bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prospective Randomized Trial of Interferon Alfa-2b and Interleukin-2 as Adjuvant Treatment for Resected Intermediate- and High-Risk Primary Melanoma Without Clinically Detectable Node Metastasis
Authors: Hauschild Axel , Weichenthal Michael , Balda Bernd-Rüdiger , Becker Jürgen C. , Wolff Helmut H. , Tilgen Wolfgang , Schulte Klaus-Werner , Ring Johannes , Schadendorf Dirk , Lischner Stephan , Burg Günter , Dummer Reinhard 
Published: July 2003

Purpose: Low-dose interferon alfa (IFNα) has been shown to have limited effects in the adjuvant treatment of patients with intermediate- and high-risk primary melanoma. We hypothesized that a combination regimen with low-dose interleukin-2 (IL-2) may improve survival prospects in these patients. Patients and Methods: After wide excision of primary melanoma without clinically detectable lymph node metastasis (pT3 to 4, cN0, M0), 225 patients from 10 participating centers were randomly assigned to receive either subcutaneous low-dose IFNα2b (3 million international units [MU]/m2/d, days 1 to 7, week 1; three times weekly, weeks 3 to 6, repeated all 6 weeks) plus IL-2 (9 MU/m2/d, days 1 to 4, week 2 of each cycle) for 48 weeks, or observation alone. The primary end point was prolongation of a relapse-free interval. Results: Of the 225 enrolled patients, 223 were found to be eligible. Median follow-up time was 79 months. All evaluated prognostic factors were well balanced between the two arms of the study. Relapses were noticed in 36 of 113 patients treated with IFNα2b plus IL-2 and in 34 of 110 patients with observation alone. Five-year disease-free survival of those who had routine surgery supplemented by IFNα2b and IL-2 treatment was 70.1% (95% confidence interval [CI], 61.3% to 78.9%), compared with 69.9% in those receiving surgery and observation alone (95% CI, 60.7% to 79.1%) in the intention-to-treat analysis. Evaluation of the overall survival did not show any difference between treated and untreated melanoma patients (P = .93). Conclusion: Adjuvant treatment of intermediate- and high-risk melanoma patients with low-dose IFNα2b and IL-2 is safe and well tolerated by most patients, but it does not improve disease-free or overall survival.
Semimonthly Versus Monthly Regimen of Fluorouracil and Leucovorin Administered for 24 or 36 Weeks as Adjuvant Therapy in Stage II and III Colon Cancer: Results of a Randomized Trial
Authors: André Thierry , Colin Philippe , Louvet Christophe , Gamelin Erik , Bouche Olivier , Achille Emmanuel , Colbert Nicolas , Boaziz Catherine , Piedbois Pascal , Tubiana-Mathieu Nicole , Boutan-Laroze Arnaud , Flesch Michel , Buyse Marc , de Gramont Aimery 
Published: July 2003

Purpose: This randomized, 2 × 2 factorial study compared a semimonthly (LVFU2) with a monthly (FULV) regimen of fluorouracil and leucovorin and 24 versus 36 weeks of each regimen as adjuvant treatment of patients with stage II (Dukes’ B2) and III (Dukes’ C) colon cancer. Patients and Methods: LVFU2 was administered semi-monthly for 2 consecutive days as dl- or l-leucovorin (200 or 100 mg/m2, respectively) as a 2-hour infusion, followed by a 400 mg/m2 FU bolus and 600 mg/m2 of FU as a 22-hour continuous infusion. FULV was administered monthly for 5 consecutive days as a 15-minute infusion of dl- or l-leucovorin, followed by 400 mg/m2 of FU as a 15-minute infusion. Results: A total of 905 patients were randomly assigned. The median follow-up was 41 months. Disease-free survival was similar between the LVFU2 and FULV groups (127 v 124 events; hazard ratio [HR] = 1.04; P = .74) and between 24 and 36 weeks of therapy (128 v 123 events; HR = 0.94; P = .63). Analysis of overall survival showed a slight excess in the number of deaths in LVFU2 compared with FULV (73 v 59), but this difference was not statistically significant (HR = 1.26; 95% confidence interval, 0.90 to 1.78; P = .18). The most commonly observed grade 3 to 4 toxicities were neutropenia, diarrhea, and mucositis. Toxicities were significantly lower in the LVFU2 group (all toxicities, P < .001). Conclusion: Our data confirm that LVFU2 is less toxic than FULV. At a median follow-up of 41 months, no statistically significant difference could be detected in disease-free or overall survival between the treatment groups or treatment durations.
AIDS-Related Kaposi’s Sarcoma: Evaluation of Potential New Prognostic Factors and Assessment of the AIDS Clinical Trial Group Staging System in the Haart Era—the Italian Cooperative Group on AIDS and Tumors and the Italian Cohort of Patients Naïve From Antiretrovirals
Authors: Nasti Guglielmo , Talamini Renato , Antinori Andrea , Martellotta Ferdinando , Jacchetti Gaia , Chiodo Francesco , Ballardini Giuseppe , Stoppini Laura , Di Perri Giovanni , Mena Maurizio , Tavio Marcello , Vaccher Emanuela , D’Arminio Monforte Antonella , Tirelli Umberto 
Published: July 2003

Purpose: To assess potential new prognostic factors and to validate the AIDS Clinical Trials Group (ACTG) for AIDS-related Kaposi’s sarcoma (AIDS-KS) staging system in the highly active antiretroviral therapy (HAART) era. Patients and Methods: We collected epidemiologic, clinical, staging, and survival data from 211 patients with AIDS-KS enrolled in two prospective Italian human immunodeficiency virus (HIV) cohort studies. We included in the analysis all patients with the diagnosis of KS made from January 1996, the time at which HAART became available in Italy. Results: In the univariate analysis, survival was not influenced by sex, age, level of HIV viremia at KS diagnosis, HAART at KS diagnosis (HAART-naïve v HAART-experienced), or type of HAART combination. Regarding ACTG classification, the 3-year survival rate was 85% for T0 patients and 69% for T1 patients (P = .007), 83% for S0 patients and 63% for S1 patients (P = .003), and 83% for I0 patients and 71% for I1 patients (P = .06). In the multivariate analysis, only the combination of poor tumor stage (T1) and poor systemic disease (S1) risk identified patients with unfavorable prognosis. The 3-year survival rate of patients with T1S1 was 53%, which was significantly lower compared with the 3-year survival rates of patients with T0S0, T1S0, and T0S1, which were 88%, 80%, and 81%, respectively (P = .0001). Conclusion: In the era of HAART, a refinement of the original ACTG staging system is needed. CD4 level does not seem to provide prognostic information. Two different risk categories are identified: a good risk (T0S0, T1S0, T0S1) and a poor risk (T1S1).
Intraperitoneal Radioactive Phosphorus (32P) Versus Observation After Negative Second-Look Laparotomy for Stage III Ovarian Carcinoma: A Randomized Trial of the Gynecologic Oncology Group
Authors: Varia Mahesh A. , Stehman Frederick B. , Bundy Brian N. , Benda Jo Ann , Clarke-Pearson Daniel L. , Alvarez Ronald D. , Long Harry J. 
Published: July 2003

Purpose: The objectives of this prospective randomized study of consolidation therapy were to evaluate recurrence-free survival (RFS), overall survival (OS), and the morbidity of intraperitoneal (IP) chromic phosphate suspension (32P) therapy in patients with stage III epithelial ovarian carcinoma who have no detectable evidence of disease at the second-look laparotomy (SLL) procedure after primary chemotherapy. Patients and Methods: In a multi-institution clinical cooperative trial, 202 eligible patients with a negative SLL were randomly selected to receive either 15 mCi IP 32P (n = 104) or no further therapy (NFT; n = 98). Results: With a median follow-up of 63 months in living patients, 68 patients in the IP 32P group (65%) and 63 patients in the NFT group (64%) have developed tumor recurrence. The relative risk of recurrence is 0.90 (IP 32P to NFT) (90% confidence interval [CI], 0.68 to 1.19). The 5-year RFS rate is 42% and 36% for the IP 32P and NFT groups, respectively; the difference is not statistically significant (log-rank test, P = .27). There was no statistically significant difference in OS (P = .19). The relative risk of death is 0.85 (IP 32P to NFT) (90% CI, 0.62 to 1.16). Sixteen patients (8%) experienced grade 3 or 4 adverse effects, with eight in each respective group. Conclusion: Intraperitoneal chromic phosphate did not decrease the risk of relapse or improve survival for patients with stage III epithelial ovarian cancer after a negative SLL. Despite complete pathologic remission at SLL after initial surgery and platinum-based chemotherapy, 61% of stage III ovarian cancer patients had tumor recurrence within 5 years of negative SLL. This indicates a need for more effective initial therapy and further studies of consolidation therapy.
Safety and Toxicity Analysis of Oxaliplatin Combined With Fluorouracil or as a Single Agent in Patients With Previously Treated Advanced Colorectal Cancer
Authors: Ramanathan Ramesh K. , Clark Jeffery W. , Kemeny Nancy E. , Lenz Heinz-Josef , Gococo Kim O. , Haller Daniel G. , Mitchell Edith P. , Kardinal Carl G. 
Published: July 2003

Purpose: Two consecutive compassionate use studies of oxaliplatin were conducted in the United States and Canada in more than 5,000 patients with locally advanced or metastatic colorectal carcinoma who had experienced treatment failure after at least one prior chemotherapy regimen. Patients and Methods: The main focus was safety. Patients were assigned to treatment with either single-agent oxaliplatin or oxaliplatin in combination with fluorouracil (FU) and with or without leucovorin (LV) in various regimens. Response data collection was not a trial objective, but time to treatment failure (TTF) was recorded in the first cohort (1,370 patients). Results: All treatment regimens were well tolerated, with an overall incidence of grade 3 or 4 hematologic toxicity of 23.2%, grade 3 or 4 treatment-related gastrointestinal toxicity of 26.4% (including diarrhea, vomiting, and mucositis), and grade 3 neurosensory toxicity 3.9%. Similar results were reported in the second cohort (3,806 patients), in which the eligibility criteria were much less restrictive. In the first cohort (in which 83% received prior irinotecan), median TTF was 14 weeks, and was similar for the five regimens combining oxaliplatin and FU with or without LV, but significantly shorter for the single-agent oxaliplatin arm. The overall dose-intensity of oxaliplatin was maintained at 85.5% (range, 80.6% to 94.3%) of that prescribed by protocol (average 36.7 mg/m2/wk). Conclusion: These data in a heavily pretreated patient population confirm that oxaliplatin is safe when used as a single agent or with a variety of FU-based regimens as salvage therapy in patients with advanced colorectal cancer.
Prognostic Significance of Visible Lesions on Transrectal Ultrasound in Impalpable Prostate Cancers: Implications for Staging
Authors: Augustin Herbert , Graefen Markus , Palisaar Jüri , Blonski Jakob , Erbersdobler Andreas , Daghofer Fedor , Huland Hartwig , Hammerer Peter G. 
Published: July 2003

Purpose: The current tumor-node metastasis (TNM) staging system classifies impalpable prostate cancers identified by needle biopsy and invisible by imaging as T1c and those visible as T2. Palpable cancers are classified as at least T2. However, most urologists consider impalpable prostate cancers T1c tumors, irrespective of findings on transrectal ultrasound (TRUS). The aim of this article is to provide a differentiated view of the significance of TRUS findings for staging purposes in impalpable prostate cancers. Patients and Methods: A consecutive series of 1,670 patients with impalpable tumors and palpable T2 cancers after radical prostatectomy were evaluated. Tumor characteristics and 5-year biochemical cure rates of cancers invisible and visible on TRUS were compared, as well as the rates of impalpable but visible and palpable T2 cancers. Results: Impalpable cancers invisible on TRUS presented significantly more favorable pathologic stages and lower cancer volumes than those visible on TRUS (P = .002, P = .010). In the latter, these clinical features were more favorable compared with T2 cancers (P < .001, P < .001). Progression-free probability of impalpable cancers invisible on TRUS was 86.8%; progression-free probability for impalpable cancers visible on TRUS was 85.4% (log-rank test P = .2060). The corresponding rate for T2 tumors was 73.9%, significantly lower when compared to those of visible and impalpable cancers (log-rank test P = .0001). Conclusion: Impalpable prostate cancers invisible on TRUS present more favorable cancer features than those that are visible on TRUS. However, these differences are not as pronounced as those between impalpable but visible cancers and palpable T2 tumors. Thus, based on our data, it seems inappropriate to classify impalpable prostate cancers visible on TRUS as T2 cancers.
Repeated Bone-Targeted Therapy for Hormone-Refractory Prostate Carcinoma: Randomized Phase II Trial With the New, High-Energy Radiopharmaceutical Rhenium-188 Hydroxyethylidenediphosphonate
Authors: Palmedo Holger , Manka-Waluch Agnieska , Albers Peter , Schmidt-Wolf Ingo G.H. , Reinhardt Michael , Ezziddin Samer , Joe Alexius , Roedel Roland , Fimmers Rolf , Knapp F.F. , Guhlke Stefan , Biersack Hans-Jürgen 
Published: July 2003

Purpose: We investigated the effect of repeated bone-targeted therapy with rhenium-188 hydroxyethylidenediphosphonate (HEDP) in patients with progressive, hormone-resistant prostate carcinoma and bone pain. The aim of this study was to determine the pain palliation and the antitumor effect of rhenium-188 HEDP treatments. Patients and Methods: Sixty-four patients were randomly assigned to one of two groups for radionuclide therapy with rhenium-188 HEDP; patients of group A received a single injection, patients of group B received two injections (interval, 8 weeks). After therapy, patients were followed-up by assessment of pain palliation and clinical outcome until death. Results: In both groups, toxicity was low, with moderate thrombopenia and leukopenia (maximum common toxicity criteria grade of 2). The effectiveness of rhenium-188 HEDP for pain palliation was better in the repeated treatment group (group B), with a response rate and time of response of 92% and 5.66 months, respectively (P = .006 and P = .001). In group B, 11 (39%) of 28 patients had a prostate-specific antigen decrease of more than 50% for at least 8 weeks, compared with two (7%) of 30 patients in the single-injection group (group A). The median times to progression of group A and group B were 2.3 months (range, 0 to 12.2 months) and 7.0 months (range, 0 to 24.1 months), respectively (P = .0013), and the median overall survival times were 7.0 months (range, 1.3 to 36.7 months) and 12.7 months (range, 4.1 to 32.2 months), respectively (P = .043). Conclusion: Compared with single-injection therapy, repeated bone-targeted therapy with rhenium-188 HEDP administered to patients with advanced progressive hormone-refractory prostate carcinoma enhanced pain palliation and improved progression-free and overall survival. Larger studies are justified to further evaluate the use of rhenium-188 HEDP.
Dermatologic and Nondermatologic Uses of Thalidomide
Authors: Nasca Maria R , Micali Giuseppe , Cheigh Nina H , West Lee E , West Dennis P 
Published: July 2003

OBJECTIVE: To review published data on thalidomide, with emphasis on current knowledge about mechanism of action, new and/or potential dermatologic and nondermatologic therapeutic applications, well-known and emerging adverse effects, and current indications for its safe use. DATA SOURCES: Review articles, in vitro research studies, references from retrieved articles, case reports, and clinical trials were identified from a computerized literature search using MEDLINE and OVID (1966—January 2003) and on the Cochrane Clinical Trials Register (January 2003). Information available from meetings' abstract books, Internet, or pharmaceutical companies was also considered. STUDY SELECTION AND DATA EXTRACTION: All articles identified as relevant, including those from non-English literature, were considered in an attempt to provide to the reader both the theoretical basis and practical guidelines for thalidomide pharmacotherapy. DATA SYNTHESIS: Thalidomide has hypnosedative, antiangiogenic, antiinflammatory, and immunomodulatory properties. Moreover, it has been shown to selectively inhibit the production of tumor necrosis factor-α and reduce the expression of various integrin receptors on the membrane of leukocytes and other cell types in a dose-dependent fashion. Controlled trials demonstrated the efficacy of thalidomide in a number of diseases, including erythema nodosum leprosum, lupus erythematosus, aphthosis, graft-versus-host disease, prurigo nodularis, and actinic prurigo. Single case reports or studies in small series have also suggested a possible role for thalidomide in numerous other dermatologic and nondermatologic disorders. Possibly severe and sometimes irreversible risks related to the clinical use of thalidomide include teratogenicity and neurotoxicity. CONCLUSIONS: Although teratogenicity and neurotoxicity are significant adverse effects requiring cautious use, thalidomide is an effective therapeutic modality in a variety of difficult-to-treat disorders and, providing careful selection of patients, should offer an acceptable risk-to-benefit ratio.
Outcomes with Changes in Prescribing of Glycoprotein IIb/IIIa Inhibitors in PCI
Authors: Dobesh Paul P , Lanfear Sara L , Abu-Shanab Joy R , Lakamp Jonathan E , Gowda Siddhesh , Haikal Maged Y 
Published: July 2003

Background Glycoprotein IIb/IIIa receptor antagonists have been shown to have an impact on the outcomes of death/myocardial infarction (MI) in patients undergoing percutaneous coronary intervention. At our institution, tirofiban has largely replaced abciximab in an attempt to decrease costs. Objective To assess the impact of this change on patient outcomes in the absence of head-to-head trials. Methods Medical records were reviewed and telephone follow-ups were conducted on patients receiving tirofiban (n = 83) at our facility between February and November 1999. Death/MI at 30 days and 6 months after infusion were recorded. Safety and length of stay (LOS) were also assessed. These data were compared using χ2 analysis with results obtained from a previous review of abciximab use (n = 83) collected between May 1997 and November 1998. Results There was no difference in the baseline incidence of (1) cardiovascular risk factors, (2) prior revascularization, (3) prior MI, (4) the number of vessels with atherosclerotic disease assessed by angiography, and (5) the number of vessels receiving procedures. Death/MI trended to be worse with tirofiban versus abciximab at our institution at 30 days (4.8% abciximab vs. 12% tirofiban; p = 0.163) and 6 months (6% abciximab vs. 18.1% tirofiban; p = 0.032). Bleeding and median LOS (3 d abciximab vs. 3 d tirofiban) were not different. Despite an increase in pharmacy cost, the use of abciximab provided these outcomes without an increase in total hospital cost. Conclusions The perceived economically driven change in medication selection from abciximab to tirofiban may not have been appropriate based on the negative trends seen in this review. To maintain optimal patient outcomes, this change should be reevaluated.
Use and Definition of Herbal Medicines Differ by Ethnicity
Authors: Bharucha Diana X , Morling Beth A , Niesenbaum Richard A 
Published: July 2003

Background While past studies have investigated uses of and attitudes toward herbal medicines by different ethnic groups, none have assessed how people may define them. Objective To determine definitions of and attitudes toward herbal medicines in different ethnic groups. Methods Surveys were distributed to 300 people of different professions and ethnic backgrounds in northern Pennsylvania. We quantified Latino/non-Latino group similarities and differences in the following variables: which of a list of 26 substances people categorized as herbal medicines, people's intent to use herbal medicines in the future, people's attitudes toward herbal medicine use, how people described their doctors' and friends' attitudes toward herbal medicines, and people's ability to use herbal medicines. These variables were based on the Theory of Planned Behavior. Results The Latino sample compared with the non-Latino white sample was more likely to categorize certain foods (e.g., garlic, carrots) as herbal medicines. Non-Latinos had more negative attitudes toward herbal medicines and were less likely to intend to use them in the future. Non-Latinos were more likely to base their attitudes on those of their health professionals, whereas Latinos were more likely to base their attitudes on their ability to buy and use herbal medicines. Conclusions Our results suggest that pharmacists have greater potential to educate and consult with the non-Latino population regarding the use of herbal medicines, and the Latino population may be at greater risk of adverse effects from herbal medicines. Our results also suggest that, because of the ways that different groups define herbal medicines, health professionals should clarify what their clients mean when they use this term.
Potentially Inappropriate Medication Use by Elderly Mexican Americans
Authors: Raji Mukaila A , Ostir Glenn V , Markides Kyriakos S , Espino David V , Goodwin James S 
Published: July 2003

BACKGROUND: Use of inappropriate medications by the elderly is a public health concern with potentially serious health consequences. Research indicates relatively high rates of inappropriate prescription drug usage for older whites and African Americans. However, rates for older Mexican Americans are unknown. OBJECTIVE: To examine the prevalence and predictors of inappropriate prescription medication use by older Mexican Americans. METHODS: A cross-sectional study of 3050 Mexican Americans aged ≥65 years living in the southwestern US was conducted. In-home interviews in 1993 and 1994 assessed prescription medication use. Descriptive statistics and logistic regression models were used to estimate prevalence and risk of inappropriate prescription drug use. RESULTS: Approximately 12% (n = 365) of the sample had used at least 1 of 32 potentially inappropriate prescription medications within 2 weeks of the baseline assessment. Four drugs, chlorpropamide, propoxyphene, amitriptyline, and dipyridamole, accounted for 54% of all inappropriate prescribing. Unmarried subjects, those with ≥1 chronic diseases, high depressive symptoms, frequent physician visits, and combined Medicaid and Medicare insurance were more likely to have used at least 1 of the 32 potentially inappropriate drugs. CONCLUSIONS: The prevalence of inappropriate medication use is lower in older Mexican Americans than in similar white and African American populations. More studies are needed on the pattern of inappropriate prescribing over time and on intervention programs to reduce potentially adverse health outcomes in older Mexican Americans most at risk.