Affiliation: National Institutes of Health
- Primer: first do no harm--when is it appropriate to plan a cancer prevention clinical trial?Eva Szabo
Lung and Upper Aerodigestive Cancer Research Group, National Cancer Institute, Bethesda, MD 20892, USA
Nat Clin Pract Oncol 5:348-56. 2008..This Review identifies the issues that are critical for decision-making when clinical trials in human beings are being contemplated and provides a framework that can be applied in making these decisions...
- Phase II cancer prevention clinical trialsEva Szabo
Lung and Upper Aerodigestive Cancer Research Group, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
Semin Oncol 37:359-66. 2010..However, the goal of all such trials is to provide evidence of interference with the development of cancer and to identify safety signals that would limit the benefit from interventions...
- Assessing efficacy in early-phase cancer prevention clinical trials: the case of ki-67 in the lungEva Szabo
Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, NIH, Department of Health and Human Services, Bethesda, Maryland 20892, USA
Cancer Prev Res (Phila) 3:128-31. 2010..The critical issue of how these data can be used to further drug development is discussed...
- Selecting targets for cancer prevention: where do we go from here?Eva Szabo
Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, 6130 Executive Boulevard, Room 2132, Bethesda, Maryland 20892, USA
Nat Rev Cancer 6:867-74. 2006....
- Altered histology provides a positive clinical signal in the bronchial epitheliumEva Szabo
Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, NIH, DHHS, Bethesda, MD 20892, USA
Cancer Prev Res (Phila) 4:775-8. 2011..e., regression), which occurred in former, but not current, smokers with sputum atypia. This Perspective discusses the strength of the clinical signal provided by this observation and its implications for further drug development...
- Higher levels of the anti-inflammatory protein CC10 are associated with improvement in bronchial dysplasia and sputum cytometric assessment in individuals at high risk for lung cancerJiping Chen
Cancer Prevention Fellowship Program, Office of Preventive Oncology, Division of Cancer Prevention, National Cancer Institute, NIH, Bethesda, Maryland 20892, USA
Clin Cancer Res 14:1590-7. 2008..We investigated whether changes in CC10 expression correlate with regression of bronchial dysplasia and/or improvement in sputum abnormalities as measured by image cytometry...
- A phase I combination study of olaparib with cisplatin and gemcitabine in adults with solid tumorsArun Rajan
Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland 20892, USA
Clin Cancer Res 18:2344-51. 2012..To determine the safety and tolerability of olaparib with cisplatin and gemcitabine, establish the maximum tolerated dose (MTD), and evaluate the pharmacodynamic and pharmacokinetic profile of the combination...
- Criteria of evidence to move potential chemopreventive agents into late phase clinical trialsRonan J Kelly
Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA
Curr Drug Targets 12:1983-8. 2011..In this review we identify the issues that are critical to decision-making prior to embarking on late phase prevention clinical trials and provide a framework for making such decisions...
- 18F-fluorodeoxyglucose positron emission tomography in the management of patients with thymic epithelial tumorsAnish Thomas
Medical Oncology Branch, National Cancer Institute, Bethesda, Maryland 20892, USA
Clin Cancer Res 19:1487-93. 2013..The primary objective of this study was to assess the usefulness of early [(18)F]-FDG PET to monitor treatment efficacy and its correlation with Response Evaluation Criteria in Solid Tumors (RECIST) in patients with TETs...
- Phase II study of belinostat in patients with recurrent or refractory advanced thymic epithelial tumorsGiuseppe Giaccone
Medical Oncology Branch, National Cancer Institute, NIH, Bethesda, MD 20892, USA
J Clin Oncol 29:2052-9. 2011..Antitumor activity of histone deacetylase (HDAC) inhibitors in this disease has been documented, including one patient with thymoma treated with the pan-HDAC inhibitor belinostat...
- Lung cancer and chronic obstructive pulmonary disease: needs and opportunities for integrated researchAntonello Punturieri
Division of Lung Diseases, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Bethesda, MD 20892 7952, USA
J Natl Cancer Inst 101:554-9. 2009....
- Progress in chemoprevention drug development: the promise of molecular biomarkers for prevention of intraepithelial neoplasia and cancer--a plan to move forwardGary J Kelloff
National Cancer Institute, Bethesda, Maryland 20852, USA
Clin Cancer Res 12:3661-97. 2006....
- Characterization and management of cardiac involvement of thymic epithelial tumorsAnish Thomas
Medical Oncology Branch, National Cancer Institute, Bethesda, Maryland 20892, USA
J Thorac Oncol 8:246-9. 2013..The purpose of this study was to describe our single-institution experience of the clinical presentation, treatment, and follow-up of cardiac involvement in patients with TETs...
- Sustained response of carcinoma ex pleomorphic adenoma treated with trastuzumab and capecitabineElad Sharon
Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, USA
Head Neck Oncol 2:12. 2010..We report here a case of a 58-year old man with metastatic carcinoma ex pleomorphic adenoma who achieved a sustained long term response to combination therapy with trastuzumab and capecitabine...
- Chemoprevention of lung cancer: new directionsEva Szabo
Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, 6130 Executive Blvd, Room 2132, Bethesda, MD 20892, USA
Recent Results Cancer Res 163:172-81; discussion 264-6. 2003..Further understanding of lung cancer biology will be critical to the success of future clinical trials...
- The association between the anti-inflammatory protein CC10 and smoking status among participants in a chemoprevention trialJiping Chen
Cancer Prevention Fellowship Program, National Cancer Institute, 6130 Executive Boulevard, Room 2132, Bethesda, MD 20892, USA
Cancer Epidemiol Biomarkers Prev 16:577-83. 2007..These results show that sustained smoking cessation is associated with higher plasma CC10 levels, suggesting that at least some of the damage associated with tobacco smoke may be repaired by long-term smoking cessation...
- Workshop on imaging science development for cancer prevention and preemptionGary J Kelloff
NIH NCI DCTD, Cancer Imaging Program, Bethesda, MD, USA
Cancer Biomark 3:1-33. 2007..Imaging devices, alone or in combination with anticancer drugs, may also provide novel interventions to treat or prevent precancer...
- Randomized controlled trials of the efficacy of lung cancer screening by sputum cytology revisited: a combined mortality analysis from the Johns Hopkins Lung Project and the Memorial Sloan-Kettering Lung StudyV Paul Doria-Rose
Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA
Cancer 115:5007-17. 2009..However, these findings were based on incomplete follow-up, and each trial on its own was underpowered to detect a modest mortality benefit...
- Use of markers for the detection and treatment of lung cancerJason S Vourlekis
Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, 6130 Executive Blvd, Rm 2132, Bethesda, MD 20892, USA
Dis Markers 20:71-85. 2004..This review examines the current status of markers of lung cancer risk, early detection, and prognosis, and their applicability to current standards of clinical care...
- Effects of gefitinib (Iressa) on mammary cancers: preventive studies with varied dosages, combinations with vorozole or targretin, and biomarker changesRonald A Lubet
National Cancer Institute, Executive Plaza North, Suite 2110, 6130 Executive Boulevard, Bethesda, MD 20852, USA
Mol Cancer Ther 7:972-9. 2008..Finally, combining suboptimal doses of Iressa with suboptimal doses of vorozole (an aromatase inhibitor) or targretin (a retinoid X receptor agonist) yielded greater chemopreventive efficacy than any of these agents given alone...
- A phase I pharmacologic and pharmacogenetic trial of sequential 24-hour infusion of irinotecan followed by leucovorin and a 48-hour infusion of fluorouracil in adult patients with solid tumorsMaurice A Wright
Medical Oncology Clinical Research Unit, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA
Clin Cancer Res 11:4144-50. 2005..CONCLUSIONS: Doses (mg/m(2)) of CPT-11 140/24 hours, leucovorin 500/0.5 hours and 5-FU 3,120/48 hours were well tolerated...
- Pharmacokinetic and pharmacodynamic effects of oral eniluracil, fluorouracil and leucovorin given on a weekly scheduleXiao-Du Guo
National Cancer Institute-Navy Medical Oncology, Cancer Therapeutics Branch, Center for Cancer Research, National Naval Medical Center, Bethesda, MD 20889-5105, USA
Cancer Chemother Pharmacol 52:79-85. 2003....
- Enhanced growth inhibition by combination differentiation therapy with ligands of peroxisome proliferator-activated receptor-gamma and inhibitors of histone deacetylase in adenocarcinoma of the lungTsg-Hui Chang
Molecular Physiology and Biophysics Unit, National Institute of Neurologic Diseases and Stroke, Bethesda, Maryland 20892, USA
Clin Cancer Res 8:1206-12. 2002....
- MUC1 expression in lung cancerEva Szabo
Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
Methods Mol Med 74:251-8. 2003
- How should we move the field of chemopreventive agent development forward in a productive manner?Frank Louis Meyskens
Department of Internal Medicine Hematology Oncology and Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA 92868, USA
Recent Results Cancer Res 166:113-24. 2005..We examine the problems associated with testing chemoprevention agents in humans and offer a process and guidelines that may better inform the logical development of this relatively young clinical field...
- Prevention of mouse lung tumors by budesonide and its modulation of biomarkersMichael A Pereira
Department of Pathology, Medical College of Ohio, HEB, Room 200F, 3055 Arlington Avenue, Toledo, OH 43614 5806, USA
Carcinogenesis 23:1185-92. 2002..Thus, short-term treatment with budesonide modulated biological and molecular end-points in lung tumors that might be developed further as biomarkers for its clinical chemopreventive efficacy in the lung...
- Predicting success in cancer prevention trialsJason S Vourlekis
J Natl Cancer Inst 95:178-9. 2003
- A randomized phase IIb trial of pulmicort turbuhaler (budesonide) in people with dysplasia of the bronchial epitheliumStephen Lam
Department of Respiratory Medicine, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada
Clin Cancer Res 10:6502-11. 2004..Preclinical studies suggest that inhaled budesonide may be an effective chemopreventive agent for lung cancer. We conducted a phase IIb study to determine the effects of inhaled budesonide in smokers with bronchial dysplasia...
- Comparative bioavailability of sulindac in capsule and tablet formulationsJoel M Reid
Mayo Clinic, College of Medicine, 200 First Street SW, Rochester, MN 55905, USA
Cancer Epidemiol Biomarkers Prev 17:674-9. 2008..These data support the use of sulindac capsules, which can be readily prepared with matching placebos, in future blinded chemoprevention trials...
- Phase I and pharmacologic study of 17-(allylamino)-17-demethoxygeldanamycin in adult patients with solid tumorsJean L Grem
Nebraska Medical Center, Omaha, NE 68198 7680, USA
J Clin Oncol 23:1885-93. 2005..To determine the clinical toxicities of 17-(allylamino)-17-demethoxygeldanamycin (17-AAG) given as a 1-hour infusion daily for 5 days every 3 weeks...
- Diet and cancer: the disconnect between epidemiology and randomized clinical trialsFrank L Meyskens
Department of Medicine, Chao Family Comprehensive Cancer Center, Hematology Oncology, University of California, Irvine, Building 44, Route 81, 101 City Drive Cancer Center, Orange, California 92668, USA
Cancer Epidemiol Biomarkers Prev 14:1366-9. 2005..We need to be much more self-critical in the important and critical assessment of dietary compounds and their role in cancer prevention given the very high appeal for this approach both within the lay and scientific communities...
- A phase I study of myo-inositol for lung cancer chemopreventionStephen Lam
Department of Respiratory Medicine, British Columbia Cancer Agency, British Columbia, Canada
Cancer Epidemiol Biomarkers Prev 15:1526-31. 2006..A phase I, open-label, multiple dose, dose-escalation clinical study was conducted to assess the safety, tolerability, maximum tolerated dose, and potential chemopreventive effect of myo-inositol in smokers with bronchial dysplasia...
- Proliferative changes in chemoprevention trials: learning from secondary endpointsEva Szabo
J Natl Cancer Inst 99:1565-7. 2007
- Lung cancer chemoprevention: ACCP evidence-based clinical practice guidelines (2nd Edition)Jhanelle Gray
Division of Thoracic Oncology, H Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Dr, MRC 4W, Room 4046, Tampa, FL 33612, USA
Chest 132:56S-68S. 2007..Chemoprevention is the use of specific agents to reverse, suppress, or prevent the process of carcinogenesis. This article reviews the major agents that have been studied for chemoprevention...