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Items: 1 to 50 of 118

1.

Physician-Reported Experience and Understanding of Adverse Event Attribution in Cancer Clinical Trials.

Le-Rademacher JG, Storrick EM, Jatoi A, Mandrekar SJ.

Mayo Clin Proc Innov Qual Outcomes. 2019 May 27;3(2):176-182. doi: 10.1016/j.mayocpiqo.2019.01.002. eCollection 2019 Jun.

PMID:
31193907
2.

Evaluation of event-free survival as a robust end point in untreated acute myeloid leukemia (Alliance A151614).

Yin J, LaPlant B, Uy GL, Marcucci G, Blum W, Larson RA, Stone RM, Mandrekar SJ.

Blood Adv. 2019 Jun 11;3(11):1714-1721. doi: 10.1182/bloodadvances.2018026112.

3.

Improving attribution of adverse events in oncology clinical trials.

George GC, Barata PC, Campbell A, Chen A, Cortes JE, Hyman DM, Jones L, Karagiannis T, Klaar S, Le-Rademacher JG, LoRusso P, Mandrekar SJ, Merino DM, Minasian LM, Mitchell SA, Montez S, O'Connor DJ, Pettit S, Silk E, Sloan JA, Stewart M, Takimoto CH, Wong GY, Yap TA, Cleeland CS, Hong DS.

Cancer Treat Rev. 2019 Jun;76:33-40. doi: 10.1016/j.ctrv.2019.04.004. Epub 2019 Apr 25. Review.

PMID:
31108240
4.

Ibrutinib Regimens in Older Patients with Untreated CLL. Reply.

Woyach JA, Ruppert AS, Mandrekar SJ.

N Engl J Med. 2019 Apr 25;380(17):1680-1681. doi: 10.1056/NEJMc1901284. No abstract available.

PMID:
31018081
5.

Application of a sequential multiple assignment randomized trial (SMART) design in older patients with chronic lymphocytic leukemia.

Ruppert AS, Yin J, Davidian M, Tsiatis AA, Byrd JC, Woyach JA, Mandrekar SJ.

Ann Oncol. 2019 Apr 1;30(4):542-550. doi: 10.1093/annonc/mdz053.

PMID:
30799502
6.

Randomized trial of 10 days of decitabine ± bortezomib in untreated older patients with AML: CALGB 11002 (Alliance).

Roboz GJ, Mandrekar SJ, Desai P, Laumann K, Walker AR, Wang ES, Kolitz JE, Powell BL, Attar EC, Stock W, Bloomfield CD, Kohlschmidt J, Mrózek K, Hassane DC, Garraway L, Jané-Valbuena J, Baltay M, Tracy A, Marcucci G, Stone RM, Larson RA.

Blood Adv. 2018 Dec 26;2(24):3608-3617. doi: 10.1182/bloodadvances.2018023689.

7.

Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL.

Woyach JA, Ruppert AS, Heerema NA, Zhao W, Booth AM, Ding W, Bartlett NL, Brander DM, Barr PM, Rogers KA, Parikh SA, Coutre S, Hurria A, Brown JR, Lozanski G, Blachly JS, Ozer HG, Major-Elechi B, Fruth B, Nattam S, Larson RA, Erba H, Litzow M, Owen C, Kuzma C, Abramson JS, Little RF, Smith SE, Stone RM, Mandrekar SJ, Byrd JC.

N Engl J Med. 2018 Dec 27;379(26):2517-2528. doi: 10.1056/NEJMoa1812836. Epub 2018 Dec 1.

PMID:
30501481
8.

An adaptive multi-stage phase I dose-finding design incorporating continuous efficacy and toxicity data from multiple treatment cycles.

Du Y, Yin J, Sargent DJ, Mandrekar SJ.

J Biopharm Stat. 2019;29(2):271-286. doi: 10.1080/10543406.2018.1535497. Epub 2018 Nov 7.

PMID:
30403559
9.

Biomarker Clinical Trials in Lung Cancer: Design, Logistics, Challenges, and Practical Considerations.

Le-Rademacher J, Dahlberg S, Lee JJ, Adjei AA, Mandrekar SJ.

J Thorac Oncol. 2018 Nov;13(11):1625-1637. doi: 10.1016/j.jtho.2018.08.2019. Epub 2018 Sep 4. Review.

PMID:
30194034
10.

Application of multi-state models in cancer clinical trials.

Le-Rademacher JG, Peterson RA, Therneau TM, Sanford BL, Stone RM, Mandrekar SJ.

Clin Trials. 2018 Oct;15(5):489-498. doi: 10.1177/1740774518789098. Epub 2018 Jul 23.

PMID:
30035644
11.

Lenalidomide consolidation benefits patients with CLL receiving chemoimmunotherapy: results for CALGB 10404 (Alliance).

Byrd JC, Ruppert AS, Heerema NA, Halvorson AE, Hoke E, Smith MR, Godwin JE, Couban S, Fehniger TA, Thirman MJ, Tallman MS, Appelbaum FR, Stone RM, Robinson S, Chang JE, Mandrekar SJ, Larson RA.

Blood Adv. 2018 Jul 24;2(14):1705-1718. doi: 10.1182/bloodadvances.2017015396.

12.

Evaluation of End Points in Cancer Clinical Trials.

Yin J, Dahlberg SE, Mandrekar SJ.

J Thorac Oncol. 2018 Jun;13(6):745-747. doi: 10.1016/j.jtho.2018.04.004. Epub 2018 Apr 26. No abstract available.

13.

A phase 2 study incorporating sorafenib into the chemotherapy for older adults with FLT3-mutated acute myeloid leukemia: CALGB 11001.

Uy GL, Mandrekar SJ, Laumann K, Marcucci G, Zhao W, Levis MJ, Klepin HD, Baer MR, Powell BL, Westervelt P, DeAngelo DJ, Stock W, Sanford B, Blum WG, Bloomfield CD, Stone RM, Larson RA.

Blood Adv. 2017 Jan 24;1(5):331-340. doi: 10.1182/bloodadvances.2016003053.

14.

Definitions and statistical properties of master protocols for personalized medicine in oncology.

Renfro LA, Mandrekar SJ.

J Biopharm Stat. 2018;28(2):217-228. doi: 10.1080/10543406.2017.1372778. Epub 2017 Oct 9.

PMID:
28877008
15.

Repeated measures dose-finding design with time-trend detection in the presence of correlated toxicity data.

Yin J, Paoletti X, Sargent DJ, Mandrekar SJ.

Clin Trials. 2017 Dec;14(6):611-620. doi: 10.1177/1740774517723829. Epub 2017 Aug 2.

16.

Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation.

Stone RM, Mandrekar SJ, Sanford BL, Laumann K, Geyer S, Bloomfield CD, Thiede C, Prior TW, Döhner K, Marcucci G, Lo-Coco F, Klisovic RB, Wei A, Sierra J, Sanz MA, Brandwein JM, de Witte T, Niederwieser D, Appelbaum FR, Medeiros BC, Tallman MS, Krauter J, Schlenk RF, Ganser A, Serve H, Ehninger G, Amadori S, Larson RA, Döhner H.

N Engl J Med. 2017 Aug 3;377(5):454-464. doi: 10.1056/NEJMoa1614359. Epub 2017 Jun 23.

17.

Keyboard: A Novel Bayesian Toxicity Probability Interval Design for Phase I Clinical Trials.

Yan F, Mandrekar SJ, Yuan Y.

Clin Cancer Res. 2017 Aug 1;23(15):3994-4003. doi: 10.1158/1078-0432.CCR-17-0220. Epub 2017 May 25.

18.

Statistical controversies in clinical research: Value of adverse events relatedness to study treatment: analyses of data from randomized double-blind placebo-controlled clinical trials.

Le-Rademacher J, Hillman SL, Meyers J, Loprinzi CL, Limburg PJ, Mandrekar SJ.

Ann Oncol. 2017 Jun 1;28(6):1183-1190. doi: 10.1093/annonc/mdx043.

PMID:
28184420
19.

Daniel J. Sargent, 1970-2016.

Mandrekar SJ.

Clin Trials. 2016 Dec;13(6):677-679. No abstract available.

PMID:
27903947
20.

Time to progression ratio: promising new metric or just another metric?

An MW, Mandrekar SJ.

Ann Transl Med. 2016 Oct;4(Suppl 1):S43. No abstract available.

21.

A Randomized Phase IIb Trial of myo-Inositol in Smokers with Bronchial Dysplasia.

Lam S, Mandrekar SJ, Gesthalter Y, Allen Ziegler KL, Seisler DK, Midthun DE, Mao JT, Aubry MC, McWilliams A, Sin DD, Shaipanich T, Liu G, Johnson E, Bild A, Lenburg ME, Ionescu DN, Mayo J, Yi JE, Tazelaar H, Harmsen WS, Smith J, Spira AE, Beane J, Limburg PJ, Szabo E; Cancer Prevention Network.

Cancer Prev Res (Phila). 2016 Dec;9(12):906-914. Epub 2016 Sep 22.

22.

Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012.

Pang HH, Wang X, Stinchcombe TE, Wong ML, Cheng P, Ganti AK, Sargent DJ, Zhang Y, Hu C, Mandrekar SJ, Redman MW, Manola JB, Schilsky RL, Cohen HJ, Bradley JD, Adjei AA, Gandara D, Ramalingam SS, Vokes EE.

J Clin Oncol. 2016 Nov 20;34(33):3992-3999. doi: 10.1200/JCO.2016.67.7088. Epub 2016 Sep 30.

23.

A Bayesian dose-finding design incorporating toxicity data from multiple treatment cycles.

Yin J, Qin R, Ezzalfani M, Sargent DJ, Mandrekar SJ.

Stat Med. 2017 Jan 15;36(1):67-80. doi: 10.1002/sim.7134. Epub 2016 Sep 15.

24.

An Inherited Genetic Variant in CEP72 Promoter Predisposes to Vincristine-Induced Peripheral Neuropathy in Adults With Acute Lymphoblastic Leukemia.

Stock W, Diouf B, Crews KR, Pei D, Cheng C, Laumann K, Mandrekar SJ, Luger S, Advani A, Stone RM, Larson RA, Evans WE.

Clin Pharmacol Ther. 2017 Mar;101(3):391-395. doi: 10.1002/cpt.506. Epub 2016 Nov 16.

25.

A Nomogram to Predict Recurrence and Survival of High-Risk Patients Undergoing Sublobar Resection for Lung Cancer: An Analysis of a Multicenter Prospective Study (ACOSOG Z4032).

Kent MS, Mandrekar SJ, Landreneau R, Nichols F, Foster NR, DiPetrillo TA, Meyers B, Heron DE, Jones DR, Tan AD, Starnes S, Putnam JB Jr, Fernando HC.

Ann Thorac Surg. 2016 Jul;102(1):239-46. doi: 10.1016/j.athoracsur.2016.01.063. Epub 2016 Apr 19.

26.

Impact of Sublobar Resection on Pulmonary Function: Long-Term Results from American College of Surgeons Oncology Group Z4032 (Alliance).

Kent MS, Mandrekar SJ, Landreneau R, Nichols F, DiPetrillo TA, Meyers B, Heron DE, Jones DR, Tan AD, Starnes S, Putnam JB Jr, Fernando HC.

Ann Thorac Surg. 2016 Jul;102(1):230-8. doi: 10.1016/j.athoracsur.2016.01.069. Epub 2016 Apr 19.

27.

Precision oncology: A new era of cancer clinical trials.

Renfro LA, An MW, Mandrekar SJ.

Cancer Lett. 2017 Feb 28;387:121-126. doi: 10.1016/j.canlet.2016.03.015. Epub 2016 Mar 14. Review.

28.

Clinical trial designs incorporating predictive biomarkers.

Renfro LA, Mallick H, An MW, Sargent DJ, Mandrekar SJ.

Cancer Treat Rev. 2016 Feb;43:74-82. doi: 10.1016/j.ctrv.2015.12.008. Epub 2016 Jan 5. Review.

29.

ALCHEMIST Trials: A Golden Opportunity to Transform Outcomes in Early-Stage Non-Small Cell Lung Cancer.

Govindan R, Mandrekar SJ, Gerber DE, Oxnard GR, Dahlberg SE, Chaft J, Malik S, Mooney M, Abrams JS, Jänne PA, Gandara DR, Ramalingam SS, Vokes EE.

Clin Cancer Res. 2015 Dec 15;21(24):5439-44. doi: 10.1158/1078-0432.CCR-15-0354. Review.

30.

Clinical Utility of Metrics Based on Tumor Measurements in Phase II Trials to Predict Overall Survival Outcomes in Phase III Trials by Using Resampling Methods.

An MW, Han Y, Meyers JP, Bogaerts J, Sargent DJ, Mandrekar SJ.

J Clin Oncol. 2015 Dec 1;33(34):4048-57. doi: 10.1200/JCO.2015.60.8778. Epub 2015 Oct 26.

31.

Designing a definitive trial for adjuvant targeted therapy in genotype defined lung cancer: the ALCHEMIST trials.

Alden RS, Mandrekar SJ, Oxnard GR.

Chin Clin Oncol. 2015 Sep;4(3):37. doi: 10.3978/j.issn.2304-3865.2015.09.03. Review.

32.

Molecular and clinical implementations of ovarian cancer mouse avatar models.

Zayed AA, Mandrekar SJ, Haluska P.

Chin Clin Oncol. 2015 Sep;4(3):30. doi: 10.3978/j.issn.2304-3865.2015.04.01. Review.

33.

Evaluating Continuous Tumor Measurement-Based Metrics as Phase II Endpoints for Predicting Overall Survival.

An MW, Dong X, Meyers J, Han Y, Grothey A, Bogaerts J, Sargent DJ, Mandrekar SJ; Response Evaluation Criteria in Solid Tumors Steering Committee.

J Natl Cancer Inst. 2015 Aug 21;107(11). pii: djv239. doi: 10.1093/jnci/djv239. Print 2015 Nov.

34.

Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer.

Foster NR, Renfro LA, Schild SE, Redman MW, Wang XF, Dahlberg SE, Ding K, Bradbury PA, Ramalingam SS, Gandara DR, Shibata T, Saijo N, Vokes EE, Adjei AA, Mandrekar SJ.

J Thorac Oncol. 2015 Jul;10(7):1099-106. doi: 10.1097/JTO.0000000000000548.

35.

Improving Clinical Trial Efficiency: Thinking outside the Box.

Mandrekar SJ, Dahlberg SE, Simon R.

Am Soc Clin Oncol Educ Book. 2015:e141-7. doi: 10.14694/EdBook_AM.2015.35.e141. Review.

36.

The direct assignment option as a modular design component: an example for the setting of two predefined subgroups.

An MW, Lu X, Sargent DJ, Mandrekar SJ.

Comput Math Methods Med. 2015;2015:210817. doi: 10.1155/2015/210817. Epub 2015 Jan 15.

37.

Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer: results from the ACOSOG Z4032 (Alliance) multicenter randomized trial.

Fernando HC, Landreneau RJ, Mandrekar SJ, Nichols FC, DiPetrillo TA, Meyers BF, Heron DE, Hillman SL, Jones DR, Starnes SL, Tan AD, Daly BD, Putnam JB; Alliance for Clinical Trials in Oncology.

J Thorac Cardiovasc Surg. 2015 Mar;149(3):718-25; discussion 725-6. doi: 10.1016/j.jtcvs.2014.11.003. Epub 2014 Nov 13.

38.
39.

A phase I/II study of bortezomib in combination with paclitaxel, carboplatin, and concurrent thoracic radiation therapy for non-small-cell lung cancer: North Central Cancer Treatment Group (NCCTG)-N0321.

Zhao Y, Foster NR, Meyers JP, Thomas SP, Northfelt DW, Rowland KM Jr, Mattar BI, Johnson DB, Molina JR, Mandrekar SJ, Schild SE, Bearden JD 3rd, Aubry MC, Adjei AA.

J Thorac Oncol. 2015 Jan;10(1):172-80. doi: 10.1097/JTO.0000000000000383.

40.

Metformin does not reduce markers of cell proliferation in esophageal tissues of patients with Barrett's esophagus.

Chak A, Buttar NS, Foster NR, Seisler DK, Marcon NE, Schoen R, Cruz-Correa MR, Falk GW, Sharma P, Hur C, Katzka DA, Rodriguez LM, Richmond E, Sharma AN, Smyrk TC, Mandrekar SJ, Limburg PJ; Cancer Prevention Network.

Clin Gastroenterol Hepatol. 2015 Apr;13(4):665-72.e1-4. doi: 10.1016/j.cgh.2014.08.040. Epub 2014 Sep 15.

41.

Impact of brachytherapy on local recurrence rates after sublobar resection: results from ACOSOG Z4032 (Alliance), a phase III randomized trial for high-risk operable non-small-cell lung cancer.

Fernando HC, Landreneau RJ, Mandrekar SJ, Nichols FC, Hillman SL, Heron DE, Meyers BF, DiPetrillo TA, Jones DR, Starnes SL, Tan AD, Daly BD, Putnam JB Jr.

J Clin Oncol. 2014 Aug 10;32(23):2456-62. doi: 10.1200/JCO.2013.53.4115. Epub 2014 Jun 30.

42.

Multipopulation Tailoring Clinical Trials: Design, Analysis, and Inference Considerations.

Millen BA, Dmitrienko A, Mandrekar SJ, Zhang Z, Williams D.

Ther Innov Regul Sci. 2014 Jul;48(4):453-462. doi: 10.1177/2168479013519630.

PMID:
30235572
43.

Early phase trial designs and endpoints for targeted therapies in rare genotype subsets.

Mandrekar SJ.

Am Soc Clin Oncol Educ Book. 2014:e107-10. doi: 10.14694/EdBook_AM.2014.34.e107. Review.

44.

Exploring the statistical and clinical impact of two interim analyses on the Phase II design with option for direct assignment.

An MW, Mandrekar SJ, Edelman MJ, Sargent DJ.

Contemp Clin Trials. 2014 Jul;38(2):157-62. doi: 10.1016/j.cct.2014.04.007. Epub 2014 Apr 24.

45.

Evaluation of alternate categorical tumor metrics and cut points for response categorization using the RECIST 1.1 data warehouse.

Mandrekar SJ, An MW, Meyers J, Grothey A, Bogaerts J, Sargent DJ.

J Clin Oncol. 2014 Mar 10;32(8):841-50. doi: 10.1200/JCO.2013.52.3019. Epub 2014 Feb 10.

46.

Dose-finding trial designs for combination therapies in oncology.

Mandrekar SJ.

J Clin Oncol. 2014 Jan 10;32(2):65-7. doi: 10.1200/JCO.2013.52.9198. Epub 2013 Dec 9. No abstract available.

PMID:
24323038
47.

Application of tumor measurement-based metrics in the real world.

An MW, Mandrekar SJ, Sargent DJ.

J Clin Oncol. 2013 Dec 1;31(34):4374. doi: 10.1200/JCO.2013.52.3662. Epub 2013 Oct 28. No abstract available.

PMID:
24166528
48.

UGT1A1 genotype-guided phase I study of irinotecan, oxaliplatin, and capecitabine.

Goetz MP, McKean HA, Reid JM, Mandrekar SJ, Tan AD, Kuffel MA, Safgren SL, McGovern RM, Goldberg RM, Grothey AA, McWilliams R, Erlichman C, Ames MM.

Invest New Drugs. 2013 Dec;31(6):1559-67. doi: 10.1007/s10637-013-0034-9. Epub 2013 Oct 10.

49.

Statistical issues in the validation of prognostic, predictive, and surrogate biomarkers.

Sargent DJ, Mandrekar SJ.

Clin Trials. 2013 Oct;10(5):647-52. doi: 10.1177/1740774513497125. Epub 2013 Aug 27.

PMID:
23983158
50.

Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients' data.

Mauguen A, Pignon JP, Burdett S, Domerg C, Fisher D, Paulus R, Mandrekar SJ, Belani CP, Shepherd FA, Eisen T, Pang H, Collette L, Sause WT, Dahlberg SE, Crawford J, O'Brien M, Schild SE, Parmar M, Tierney JF, Le Pechoux C, Michiels S; Surrogate Lung Project Collaborative Group.

Lancet Oncol. 2013 Jun;14(7):619-26. doi: 10.1016/S1470-2045(13)70158-X. Epub 2013 May 14.

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