Richard L Schilsky

Summary

Affiliation: University of Chicago
Country: USA

Publications

  1. doi request reprint Randomized controlled trials and comparative effectiveness research
    Olwen M Hahn
    The University of Chicago, Chicago, IL 60637 1470, USA
    J Clin Oncol 30:4194-201. 2012
  2. ncbi request reprint Eniluracil: an irreversible inhibitor of dihydropyrimidine dehydrogenase
    R L Schilsky
    Biological Sciences Division, University of Chicago Medical Center, 5841 S Maryland Avenue, MC 2115, Chicago, IL 60637, USA
    Expert Opin Investig Drugs 9:1635-49. 2000
  3. ncbi request reprint Dose-escalating study of capecitabine plus gemcitabine combination therapy in patients with advanced cancer
    Richard L Schilsky
    Department of Medicine, Section of Hematology Oncology, Cancer Research Center and Committee on Clinical Pharmacology, University of Chicago, Chicago, IL 60637, USA
    J Clin Oncol 20:582-7. 2002
  4. doi request reprint Personalized medicine in oncology: the future is now
    Richard L Schilsky
    Comprehensive Cancer Center, University of Chicago, 5841 South Maryland Avenue, MC 2115, Chicago, IL 60637, USA
    Nat Rev Drug Discov 9:363-6. 2010
  5. doi request reprint Accrual to cancer clinical trials in the era of molecular medicine
    Richard L Schilsky
    Section of Hematology Oncology and Comprehensive Cancer Center, University of Chicago, Chicago, IL 60637, USA
    Sci Transl Med 3:75cm9. 2011
  6. doi request reprint How not to treat cancer
    Richard L Schilsky
    Section of Hematology Oncology, University of Chicago, Chicago, IL, USA
    Lancet Oncol 9:504-5. 2008
  7. ncbi request reprint Pharmacology and clinical status of capecitabine
    R L Schilsky
    Biological Sciences Division, University of Chicago, Illinois, USA
    Oncology (Williston Park) 14:1297-306; discussion 1309-11. 2000
  8. ncbi request reprint Phase I clinical and pharmacological study of O6-benzylguanine followed by carmustine in patients with advanced cancer
    R L Schilsky
    Department of Medicine, Cancer Research Center and Committee on Clinical Pharmacology, University of Chicago, Illinois 60637, USA
    Clin Cancer Res 6:3025-31. 2000
  9. ncbi request reprint A multicenter phase II study of a five-day regimen of oral 5-fluorouracil plus eniluracil with or without leucovorin in patients with metastatic colorectal cancer
    R L Schilsky
    Biological Sciences Division, University of Chicago, Illinois 60637, USA
    Ann Oncol 11:415-20. 2000
  10. ncbi request reprint First-line treatment options for patients with metastatic colorectal cancer
    Richard L Schilsky
    Biological Sciences Division, University of Chicago, IL 60637, USA
    Nat Clin Pract Oncol 1:70-1. 2004

Research Grants

  1. CALGB STUDIES OF BREAST CANCER IN THE ELDERLY
    Richard Schilsky; Fiscal Year: 2004

Detail Information

Publications86

  1. doi request reprint Randomized controlled trials and comparative effectiveness research
    Olwen M Hahn
    The University of Chicago, Chicago, IL 60637 1470, USA
    J Clin Oncol 30:4194-201. 2012
    ..In this article, we review the role of RCTs in achieving the goals of CER, with particular emphasis on the role of publicly funded clinical trials...
  2. ncbi request reprint Eniluracil: an irreversible inhibitor of dihydropyrimidine dehydrogenase
    R L Schilsky
    Biological Sciences Division, University of Chicago Medical Center, 5841 S Maryland Avenue, MC 2115, Chicago, IL 60637, USA
    Expert Opin Investig Drugs 9:1635-49. 2000
    ..Eniluracil is a promising drug, which permits reliable and safe administration of oral 5-FU and has the potential to overcome 5-FU resistance mediated by overexpression of DPD...
  3. ncbi request reprint Dose-escalating study of capecitabine plus gemcitabine combination therapy in patients with advanced cancer
    Richard L Schilsky
    Department of Medicine, Section of Hematology Oncology, Cancer Research Center and Committee on Clinical Pharmacology, University of Chicago, Chicago, IL 60637, USA
    J Clin Oncol 20:582-7. 2002
    ..The goals of this phase I study were to determine the maximum-tolerated doses of capecitabine and gemcitabine in patients with advanced cancer and to describe the dose-limiting toxicities (DLT) and safety profile of this combination...
  4. doi request reprint Personalized medicine in oncology: the future is now
    Richard L Schilsky
    Comprehensive Cancer Center, University of Chicago, 5841 South Maryland Avenue, MC 2115, Chicago, IL 60637, USA
    Nat Rev Drug Discov 9:363-6. 2010
    ..The development and use of such agents in biomarker-defined populations enables a more personalized approach to cancer treatment than previously possible and has the potential to reduce the cost of cancer care...
  5. doi request reprint Accrual to cancer clinical trials in the era of molecular medicine
    Richard L Schilsky
    Section of Hematology Oncology and Comprehensive Cancer Center, University of Chicago, Chicago, IL 60637, USA
    Sci Transl Med 3:75cm9. 2011
    ..Explored in this Commentary are challenges of and potential solutions for the clinical testing of modern cancer therapies...
  6. doi request reprint How not to treat cancer
    Richard L Schilsky
    Section of Hematology Oncology, University of Chicago, Chicago, IL, USA
    Lancet Oncol 9:504-5. 2008
  7. ncbi request reprint Pharmacology and clinical status of capecitabine
    R L Schilsky
    Biological Sciences Division, University of Chicago, Illinois, USA
    Oncology (Williston Park) 14:1297-306; discussion 1309-11. 2000
    ..It has demonstrated efficacy in patients with advanced colorectal carcinoma, and studies are ongoing in other tumor types...
  8. ncbi request reprint Phase I clinical and pharmacological study of O6-benzylguanine followed by carmustine in patients with advanced cancer
    R L Schilsky
    Department of Medicine, Cancer Research Center and Committee on Clinical Pharmacology, University of Chicago, Illinois 60637, USA
    Clin Cancer Res 6:3025-31. 2000
    ..Bone marrow suppression, which may be cumulative, is the dose-limiting toxicity of the combination. Prolonged AGT suppression is likely attributable primarily to the effect of O6-benzyl-8-oxoguanine...
  9. ncbi request reprint A multicenter phase II study of a five-day regimen of oral 5-fluorouracil plus eniluracil with or without leucovorin in patients with metastatic colorectal cancer
    R L Schilsky
    Biological Sciences Division, University of Chicago, Illinois 60637, USA
    Ann Oncol 11:415-20. 2000
    ..To evaluate the safety and efficacy of a five-day regimen of oral 5-fluorouracil (5-FU) plus eniluracil (776C85) in patients with metastatic colorectal cancer (CRC)...
  10. ncbi request reprint First-line treatment options for patients with metastatic colorectal cancer
    Richard L Schilsky
    Biological Sciences Division, University of Chicago, IL 60637, USA
    Nat Clin Pract Oncol 1:70-1. 2004
  11. ncbi request reprint The cancer and leukemia group B pharmacology and experimental therapeutics committee: a historical perspective
    Mark J Ratain
    University of Chicago, Chicago, Illinois, USA
    Clin Cancer Res 12:3612s-6s. 2006
    ..It is anticipated that the results of the current studies will contribute significantly to the goal of individualizing cancer treatment...
  12. ncbi request reprint Pharmacokinetic modulation of oral etoposide by ketoconazole in patients with advanced cancer
    Wei Peng Yong
    Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, 5841 S Maryland Ave, MC2115, Chicago, IL 60637, USA
    Cancer Chemother Pharmacol 60:811-9. 2007
    ..Hence, this study was designed to evaluate if pharmacokinetic modulation of oral etoposide with ketoconazole could lead to a favorable alteration of etoposide pharmacokinetics, and to assess the feasibility and safety of this approach...
  13. ncbi request reprint Randomized, open-label, phase III study of a 28-day oral regimen of eniluracil plus fluorouracil versus intravenous fluorouracil plus leucovorin as first-line therapy in patients with metastatic/advanced colorectal cancer
    Richard L Schilsky
    Biological Sciences Division, University of Chicago, Chicago, IL 60637 1463, USA
    J Clin Oncol 20:1519-26. 2002
    ..To compare the efficacy and tolerability of eniluracil (EU)/fluorouracil (5-FU) with that of 5-FU/leucovorin (LV) as first-line therapy for patients with metastatic/advanced colorectal cancer...
  14. ncbi request reprint Are targeted therapies really targeted?
    Richard L Schilsky
    University of Chicago, IL, USA
    Clin Adv Hematol Oncol 1:722-3. 2003
  15. ncbi request reprint A phase II prospective multi-institutional trial of adjuvant active specific immunotherapy following curative resection of colorectal cancer hepatic metastases: cancer and leukemia group B study 89903
    Mitchell C Posner
    University of Chicago, 5841 S Maryland Avenue MC5031, Chicago 60637, IL, USA
    Ann Surg Oncol 15:158-64. 2008
    ....
  16. ncbi request reprint Phase I study of an oral formulation of ZD9331 administered daily for 28 days
    Michael B Sawyer
    Committe on Clinical Pharmacology, Department of Medicine, Cancer Research Center and Section of Hematology Oncology, University of Chicago, IL USA
    J Clin Oncol 21:1859-65. 2003
    ..To define the maximum-tolerated dose and dose-limiting toxicities (DLTs) of an oral formulation of ZD9331, a novel thymidylate synthase inhibitor that is not a substrate for folylpolyglutamate synthase...
  17. ncbi request reprint Inhibiting 5-fluorouracil breakdown: a broken down approach to 5-fluorouracil modulation
    Richard L Schilsky
    Biological Sciences Division, University of Chicago, IL, USA
    Clin Colorectal Cancer 2:51-2. 2002
  18. ncbi request reprint A phase I trial of pharmacologic modulation of irinotecan with cyclosporine and phenobarbital
    Federico Innocenti
    Department of Medicine, Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, IL 60637, USA
    Clin Pharmacol Ther 76:490-502. 2004
    ..Five partial responses were observed. Pharmacokinetic modulation of irinotecan with cyclosporine and phenobarbital has been demonstrated; further studies are necessary to evaluate whether this strategy improves the therapeutic index...
  19. pmc Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGB 80303)
    Hedy Lee Kindler
    University of Chicago Cancer Research Center, Chicago, IL 60637 1470, USA
    J Clin Oncol 28:3617-22. 2010
    ..These encouraging data led Cancer and Leukemia Group B (CALGB) to conduct a double-blind, placebo-controlled, randomized phase III trial of gemcitabine/bevacizumab versus gemcitabine/placebo in advanced pancreatic cancer patients...
  20. doi request reprint Molecular markers to individualize adjuvant therapy for colon cancer
    Tara Gangadhar
    Section of Hematology Oncology and Comprehensive Cancer Center, University of Chicago, 5841 South Maryland Avenue, Chicago, IL 60637, USA
    Nat Rev Clin Oncol 7:318-25. 2010
    ..Here, we review the data on the clinical development of molecular markers to individualize adjuvant therapy in colon cancer...
  21. pmc The Translational Research Working Group developmental pathway for anticancer agents (drugs or biologics)
    Richard L Schilsky
    University of Chicago, Chicago, Illinois, USA
    Clin Cancer Res 14:5685-91. 2008
    ..This article presents the Agents Developmental Pathway and discusses key challenges associated with the processes described...
  22. ncbi request reprint Phase I study to evaluate multiple regimens of intravenous 5-fluorouracil administered in combination with weekly gemcitabine in patients with advanced solid tumors: a potential broadly active regimen for advanced solid tumor malignancies
    S Mani
    University of Chicago Medical Center, Section of Hematology Oncology, Chicago, Illinois, USA
    Cancer 92:1567-76. 2001
    ..The purpose of this study was to determine the maximum tolerated dose and toxicity profile of gemcitabine given on a weekly schedule with continuous infusion 5-fluorouracil...
  23. pmc Circadian variation in plasma 5-fluorouracil concentrations during a 24 hour constant-rate infusion
    Gini F Fleming
    Section of Hematology Oncology, Department of Medicine, 5841 South Maryland Avenue, MC 2115, Chicago, IL, 60637, USA
    BMC Cancer 15:69. 2015
    ..It has been hypothesized that circadian variation in drug disposition is a contributing factor. We analyzed 5-FU concentrations during a 24-hour continuous 5-FU infusion...
  24. pmc Dose-finding and pharmacokinetic study to optimize the dosing of irinotecan according to the UGT1A1 genotype of patients with cancer
    Federico Innocenti
    Federico Innocenti, Richard L Schilsky, Jacqueline Ramírez, Linda Janisch, Samir Undevia, Larry K House, Soma Das, Kehua Wu, Michelle Turcich, Theodore Karrison, Michael L Maitland, Ravi Salgia, and Mark J Ratain, University of Chicago, Chicago and Robert Marsh, NorthShore University Health System, Evanston, IL
    J Clin Oncol 32:2328-34. 2014
    ..We aimed to identify the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of irinotecan in patients with advanced solid tumors stratified by the *1/*1, *1/*28, and *28/*28 genotypes...
  25. ncbi request reprint A phase I study of cantuzumab mertansine administered as a single intravenous infusion once weekly in patients with advanced solid tumors
    Paul R Helft
    University of Chicago, Chicago, Illinois, USA
    Clin Cancer Res 10:4363-8. 2004
    ..v. infusion without interruption...
  26. ncbi request reprint Estimation of the effect of food on the disposition of oral 5-fluorouracil in combination with eniluracil
    Dale R Shepard
    University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637, USA
    Cancer Chemother Pharmacol 49:398-402. 2002
    ..To determine the effect of food on the pharmacokinetics of 5-fluoruracil (5-FU) taken orally with eniluracil and to compare the performance of different pharmacokinetic analysis methods in the detection a potential food-drug interaction...
  27. doi request reprint Role of randomized phase III trials in an era of effective targeted therapies
    Manish R Sharma
    Section of Hematology Oncology, Department of Medicine, and Comprehensive Cancer Center, University of Chicago, 5841 South Maryland Avenue, MC 2115, Chicago, IL 60637 1470, USA
    Nat Rev Clin Oncol 9:208-14. 2012
    ..We explore the consequences (both good and bad) of foregoing randomized phase III trials and propose criteria that might be used to select drugs for consideration of such an approach...
  28. ncbi request reprint A phase I trial of escalating doses of trastuzumab combined with daily subcutaneous interleukin 2: report of cancer and leukemia group B 9661
    Gini F Fleming
    Department of Medicine, University of Chicago, Chicago, Illinois 60637, USA
    Clin Cancer Res 8:3718-27. 2002
    ..The purpose of this study was to determine the toxicity of escalating doses of trastuzumab when combined with a fixed dose regimen of interleukin (IL)-2...
  29. pmc Clinical trials in the era of personalized oncology
    Michael L Maitland
    Section of Hematology Oncology, Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, IL 60637, USA
    CA Cancer J Clin 61:365-81. 2011
    ....
  30. doi request reprint American Society of Clinical Oncology provisional clinical opinion: testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy
    Carmen J Allegra
    Division of Hematology Oncology, Department of Medicine, University of Florida Shands CancerCenter, Gainesville, FL, USA
    J Clin Oncol 27:2091-6. 2009
    ....
  31. pmc Optimizing collection of adverse event data in cancer clinical trials supporting supplemental indications
    Lee D Kaiser
    Genentech, South San Francisco, CA, USA
    J Clin Oncol 28:5046-53. 2010
    ..The main purpose of this analysis was to assess the amount of safety and concomitant medication data collected to determine a more optimal approach in the collection of these data when used in support of supplemental applications...
  32. ncbi request reprint Multicenter phase II study to evaluate a 28-day regimen of oral fluorouracil plus eniluracil in the treatment of patients with previously untreated metastatic colorectal cancer
    S Mani
    University of Chicago Cancer Research Center, Chicago, IL, USA
    J Clin Oncol 18:2894-901. 2000
    ..To determine the efficacy of fluorouracil (5-FU) plus eniluracil when administered to patients with previously untreated metastatic colorectal cancer...
  33. pmc Evaluation of food effect on pharmacokinetics of vismodegib in advanced solid tumor patients
    Manish R Sharma
    Department of Medicine, University of Chicago, Chicago, Illinois 60637, USA
    Clin Cancer Res 19:3059-67. 2013
    ..We conducted a pharmacokinetic study of vismodegib in patients with advanced solid tumors to explore the effects of food on drug exposure...
  34. pmc A genome-wide association study of overall survival in pancreatic cancer patients treated with gemcitabine in CALGB 80303
    Federico Innocenti
    Department of Medicine, Cancer and Leukemia Group B CALGB, University of Chicago, Chicago, Illinois, USA
    Clin Cancer Res 18:577-84. 2012
    ..We prospectively collected germline DNA and conducted a genome-wide association study (GWAS) using overall survival (OS) as the endpoint...
  35. ncbi request reprint Target practice: oncology drug development in the era of genomic medicine
    Richard L Schilsky
    Biological Sciences Department, University of Chicago, Chicago, IL 60637, USA
    Clin Trials 4:163-6; discussion 173-7. 2007
  36. doi request reprint The next phase of chemoprevention research
    Ezra E W Cohen
    Section of Hematology Oncology, Department of Medicine, University of Chicago MC2115, Chicago, IL 60637, USA
    Cancer Prev Res (Phila) 4:293-5. 2011
    ..Indeed, aspects of the phase 0 design lend themselves well to chemoprevention research, suggesting that this approach will become more common in the near future...
  37. ncbi request reprint Cooperative group tissue banks as research resources: the cancer and leukemia group B tissue repositories
    Richard L Schilsky
    University of Chicago, Biological Sciences Division, Illinois 60637, USA
    Clin Cancer Res 8:943-8. 2002
  38. ncbi request reprint Prospective, randomized comparison of high-dose chemotherapy with stem-cell support versus intermediate-dose chemotherapy after surgery and adjuvant chemotherapy in women with high-risk primary breast cancer: a report of CALGB 9082, SWOG 9114, and NCIC MA
    William P Peters
    Cancer and Leukemia Group B, 230 W Monroe St, Suite 2050, Chicago, IL 60606, USA
    J Clin Oncol 23:2191-200. 2005
    ..The prognosis for women with primary breast cancer involving multiple axillary nodes remains poor. High-dose chemotherapy with stem-cell support produced promising results in initial clinical trials conducted at single institutions...
  39. ncbi request reprint Phase I and pharmacokinetic study of 24-hour infusion 5-fluorouracil and leucovorin in patients with organ dysfunction
    G F Fleming
    Department of Medicine, University of Chicago Medical Center, IL 60637 1470, USA
    Ann Oncol 14:1142-7. 2003
    ..Patients with hepatic or renal dysfunction are often treated with 5-fluorouracil (5-FU), but there are few data to confirm the safety of this practice...
  40. ncbi request reprint O6-benzylguanine in humans: metabolic, pharmacokinetic, and pharmacodynamic findings
    M E Dolan
    Section of Hematology Oncology, Cancer Research Center and Committee on Clinical Pharmacology, The University of Chicago, IL 60637, USA
    J Clin Oncol 16:1803-10. 1998
    ..The objective of this study was to determine the pharmacokinetics and metabolic fate of O6-Benzylguanine in humans and its effect on AGT activity in peripheral-blood mononuclear cells (PBMCs)...
  41. ncbi request reprint Phase II and pharmacodynamic studies of pyrazine diazohydroxide (NSC 361456) in patients with advanced renal and colorectal cancer
    N J Vogelzang
    Cancer Research Center, University of Chicago Pritzker School of Medicine, Illinois 60637 1470, USA
    Clin Cancer Res 4:929-34. 1998
    ..Curiously, an increase in alkaline phosphatase was associated with an increase in the platelet nadir (P = 0.02). If PZDH continues to be developed as an antineoplastic agent, further studies of these relationships are suggested...
  42. ncbi request reprint A phase I study of the oral combination of CI-994, a putative histone deacetylase inhibitor, and capecitabine
    S D Undevia
    Section of Hematology Oncology, Department of Medicine, University of Chicago, Chicago, IL, USA
    Ann Oncol 15:1705-11. 2004
    ..This study was conducted to determine the toxicity profile, maximum tolerated dose (MTD) and pharmacokinetics of the putative histone deacetylase inhibitor CI-994 in combination with capecitabine...
  43. ncbi request reprint Phase I study of ZD9331 on short daily intravenous bolus infusion for 5 days every 3 weeks with fixed dosing recommendations
    B C Goh
    Section of Hematology/Oncology, Cancer Research Center, University of Chicago, Chicago, IL, USA
    J Clin Oncol 19:1476-84. 2001
    ..CONCLUSION: The recommended dose for ZD9331 on this schedule is 25 mg/d. Neutropenia, thrombocytopenia, and rash were dose-limiting, and efficacy studies in colorectal cancer are indicated...
  44. ncbi request reprint Phase I clinical and pharmacologic study of eniluracil plus fluorouracil in patients with advanced cancer
    R L Schilsky
    University of Chicago Cancer Research Center and the University of Chicago Committee on Clinical Pharmacology, IL 60637, USA
    J Clin Oncol 16:1450-7. 1998
    ....
  45. ncbi request reprint Oral fluoropyrimidine treatment of colorectal cancer
    C Eng
    Section of Hematology Oncology, University of Chicago Medical Center, 5841 S Maryland Avenue, MC 2115, USA
    Clin Colorectal Cancer 1:95-103. 2001
    ..The goal of this article is to review the features of the main oral 5-FU prodrugs, which include capecitabine, uracil and tegafur (UFT)/leucovorin, S-1, and BOF-A2 and to describe their potential efficacy in treating colorectal cancer...
  46. doi request reprint First-in-human, phase I study of elisidepsin (PM02734) administered as a 30-min or as a 3-hour intravenous infusion every three weeks in patients with advanced solid tumors
    Mark J Ratain
    Department of Medicine, University of Chicago, MC2115, 5841 South Maryland Avenue, Chicago, IL, 60637, USA
    Invest New Drugs 33:901-10. 2015
    ..In conclusion, elisidepsin doses of 1.1 mg/m(2) (equivalent to a FD of 2.0 mg) and 11.0 mg FD are the dose levels achieved for further phase II trials testing the 30-min q3wk and 3-h q3wk schedules, respectively...
  47. pmc Development and use of integral assays in clinical trials
    Richard L Schilsky
    University of Chicago, Chicago, IL, USA
    Clin Cancer Res 18:1540-6. 2012
    ..In this article we elaborate on the steps required to get a biomarker assay ready for use as an integral component of a clinical trial and give an example of the use of an integral assay in a phase III trial...
  48. ncbi request reprint A concise history of the cancer and leukemia group B
    Richard L Schilsky
    Cancer and Leukemia Group B, Central Office of the Chairman and University of Chicago, Chicago, Illinois, USA
    Clin Cancer Res 12:3553s-5s. 2006
    ....
  49. doi request reprint Ethical, scientific, and regulatory perspectives regarding the use of placebos in cancer clinical trials
    Christopher K Daugherty
    University of Chicago, Pritzker School of Medicine, 5841 South Maryland Ave, MC 2115, Chicago, IL 60637 1463, USA
    J Clin Oncol 26:1371-8. 2008
    ..To examine the ethical, scientific, and regulatory issues in the design and conduct of placebo-controlled cancer clinical trials...
  50. ncbi request reprint Phase II trial of uracil/tegafur (UFT) plus leucovorin in patients with advanced biliary carcinoma
    S Mani
    Hematology Oncology, University of Chicago Pritzker School of Medicine, IL, USA
    Invest New Drugs 17:97-101. 1999
    ..UFT 300 mg/m2/day and leucovorin 90 mg/day could be administered safely to patients with advanced biliary cancer with good performance status; however, this combination and schedule of 28-day administration has no activity in this disease...
  51. doi request reprint Circadian variation in plasma 5-fluorouracil concentrations during a 24 hour constant-rate infusion
    Gini F Fleming
    Section of Hematology Oncology, Department of Medicine, 5841 South Maryland Avenue, MC 2115, Chicago, IL, 60637, USA
    BMC Cancer 15:1075. 2015
    ..It has been hypothesized that circadian variation in drug disposition is a contributing factor. We analyzed 5-FU concentrations during a 24-hour continuous 5-FU infusion...
  52. pmc Generalizability of trial results to elderly Medicare patients with advanced solid tumors (Alliance 70802)
    Elizabeth B Lamont
    Massachusetts General Hospital Cancer Center, Boston, MA EL Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA EL, yh, AM American Society of Clinical Oncology, Alexandria, VA RLS Department of Medicine, University of North Carolina, Chapel Hill, NC HM Department of Medicine, Duke University, Durham, NC HJC City of Hope, Duarte, CA AH Department of Medicine, University of Chicago, Chicago, IL HLK Department of Medicine, University of California San Francisco, San Francisco, CA AV Yale Cancer Center, New Haven, CT RL Department of Medicine, The University of Tennessee, Memphis, TN HN Department of Medicine, Ohio State University, Columbus, OH RMG Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA SJ
    J Natl Cancer Inst 107:336. 2015
    ....
  53. pmc Prevalence of off-label use and spending in 2010 among patent-protected chemotherapies in a population-based cohort of medical oncologists
    Rena M Conti
    Department of Pediatrics, Section of Hematology Oncology, University of Chicago, Chicago, IL, USA
    J Clin Oncol 31:1134-9. 2013
    ..The prevalence of off-label anticancer drug use is not well characterized. The extent of off-label use is a policy concern because the clinical benefits of such use to patients may not outweigh costs or adverse health outcomes...
  54. ncbi request reprint Tumor markers as clinical cancer tests--are we there yet?
    Richard L Schilsky
    University of Chicago, USA
    Semin Oncol 29:211-2. 2002
  55. ncbi request reprint Safety and efficacy of using a single agent or a phase II agent before instituting standard combination chemotherapy in previously untreated metastatic breast cancer patients: report of a randomized study--Cancer and Leukemia Group B 8642
    M E Costanza
    Department of Medicine, University of Massachusetts Medical School, Worcester, 01655, USA
    J Clin Oncol 17:1397-406. 1999
    ..We undertook a prospective, randomized phase III trial to evaluate the safety and efficacy of using a phase II agent before initiating therapy with standard combination chemotherapy in metastatic breast cancer patients...
  56. pmc Publicly funded clinical trials and the future of cancer care
    Richard L Schilsky
    Section of Hematology Oncology, The University of Chicago, Chicago, Illinois, USA
    Oncologist 18:232-8. 2013
    ..Thus, publicly funded trials are vital to developing and refining new cancer treatments and disseminating results to the medical community and the general public...
  57. doi request reprint GI cancers in 2010: New standards and a predictive biomarker for adjuvant therapy
    Manish R Sharma
    Section of Hematology Oncology, Department of Medicine, Comprehensive Cancer Center, University of Chicago, 5841 South Maryland Avenue, Chicago, IL 60637 1470, USA
    Nat Rev Clin Oncol 8:70-2. 2011
    ..There is now a validated predictive biomarker to guide use of adjuvant chemotherapy in patients with stage II colon cancer...
  58. ncbi request reprint Construct validity of medicare chemotherapy claims: the case of 5FU
    Elizabeth B Lamont
    Section of Hematology Oncology, University of Chicago, Illinois 60637, USA
    Med Care 40:201-11. 2002
    ..The elderly are under represented in clinical trials of cancer therapy and the elderly who are enrolled may be unrepresentative...
  59. ncbi request reprint The role of cooperative groups in cancer clinical trials
    Ann M Mauer
    Cancer and Leukemia Group B, Central Office of the Chairman, Chicago, Illinois, USA
    Cancer Treat Res 132:111-29. 2007
  60. ncbi request reprint Evaluation of cognition in cancer patients: special focus on the elderly
    Andrea K Bial
    The University of Chicago, Department of Medicine, Sections of Geriatrics and Hematology Oncology, 5841 S Maryland Avenue, MC 6098, Chicago, IL 60637, United States
    Crit Rev Oncol Hematol 60:242-55. 2006
    ..The risks of both cognitive dysfunction and most cancers increase with age. A literature review was undertaken to identify how cognitive issues in older patients were being assessed in the oncology literature...
  61. ncbi request reprint Phase I clinical and pharmacogenetic study of weekly TAS-103 in patients with advanced cancer
    R B Ewesuedo
    Committee on Clinical Pharmacology, Section of Pediatric Hematology-Oncology, Department of Pediatrics, University of Chicago, IL 60637, USA
    J Clin Oncol 19:2084-90. 2001
    ..Further studies to characterize the pharmacodynamics and pharmacogenetics of TAS-103 are warranted...
  62. ncbi request reprint A phase I study of antisense oligonucleotide GTI-2040 given by continuous intravenous infusion in patients with advanced solid tumors
    A A Desai
    Section of Hematology and Oncology, University of Chicago, Chicago, IL 60637, USA
    Ann Oncol 16:958-65. 2005
    ..Plasma pharmacokinetics of GTI-2040 and suppression of RNR expression in peripheral blood mononuclear cells were also studied...
  63. ncbi request reprint Inhibition of thymidylate synthase by the diastereoisomers of leucovorin
    P P Lee
    Section of Hematology Oncology, University of Chicago Pritzker School of Medicine, IL 60637
    Cancer Chemother Pharmacol 26:273-7. 1990
    ..In view of the high doses of leucovorin given clinically and the slow clearance of the unnatural isomer, our observations suggest that leucovorin may have important direct inhibitory effects on folate-requiring enzymes...
  64. pmc Adjuvant paclitaxel plus carboplatin compared with observation in stage IB non-small-cell lung cancer: CALGB 9633 with the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups
    Gary M Strauss
    Tufts Medical Center, Division of Medical Oncology, Tufts NEMC, Boston, MA 02111, USA
    J Clin Oncol 26:5043-51. 2008
    ..This report provides a mature analysis of Cancer and Leukemia Group B (CALGB) 9633, the only RCT designed specifically for stage IB NSCLC...
  65. ncbi request reprint Colorectal adenomas: a prototype for the use of surrogate end points in the development of cancer prevention drugs
    Gary J Kelloff
    Division of Cancer Treatment and Diagnostics, National Cancer Institute, Bethesda, Maryland 20892, USA
    Clin Cancer Res 10:3908-18. 2004
  66. ncbi request reprint Clinical cancer advances 2006: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology
    Robert F Ozols
    American Society of Clinical Oncology, Alexandria, VA 22314, USA
    J Clin Oncol 25:146-62. 2007
    ..This report demonstrates the essential role of clinical cancer research in finding new and better ways to treat, diagnose, and prevent a group of diseases that strike half of men and one-third of women in the United States...
  67. ncbi request reprint Processes to activate phase III clinical trials in a Cooperative Oncology Group: the Case of Cancer and Leukemia Group B
    David M Dilts
    Center for Management Research in Healthcare, Vanderbilt University, Nashville, TN, USA
    J Clin Oncol 24:4553-7. 2006
    ..We examine the processes and document the calendar time required to activate such studies opened by the Cancer and Leukemia Group B (CALGB)...
  68. ncbi request reprint Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803
    Jeffrey A Meyerhardt
    Division of Medical Oncology, Dana Farber Cancer Institute, Boston, MA 02115, USA
    J Clin Oncol 24:3535-41. 2006
    ..Regular physical activity reduces the risk of developing colon cancer, however, its influence on patients with established disease is unknown...
  69. ncbi request reprint Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia
    Marc L Citron
    ProHEALTH Care Associates, LLP, 2800 Marcus Ave, Lake Success, NY 11042, USA
    J Clin Oncol 21:1431-9. 2003
    ....
  70. ncbi request reprint Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy
    Frederick H Hausheer
    BioNumerik Pharmaceuticals, Inc, San Antonio, TX 78229, USA
    Semin Oncol 33:15-49. 2006
    ..The development of new and reliable methods for the assessment of CIPN as well as safe and effective treatments to prevent this complication of treatment would represent important medical advancements for cancer patients...
  71. ncbi request reprint Cetuximab in the treatment of colorectal cancer
    Richard M Goldberg
    Division of Hematology Oncology, University of North Carolina, Chapell Hill, NC, USA
    Clin Adv Hematol Oncol 2:1-10; quiz 11-12. 2004
  72. ncbi request reprint Cancer and Leukemia Group B 90206: A randomized phase III trial of interferon-alpha or interferon-alpha plus anti-vascular endothelial growth factor antibody (bevacizumab) in metastatic renal cell carcinoma
    Brian I Rini
    University of California at San Francisco, San Francisco, California 94115, USA
    Clin Cancer Res 10:2584-6. 2004
    ..A Phase III trial is now being conducted randomizing untreated, metastatic clear cell RCC patients to IFN-alpha alone or IFN-alpha plus Avastin...
  73. ncbi request reprint Clinical cancer advances 2007: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology
    Julie Gralow
    American Society of Clinical Oncology, 1900 Duke St, Suite 200, Alexandria, VA 22314, USA
    J Clin Oncol 26:313-25. 2008
    ..I hope you find it useful. Sincerely, Nancy E. Davidson, MD President American Society of Clinical Oncology...
  74. ncbi request reprint Silence is golden: gene hypermethylation and survival in large-cell lymphoma
    M Eileen Dolan
    J Natl Cancer Inst 94:6-7. 2002
  75. ncbi request reprint End points in cancer clinical trials and the drug approval process
    Richard L Schilsky
    Clin Cancer Res 8:935-8. 2002
    ..This editorial will review commonly used clinical trial end points and describe their potential advantages and disadvantages to expedite the drug approval process required in the United States...
  76. ncbi request reprint Improved outcomes from adding sequential Paclitaxel but not from escalating Doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer
    I Craig Henderson
    University of California at San Francisco, San, Francisco, CA 94143, USA
    J Clin Oncol 21:976-83. 2003
    ..This study was designed to determine whether increasing the dose of doxorubicin in or adding paclitaxel to a standard adjuvant chemotherapy regimen for breast cancer patients would prolong time to recurrence and survival...
  77. doi request reprint American Society of Clinical Oncology Statement on minimum standards and exemplary attributes of clinical trial sites
    Robin Zon
    Michiana Hematology Oncology, South Bend, IN, USA
    J Clin Oncol 26:2562-7. 2008
    ..To describe both minimum requirements for a site conducting quality clinical trials and attributes of an exemplary site...
  78. ncbi request reprint Criterion validity of Medicare chemotherapy claims in Cancer and Leukemia Group B breast and lung cancer trial participants
    Elizabeth B Lamont
    Department of Medicine and Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA 02114, USA
    J Natl Cancer Inst 97:1080-3. 2005
    ..Administrative Medicare claims data appear to be a valid source of information for chemotherapy administered to elderly Medicare beneficiaries with cancer...
  79. ncbi request reprint Biomarkers, surrogate end points, and the acceleration of drug development for cancer prevention and treatment: an update prologue
    Gary J Kelloff
    Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland 20892, USA
    Clin Cancer Res 10:3881-4. 2004
  80. pmc Measuring clinically significant chemotherapy-related toxicities using Medicare claims from Cancer and Leukemia Group B (CALGB) trial participants
    Elizabeth B Lamont
    Massachusetts General Hospital, Boston, Massachusetts, USA
    Med Care 46:303-8. 2008
    ..Because the elderly are underrepresented on clinical trials, physicians have few sources of information to estimate the risks (ie, toxicities) and benefits of chemotherapy administration to the elderly...
  81. ncbi request reprint Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants
    Ann H Partridge
    Dana Farber Cancer Institute, Boston, MA 02115, USA
    J Natl Cancer Inst 96:629-32. 2004
    ..Future studies should consider sharing trial results with patients and evaluating the process and its effect on both patients and clinicians...
  82. ncbi request reprint 3rd EORTC-NCI International Meeting on Cancer Molecular Markers: From Discovery to Clinical Practice
    Sheila E Taube
    Division of Cancer Treatment and Diagnosis, NCI, EPN 6035A, 6130 Executive Blvd, Rockville, MD 20892, USA
    Expert Rev Mol Diagn 4:431-3. 2004
  83. pmc Measuring disease-free survival and cancer relapse using Medicare claims from CALGB breast cancer trial participants (companion to 9344)
    Elizabeth B Lamont
    Massachusetts General Hospital Cancer Center and Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA, USA
    J Natl Cancer Inst 98:1335-8. 2006
    ....
  84. ncbi request reprint Hurry up and wait: is accelerated approval of new cancer drugs in the best interests of cancer patients?
    Richard L Schilsky
    J Clin Oncol 21:3718-20. 2003
  85. ncbi request reprint Progress and promise of FDG-PET imaging for cancer patient management and oncologic drug development
    Gary J Kelloff
    Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH, Bethesda, Maryland 20892, USA
    Clin Cancer Res 11:2785-808. 2005
    ....

Research Grants1

  1. CALGB STUDIES OF BREAST CANCER IN THE ELDERLY
    Richard Schilsky; Fiscal Year: 2004
    ..This well integrated project provides a multidisciplinary approach that will address many issues relevant to the treatment of elderly women with breast cancer. ..