemiology , Epidemiologic Methods , Female , Humans , Male , Melanoma/pathology , Melanoma/therapy , Middle Aged , Neoplasm Recurrence, Local/pathology , Neoplasm Staging/methods , New South Wales/epidemiology , Skin Neoplasms/pathology , Skin Neoplasms/therapy , Time Factors
2.
Antimicrob Agents Chemother ; 50(7): 2409-14, 2006 Jul.
Article in English | MEDLINE | ID: mdl-16801419

ABSTRACT

Enteroviral meningitis causes appreciable morbidity in adults, including hospitalization, decreased activity, and headache. Limited data define the natural history of disease. No antiviral therapeutic agent has demonstrated improved outcome in controlled clinical trials. Pleconaril, an inhibitor of enterovirus replication, was tested in two placebo-controlled clinical trials. Of 607 randomized patients in a multicenter, double-blind placebo-controlled study of pleconaril (200 mg three times daily versus an identical-appearing placebo), 240 patients were confirmed to have enterovirus infection. The time to headache resolution was evaluated by using Kaplan-Meier survival methodology. A Cox regression model evaluated multivariate factors associated with disease resolution. Resolution of headache in patients with concomitant moderate to severe nausea at baseline occurred at a median of 9.5 days in the absence of therapy and was reduced to 7.0 days for pleconaril recipients (P = 0.009). For a headache score of > 5 alone, treated patients resolved headache significantly more rapidly (P = 0.005). Males resolved headache 50% faster than females. Regardless of randomization group, patients with a baseline headache score of 5 or greater resolved headache 50% more slowly than patients with a baseline headache score of 4. No differences in either clinical or laboratory adverse events were noted. Over 50% of untreated patients had a persistent headache that was greater than 1 week in duration. Pleconaril shortened the course of illness compared to placebo recipients, especially in the early disease course. However, the benefit was achieved only modestly in a subgroup analysis of patients with more severe disease after adjusting for confounding variables.


Subject(s)
Antiviral Agents/therapeutic use , Enterovirus Infections/drug therapy , Enterovirus Infections/physiopathology , Headache/drug therapy , Meningitis, Viral/drug therapy , Meningitis, Viral/physiopathology , Oxadiazoles/therapeutic use , Adult , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Double-Blind Method , Enterovirus Infections/virology , Female , Headache/virology , Humans , Male , Meningitis, Viral/virology , Multivariate Analysis , Oxadiazoles/administration & dosage , Oxadiazoles/adverse effects , Oxazoles , Treatment Outcome
3.
Stat Med ; 20(16): 2429-39, 2001 Aug 30.
Article in English | MEDLINE | ID: mdl-11512133

ABSTRACT

Herpes zoster or shingles is a frequent occurrence in both elderly individuals and immunocompromised hosts. The pain associated with herpes zoster is the most debilitating complication of the disease. It can be described as acute pain and post-herpetic neuralgia or zoster associated pain (ZAP). The latter definition encompasses pain from the onset of disease through its resolution and provides a convenient analytic tool for evaluation of antiviral therapy. A heuristic examination of ZAP historical data suggests the existence of three phases of pain resolution: the acute, subacute and chronic phases. The subacute and chronic phases comprise the post-herpetic neuralgia (PHN) stage. Common analytic methods, such as a Kaplan-Meier survival function or a Cox's model, have been used to assess the pain. However, such approaches do not adequately allow for phase comparison. Notably, in the clinical trial setting the comparison of specific treatment effects on the latter stages of pain are of the greatest medical relevance since this is the most debilitating phase of the illness. In order to incorporate the phase-specific information in the modelling of time to cessation of ZAP, we assumed the hazard function was a stepwise constant. Utilizing the full likelihood function, we obtained the maximum likelihood estimate for the transition times (that is, change-points), and other parameters of medical importance. The standard error of the change-point estimates were obtained through a bootstrapping method. The asymptotic properties of the parameter estimates are also discussed. Hence, the rates of pain resolution across all phases can be examined in order to precisely define the existence of multiple phases. In addition, the covariates effect can be examined across phases and populations, thereby allowing us to translate potential efficacy of a standard therapy to different populations. These results can be utilized in the design of clinical trials or in targeting the outcome for a specific phase while controlling for the effect of other variables.


Subject(s)
Clinical Trials as Topic , Data Interpretation, Statistical , Herpes Zoster/complications , Herpes Zoster/drug therapy , Likelihood Functions , Neuralgia/diagnosis , Neuralgia/virology , Pain Measurement/methods , Proportional Hazards Models , Acute Disease , Aged , Analysis of Variance , Antiviral Agents/therapeutic use , Bias , Chronic Disease , Confounding Factors, Epidemiologic , Convalescence , Disease Progression , Effect Modifier, Epidemiologic , Humans , Pain Measurement/standards , Survival Analysis , Time Factors , Treatment Outcome
4.
J Clin Oncol ; 19(16): 3622-34, 2001 Aug 15.
Article in English | MEDLINE | ID: mdl-11504744

ABSTRACT

PURPOSE: The American Joint Committee on Cancer (AJCC) recently proposed major revisions of the tumor-node-metastases (TNM) categories and stage groupings for cutaneous melanoma. Thirteen cancer centers and cancer cooperative groups contributed staging and survival data from a total of 30,450 melanoma patients from their databases in order to validate this staging proposal. PATIENTS AND METHODS: There were 17,600 melanoma patients with complete clinical, pathologic, and follow-up information. Factors predicting melanoma-specific survival rates were analyzed using the Cox proportional hazards regression model. Follow-up survival data for 5 years or longer were available for 73% of the patients. RESULTS: This analysis demonstrated that (1) in the T category, tumor thickness and ulceration were the most powerful predictors of survival, and the level of invasion had a significant impact only within the subgroup of thin (< or = 1 mm) melanomas; (2) in the N category, the following three independent factors were identified: the number of metastatic nodes, whether nodal metastases were clinically occult or clinically apparent, and the presence or absence of primary tumor ulceration; and (3) in the M category, nonvisceral metastases was associated with a better survival compared with visceral metastases. A marked diversity in the natural history of pathologic stage III melanoma was demonstrated by five-fold differences in 5-year survival rates for defined subgroups. This analysis also demonstrated that large and complex data sets could be used effectively to examine prognosis and survival outcome in melanoma patients. CONCLUSION: The results of this evidence-based methodology were incorporated into the AJCC melanoma staging as described in the companion publication.


Subject(s)
Melanoma/mortality , Melanoma/pathology , Neoplasm Staging/standards , Skin Neoplasms/mortality , Skin Neoplasms/secondary , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Child , Female , Humans , Male , Middle Aged , Neoplasm Metastasis , Predictive Value of Tests , Proportional Hazards Models , Survival Analysis , United States/epidemiology
5.
J Clin Oncol ; 19(16): 3635-48, 2001 Aug 15.
Article in English | MEDLINE | ID: mdl-11504745

ABSTRACT

PURPOSE: To revise the staging system for cutaneous melanoma under the auspices of the American Joint Committee on Cancer (AJCC). MATERIALS AND METHODS: The prognostic factors analysis described in the companion publication (this issue), as well as evidence from the published literature, was used to assemble the tumor-node-metastasis criteria and stage grouping for the melanoma staging system. RESULTS: Major changes include (1) melanoma thickness and ulceration but not level of invasion to be used in the T category (except for T1 melanomas); (2) the number of metastatic lymph nodes rather than their gross dimensions and the delineation of clinically occult (ie, microscopic) versus clinically apparent (ie, macroscopic) nodal metastases to be used in the N category; (3) the site of distant metastases and the presence of elevated serum lactic dehydrogenase to be used in the M category; (4) an upstaging of all patients with stage I, II, and III disease when a primary melanoma is ulcerated; (5) a merging of satellite metastases around a primary melanoma and in-transit metastases into a single staging entity that is grouped into stage III disease; and (6) a new convention for defining clinical and pathologic staging so as to take into account the staging information gained from intraoperative lymphatic mapping and sentinel node biopsy. CONCLUSION: This revision will become official with publication of the sixth edition of the AJCC Cancer Staging Manual in the year 2002.


Subject(s)
Melanoma/mortality , Melanoma/pathology , Neoplasm Staging/standards , Skin Neoplasms/pathology , Skin Neoplasms/secondary , Humans , Neoplasm Metastasis , Proportional Hazards Models , Survival Analysis , United States/epidemiology
6.
Pediatrics ; 108(2): 223-9, 2001 Aug.
Article in English | MEDLINE | ID: mdl-11483781

ABSTRACT

OBJECTIVE: During the 2 decades in which effective antiviral therapies have been available for neonatal herpes simplex virus (HSV) disease, changes have been documented not only in the outcomes of infected infants, but also in the natural history of the disease itself. Numerous studies previously have reported that early institution of antiviral therapy is beneficial to the outcome of the disease. The objective of this study was to provide an update of neonatal HSV disease to identify means by which future improvements in the management of HSV-infected neonates can be made. DESIGN/METHODS: Neonates enrolled in 2 studies of parenteral acyclovir for the treatment of neonatal HSV disease provided the data source. The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group conducted the studies between 1981 and 1997. A total of 186 patients are summarized, all of whom were treated with acyclovir. Demographic and clinical characteristics of these patients are reported. RESULTS: Comparisons between patients treated in the periods between 1981-1988 and 1989-1997 according to extent of disease revealed that the mean time between the onset of disease symptoms and initiation of therapy has not changed significantly from the early 1980s to the late 1990s. Of all patients evaluated, 40% had fetal scalp monitors during the delivery process. A significant minority of patients did not have skin vesicles at the time of their presentation and did not develop them during the acute HSV disease (39% of patients with disseminated disease; 32% of patients with central nervous system [CNS] disease; and 17% of patients with skin, eye, and/or mouth disease). Among patients with CNS disease, mortality was associated with prematurity. Among patients with disseminated HSV disease treated with acyclovir at 30 mg/kg/d, mortality was associated with aspartate transaminase elevations of >/=10 times the upper limit of normal at the time of initiation of acyclovir therapy. Mortality was also associated with lethargy at initiation of antiviral therapy for patients with disseminated disease. Patients' morbidity status was associated with the extent of disease (skin, eye, and/or mouth disease vs CNS vs disseminated). For those patients with CNS disease, morbidity was also associated with seizures at initiation of antiviral therapy. CONCLUSION: Data presented in the current comparison of neonatal HSV disease over the 2 periods (1981-1988 vs 1989-1997) demonstrate that no progress has been made in decreasing the interval between onset of HSV symptoms and initiation of antiviral therapy. Additional strides in the improvement of disease outcome may occur only if the interval between onset of symptoms and initiation of therapy is shortened. The means by which this will be accomplished lie in increased consideration of neonatal HSV infections in acutely ill infants. Specific data and recommendations to facilitate this goal are contained within.


Subject(s)
Acyclovir/therapeutic use , Antiviral Agents/therapeutic use , Herpes Simplex/drug therapy , Acyclovir/administration & dosage , Antiviral Agents/administration & dosage , Aspartate Aminotransferases/blood , Diagnosis, Differential , Diagnostic Imaging , Electroencephalography/statistics & numerical data , Herpes Simplex/diagnosis , Herpes Simplex/microbiology , Herpesvirus 1, Human/drug effects , Herpesvirus 1, Human/isolation & purification , Herpesvirus 2, Human/drug effects , Herpesvirus 2, Human/isolation & purification , Humans , Infant , Infant, Newborn , Infant, Premature, Diseases/diagnosis , Infant, Premature, Diseases/drug therapy , Infusions, Parenteral , Proportional Hazards Models , Prospective Studies , Treatment Outcome
7.
Pediatrics ; 108(2): 230-8, 2001 Aug.
Article in English | MEDLINE | ID: mdl-11483782

ABSTRACT

OBJECTIVE: The objective of this investigation was to establish the safety of high-dose (HD) acyclovir for the treatment of neonatal herpes simplex virus (HSV) disease. In addition, an estimate of therapeutic efficacy was sought, both with respect to mortality and to morbidity. Virologic efficacy of HD acyclovir was also assessed. PARTICIPANTS: Infants who were

Subject(s)
Acyclovir/administration & dosage , Herpes Simplex/drug therapy , Acyclovir/therapeutic use , Drug Administration Schedule , Humans , Infant, Newborn , Infusions, Intravenous , Injections, Intravenous
8.
Ann Surg Oncol ; 8(2): 101-8, 2001 Mar.
Article in English | MEDLINE | ID: mdl-11258773

ABSTRACT

BACKGROUND: The Intergroup Melanoma Surgical Trial began in 1983 to examine the optimal surgical margins of excision for primary melanomas of intermediate thickness (i.e., 1-4 mm). There is now a median 10-year follow-up. METHODS: There were two cohorts entered into a prospective multi-institutional trial: (1) 468 patients with melanomas on the trunk or proximal extremity who randomly received a 2 cm or 4 cm radial excision margin and (2) 272 patients with melanomas on the head, neck, or distal extremities who received a 2 cm radial excision margin. RESULTS: A local recurrence (LR) was associated with a high mortality rate, with a 5-year survival rate of only 9% (as a first relapse) or 11% (anytime) compared with an 86% survival for those patients who did not have a LR (P < .0001). The 10-year survival for all patients with a LR was 5%. The 10-year survival rates were not significantly different when comparing 2 cm vs. 4 cm margins of excision (70% vs. 77%) or comparing the management of the regional lymph nodes (observation vs. elective node dissection). The incidences of LR were the same for patients having a 2 cm vs. 4 cm excision margin regardless of whether the comparisons were made as first relapse (0.4% vs. 0.9%) or at anytime (2.1% vs. 2.6%). When analyzed by anatomic site, the LR rates were 1.1% for melanomas arising on the proximal extremity, 3.1% for the trunk, 5.3% for the distal extremities, and 9.4% for the head and neck. The most profound influence on LR rates was the presence or absence of ulceration; it was 6.6% vs. 1.1% in the randomized group involving the trunk and proximal extremity and was 16.2% vs. 2.1% in the non-randomized group involving the distal extremity and head and neck (P < .001). A multivariate (Cox) regression analysis showed that ulceration was an adverse and independent factor (P = .0001) as was head and neck melanoma site (P = .01), while the remaining factors were not significant (all with P > .12). CONCLUSION: For this group of melanoma patients, a local recurrence is associated with a high mortality rate, a 2-cm margin of excision is safe and ulceration of the primary melanoma is the most significant prognostic factor heralding an increased risk for a local recurrence.


Subject(s)
Melanoma/surgery , Skin Neoplasms/surgery , Humans , Lymph Node Excision/adverse effects , Melanoma/mortality , Melanoma/pathology , Multivariate Analysis , Neoplasm Invasiveness/pathology , Neoplasm Recurrence, Local/mortality , Neoplasm Staging , Neoplasm, Residual , Prospective Studies , Regression Analysis , Skin Neoplasms/mortality , Skin Neoplasms/pathology , Survival Rate , Time Factors , Treatment Outcome
9.
Ann Surg Oncol ; 8(10): 766-70, 2001 Dec.
Article in English | MEDLINE | ID: mdl-11776489

ABSTRACT

BACKGROUND: Elective lymph node dissection (ELND) may contribute to a survival benefit in certain stratified subsets of melanoma patients. We hypothesized that lymphatic mapping and sentinel lymph node (SLN) biopsy (with complete node dissection if metastases are present) may improve both staging and survival of patients with clinically negative nodes, without subjecting all patients to the morbidity associated with complete ELND. METHODS: We reviewed the data for all 14,914 N0 patients of the AJCC Melanoma Staging Database to determine the effect of SLN biopsy and ELND on staging and survival. RESULTS: Retrospective analysis revealed that there was an apparent statistically significant survival advantage to SLN biopsy in patients with melanomas > 1 mm (n = 9024; 68.5% and 26.2% reduction in mortality compared with patients staged to be N0 by clinical exam and ELND, respectively; P < .0001). Five-year survivals were 90.5%, 77.7%, and 69.8%, respectfully, for patients staged by SLN biopsy (n = 2552), ELND (n = 2014), and clinical examination alone (n = 5192). The survival advantage of SLN biopsy was statistically significant for each T-stage category (T2, T3, and T4) and ulceration status. There was no advantage to SLN biopsy in patients with melanomas <1 mm (n = 5890). CONCLUSIONS: SLN biopsy provides more accurate staging and may contribute to a survival benefit in populations of patients with melanoma.


Subject(s)
Melanoma/pathology , Skin Neoplasms/pathology , Adult , Female , Humans , Immunochemistry , Male , Melanoma/surgery , Middle Aged , Neoplasm Staging , Sentinel Lymph Node Biopsy/methods , Skin Neoplasms/surgery , Survival Rate
10.
J Clin Oncol ; 18(8): 1614-21, 2000 Apr.
Article in English | MEDLINE | ID: mdl-10764421

ABSTRACT

PURPOSE: To evaluate granulocyte-macrophage colony-stimulating factor (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma who are at high risk of recurrence. PATIENTS AND METHODS: Forty-eight assessable patients with stage III or IV melanoma were treated in a phase II trial with long-term, chronic, intermittent GM-CSF after surgical resection of disease. Patients with stage III disease were required to have more than four positive nodes or a more than 3-cm mass. All patients were rendered clinically disease-free by surgery before enrollment. The GM-CSF was administered subcutaneously in 28-day cycles, such that a dose of 125 microg/m(2) was delivered daily for 14 days followed by 14 days of rest. Treatment cycles continued for 1 year or until disease recurrence. Patients were evaluated for toxicity and disease-free and overall survival. RESULTS: Overall and disease-free survival were significantly prolonged in patients who received GM-CSF compared with matched historical controls. The median survival duration was 37.5 months in the study patients versus 12.2 months in the matched controls (P <.001). GM-CSF was well tolerated; only one subject discontinued drug due to an adverse event (grade 2 injection site reaction). CONCLUSION: GM-CSF may provide an antitumor effect that prolongs survival and disease-free survival in patients with stage III and IV melanoma who are clinically disease-free. These results support institution of a prospective, randomized clinical trial to definitively determine the value of surgical adjuvant therapy with GM-CSF in such patients.


Subject(s)
Granulocyte-Macrophage Colony-Stimulating Factor/therapeutic use , Melanoma/therapy , Skin Neoplasms/therapy , Aged , Combined Modality Therapy , Disease-Free Survival , Female , Granulocyte-Macrophage Colony-Stimulating Factor/adverse effects , Humans , Life Tables , Lymphatic Metastasis , Male , Melanoma/mortality , Melanoma/pathology , Melanoma/surgery , Skin Neoplasms/pathology , Skin Neoplasms/surgery , Survival Rate
11.
Cancer ; 88(6): 1484-91, 2000 Mar 15.
Article in English | MEDLINE | ID: mdl-10717634

ABSTRACT

The Melanoma Staging Committee of the AJCC has proposed major revisions of the melanoma TNM and stage grouping criteria. The committee members represent most of the major cooperative groups and cancer centers worldwide with a special interest in melanoma; the committee also collectively has had clinical experience with over 40,000 patients. The new staging system better reflects independent prognostic factors that are used in clinical trials and in reporting the outcomes of various melanoma treatment modalities. Major revisions include 1) melanoma thickness and ulceration, but not level of invasion, to be used in the T classification; 2) the number of metastatic lymph nodes, rather than their gross dimensions, the delineation of microscopic versus macroscopic lymph node metastases, and presence of ulceration of the primary melanoma to be used in the N classification; 3) the site of distant metastases and the presence of elevated serum LDH, to be used in the M classification; 4) an upstaging of all patients with Stage I,II, and III disease when a primary melanoma is ulcerated; 5) a merging of satellite metastases around a primary melanoma and in-transit metastases into a single staging entity that is grouped into Stage III disease; and 6) a new convention for defining clinical and pathologic staging so as to take into account the new staging information gained from intraoperative lymphatic mapping and sentinel lymph node biopsy. The AJC Melanoma Staging Committee invites comments and suggestions regarding this proposed staging system before a final recommendation is made.


Subject(s)
Melanoma/pathology , Neoplasm Staging/methods , Skin Neoplasms/pathology , Biopsy , Clinical Trials as Topic , Humans , Intraoperative Care , L-Lactate Dehydrogenase/blood , Lymph Node Excision , Lymph Nodes/pathology , Lymphatic Metastasis/pathology , Melanoma/classification , Melanoma/secondary , Neoplasm Invasiveness , Prognosis , Skin Neoplasms/classification , Skin Ulcer/pathology , Treatment Outcome , United States
12.
J Infect Dis ; 179(1): 9-15, 1999 Jan.
Article in English | MEDLINE | ID: mdl-9841816

ABSTRACT

Acute neuritis and persistent pain are the most significant clinical manifestations of herpes zoster and are end points for clinical trials therapy. In an acyclovir and prednisone study, patients were categorized according to pain severity and number of lesions at presentation. Risk categories were defined according to the magnitude of risk ratios (RRs) and a comparison of Kaplan-Meier survival estimates. For acute neuritis and zoster-associated pain, RRs defined rate of resolution. Patients who presented with severe or incapacitating pain and a large number of lesions were less likely to achieve resolution of both acute neuritis and zoster-associated pain (RR, 18.0; 95% confidence interval [CI], 6. 6-48.6, and RR, 5.3; 95% CI, 4.2-17.2, respectively). These analyses identify the subgroups of patients for whom aggressive interventions are most strongly indicated.


Subject(s)
Acyclovir/therapeutic use , Anti-Inflammatory Agents/therapeutic use , Antiviral Agents/therapeutic use , Herpes Zoster/drug therapy , Herpes Zoster/physiopathology , Pain/physiopathology , Prednisone/therapeutic use , Activities of Daily Living , Aged , Female , Herpes Zoster/pathology , Humans , Male , Middle Aged , Neuritis/drug therapy , Neuritis/physiopathology , Pain/drug therapy , Quality of Life , Risk Factors , Time Factors
13.
Ann Epidemiol ; 8(5): 327-33, 1998 Jul.
Article in English | MEDLINE | ID: mdl-9669615

ABSTRACT

PURPOSE: This investigation examines the relationship between socioeconomic status (SES) and melanoma incidence in counties included in the Surveillance, Epidemiology, and End Results Registry (SEER) in the United States from 1973 to 1993. METHODS: Cases included whites, aged at least 15 years, with a morphologic diagnosis of malignant melanoma, residing in one of 199 counties at the time of diagnosis. County level measures of SES including median household income, percentage of high school graduates, and percentage of families below poverty were abstracted from the 1950, 1960, 1970, 1980, and 1990 U.S. Census data. The relationship between SES factors and melanoma rates was examined by hierarchical Poisson regression. RESULTS: The percentage of high school graduates was significantly and positively associated with the incidence of melanoma (relative risk (RR), 1.28; 95% confidence interval (CI), 1.21-1.35), after controlling for age at diagnosis, gender, time period, latitude, and percentage of Hispanics in the county. Percentage of families below poverty was significantly inversely associated with the incidence of melanoma (RR, 0.66; 95% CI, 0.55-0.78). When education and poverty were included in the same model, both the positive effects of education (RR, 1.23; 95% CI, 1.16-1.31) and the negative effects of poverty (RR, 0.85; 95% CI, 0.74-0.98) persisted. In contrast, median household income was not associated with melanoma incidence in a similar multivariable model (RR, 1.00; 95% CI, 0.99-1.00). CONCLUSION: Whether the effect of education on incidence of melanoma reflects lifestyle behaviors that modify exposure to sunlight or some other factor remains unclear. Nonetheless, the findings of this study suggest that the determinant is primarily related to education, not income.


Subject(s)
Melanoma/epidemiology , Skin Neoplasms/epidemiology , Social Class , Adolescent , Adult , Aged , Aged, 80 and over , Cohort Studies , Education , Female , Humans , Incidence , Income , Life Style , Male , Middle Aged , Risk Factors
14.
Antimicrob Agents Chemother ; 42(5): 1139-45, 1998 May.
Article in English | MEDLINE | ID: mdl-9593141

ABSTRACT

The present randomized, double-blind, placebo-controlled, multicenter clinical trial was designed to compare the efficacy and tolerability of sorivudine [1-beta-D-arabinofuranosyl-E-(2-bromovinyl)uracil] and acyclovir for the treatment of dermatomal herpes zoster in human immunodeficiency virus (HIV)-seropositive patients. A total of 170 HIV-seropositive adults presenting with herpes zoster (confirmed by direct fluorescent-antigen testing and/or viral culture) were enrolled and randomized to receive a 10-day course of orally administered sorivudine (40 mg once daily plus acyclovir placebos) or acyclovir (800 mg five times daily plus sorivudine placebo). Patients were monitored daily to document the events of cutaneous healing, pain, zoster-related complications, and drug-related adverse events. Patients were reassessed on days 21 and 28 and then once monthly for 1 year. The primary efficacy endpoint was time to the cessation of new vesicle formation. Secondary efficacy endpoints included times to other events of cutaneous healing, resolution of pain, and frequency of dissemination and zoster recurrence. In a multivariate analysis, sorivudine was superior to acyclovir for reducing the times to the cessation of new vesicle formation (relative risk [RR] = 1.54, 95% confidence interval [CI] = 1.00 to 2.36; P = 0.049) and total lesion crusting (RR = 1.48, 95% CI = 1.07 to 2.04; P = 0.017). In a univariate analysis, there was a trend favoring sorivudine for the cessation of new vesicle formation (median of 3 versus 4 days; P = 0.07) and a significant advantage for time to total lesion crusting (median of 7 versus 8 days; P = 0.02). The time to the resolution of zoster-associated pain, the frequency of dissemination, and the frequency of zoster recurrence were not different between the two treatment groups. Both drugs were well tolerated. Sorivudine is an effective drug for the treatment of herpes zoster in HIV-infected patients and results in accelerated cutaneous healing when compared with acyclovir therapy.


Subject(s)
AIDS-Related Opportunistic Infections/drug therapy , Acyclovir/therapeutic use , Antiviral Agents/therapeutic use , Arabinofuranosyluracil/analogs & derivatives , Herpes Zoster/drug therapy , AIDS-Related Opportunistic Infections/virology , Acyclovir/adverse effects , Adolescent , Adult , Aged , Antiviral Agents/adverse effects , Arabinofuranosyluracil/adverse effects , Arabinofuranosyluracil/therapeutic use , Double-Blind Method , Female , Herpes Zoster/complications , Herpes Zoster/mortality , Herpes Zoster/prevention & control , Humans , Male , Middle Aged , Quality of Life , Recurrence , Treatment Outcome
15.
J Surg Oncol ; 67(4): 228-33, 1998 Apr.
Article in English | MEDLINE | ID: mdl-9579369

ABSTRACT

BACKGROUND AND OBJECTIVES: Approximately one third of all melanoma patients will experience disease recurrence. Factors that affect patient survival following local, regional, or distant first recurrences of localized melanoma are the subject of this investigation. METHODS: Survival times for a total of 1,085 first recurrences from 4,568 localized melanoma patients were examined in relationship to patient and disease factors by Cox regression. Nearly half (48.8%) of all first recurrences were regional, 21.8% were local, and 29.4% were distant recurrences. RESULTS: Survival following recurrence differed significantly by site of recurrence (local, regional, or distant; P < 0.0001). Within each site, the median survival time did not differ by time of recurrence following diagnosis. Significant tumor factors for survival following local recurrence included tumor thickness (P = 0.0263) and lesion location (P < 0.0001). For regional recurrences, survival was significantly related to ulceration (P = 0.0105) and whether the recurrence was combined with a local recurrence (P = 0.0429). Survival following distant metastasis was related to number of distant sites (P < 0.0001) and whether a visceral site was involved (P < 0.0001). CONCLUSIONS: Patient and tumor characteristics predict survival following recurrence. Regardless of disease-free interval, long-term follow-up of melanoma patients is necessary. Patients experiencing distant metastasis have the shortest median survival time compared to patients experiencing local or regional recurrences.


Subject(s)
Melanoma/mortality , Melanoma/secondary , Neoplasm Recurrence, Local/mortality , Disease-Free Survival , Humans , Lymph Nodes/pathology , Lymphatic Metastasis , Multivariate Analysis , Neoplasm Metastasis , Prognosis , Proportional Hazards Models , Survival Analysis
16.
Am J Med Sci ; 315(1): 11-6, 1998 Jan.
Article in English | MEDLINE | ID: mdl-9427569

ABSTRACT

We evaluated the willingness of clients at a large urban sexually transmitted diseases (STD) clinic in the southeastern United States to participate in future trials of preventive vaccines for HIV type 1 (HIV-1). A single trained interviewer administered an oral survey instrument to STD clinic clients over a 4-week enrollment period. The participants were 167 randomly selected clients (90 men and 77 women), most of whom were young, African-American heterosexuals. Risk behaviors for HIV-1 infection were highly prevalent. Overall, 67% of clients expressed willingness to consider participation in an HIV-1 vaccine trial. By univariate analysis, prior HIV-1 testing was significantly associated with willingness to participate (P = 0.04). Multivariate analysis revealed that female gender (P = 0.05) and prior HIV-1 testing (P = 0.03) were significant predictors of willingness to participate.


Subject(s)
AIDS Vaccines , Acquired Immunodeficiency Syndrome/prevention & control , HIV-1 , Patient Acceptance of Health Care , Adult , Black or African American , Alabama , Analysis of Variance , Clinical Trials as Topic , Community Health Services , Female , Heterosexuality , Humans , Male , Multivariate Analysis , Risk-Taking , Sexually Transmitted Diseases , Southeastern United States , Surveys and Questionnaires , Urban Population , White People
17.
Biometrics ; 54(4): 1420-33, 1998 Dec.
Article in English | MEDLINE | ID: mdl-9883542

ABSTRACT

Survival trees methods are nonparametric alternatives to the semiparametric Cox regression in survival analysis. In this paper, a tree-based method for censored survival data with time-dependent covariates is proposed. The proposed method assumes a very general model for the hazard function and is fully nonparametric. The recursive partitioning algorithm uses the likelihood estimation procedure to grow trees under a piecewise exponential structure that handles time-dependent covariates in a parallel way to time-independent covariates. In general, the estimated hazard at a node gives the risk for a group of individuals during a specific time period. Both cross-validation and bootstrap resampling techniques are implemented in the tree selection procedure. The performance of the proposed survival trees method is shown to be good through simulation and application to real data.


Subject(s)
Biometry/methods , Survival Analysis , Evaluation Studies as Topic , Heart Transplantation/mortality , Humans , Middle Aged , Models, Statistical , Proportional Hazards Models
18.
J Insur Med ; 30(3): 157-68, 1998.
Article in English | MEDLINE | ID: mdl-10351176

ABSTRACT

BACKGROUND: The rates for incidence and mortality from melanoma are continuing to rise, although long term survival experience for patients with in situ and localized melanomas is favorable. RESULTS: Excess mortality varied with age at diagnosis, sex, duration since diagnosis and tumor thickness. CONCLUSIONS: Compared to the general white population in the United States, patients with localized melanoma experience a mild increase in Excess Death Rates (EDRs) the first year following diagnosis. For 1-5 years following diagnosis the EDRs are markedly increased across all age groups and decline thereafter. At 15-20 years following diagnosis the EDRS are not elevated except among patients < 40 years of age at diagnosis. Patients with tumors > 1.5 mm thick have mild to moderate increases in EDR for the first year following diagnosis, and extremely high EDRs up to 5 years. There is no elevation in mortality ratios or EDR for patients diagnosed with in situ melanomas.


Subject(s)
Carcinoma in Situ/mortality , Melanoma/mortality , Skin Neoplasms/mortality , Adult , Aged , Aged, 80 and over , Carcinoma in Situ/pathology , Cause of Death , Female , Follow-Up Studies , Humans , Male , Melanoma/pathology , Middle Aged , Odds Ratio , Skin Neoplasms/pathology , Survival Rate
19.
J Health Care Poor Underserved ; 9(4): 420-32, 1998 Nov.
Article in English | MEDLINE | ID: mdl-10073217

ABSTRACT

The association between low socioeconomic status (SES) in minority groups and higher incidence and mortality from cervical cancer was examined using two large U.S. databases. With cases from 1973 to 1992, all registries of the Surveillance, Epidemiology, and End Results (SEER) (except Hawaii) were used to calculate incidence rates of in situ and invasive cervical cancers by race group. SES indicators were derived from the Regional Economic Information System, Department of Commerce. Higher levels of SES indicators were related to decreased risk and lower incidence of invasive cancers in all race groups, but especially white and black populations, and to increased incidence of situ cancer in these populations. Results suggest that higher SES status is related to a decrease in invasive cervical cancer, but an increase in in situ cervical cancer in recent years. These findings may explain the racial differences in cervical cancer incidence and help target intervention programs.


Subject(s)
Health Status Indicators , Social Class , Uterine Cervical Neoplasms/ethnology , Adolescent , Adult , Carcinoma in Situ/ethnology , Databases, Factual , Ethnicity , Female , Humans , Incidence , Logistic Models , Middle Aged , Risk Factors , SEER Program , United States/epidemiology
20.
South Med J ; 90(10): 986-92, 1997 Oct.
Article in English | MEDLINE | ID: mdl-9347808

ABSTRACT

BACKGROUND: A seven-county, predominantly black, rural-poor population in Alabama is targeted for a program aimed at improving access to state-of-the-art cancer care. This paper presents combined age-adjusted cancer incidence rates for predominantly black, rural counties in North Carolina and Georgia similar to the Alabama counties and compares these rates with Surveillance, Epidemiology, and End Results (SEER) incidence rates. METHODS: Cancer incidence data from 1990 to 1993 were obtained from the Georgia Center for Cancer Statistics for 10 rural counties with predominantly black populations. Likewise, cancer incidence data from 1990 to 1993 were obtained for seven rural-poor counties in North Carolina from the North Carolina Central Cancer Registry. SEER incidence rates from 1990 to 1992 were obtained for nine SEER sites. RESULTS: The overall cancer incidence rate from North Carolina and Georgia is lower by 22% than the SEER rate. Cancer incidence rates for cancers of the breast, colon/rectum, lung, and prostate were at least 15% lower than the SEER rates, while the invasive cervical cancer rate was 1.78 times higher than the SEER rate. CONCLUSION: Blacks comprise about 50% of the population in these counties. In contrast, the SEER population is predominantly white, and the black population is primarily urban. Estimates of the number of cancer cases in black, rural-poor populations based on SEER incidence rates is not reflective of the cancer experience in these populations.


Subject(s)
Black or African American , Neoplasms/epidemiology , Adult , Black or African American/statistics & numerical data , Aged , Aged, 80 and over , Alabama/epidemiology , Female , Georgia/epidemiology , Humans , Male , Middle Aged , North Carolina/epidemiology , Population Surveillance , Poverty , Rural Population , SEER Program
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