Daniel Sargent

Summary

Affiliation: Mayo Clinic
Country: USA

Publications

  1. ncbi request reprint General and statistical hierarchy of appropriate biologic endpoints
    Daniel Sargent
    Cancer Center Statistics, Mayo Clinic, Rochester, Minnesota 55905, USA
    Oncology (Williston Park) 20:5-9. 2006
  2. ncbi request reprint Molecular testing for lymph node metastases as a determinant of colon cancer recurrence: results from a retrospective multicenter study
    Daniel J Sargent
    Division of Biomedical Statistics and Informatics
    Clin Cancer Res 20:4361-9. 2014
  3. doi request reprint What constitutes reasonable evidence of efficacy and effectiveness to guide oncology treatment decisions?
    Daniel Sargent
    Mayo Clinic, Rochester, Minnesota 55905, USA
    Oncologist 15:19-23. 2010
  4. ncbi request reprint Clinical trial designs for predictive marker validation in cancer treatment trials
    Daniel J Sargent
    Mayo Clinic, Kahler 1A, 200 First St, SW, Rochester, MN 55905, USA
    J Clin Oncol 23:2020-7. 2005
  5. ncbi request reprint Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials
    Daniel J Sargent
    North Central Cancer Treatment Group, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
    J Clin Oncol 23:8664-70. 2005
  6. ncbi request reprint Current issues in oncology drug development, with a focus on Phase II trials
    Daniel J Sargent
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Biopharm Stat 19:556-62. 2009
  7. ncbi request reprint A flexible approach to time-varying coefficients in the Cox regression setting
    D J Sargent
    Mayo Clinic, Cancer Center Statistics, Rochester, MN 55905, USA
    Lifetime Data Anal 3:13-25. 1997
  8. pmc Pooled safety and efficacy analysis examining the effect of performance status on outcomes in nine first-line treatment trials using individual data from patients with metastatic colorectal cancer
    Daniel J Sargent
    Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA
    J Clin Oncol 27:1948-55. 2009
  9. pmc Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer
    Daniel J Sargent
    Division of Biomedical Statistics and Informatics, Department of Pathology, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 28:3219-26. 2010
  10. pmc Evidence for cure by adjuvant therapy in colon cancer: observations based on individual patient data from 20,898 patients on 18 randomized trials
    Daniel Sargent
    Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA
    J Clin Oncol 27:872-7. 2009

Detail Information

Publications103 found, 100 shown here

  1. ncbi request reprint General and statistical hierarchy of appropriate biologic endpoints
    Daniel Sargent
    Cancer Center Statistics, Mayo Clinic, Rochester, Minnesota 55905, USA
    Oncology (Williston Park) 20:5-9. 2006
    ....
  2. ncbi request reprint Molecular testing for lymph node metastases as a determinant of colon cancer recurrence: results from a retrospective multicenter study
    Daniel J Sargent
    Division of Biomedical Statistics and Informatics
    Clin Cancer Res 20:4361-9. 2014
    ..The aim of this retrospective multicenter study was to evaluate the clinical utility of guanylyl cyclase C (GCC) mRNA levels in lymph nodes on colon cancer recurrence...
  3. doi request reprint What constitutes reasonable evidence of efficacy and effectiveness to guide oncology treatment decisions?
    Daniel Sargent
    Mayo Clinic, Rochester, Minnesota 55905, USA
    Oncologist 15:19-23. 2010
    ..In the genomic age, in which targeted therapies with or without specific biomarkers are emerging in cancer care, new approaches are necessary to generate the evidence required for decision making...
  4. ncbi request reprint Clinical trial designs for predictive marker validation in cancer treatment trials
    Daniel J Sargent
    Mayo Clinic, Kahler 1A, 200 First St, SW, Rochester, MN 55905, USA
    J Clin Oncol 23:2020-7. 2005
    ..We discuss the advantages and disadvantages of the two trial designs and their appropriateness to specific clinical situations to assist investigators seeking to design rigorous, marker-based clinical trials...
  5. ncbi request reprint Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials
    Daniel J Sargent
    North Central Cancer Treatment Group, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
    J Clin Oncol 23:8664-70. 2005
    ..A shorter-term end point providing convincing evidence to allow treatment comparisons could significantly speed the translation of advances into practice...
  6. ncbi request reprint Current issues in oncology drug development, with a focus on Phase II trials
    Daniel J Sargent
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Biopharm Stat 19:556-62. 2009
    ....
  7. ncbi request reprint A flexible approach to time-varying coefficients in the Cox regression setting
    D J Sargent
    Mayo Clinic, Cancer Center Statistics, Rochester, MN 55905, USA
    Lifetime Data Anal 3:13-25. 1997
    ..We present our method in terms of a Bayesian hierarchical model. We fit the model to the data using Markov chain Monte Carlo methods. Finally, we illustrate the approach with several examples...
  8. pmc Pooled safety and efficacy analysis examining the effect of performance status on outcomes in nine first-line treatment trials using individual data from patients with metastatic colorectal cancer
    Daniel J Sargent
    Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA
    J Clin Oncol 27:1948-55. 2009
    ..Clinical trials typically enroll less than 10% of patients with a PS of 2 (PS2); thus, the benefit of systemic chemotherapy in PS2 patients is uncertain...
  9. pmc Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer
    Daniel J Sargent
    Division of Biomedical Statistics and Informatics, Department of Pathology, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 28:3219-26. 2010
    ..We examined MMR status as a predictor of adjuvant therapy benefit in patients with stages II and III colon cancer...
  10. pmc Evidence for cure by adjuvant therapy in colon cancer: observations based on individual patient data from 20,898 patients on 18 randomized trials
    Daniel Sargent
    Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA
    J Clin Oncol 27:872-7. 2009
    ..Limited data are available on the time course of treatment failures (recurrence and/or death), the nature and duration of adjuvant treatment benefit, and long-term recurrence rates in patients with resected stage II and III colon cancer...
  11. ncbi request reprint A flexible design for multiple armed screening trials
    D J Sargent
    Section of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905, USA
    Stat Med 20:1051-60. 2001
    ..The goal of this design is to mirror clinical practice, where a treatment's success probability is often only one of many considerations in determining a treatment recommendation for a particular patient...
  12. ncbi request reprint A three-outcome design for phase II clinical trials
    D J Sargent
    Section of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA
    Control Clin Trials 22:117-25. 2001
    ..We describe the theoretical properties of this design and illustrate it with several examples. We focus on the clinical implications of the three-outcome design. Control Clin Trials 2001;22:117-125..
  13. ncbi request reprint End points for colon cancer adjuvant trials: observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the ACCENT Group
    Daniel J Sargent
    Department of Health Sciences Research, North Central Cancer Treatment Group, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 25:4569-74. 2007
    ..We previously validated disease-free survival (DFS) after 3-year follow-up as an excellent predictor of 5-year OS results. Here we explore shorter term DFS and OS end points, as well as stage dependency...
  14. doi request reprint Evaluation of guanylyl cyclase C lymph node status for colon cancer staging and prognosis
    Daniel J Sargent
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA
    Ann Surg Oncol 18:3261-70. 2011
    ..We report a planned analysis performed on 241 patients...
  15. pmc Two or three year disease-free survival (DFS) as a primary end-point in stage III adjuvant colon cancer trials with fluoropyrimidines with or without oxaliplatin or irinotecan: data from 12,676 patients from MOSAIC, X-ACT, PETACC-3, C-06, C-07 and C89803
    D Sargent
    NCCTG, Mayo Clinic, Rochester, MN, USA
    Eur J Cancer 47:990-6. 2011
    ..The relationship between end-points in trials with oral fluoropyrimidines, oxaliplatin and irinotecan is unknown...
  16. pmc Validation of novel imaging methodologies for use as cancer clinical trial end-points
    D J Sargent
    Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA
    Eur J Cancer 45:290-9. 2009
    ..We also include a discussion of situations where flexibility may be required, relative to the ideal rigorous evaluation, to accommodate inevitable real-world feasibility constraints...
  17. ncbi request reprint Pooled analysis of fluorouracil-based adjuvant therapy for stage II and III colon cancer: who benefits and by how much?
    Sharlene Gill
    Mayo Clinic and Foundation, Rochester, MN 55905, USA
    J Clin Oncol 22:1797-806. 2004
    ....
  18. ncbi request reprint Pooled analysis of safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer
    Richard M Goldberg
    Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 24:4085-91. 2006
    ..This analysis compares the safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly (FOLFOX4) in patients age younger than and at least 70 years...
  19. pmc Benefits and adverse events in younger versus older patients receiving adjuvant chemotherapy for colon cancer: findings from the Adjuvant Colon Cancer Endpoints data set
    Joleen Hubbard
    Mayo Clinic, Rochester, MN, USA
    J Clin Oncol 30:2334-9. 2012
    ..We examined disease-free survival (DFS), overall survival (OS), recurrence-free interval (RFI), and grade 3+ adverse events (AEs) in younger patients in the 33,574 patient Adjuvant Colon Cancer Endpoints Group data set...
  20. ncbi request reprint Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment
    Axel Grothey
    Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 22:1209-14. 2004
    ..However, the importance of the availability of all three active cytotoxic agents, FU-LV, irinotecan, and oxaliplatin, on overall survival (OS) has not yet been evaluated...
  21. ncbi request reprint FOLFOX for stage II colon cancer? A commentary on the recent FDA approval of oxaliplatin for adjuvant therapy of stage III colon cancer
    Axel Grothey
    Mayo Clinic College of Medicine, Department of Medical Oncology, Rochester, MN, USA
    J Clin Oncol 23:3311-3. 2005
  22. ncbi request reprint A phase I study of radiation therapy and twice-weekly gemcitabine and cisplatin in patients with locally advanced pancreatic cancer
    James A Martenson
    Mayo Clinic, Rochester, MN 55905, USA
    Int J Radiat Oncol Biol Phys 55:1305-10. 2003
    ..Gemcitabine's radiosensitizing properties can theoretically be exploited by twice-weekly administration. This study assessed toxicity in patients with pancreatic cancer treated with radiation therapy, gemcitabine, and cisplatin...
  23. pmc Postoperative surveillance recommendations for early stage colon cancer based on results from the clinical outcomes of surgical therapy trial
    Vassiliki L Tsikitis
    Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 27:3671-6. 2009
    ..We hypothesized that stage I and IIA colon cancer patients would experience similar benefits...
  24. ncbi request reprint Mortality associated with daily bolus 5-fluorouracil/leucovorin administered in combination with either irinotecan or oxaliplatin: results from Intergroup Trial N9741
    Thierry Delaunoit
    Department of Oncology, Mayo Clinic, Rochester, Minnesota 55905, USA
    Cancer 101:2170-6. 2004
    ..The complications observed in these arms highlight the importance of aggressive and immediate supportive care in the management of digestive toxicity...
  25. ncbi request reprint Updated efficacy and toxicity analysis of irinotecan and oxaliplatin (IROX) : intergroup trial N9741 in first-line treatment of metastatic colorectal cancer
    Amanda C Ashley
    Division of Medical Oncology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota, USA
    Cancer 110:670-7. 2007
    ..Efficacy and toxicity of oxaliplatin (Eloxatin; Sanofi-Aventis, Paris, France) combined with irinotecan (IROX) were examined in 383 patients enrolled on the IROX arm of Intergroup Study N9741...
  26. doi request reprint Bevacizumab beyond first progression is associated with prolonged overall survival in metastatic colorectal cancer: results from a large observational cohort study (BRiTE)
    Axel Grothey
    Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 26:5326-34. 2008
    ..1 months was reported. The association between various pre- and post-treatment factors (including the use of bevacizumab beyond first progression [BBP]) and survival was examined...
  27. ncbi request reprint Acute diarrhea during adjuvant therapy for rectal cancer: a detailed analysis from a randomized intergroup trial
    Robert C Miller
    North Central Cancer Treatment Group, Coordinating Center, Rochester, MN, USA
    Int J Radiat Oncol Biol Phys 54:409-13. 2002
    ..Toxicity from a previously reported randomized clinical trial was analyzed to quantify the difference in this risk. Additionally, the persistence of diarrhea after RT was analyzed...
  28. ncbi request reprint Issues in clinical trial design for tumor marker studies
    Daniel Sargent
    Cancer Center Statistics, Mayo Clinic Cancer Center, Rochester, MN 55905, USA
    Semin Oncol 29:222-30. 2002
    ..This will be followed by explicit consideration of study design, specifically the trial randomization schema for both prognostic and predictive factor studies...
  29. ncbi request reprint Microsatellite instability accounts for tumor site-related differences in clinicopathologic variables and prognosis in human colon cancers
    Frank A Sinicrope
    Mayo Clinic and Mayo College of Medicine, Rochester, Minnesota 55905, USA
    Am J Gastroenterol 101:2818-25. 2006
    ..Given that 15-20% of sporadic colon cancers are MSI-H, we determined whether tumor site-specific differences in clinicopathological variables, biomarkers, and prognosis are due to inclusion of MSI-H cases...
  30. pmc Curative potential of multimodality therapy for locally recurrent rectal cancer
    Dieter Hahnloser
    Division of Colon and Rectal Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA
    Ann Surg 237:502-8. 2003
    ..To assess the results of multimodality therapy for patients with recurrent rectal cancer and to analyze factors predictive of curative resection and prognostic for overall survival...
  31. ncbi request reprint A pilot study of high-dose intraarterial cisplatin chemotherapy with concomitant accelerated radiotherapy for patients with previously untreated T4 and selected patients with T3N0-N3M0 squamous cell carcinoma of the upper aerodigestive tract
    Robert L Foote
    Division of Radiation Oncology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota, USA
    Cancer 103:559-68. 2005
    ....
  32. ncbi request reprint Clinical trial designs for prospective validation of biomarkers
    Sumithra J Mandrekar
    Division of Biostatistics, Mayo Clinic, Rochester, Minnesota, USA
    Am J Pharmacogenomics 5:317-25. 2005
    ..Additional research is clearly warranted to achieve the goal of 'predictive oncology'...
  33. pmc Phase III noninferiority trial comparing irinotecan with oxaliplatin, fluorouracil, and leucovorin in patients with advanced colorectal carcinoma previously treated with fluorouracil: N9841
    George P Kim
    Mayo Clinic Jacksonville, 4500 San Pablo Rd, Jacksonville, FL 32224, USA
    J Clin Oncol 27:2848-54. 2009
    ..Cross-over to the other treatment on disease progression was mandated...
  34. pmc Evaluation of the value of attribution in the interpretation of adverse event data: a North Central Cancer Treatment Group and American College of Surgeons Oncology Group investigation
    Shauna L Hillman
    Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 28:3002-7. 2010
    ..In March 1998, Common Toxicity Criteria (CTC) version 2.0 introduced the collection of attribution of adverse events (AEs) to study drug. We investigate whether attribution adds value to the interpretation of AE data...
  35. pmc Clinical trial designs for predictive biomarker validation: one size does not fit all
    Sumithra J Mandrekar
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Biopharm Stat 19:530-42. 2009
    ..The review and evaluation of these designs represents an essential step toward the goal of personalized medicine because we explicitly seek to explore and evaluate the methodology for the clinical validation of biomarker guided therapy...
  36. ncbi request reprint Surgeon volume does not predict outcomes in the setting of technical credentialing: results from a randomized trial in colon cancer
    David W Larson
    Division of Colon and Rectal Surgery, Mayo Clinic College of Medicine, Mayo Clinic Rochester, Rochester, Minnesota 55905, USA
    Ann Surg 248:746-50. 2008
    ..To test the hypothesis that surgeon volume would not predict short- and long-term outcomes when evaluated in the setting of technical credentialing...
  37. ncbi request reprint North Central Cancer Treatment Group--achievements and perspectives
    Axel Grothey
    Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905, USA
    Semin Oncol 35:530-44. 2008
    ....
  38. pmc Stool DNA and occult blood testing for screen detection of colorectal neoplasia
    David A Ahlquist
    Mayo Clinic, Rochester, Minnesota 55905, USA
    Ann Intern Med 149:441-50, W81. 2008
    ..Stool DNA testing is a new approach to colorectal cancer detection. Few data are available from the screening setting...
  39. pmc Obesity is an independent prognostic variable in colon cancer survivors
    Frank A Sinicrope
    Divisions of Oncology and Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
    Clin Cancer Res 16:1884-93. 2010
    ..Obesity is associated with an increased risk of colon cancer. However, the influence of body mass index (BMI) on the prognosis of colon cancer survivors and its relationship to gender remains unknown...
  40. pmc Proapoptotic Bad and Bid protein expression predict survival in stages II and III colon cancers
    Frank A Sinicrope
    Division of Oncology, Mayo Clinic, Guggenheim 10 11C, 200 1st Street Southwest, Rochester, MN 55905, USA
    Clin Cancer Res 14:4128-33. 2008
    ..We determined if expression of these proteins in colon cancers may account for differences in patient survival...
  41. pmc Comparison of error rates in single-arm versus randomized phase II cancer clinical trials
    Hui Tang
    Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA
    J Clin Oncol 28:1936-41. 2010
    ..Given a large enough patient pool, the randomized phase II designs provide a more accurate decision for screening agents before phase III testing...
  42. pmc Model-based phase I designs incorporating toxicity and efficacy for single and dual agent drug combinations: methods and challenges
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    Stat Med 29:1077-83. 2010
    ..We review and offer practical solutions to potentially overcome some of these challenges. The acceptance and integration of these designs in practice may be quicker and easier if they are developed in concert with a clinical paradigm...
  43. ncbi request reprint Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials
    Aminah Jatoi
    Mayo Clinic Rochester, Rochester, MN 55905, USA
    Int J Oncol 36:601-6. 2010
    ..Although age should not preclude trial entry, these adverse event rates suggest a need to develop more tolerable regimens for older patients with these malignancies...
  44. ncbi request reprint Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program
    Richard M Goldberg
    Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 20:4591-6. 2002
    ..We believe the methods described present opportunities for improving patient safety in clinical research...
  45. pmc Revised tumor and node categorization for rectal cancer based on surveillance, epidemiology, and end results and rectal pooled analysis outcomes
    Leonard L Gunderson
    Mayo Clinic Cancer Center Arizona, 13400 East Shea Blvd, Scottsdale, AZ 85259, USA
    J Clin Oncol 28:256-63. 2010
    ..The AJCC Hindgut Taskforce sought population-based validation that depth of invasion interacts with nodal status to affect survival...
  46. pmc Predictive biomarker validation in practice: lessons from real trials
    Sumithra J Mandrekar
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN 55905, USA
    Clin Trials 7:567-73. 2010
    ..Biomarker validation has therefore become a central topic of discussion in the field of medicine, primarily due to the changing landscape of therapies for treatment of a disease and these therapies purported mechanism(s) of action...
  47. pmc Revised TN categorization for colon cancer based on national survival outcomes data
    Leonard L Gunderson
    Mayo Clinic Cancer Center Scottsdale, Radiation Oncology, 13400 East Shea Blvd, Scottsdale, AZ 85259, USA
    J Clin Oncol 28:264-71. 2010
    ..The AJCC Hindgut Taskforce sought population-based validation that depth of invasion and nodal status interact to affect survival...
  48. pmc Genomic advances and their impact on clinical trial design
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    Genome Med 1:69. 2009
    ..Here, we highlight the impact of genomic advances on various aspects of clinical trial design...
  49. pmc Clinical predictors of severe cetuximab-induced rash: observations from 933 patients enrolled in north central cancer treatment group study N0147
    Aminah Jatoi
    Mayo Clinic, Rochester, MN 55905, USA
    Oncology 77:120-3. 2009
    ..The objective of this study was to identify clinical predictors of severe rash in the hope of utilizing such factors in the design of future rash palliative and prevention trials...
  50. pmc Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 27:4027-34. 2009
    ..We discuss and evaluate various clinical trial designs for the validation of biomarker-guided therapy...
  51. pmc Intraepithelial effector (CD3+)/regulatory (FoxP3+) T-cell ratio predicts a clinical outcome of human colon carcinoma
    Frank A Sinicrope
    Miles and Shirley Fiterman Digestive Disease Center, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota 55905, USA
    Gastroenterology 137:1270-9. 2009
    ..We investigated whether the intratumoral densities of FoxP3(+) and effector CD3(+) lymphocytes are associated with prognosis of patients with colon cancer...
  52. pmc Model-based prediction of defective DNA mismatch repair using clinicopathological variables in sporadic colon cancer patients
    Frank Sinicrope
    Division of Oncology, Mayo Clinic, Rochester, Minnesota, USA
    Cancer 116:1691-8. 2010
    ..The authors developed models to predict MMR deficiency in sporadic colon cancer patients using routine clinical and pathological data...
  53. pmc Randomized phase II trials: time for a new era in clinical trial design
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Thorac Oncol 5:932-4. 2010
    ....
  54. pmc Clinical implications of microsatellite instability in sporadic colon cancers
    Frank A Sinicrope
    Division of Oncology, Mayo Clinic, Rochester, Minnesota, USA
    Curr Opin Oncol 21:369-73. 2009
    ..To review data demonstrating the prognostic and predictive impact of microsatellite instability (MSI) in human colon carcinomas...
  55. pmc Evaluation of the optimal number of lesions needed for tumor evaluation using the response evaluation criteria in solid tumors: a north central cancer treatment group investigation
    Shauna L Hillman
    Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
    J Clin Oncol 27:3205-10. 2009
    ..CONCLUSION Based on these trials, the assessment of more than two lesions did not alter the conclusions regarding a treatment's efficacy as judged by response rate or TTP...
  56. doi request reprint Meta-analysis for the evaluation of surrogate endpoints in cancer clinical trials
    Qian Shi
    Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA
    Int J Clin Oncol 14:102-11. 2009
    ..We also discuss several limitations of surrogate endpoints, including the critical issues that the extrapolation of the validity of a surrogate is always context-dependent and that such extrapolation should be exercised with caution...
  57. pmc Prognostic significance of defective mismatch repair and BRAF V600E in patients with colon cancer
    Amy J French
    Laboratory Medicine and Pathology, Mayo Clinic College of Medicine, 200 First Street Southwest, 920 Hilton Building, Rochester, MN 55905, USA
    Clin Cancer Res 14:3408-15. 2008
    ..Although the presence of dMMR seems to be a favorable prognostic marker, data suggest that these patients do not respond as well to adjuvant chemotherapy...
  58. doi request reprint Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107
    Axel Grothey
    Mayo Clinic College of Medicine, 200 First St SW, Rochester, MN 55905, USA
    J Clin Oncol 26:183-9. 2008
    ..As these two superior therapies have differing mechanisms of action, we explored whether the improved survival associated with the superior therapy was dependent on tumor response...
  59. ncbi request reprint Alterations in cell proliferation and apoptosis in colon cancers with microsatellite instability
    Frank A Sinicrope
    Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA
    Int J Cancer 120:1232-8. 2007
    ....
  60. ncbi request reprint A new graphic for quality adjusted life years (Q-TWiST) survival analysis: the Q-TWiST plot
    Jeff A Sloan
    Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA
    Qual Life Res 11:37-45. 2002
    ..We explore alternative options to customize the graphic representation for other data sets drawn from several NCCTG clinical trials...
  61. ncbi request reprint Phase III study of adjuvant chemotherapy and radiation therapy compared with chemotherapy alone in the surgical adjuvant treatment of colon cancer: results of intergroup protocol 0130
    James A Martenson
    North Central Cancer Treatment Group, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
    J Clin Oncol 22:3277-83. 2004
    ..Some patients with colon cancer have a high risk of local recurrence postoperatively. This trial was undertaken to determine whether radiation therapy added to an adjuvant chemotherapy regimen improves outcome in high-risk patients...
  62. ncbi request reprint Thymidylate synthase expression in colon carcinomas with microsatellite instability
    Frank A Sinicrope
    Mayo Clinic and Mayo College of Medicine, Rochester, Minnesota 55905, USA
    Clin Cancer Res 12:2738-44. 2006
    ..Given that thymidylate synthase (TS) is inhibited by 5-FU, we studied the relationship between MSI and TS expression, and the prognostic effect of these and other markers (i.e., p53 and 17p allelic imbalance)...
  63. ncbi request reprint Efficacy and quality-of-life data are related in a phase II trial of oral chemotherapy in previously untreated patients with metastatic colorectal carcinoma
    Timothy J Hobday
    Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA
    J Clin Oncol 20:4574-80. 2002
    ..To evaluate quality of life (QOL) and tumor response after administration of an oral chemotherapy regimen in patients with previously untreated metastatic colorectal cancer...
  64. ncbi request reprint Dealing with a deluge of data: an assessment of adverse event data on North Central Cancer Treatment Group trials
    Michelle R Mahoney
    Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA
    J Clin Oncol 23:9275-81. 2005
    ..We assessed the utility of the RAE data collected, relative to the volume...
  65. ncbi request reprint A prospective randomized trial comparing standard pancreatoduodenectomy with pancreatoduodenectomy with extended lymphadenectomy in resectable pancreatic head adenocarcinoma
    Michael B Farnell
    Mayo Clinic, Rochester, Minnesota 55905, USA
    Surgery 138:618-28; discussion 628-30. 2005
    ..To compare operative morbidity, mortality, quality of life, and survival after pancreatoduodenectomy (PD) versus pancreatoduodenectomy with extended lymphadenectomy (PD/ELND) in patients with resectable pancreatic cancer...
  66. ncbi request reprint Oxaliplatin, fluorouracil, and leucovorin for patients with unresectable liver-only metastases from colorectal cancer: a North Central Cancer Treatment Group phase II study
    Steven R Alberts
    Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA
    J Clin Oncol 23:9243-9. 2005
    ..The use of neoadjuvant chemotherapy to improve the likelihood of resection in disease that is not optimally resectable has not been as well studied...
  67. ncbi request reprint Immunohistochemistry versus microsatellite instability testing in phenotyping colorectal tumors
    Noralane M Lindor
    Department of Medical Genetics, Mayo Foundation, Rochester, MN 55905, USA
    J Clin Oncol 20:1043-8. 2002
    ..To compare microsatellite instability (MSI) testing with immunohistochemical (IHC) detection of hMLH1 and hMSH2 in colorectal cancer...
  68. ncbi request reprint Impact of T and N stage and treatment on survival and relapse in adjuvant rectal cancer: a pooled analysis
    Leonard L Gunderson
    Radiation Oncology Department, Mayo Clinic Cancer Center, Scottsdale, AZ 85259, USA
    J Clin Oncol 22:1785-96. 2004
    ..To determine survival and relapse rates by T and N stage and treatment method in five randomized phase III North American rectal adjuvant studies...
  69. ncbi request reprint Prognostic value of proliferation, apoptosis, defective DNA mismatch repair, and p53 overexpression in patients with resected Dukes' B2 or C colon cancer: a North Central Cancer Treatment Group Study
    Megan M Garrity
    Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA
    J Clin Oncol 22:1572-82. 2004
    ..This study investigated the prognostic significance of TUNEL, bcl-2, p53, proliferation marker Ki-67 and DNA mismatch repair (MMR) status in patients with Dukes' stage B2 and C colorectal adenocarcinomas...
  70. ncbi request reprint Prognostic impact of microsatellite instability and DNA ploidy in human colon carcinoma patients
    Frank A Sinicrope
    Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA
    Gastroenterology 131:729-37. 2006
    ..Given that high-frequency MSI (MSI-H) and diploidy are correlated, we determined whether they are independent prognostic variables...
  71. ncbi request reprint An adaptive phase I design for identifying a biologically optimal dose for dual agent drug combinations
    Sumithra J Mandrekar
    Division of Biostatistics, Mayo Clinic, Rochester, MN 55905, USA
    Stat Med 26:2317-30. 2007
    ..The proposed approach allowing the incorporation of both the toxicity and efficacy of each agent into the identification of an optimal dosing region for a combination is novel and warrants further consideration...
  72. ncbi request reprint Women experience greater toxicity with fluorouracil-based chemotherapy for colorectal cancer
    Jeff A Sloan
    Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA
    J Clin Oncol 20:1491-8. 2002
    ..After these findings, an additional meta-analysis of the toxicity profiles on five NCCTG colorectal cancer treatment trials was undertaken...
  73. ncbi request reprint Impact of complete response to chemotherapy on overall survival in advanced colorectal cancer: results from Intergroup N9741
    Grace K Dy
    Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
    J Clin Oncol 25:3469-74. 2007
    ..To evaluate clinical characteristics and survival outcomes among patients with locally advanced or metastatic colorectal cancer who achieve a complete response (CR) to systemic treatment either alone or with multimodality approach...
  74. pmc Prognostic impact of bim, puma, and noxa expression in human colon carcinomas
    Frank A Sinicrope
    Division of Oncology, Mayo Clinic, Rochester, MN 55905, USA
    Clin Cancer Res 14:5810-8. 2008
    ..Expression of these proteins in colon cancer patients may account for differences in recurrence and survival rates...
  75. ncbi request reprint Adverse-event rates: journals versus databases
    Michelle R Mahoney
    Division of Biostatistics, Mayo Clinic, Rochester, MN 55905, USA
    Lancet 369:171-2. 2007
  76. ncbi request reprint Use of intraoperative electron beam radiotherapy in the management of retroperitoneal soft tissue sarcomas
    Ivy A Petersen
    Division of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA
    Int J Radiat Oncol Biol Phys 52:469-75. 2002
    ..To evaluate the disease control, survival results, and tolerance of intraoperative electron beam radiotherapy (IOERT) as a component of treatment for retroperitoneal soft tissue sarcomas...
  77. pmc Incorporation of biomarker assessment in novel clinical trial designs: personalizing brain tumor treatments
    Evanthia Galanis
    Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA
    Curr Oncol Rep 13:42-9. 2011
    ..In this article, we review the use and potential of several such designs in neurooncology trials in order to support the development of personalized treatment approaches for brain tumor patients...
  78. pmc Tumor status at 12 weeks predicts survival in advanced colorectal cancer: findings from NCCTG N9741
    James M Heun
    Mayo Clinic, Rochester, Minnesota 55905, USA
    Oncologist 16:859-67. 2011
    ....
  79. pmc Association between disease-free survival and overall survival when survival is prolonged after recurrence in patients receiving cytotoxic adjuvant therapy for colon cancer: simulations based on the 20,800 patient ACCENT data set
    Aimery de Gramont
    Hopital Saint Antoine, Group Hospitalier Pitie Salpetriere, Paris, France
    J Clin Oncol 28:460-5. 2010
    ..New therapies have extended survival after recurrence from 1 to approximately 2 years. We examined the possible impact of this improvement on the DFS/OS association...
  80. ncbi request reprint Substitution of oral fluoropyrimidines for infusional fluorouracil with radiotherapy: how much data do we need?
    Christopher H Crane
    J Clin Oncol 22:2978-81. 2004
  81. pmc Tumor microsatellite-instability status as a predictor of benefit from fluorouracil-based adjuvant chemotherapy for colon cancer
    Christine M Ribic
    Centre for Cancer Genetics, Samuel Lunenfeld Research Institute, Toronto
    N Engl J Med 349:247-57. 2003
    ..We investigated the usefulness of microsatellite-instability status as a predictor of the benefit of adjuvant chemotherapy with fluorouracil in stage II and stage III colon cancer...
  82. ncbi request reprint A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer
    Richard M Goldberg
    Division of Hematology Oncology, University of North Carolina at Chapel Hill, CB 7305, 3009 Old Clinic Building, Chapel Hill, NC 27599 7305, USA
    J Clin Oncol 22:23-30. 2004
    ..In this study, we compared the activity and toxicity of three different two-drug combinations in patients with metastatic colorectal cancer who had not been treated previously for advanced disease...
  83. ncbi request reprint Intraoperative radiotherapy for head and neck and skull base cancer
    A Daniel Pinheiro
    Department of Otorhinolaryngology, Mayo Clinic, Rochester, Minnesota 55905, USA
    Head Neck 25:217-25; discussion 225-6. 2003
    ..The purpose of this study was to evaluate the use of intraoperative electron beam radiotherapy (IORT) as an adjuvant modality in the treatment of advanced head and neck and skull base cancer...
  84. ncbi request reprint Investigation of the prognostic and predictive value of thymidylate synthase, p53, and Ki-67 in patients with locally advanced colon cancer
    Carmen J Allegra
    National Cancer Institute, Bethesda, MD, USA
    J Clin Oncol 20:1735-43. 2002
    ..To evaluate the value of thymidylate synthase (TS), Ki-67, and p53 as prognostic markers in patients with Dukes' B2 and C colon carcinoma...
  85. doi request reprint New lessons from "old" chemotherapy in colorectal cancer
    Axel Grothey
    J Clin Oncol 26:4532-4. 2008
  86. ncbi request reprint Impact of T and N substage on survival and disease relapse in adjuvant rectal cancer: a pooled analysis
    Leonard L Gunderson
    Department of Radiation Oncology, Mayo Clinic Scottsdale, Scottsdale, AZ 85259, USA
    Int J Radiat Oncol Biol Phys 54:386-96. 2002
    ..To determine the rates of survival and disease control by TNM and MAC stage in three randomized North American rectal adjuvant studies...
  87. ncbi request reprint New treatment options for colorectal cancer
    Charles Erlichman
    N Engl J Med 351:391-2. 2004
  88. ncbi request reprint Progression-free survival is a surrogate for survival in advanced colorectal cancer
    Marc Buyse
    International Drug Development Institute, Louvain la Neuve, Belgium
    J Clin Oncol 25:5218-24. 2007
    ..We investigated whether progression-free survival (PFS) could be considered a valid surrogate for OS in advanced colorectal cancer...
  89. ncbi request reprint Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial
    James Fleshman
    Department of Surgery, Washington University School of Medicine, MO, and Department of General and Colorectal Surgery, St Joseph Mercy Hospital, MI, USA
    Ann Surg 246:655-62; discussion 662-4. 2007
    ....
  90. ncbi request reprint Laparoscopically assisted vs open colectomy for colon cancer: a meta-analysis
    H Jacob Bonjer
    Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands
    Arch Surg 142:298-303. 2007
    ..To perform a meta-analysis of trials randomizing patients with colon cancer to laparoscopically assisted or open colectomy to enhance the power in determining whether laparoscopic colectomy for cancer is oncologically safe...
  91. ncbi request reprint Adjuvant therapy in the elderly: making the right decision
    Hyman B Muss
    University of Vermont and Vermont Cancer Center, Burlington, VT 05401, USA
    J Clin Oncol 25:1870-5. 2007
    ..In addition, we discuss the role of comorbidity and how it factors in treatment decisions. Finally, we discuss future research directions and funding for elders with cancer...
  92. ncbi request reprint Assessing the measure of a new drug: is survival the only thing that matters?
    Daniel J Sargent
    J Clin Oncol 26:1922-3. 2008
  93. ncbi request reprint Randomized clinical trial of high-dose levamisole combined with 5-fluorouracil and leucovorin as surgical adjuvant therapy for high-risk colon cancer
    MICHAEL J O'CONNELL
    Department of Medical Oncology, Allegheny General Hospital, Pittsburgh, PA, USA
    Clin Colorectal Cancer 6:133-9. 2006
    ..A clinical trial was designed to test the value of levamisole given at its maximum tolerated dose in combination with 5-FU-based chemotherapy...
  94. ncbi request reprint Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: a North American Intergroup Trial
    Richard M Goldberg
    Division of Hematology and Oncology, University of North Carolina at Chapel Hill, CB 7305, 3009 Old Clinic Bldg, Chapel Hill, NC 27514, USA
    J Clin Oncol 24:3347-53. 2006
    ..High rates of grade > or = 3 toxicity on IFL (resulting in some deaths) led us to reduce the starting doses of both irinotecan and FU by 20% (rIFL). This article compares rIFL with FOLFOX4...
  95. ncbi request reprint Is en-bloc resection of locally recurrent rectal carcinoma involving the urinary tract indicated?
    Luca Stocchi
    Department of Colorectal Surgery, A30, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195, USA
    Ann Surg Oncol 13:740-4. 2006
    ..This study investigated morbidity, mortality, and long-term survival after multimodality management of locally recurrent rectal carcinoma involving the urinary tract...
  96. ncbi request reprint Cost-effectiveness projections of oxaliplatin and infusional fluorouracil versus irinotecan and bolus fluorouracil in first-line therapy for metastatic colorectal carcinoma
    Bruce E Hillner
    Department of Internal Medicine and Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia 23298, USA
    Cancer 104:1871-84. 2005
    ..The trade-offs between costs and survival for these two regimens have not been explored...
  97. ncbi request reprint Novel endpoints in phase III clinical trials
    Daniel J Sargent
    Mayo Clinic, 200 First Street SW, Rochester, MN 55902, USA
    Clin Adv Hematol Oncol 3:21-3. 2005
  98. ncbi request reprint Isolated loss of PMS2 expression in colorectal cancers: frequency, patient age, and familial aggregation
    Sharlene Gill
    British Columbia Cancer Agency, Vancouver, British Columbia, Canada
    Clin Cancer Res 11:6466-71. 2005
    ..Rarely, there is selective loss of PMS2 expression. We sought to describe the frequency and clinical correlates of selective loss of expression of PMS2 with the MSI-H tumor phenotype...
  99. ncbi request reprint Adjuvant therapy for colon cancer--the pace quickens
    Carmen Allegra
    N Engl J Med 352:2746-8. 2005
  100. ncbi request reprint Associations between plasma insulin-like growth factor proteins and C-peptide and quality of life in patients with metastatic colorectal cancer
    Jeffrey A Meyerhardt
    Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts 02115, USA
    Cancer Epidemiol Biomarkers Prev 14:1402-10. 2005
    ..The insulin-like growth factor (IGF) family of proteins is associated with QOL in noncancer populations. We sought to study whether these proteins are associated with QOL in patients with colorectal cancer...