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Eosinophilic Airway Inflammation in Patients with Stable Biomass Smoke- versus Tobacco Smoke-Associated Chronic Obstructive Pulmonary Disease.

Fernandes L, Rane S, Mandrekar S, Mesquita AM.

J Health Pollut. 2019 Nov 27;9(24):191209. doi: 10.5696/2156-9614-9.24.191209. eCollection 2019 Dec.


A Phase II Study of Pazopanib in Patients with Malignant Pleural Mesothelioma: NCCTG N0623 (Alliance).

Parikh K, Mandrekar SJ, Allen-Ziegler K, Esplin B, Tan AD, Marchello B, Adjei AA, Molina JR.

Oncologist. 2019 Dec 24. doi: 10.1634/theoncologist.2019-0574. [Epub ahead of print]


Missing tumor measurement (TM) data in the search for alternative TM-based endpoints in cancer clinical trials.

An MW, Tang J, Grothey A, Sargent DJ, Ou FS, Mandrekar SJ.

Contemp Clin Trials Commun. 2019 Nov 22;17:100492. doi: 10.1016/j.conctc.2019.100492. eCollection 2020 Mar.


Impact of NPM1/FLT3-ITD genotypes defined by the 2017 European LeukemiaNet in patients with acute myeloid leukemia.

Döhner K, Thiede C, Jahn N, Panina E, Gambietz A, Larson RA, Prior TW, Marcucci G, Jones D, Krauter J, Heuser M, Voso MT, Ottone T, Nomdedeu JF, Mandrekar SJ, Klisovic RB, Wei AH, Sierra J, Sanz MA, Brandwein JM, de Witte T, Jansen JH, Niederwieser D, Appelbaum FR, Medeiros BC, Tallman MS, Schlenk RF, Ganser A, Serve H, Ehninger G, Amadori S, Gathmann I, Benner A, Pallaud C, Stone RM, Döhner H, Bloomfield CD.

Blood. 2020 Jan 30;135(5):371-380. doi: 10.1182/blood.2019002697.


Effects of carrying school bags on cervical and shoulder posture in static and dynamic conditions in adolescent students.

Mandrekar S, Chavhan D, Shyam AK, Sancheti PK.

Int J Adolesc Med Health. 2019 Oct 30. pii: /j/ijamh.ahead-of-print/ijamh-2019-0073/ijamh-2019-0073.xml. doi: 10.1515/ijamh-2019-0073. [Epub ahead of print]


A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study.

Schenk EL, Mandrekar SJ, Dy GK, Aubry MC, Tan AD, Dakhil SR, Sachs BA, Nieva JJ, Bertino E, Lee Hann C, Schild SE, Wadsworth TW, Adjei AA, Molina JR.

J Thorac Oncol. 2020 Jan;15(1):110-119. doi: 10.1016/j.jtho.2019.09.083. Epub 2019 Oct 9.


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.


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.


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.


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.


An Unusual Case of Biliary Stent Migration in Sacrum.

Ramani AS, Mandrekar S, Samant D, Noronha F.

Niger J Surg. 2019 Jan-Jun;25(1):104-106. doi: 10.4103/njs.NJS_28_18.


RECIST 1.1 for Response Evaluation Apply Not Only to Chemotherapy-Treated Patients But Also to Targeted Cancer Agents: A Pooled Database Analysis.

Litière S, Isaac G, De Vries EGE, Bogaerts J, Chen A, Dancey J, Ford R, Gwyther S, Hoekstra O, Huang E, Lin N, Liu Y, Mandrekar S, Schwartz LH, Shankar L, Therasse P, Seymour L; RECIST Working Group.

J Clin Oncol. 2019 May 1;37(13):1102-1110. doi: 10.1200/JCO.18.01100. Epub 2019 Mar 12.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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. Review.


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.


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.


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.


iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.

Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litière S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group.

Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2. Review. Erratum in: Lancet Oncol. 2019 May;20(5):e242.


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.


Daniel J. Sargent, 1970-2016.

Mandrekar SJ.

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


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.


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.


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.


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.


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.


Comparison of futility monitoring guidelines using completed phase III oncology trials.

Zhang Q, Freidlin B, Korn EL, Halabi S, Mandrekar S, Dignam JJ.

Clin Trials. 2017 Feb;14(1):48-58. doi: 10.1177/1740774516666502. Epub 2016 Sep 22.


RECIST 1.1 - Standardisation and disease-specific adaptations: Perspectives from the RECIST Working Group.

Schwartz LH, Seymour L, Litière S, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, Hayes W, Hodi FS, Hoekstra OS, Huang EP, Lin N, Liu Y, Therasse P, Wolchok JD, de Vries E.

Eur J Cancer. 2016 Jul;62:138-45. doi: 10.1016/j.ejca.2016.03.082. Epub 2016 May 26. Review.


Utility of Cell-Block of Bronchial Washings in Diagnosis of Lung Cancer- A Comparative Analysis with Conventional Smear Cytology.

Kakodkar UC, Vadala R, Mandrekar S.

J Clin Diagn Res. 2016 Apr;10(4):OC25-8. doi: 10.7860/JCDR/2016/15911.7634. Epub 2016 Apr 1.


RECIST 1.1-Update and clarification: From the RECIST committee.

Schwartz LH, Litière S, de Vries E, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, Hayes W, Hodi FS, Hoekstra OS, Huang EP, Lin N, Liu Y, Therasse P, Wolchok JD, Seymour L.

Eur J Cancer. 2016 Jul;62:132-7. doi: 10.1016/j.ejca.2016.03.081. Epub 2016 May 14.


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.


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.


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.


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.


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.


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.


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.


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.


Introduction to special issue on biomarker-based clinical trial designs in oncology.

Sargent DJ, Mandrekar S, Grothey A.

Chin Clin Oncol. 2015 Sep;4(3):28. doi: 10.3978/j.issn.2304-3865.2015.09.05. No abstract available.


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.


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.


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.


Radiotherapy for extensive stage small-cell lung cancer.

Mansfield A, Mandrekar S.

Lancet. 2015 Apr 4;385(9975):1291. doi: 10.1016/S0140-6736(15)60676-6. No abstract available.


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