471 results on '"Susan, Halabi"'
Search Results
452. Measures of social class based on education for use in health studies in developing countries
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M Deeb, Susan Halabi, and H Zurayk
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Male ,Epidemiology ,Applied psychology ,Developing country ,Social class ,Sensitivity and Specificity ,Representation (politics) ,Humans ,Medicine ,Family ,Lebanon ,Occupations ,Developing Countries ,Family health ,Measure (data warehouse) ,Jordan ,business.industry ,Public Health, Environmental and Occupational Health ,Models, Theoretical ,Health Surveys ,Test (assessment) ,Social Class ,Community health ,Educational Status ,Feasibility Studies ,Female ,business ,Research Article - Abstract
In this paper we consider the appropriateness of education, compared to occupation and income, as a measure of social class for use in health-related studies in developing societies in transition. Three evaluation criteria were used, namely, the feasibility of constructing the measure, its sensitivity in reflecting relevant social class life conditions, and its ability to produce a family-level measure of social class. We used two data sets from community health surveys in areas of Amman city, Jordan, and in Beirut city, Lebanon, to define a family-based average educational score. We then proceeded, using the Beirut data, to test the score's ability to discriminate social class effects on family health, compared to a more standard representation based on the educational level of the head of the family. It was found that the performance of the average educational score was often better than, but not consistently superior to, the educational level of the head of the family.
- Published
- 1987
453. Hospital visitors as controls
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Haroutune K. Armenian, Abla M. Sibai, Naila G. Lakkis, and Susan Halabi
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Gerontology ,medicine.medical_specialty ,Epidemiology ,business.industry ,Breast Neoplasms ,Coronary Disease ,Visitors to Patients ,Sampling Studies ,Random Allocation ,Family medicine ,Medicine ,Humans ,Lebanon ,business - Published
- 1988
454. Epidemiology of primary health problems in Beirut
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Haroutune K. Armenian, Susan Halabi, and Myriam Khlat
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Gerontology ,Male ,medicine.medical_specialty ,Peptic Ulcer ,Epidemiology ,Disease ,Risk Factors ,medicine ,Prevalence ,Humans ,Lebanon ,Neighbourhood (mathematics) ,Primary Health Care ,business.industry ,Public Health, Environmental and Occupational Health ,Case-control study ,Headache ,Odds ratio ,medicine.disease ,Confidence interval ,Back Pain ,Peptic ulcer ,Case-Control Studies ,Population Surveillance ,Female ,Headaches ,medicine.symptom ,Morbidity ,business ,Demography ,Research Article - Abstract
As a result of 12 years of civil war in Lebanon, it has been impossible to collect regular morbidity information at the primary level. This report is based on a case-control analysis of various health problems as identified from a population based health survey in Beirut in 1983-1984. Cases of headache, backpain and peptic ulcer, as identified from this survey of 2752 households, were matched for age, sex, and neighbourhood with controls from the same sample. Cases and controls were compared for the presence of various characteristics as collected in the household interview. Headaches were more prevalent in females and in the higher educational categories, and the odds ratio was 1.3 (95 per cent confidence interval 1.01-1.68) for the married compared to the non-married. In comparisons of backpain, the odds ratio for alcohol consumption was 2.40 (1.14-5.08), and for belonging to skilled and unskilled labour categories of occupation it was 2.33 (1.05-5.15) when the analysis was limited to the employed group only. Although the peptic ulcer cases were of lower educational background compared to their controls, no other findings were identified in this third case-control comparison. The methodological shortcomings of such studies and the various interpretations of the findings are presented in the discussion.
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- 1989
455. Overview of bladder cancer trials in the cancer and leukemia group B
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Susan Halabi, Raj Pruthi, Guido Dalbagni, Dean Bajorin, Eric J. Small, Martin Edelman, and George Phillips
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Oncology ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Cystectomy ,chemistry.chemical_compound ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Chemotherapy ,Carcinoma, Transitional Cell ,Clinical Trials as Topic ,Bladder cancer ,business.industry ,Cancer ,medicine.disease ,Gemcitabine ,Carboplatin ,Surgery ,Regimen ,Transitional cell carcinoma ,chemistry ,Urinary Bladder Neoplasms ,business ,medicine.drug - Abstract
The Cancer and Leukemia Group B (CALGB) Genitourinary Committee has developed a broad range of clinical trials across most stages of bladder cancer. Recurrence rates of superficial bladder cancer after transurethral resection range from 50-70%. Although adjuvant bacillus Calmette-Guerin reduces the risk of disease recurrence or progression, only 30% of patients have long-term disease-free survival. Because the development of novel secondline agents is needed, the CALGB is evaluating the utility of intravesicle gemcitabine as well as an oral proapoptotic agent (CP-461). In patients with locally advanced disease with an increased risk of disease recurrence after cystectomy, a randomized trial of conventional chemotherapy versus sequential dose-dense therapy is under development. The gemcitabine/cisplatin combination has become a commonly used regimen for the treatment of advanced transitional cell carcinoma (TCC). The CALGB is undertaking a Phase II study that incorporates a fixed dose rate gemcitabine infusion in this regimen, together with a selective epidermal growth factor receptor tyrosine kinase inhibitor, Iressa (Astra Zeneca, Wilmington, DE). In patients with renal insufficiency, a regimen of carboplatin, gemcitabine, and Iressa is planned. Novel agents, including arsenic trioxide and trastuzumab (Herceptin; Genentech, Inc., South San Francisco, CA), are being evaluated as secondline therapy in patients with advanced TCC who have disease progression after frontline therapy.
456. Barriers to cardiac transplantation in idiopathic dilated cardiomyopathy: The Washington, DC, dilated cardiomyopathy study
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Coughlin, S. S., Susan Halabi, and Metayer, C.
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Cardiomyopathy, Dilated ,Male ,Waiting Lists ,Patient Selection ,Black People ,Middle Aged ,Health Services Accessibility ,Insurance Coverage ,White People ,Survival Rate ,Socioeconomic Factors ,Risk Factors ,District of Columbia ,Insurance, Health, Reimbursement ,Heart Transplantation ,Humans ,Female ,Research Article ,Follow-Up Studies - Abstract
Although cardiac transplantation offers prolonged survival and improved quality of life to patients with end-stage heart failure, many patients with idiopathic dilated cardiomyopathy do not undergo this procedure. Possible barriers to cardiac transplantation were examined among 138 patients with idiopathic dilated cardiomyopathy from five hospitals in Washington, DC. Patients underwent follow-up for approximately 5 years. The patients or a close family member were interviewed at baseline about socioeconomic factors and medical history. The patients or their next-of-kin were recontacted at 1-year intervals to determine patients' vital status and to obtain information about cardiac transplantation. Overall, the cumulative survival at 12 and 60 months was 75.8% and 37.3%, respectively. Only 3.6% (5 of 138) of the patients underwent cardiac transplantation, and 19 (13.8%) patients had been placed on a waiting list for a heart transplant. Black race and nonmarried status were inversely associated with cardiac transplantation. Factors associated with not having been placed on a waiting list included older age, lower income, and lack of private health insurance. Black race was found to be significantly, but inversely associated with cardiac transplantation while older age was inversely associated with having been placed on a waiting list after adjusting for sex, race, education, and private insurance. These findings suggest that black patients with idiopathic dilated cardiomyopathy are less likely to undergo cardiac transplantation.
457. Prognostic significance of plasma vascular endothelial growth factor levels in patients with hormone-refractory prostate cancer treated on Cancer and Leukemia Group B 9480
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George, D. J., Susan Halabi, Shepard, T. F., Vogelzang, N. J., Hayes, D. F., Small, E. J., and Kantoff, P. W.
458. Vascular endothelial growth factor and basic fibroblast growth factor urine levels as predictors of outcome in hormone-refractory prostate cancer patients: A cancer and leukemia group B study
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Bok, R. A., Susan Halabi, Fei, D. T., Rodriquez, C. R., Hayes, D. F., Vogelzang, N. J., Kantoff, P., Shuman, M. A., and Small, E. J.
459. Use of Nonsteroidal Antiinflammatory Drugs and Distal Large Bowel Cancer in Whites and African Americans.
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Sangmi Kim, Christopher Martin, Joseph Galanko, John T. Woosley, Jane C. Schroeder, Temitope O. Keku, Jessie A. Satia, Susan Halabi, and Robert S. Sandler
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NONSTEROIDAL anti-inflammatory agents ,LARGE intestine cancer ,DISEASES in African Americans ,ETIOLOGY of cancer ,RECTAL cancer ,COLON cancer ,ADENOCARCINOMA ,CANCER chemoprevention ,CANCER risk factors - Abstract
Despite the belief that the etiology of and risk factors for rectal cancer might differ from those for colon cancer, relatively few studies have examined rectal cancer in relation to use of nonsteroidal antiinflammatory drugs (NSAIDs). The authors evaluated the association between NSAIDs and distal large bowel cancer in African Americans and whites, using data from a population-based case-control study of 1,057 incident cases of adenocarcinoma of the sigmoid colon, rectosigmoid junction, and rectum and 1,019 controls from North Carolina (2001–2006). NSAID use was inversely associated with distal large bowel cancer in whites (odds ratio (OR) = 0.60, 95% confidence interval (CI): 0.46, 0.79). The inverse association was evident for all types of NSAIDs but was slightly stronger with prescription NSAIDs, particularly selective cyclooxygenase 2 inhibitors (OR = 0.38, 95% CI: 0.25, 0.56). Compared with whites, a relatively weak inverse association was found in African Americans (OR = 0.87, 95% CI: 0.55, 1.40), although odds ratio heterogeneity by race could not be confirmed (P = 0.21). In addition, the strength of the association with NSAIDs varied by tumor location, suggesting more potent effects for rectal and rectosigmoid cancers than for sigmoid cancer. The chemopreventive potential of NSAIDs might differ by population and by tumor characteristics. [ABSTRACT FROM AUTHOR]
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- 2008
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460. Hormonal Risk Factors for Ovarian Cancer in Premenopausal and Postmenopausal Women.
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Patricia G. Moorman, Brian Calingaert, Rachel T. Palmieri, Edwin S. Iversen, Rex C. Bentley, Susan Halabi, Andrew Berchuck, and Joellen M. Schildkraut
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CANCER education ,CANCER in women ,CANCER patients ,CONTRACEPTIVES ,MEDICAL care - Abstract
Ovarian cancer is most frequently diagnosed in postmenopausal women; however, the strongest risk predictors, pregnancy and oral contraceptive use, occur in most women in their twenties and thirties. Relatively few studies have examined how reproductive risk factors vary between pre- and postmenopausal ovarian cancer. The authors used data from a population-based, case-control study of ovarian cancer (896 cases, 967 controls) conducted in North Carolina from 1999 to 2006. Odds ratios and 95% confidence intervals were calculated by using unconditional logistic regression. Inverse associations with ovarian cancer were observed with duration of oral contraceptive use, later age at last use, and more recent use among premenopausal women; no significant associations were found for postmenopausal women. Analyses limited to oral contraceptive users showed that duration was a more significant predictor of risk than was timing of use. Parity was inversely associated with premenopausal but not postmenopausal ovarian cancer. Later age at pregnancy was associated with reduced risk for both pre- and postmenopausal women. Analyses among parous women showed that pregnancy timing was a stronger risk predictor than number of pregnancies. Findings suggest that associations between ovarian cancer and reproductive characteristics vary by menopausal status. Additional research is needed to further elucidate risk factors for postmenopausal disease. [ABSTRACT FROM AUTHOR]
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- 2008
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461. Reply to J.A. Garcia et al.
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Halabi S, Guo S, Roy A, Rydzewska LE, Godolphin P, Hussain M, Tangen C, Thompson I, Xie W, Carducci MA, Morris MJ, Smith MR, Gravis G, Dearnaley DP, Verhagen PJ, Goto TJ, James ND, Buyse ME, Tierney JF, and Sweeney CJ
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- 2024
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462. Reply to L. Dirix, B. De Laere et al, and A. Sharp et al.
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Armstrong AJ, Halabi S, Luo J, Nanus DM, Scher HI, Antonarakis ES, and George DJ
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- Humans, Male, Prospective Studies, Prostatic Neoplasms, Castration-Resistant, Receptors, Androgen
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- 2019
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463. Role of Bone-Modifying Agents in Multiple Myeloma: American Society of Clinical Oncology Clinical Practice Guideline Update.
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Anderson K, Ismaila N, Flynn PJ, Halabi S, Jagannath S, Ogaily MS, Omel J, Raje N, Roodman GD, Yee GC, and Kyle RA
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- Female, Humans, Male, United States, Bone Density Conservation Agents pharmacology, Bone Density Conservation Agents therapeutic use, Multiple Myeloma drug therapy, Multiple Myeloma pathology
- Abstract
Purpose To update guideline recommendations on the role of bone-modifying agents in multiple myeloma. Methods An update panel conducted a targeted systematic literature review by searching PubMed and the Cochrane Library for randomized controlled trials, systematic reviews, meta-analyses, clinical practice guidelines, and observational studies. Results Thirty-five relevant studies were identified, and updated evidence supports the current recommendations. Recommendations For patients with active symptomatic multiple myeloma that requires systemic therapy with or without evidence of lytic destruction of bone or compression fracture of the spine from osteopenia on plain radiograph(s) or other imaging studies, intravenous administration of pamidronate 90 mg over at least 2 hours or zoledronic acid 4 mg over at least 15 minutes every 3 to 4 weeks is recommended. Denosumab has shown to be noninferior to zoledronic acid for the prevention of skeletal-related events and provides an alternative. Fewer adverse events related to renal toxicity have been noted with denosumab compared with zoledronic acid and may be preferred in this setting. The update panel recommends that clinicians consider reducing the initial pamidronate dose in patients with preexisting renal impairment. Zoledronic acid has not been studied in patients with severe renal impairment and is not recommended in this setting. The update panel suggests that bone-modifying treatment continue for up to 2 years. Less frequent dosing has been evaluated and should be considered in patients with responsive or stable disease. Continuous use is at the discretion of the treating physician and the risk of ongoing skeletal morbidity. Retreatment should be initiated at the time of disease relapse. The update panel discusses measures regarding osteonecrosis of the jaw. Additional information is available at www.asco.org/hematologic-malignancies-guidelines and www.asco.org/guidelineswiki .
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- 2018
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464. Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer.
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Xie W, Regan MM, Buyse M, Halabi S, Kantoff PW, Sartor O, Soule H, Clarke NW, Collette L, Dignam JJ, Fizazi K, Paruleker WR, Sandler HM, Sydes MR, Tombal B, Williams SG, and Sweeney CJ
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- Combined Modality Therapy, Disease-Free Survival, Endpoint Determination, Humans, Male, Neoplasm Metastasis, Randomized Controlled Trials as Topic, Risk Factors, Prostatic Neoplasms pathology, Prostatic Neoplasms therapy, Survival Analysis
- Abstract
Purpose Adjuvant therapy for intermediate-risk and high-risk localized prostate cancer decreases the number of deaths from this disease. Surrogates for overall survival (OS) could expedite the evaluation of new adjuvant therapies. Methods By June 2013, 102 completed or ongoing randomized trials were identified and individual patient data were collected from 28 trials with 28,905 patients. Disease-free survival (DFS) and metastasis-free survival (MFS) were determined for 21,140 patients from 24 trials and 12,712 patients from 19 trials, respectively. We evaluated the surrogacy of DFS and MFS for OS by using a two-stage meta-analytic validation model by determining the correlation of an intermediate clinical end point with OS and the correlation of treatment effects on both the intermediate clinical end point and OS. Results Trials enrolled patients from 1987 to 2011. After a median follow-up of 10 years, 45% of 21,140 men and 45% of 12,712 men experienced a DFS and MFS event, respectively. For DFS and MFS, 61% and 90% of the patients, respectively, were from radiation trials, and 63% and 66%, respectively, had high-risk disease. At the patient level, Kendall's τ correlation with OS was 0.85 and 0.91 for DFS and MFS, respectively. At the trial level, R
2 was 0.86 (95% CI, 0.78 to 0.90) and 0.83 (95% CI, 0.71 to 0.88) from weighted linear regression of 8-year OS rates versus 5-year DFS and MFS rates, respectively. Treatment effects-measured by log hazard ratios-for the surrogates and OS were well correlated ( R2 , 0.73 [95% CI, 0.53 to 0.82] for DFS and 0.92 [95% CI, 0.81 to 0.95] for MFS). Conclusion MFS is a strong surrogate for OS for localized prostate cancer that is associated with a significant risk of death from prostate cancer.- Published
- 2017
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465. Reply to B. Rini et al and S. Buti et al.
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Choueiri TK, Halabi S, Morris MJ, and George D
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- Anilides, Humans, Pyridines, Sunitinib, Carcinoma, Renal Cell, Kidney Neoplasms
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- 2017
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466. Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial.
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Choueiri TK, Halabi S, Sanford BL, Hahn O, Michaelson MD, Walsh MK, Feldman DR, Olencki T, Picus J, Small EJ, Dakhil S, George DJ, and Morris MJ
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- Adult, Aged, Aged, 80 and over, Carcinoma, Renal Cell pathology, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Kidney Neoplasms pathology, Male, Middle Aged, Molecular Targeted Therapy, Neoplasm Metastasis, Risk Factors, Sunitinib, Anilides administration & dosage, Antineoplastic Agents administration & dosage, Carcinoma, Renal Cell drug therapy, Indoles administration & dosage, Kidney Neoplasms drug therapy, Pyridines administration & dosage, Pyrroles administration & dosage
- Abstract
Purpose Cabozantinib is an oral potent inhibitor of vascular endothelial growth factor receptor 2, MET, and AXL and is a standard second-line therapy for metastatic renal cell carcinoma (mRCC). This randomized phase II multicenter trial evaluated cabozantinib compared with sunitinib as first-line therapy in patients with mRCC. Patients and Methods Eligible patients had untreated clear cell mRCC and Eastern Cooperative Oncology Group performance status of 0 to 2 and were intermediate or poor risk per International Metastatic Renal Cell Carcinoma Database Consortium criteria. Patients were randomly assigned at a one-to-one ratio to cabozantinib (60 mg once per day) or sunitinib (50 mg once per day; 4 weeks on, 2 weeks off). Progression-free survival (PFS) was the primary end point. Objective response rate (ORR), overall survival, and safety were secondary end points. Results From July 2013 to April 2015, 157 patients were randomly assigned (cabozantinib, n = 79; sunitinib, n = 78). Compared with sunitinib, cabozantinib treatment significantly increased median PFS (8.2 v 5.6 months) and was associated with a 34% reduction in rate of progression or death (adjusted hazard ratio, 0.66; 95% CI, 0.46 to 0.95; one-sided P = .012). ORR was 33% (95% CI, 23 to 44) for cabozantinib versus 12% (95% CI, 5.4 to 21) for sunitinib. All-causality grade 3 or 4 adverse events were 67% for cabozantinib and 68% for sunitinib and included diarrhea (cabozantinib, 10% v sunitinib, 11%), fatigue (6% v 15%), hypertension (28% v 22%), palmar-plantar erythrodysesthesia (8% v 4%), and hematologic adverse events (3% v 22%). Conclusion Cabozantinib demonstrated a significant clinical benefit in PFS and ORR over standard-of-care sunitinib as first-line therapy in patients with intermediate- or poor-risk mRCC.
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- 2017
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467. Meta-Analysis Evaluating the Impact of Site of Metastasis on Overall Survival in Men With Castration-Resistant Prostate Cancer.
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Halabi S, Kelly WK, Ma H, Zhou H, Solomon NC, Fizazi K, Tangen CM, Rosenthal M, Petrylak DP, Hussain M, Vogelzang NJ, Thompson IM, Chi KN, de Bono J, Armstrong AJ, Eisenberger MA, Fandi A, Li S, Araujo JC, Logothetis CJ, Quinn DI, Morris MJ, Higano CS, Tannock IF, and Small EJ
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- Aged, Bone Neoplasms mortality, Bone Neoplasms secondary, Clinical Trials, Phase III as Topic, Humans, Liver Neoplasms mortality, Liver Neoplasms secondary, Lung Neoplasms mortality, Lung Neoplasms secondary, Male, Middle Aged, Neoplasm Metastasis, Randomized Controlled Trials as Topic, Prostatic Neoplasms, Castration-Resistant mortality, Prostatic Neoplasms, Castration-Resistant pathology
- Abstract
Purpose: Reports have suggested that metastatic site is an important predictor of overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC), but these were based on a limited number of patients. We investigate the impact of site of metastases on OS of a substantial sample of men with mCRPC who received docetaxel chemotherapy in nine phase III trials., Patients and Methods: Individual patient data from 8,820 men with mCRPC enrolled onto nine phase III trials were combined. Site of metastases was categorized as lymph node (LN) only, bone with or without LN (with no visceral metastases), any lung metastases (but no liver), and any liver metastases., Results: Most patients had bone with or without LN metastases (72.8%), followed by visceral disease (20.8%) and LN-only disease (6.4%). Men with liver metastases had the worst median OS (13.5 months). Although men with lung metastases had better median OS (19.4 months) compared with men with liver metastases, they had significantly worse median survival duration than men with nonvisceral bone metastases (21.3 months). Men with LN-only disease had a median OS of 31.6 months. The pooled hazard ratios for death in men with lung metastases compared with men with bone with or without LN metastases and in men with any liver metastases compared with men with lung metastases were 1.14 (95% CI, 1.04 to 1.25; P = .007) and 1.52 (95% CI, 1.35 to 1.73; P < .0001), respectively., Conclusion: Specific sites of metastases in men with mCRPC are associated with differential OS, with successive increased lethality for lung and liver metastases compared with bone and nonvisceral involvement. These data may help in treatment decisions, the design of future clinical trials, and understanding the variation in biology of different sites of metastases in men with mCRPC., (© 2016 by American Society of Clinical Oncology.)
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- 2016
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468. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3.
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Scher HI, Morris MJ, Stadler WM, Higano C, Basch E, Fizazi K, Antonarakis ES, Beer TM, Carducci MA, Chi KN, Corn PG, de Bono JS, Dreicer R, George DJ, Heath EI, Hussain M, Kelly WK, Liu G, Logothetis C, Nanus D, Stein MN, Rathkopf DE, Slovin SF, Ryan CJ, Sartor O, Small EJ, Smith MR, Sternberg CN, Taplin ME, Wilding G, Nelson PS, Schwartz LH, Halabi S, Kantoff PW, and Armstrong AJ
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- Antineoplastic Agents adverse effects, Biomarkers, Tumor blood, Biomarkers, Tumor genetics, Biopsy, Consensus, Diagnostic Imaging, Disease Progression, Disease-Free Survival, Drug Resistance, Neoplasm, Genetic Predisposition to Disease, Humans, Kallikreins blood, Male, Molecular Diagnostic Techniques, Phenotype, Predictive Value of Tests, Prostate-Specific Antigen blood, Prostatic Neoplasms, Castration-Resistant blood, Prostatic Neoplasms, Castration-Resistant genetics, Prostatic Neoplasms, Castration-Resistant pathology, Risk Assessment, Risk Factors, Surveys and Questionnaires, Time Factors, Treatment Outcome, Antineoplastic Agents therapeutic use, Clinical Trials as Topic standards, Drug Approval, Prostatic Neoplasms, Castration-Resistant drug therapy, Research Design standards
- Abstract
Purpose: Evolving treatments, disease phenotypes, and biology, together with a changing drug development environment, have created the need to revise castration-resistant prostate cancer (CRPC) clinical trial recommendations to succeed those from prior Prostate Cancer Clinical Trials Working Groups., Methods: An international expert committee of prostate cancer clinical investigators (the Prostate Cancer Clinical Trials Working Group 3 [PCWG3]) was reconvened and expanded and met in 2012-2015 to formulate updated criteria on the basis of emerging trial data and validation studies of the Prostate Cancer Clinical Trials Working Group 2 recommendations., Results: PCWG3 recommends that baseline patient assessment include tumor histology, detailed records of prior systemic treatments and responses, and a detailed reporting of disease subtypes based on an anatomic pattern of metastatic spread. New recommendations for trial outcome measures include the time to event end point of symptomatic skeletal events, as well as time to first metastasis and time to progression for trials in the nonmetastatic CRPC state. PCWG3 introduces the concept of no longer clinically benefiting to underscore the distinction between first evidence of progression and the clinical need to terminate or change treatment, and the importance of documenting progression in existing lesions as distinct from the development of new lesions. Serial biologic profiling using tumor samples from biopsies, blood-based diagnostics, and/or imaging is also recommended to gain insight into mechanisms of resistance and to identify predictive biomarkers of sensitivity for use in prospective trials., Conclusion: PCWG3 moves drug development closer to unmet needs in clinical practice by focusing on disease manifestations most likely to affect prognosis adversely for therapeutics tested in both nonmetastatic and metastatic CRPC populations. Consultation with regulatory authorities is recommended if a trial is intended to seek support for drug approval., (© 2016 by American Society of Clinical Oncology.)
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- 2016
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469. Randomized controlled trial of early zoledronic acid in men with castration-sensitive prostate cancer and bone metastases: results of CALGB 90202 (alliance).
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Smith MR, Halabi S, Ryan CJ, Hussain A, Vogelzang N, Stadler W, Hauke RJ, Monk JP, Saylor P, Bhoopalam N, Saad F, Sanford B, Kelly WK, Morris M, and Small EJ
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- Aged, Androgen Antagonists therapeutic use, Bone Neoplasms diagnosis, Diagnostic Imaging, Disease Progression, Humans, Male, Orchiectomy, Treatment Outcome, Zoledronic Acid, Adenocarcinoma drug therapy, Adenocarcinoma secondary, Bone Density Conservation Agents therapeutic use, Bone Neoplasms drug therapy, Bone Neoplasms secondary, Diphosphonates therapeutic use, Imidazoles therapeutic use, Prostatic Neoplasms drug therapy, Prostatic Neoplasms pathology
- Abstract
Purpose: Zoledronic acid decreases the risk for skeletal-related events (SREs) in men with castration-resistant prostate cancer and bone metastases but its role earlier in the natural history of the disease is unknown. This phase III study evaluated the efficacy and safety of earlier treatment with zoledronic acid in men with castration-sensitive metastatic prostate cancer., Patients and Methods: Men with castration-sensitive prostate cancer and bone metastases whose androgen-deprivation therapy was initiated within 6 months of study entry were randomly assigned in a blinded 1:1 ratio to receive zoledronic acid (4 mg intravenously every 4 weeks) or a placebo. After their disease progressed to castration-resistant status, all patients received open-label treatment with zoledronic acid. The primary end point was time to first SRE, defined as radiation to bone, clinical fracture, spinal cord compression, surgery to bone, or death as a result of prostate cancer. Target accrual was 680 patients. Primary analysis was planned after 470 SREs. The study was discontinued prematurely (645 patients; 299 SREs) after the corporate supporter withdrew study drug supply., Results: Early zoledronic acid was not associated with increased time to first SRE. The median time to first SRE was 31.9 months in the zoledronic acid group (95% CI, 24.2 to 40.3) and 29.8 months in the placebo group (95% CI, 25.3 to 37.2; hazard ratio, 0.97; 95% CI, 0 to 1.17; one-sided stratified log-rank P = .39). Overall survival was similar between the groups (hazard ratio, 0.88; 95% CI, 0.70 to 1.12; P = .29). Rates of adverse events were similar between the groups., Conclusion: In men with castration-sensitive prostate cancer and bone metastases, early treatment with zoledronic acid was not associated with lower risk for SREs.
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- 2014
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470. Updated prognostic model for predicting overall survival in first-line chemotherapy for patients with metastatic castration-resistant prostate cancer.
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Halabi S, Lin CY, Kelly WK, Fizazi KS, Moul JW, Kaplan EB, Morris MJ, and Small EJ
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- Aged, Antibodies, Monoclonal, Humanized administration & dosage, Bevacizumab, Biomarkers, Tumor blood, Clinical Trials, Phase III as Topic, Docetaxel, Germany, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Nomograms, Predictive Value of Tests, Prednisone administration & dosage, Prognosis, Proportional Hazards Models, Prostate-Specific Antigen blood, Prostatic Neoplasms blood, Prostatic Neoplasms drug therapy, Random Allocation, Reproducibility of Results, Risk Assessment, Risk Factors, Taxoids administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Orchiectomy, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology
- Abstract
Purpose: Prognostic models for overall survival (OS) for patients with metastatic castration-resistant prostate cancer (mCRPC) are dated and do not reflect significant advances in treatment options available for these patients. This work developed and validated an updated prognostic model to predict OS in patients receiving first-line chemotherapy., Methods: Data from a phase III trial of 1,050 patients with mCRPC were used (Cancer and Leukemia Group B CALGB-90401 [Alliance]). The data were randomly split into training and testing sets. A separate phase III trial served as an independent validation set. Adaptive least absolute shrinkage and selection operator selected eight factors prognostic for OS. A predictive score was computed from the regression coefficients and used to classify patients into low- and high-risk groups. The model was assessed for its predictive accuracy using the time-dependent area under the curve (tAUC)., Results: The model included Eastern Cooperative Oncology Group performance status, disease site, lactate dehydrogenase, opioid analgesic use, albumin, hemoglobin, prostate-specific antigen, and alkaline phosphatase. Median OS values in the high- and low-risk groups, respectively, in the testing set were 17 and 30 months (hazard ratio [HR], 2.2; P < .001); in the validation set they were 14 and 26 months (HR, 2.9; P < .001). The tAUCs were 0.73 (95% CI, 0.70 to 0.73) and 0.76 (95% CI, 0.72 to 0.76) in the testing and validation sets, respectively., Conclusion: An updated prognostic model for OS in patients with mCRPC receiving first-line chemotherapy was developed and validated on an external set. This model can be used to predict OS, as well as to better select patients to participate in trials on the basis of their prognosis.
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- 2014
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471. Prostate-specific antigen changes as surrogate for overall survival in men with metastatic castration-resistant prostate cancer treated with second-line chemotherapy.
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Halabi S, Armstrong AJ, Sartor O, de Bono J, Kaplan E, Lin CY, Solomon NC, and Small EJ
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- Aged, Androgen Antagonists therapeutic use, Antineoplastic Agents therapeutic use, Antineoplastic Agents, Hormonal therapeutic use, Drug Resistance, Neoplasm, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Mitoxantrone therapeutic use, Neoplasm Metastasis, Prostatic Neoplasms, Castration-Resistant drug therapy, Taxoids therapeutic use, Prostate-Specific Antigen blood, Prostatic Neoplasms, Castration-Resistant blood, Prostatic Neoplasms, Castration-Resistant mortality
- Abstract
Purpose: Prostate-specific antigen (PSA) kinetics, and more specifically a ≥ 30% decline in PSA within 3 months after initiation of first-line chemotherapy with docetaxel, are associated with improvement in overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC). The objective of this analysis was to evaluate post-treatment PSA kinetics as surrogates for OS in patients receiving second-line chemotherapy., Patients and Methods: Data from a phase III trial of patients with mCRPC randomly assigned to cabazitaxel plus prednisone (C + P) or mitoxantrone plus prednisone were used. PSA decline (≥ 30% and ≥ 50%), velocity, and rise within the first 3 months of treatment were evaluated as surrogates for OS. The Prentice criteria, proportion of treatment explained (PTE), and meta-analytic approaches were used as measures of surrogacy., Results: The observed hazard ratio (HR) for death for patients treated with C + P was 0.66 (95% CI, 0.55 to 0.79; P < .001). Furthermore, a ≥ 30% decline in PSA was a statistically significant predictor of OS (HR for death, 0.52; 95% CI, 0.43 to 0.64; P < .001). Adjusting for treatment effect, the HR for a ≥ 30% PSA decline was 0.50 (95% CI, 0.40 to 0.62; P < .001), but treatment remained statistically significant, thus failing the third Prentice criterion. The PTE for a ≥ 30% decline in PSA was 0.34 (95% CI, 0.11 to 0.56), indicating a lack of surrogacy for OS. The values of R(2) were < 1, suggesting that PSA decline was not surrogate for OS., Conclusion: Surrogacy for any PSA-based end point could not be demonstrated in this analysis. Thus, the benefits of cabazitaxel in mediating a survival benefit are not fully captured by early PSA changes.
- Published
- 2013
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