• 6273 Citations
  • 41 Scopus h-Index
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Article
2019

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

Yin, J., Laplant, B., Uy, G. L., Marcucci, G., Blum, W., Larson, R. A., Stone, R. M. & Mandrekar, S. J., Jun 11 2019, In : Blood Advances. 3, 11, p. 1714-1721 8 p.

Research output: Contribution to journalArticle

Open Access
2 Scopus citations
3 Scopus citations

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, E. G. E., Bogaerts, J., Chen, A., Dancey, J., Ford, R., Gwyther, S., Hoekstra, O., Huang, E., Lin, N., Liu, Y., Mandrekar, S., Schwartz, L. H., Shankar, L., Therasse, P. & Seymour, L., Jan 1 2019, In : Journal of Clinical Oncology. 37, 13, p. 1102-1110 9 p.

Research output: Contribution to journalArticle

4 Scopus citations
2018

Application of multi-state models in cancer clinical trials

Le-Rademacher, J., Peterson, R. A., Therneau, T. M., Sanford, B. L., Stone, R. M. & Mandrekar, S. J., Jan 1 2018, (Accepted/In press) In : Clinical Trials.

Research output: Contribution to journalArticle

4 Scopus citations

Evaluation of End Points in Cancer Clinical Trials

Yin, J., Dahlberg, S. E. & Mandrekar, S. J., Jan 1 2018, (Accepted/In press) In : Journal of Thoracic Oncology.

Research output: Contribution to journalArticle

1 Scopus citations

Ibrutinib regimens versus chemoimmunotherapy in older patients with untreated CLL

Woyach, J. A., Ruppert, A. S., Heerema, N. A., Zhao, W., Booth, A. M., Ding, W., Bartlett, N. L., Brander, D. M., Barr, P. M., Rogers, K. A., Parikh, S. A., Coutre, S., Hurria, A., Brown, J. R., Lozanski, G., Blachly, J. S., Ozer, H. G., Major-Elechi, B., Fruth, B., Nattam, S. & 11 others, Larson, R. A., Erba, H., Litzow, M., Owen, C., Kuzma, C., Abramson, J. S., Little, R. F., Smith, S. E., Stone, R. M., Mandrekar, S. J. & Byrd, J. C., Dec 27 2018, In : New England Journal of Medicine. 379, 26, p. 2517-2528 12 p.

Research output: Contribution to journalArticle

135 Scopus citations

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

Byrd, J. C., Ruppert, A. S., Heerema, N. A., Halvorson, A. E., Hoke, E., Smith, M. R., Godwin, J. E., Couban, S., Fehniger, T. A., Thirman, M. J., Tallman, M. S., Appelbaum, F. R., Stone, R. M., Robinson, S., Chang, J. E., Mandrekar, S. J. & Larson, R. A., Jul 24 2018, In : Blood advances. 2, 14, p. 1705-1718 14 p.

Research output: Contribution to journalArticle

4 Scopus citations

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

Roboz, G. J., Mandrekar, S. J., Desai, P., Laumann, K., Walker, A. R., Wang, E. S., Kolitz, J. E., Powell, B. L., Attar, E. C., Stock, W., Bloomfield, C. D., Kohlschmidt, J., Mrózek, K., Hassane, D. C., Garraway, L., Jané-Valbuena, J., Baltay, M., Tracy, A., Marcucci, G., Stone, R. M. & 1 others, Larson, R. A., Dec 26 2018, In : Blood advances. 2, 24, p. 3608-3617 10 p.

Research output: Contribution to journalArticle

6 Scopus citations
2017

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

Uy, G. L., Mandrekar, S. J., Laumann, K., Marcucci, G., Zhao, W., Levis, M. J., Klepin, H. D., Baer, M. R., Powell, B. L., Westervelt, P., DeAngelo, D. J., Stock, W., Sanford, B., Blum, W. G., Bloomfield, C. D., Stone, R. M. & Larson, R. A., Jan 24 2017, In : Blood Advances. 1, 5, p. 331-340 10 p.

Research output: Contribution to journalArticle

25 Scopus citations

Comparison of futility monitoring guidelines using completed phase III oncology trials

Zhang, Q., Freidlin, B., Korn, E. L., Halabi, S., Mandrekar, S. J. & Dignam, J. J., Feb 1 2017, In : Clinical Trials. 14, 1, p. 48-58 11 p.

Research output: Contribution to journalArticle

2 Scopus citations

Keyboard: A novel Bayesian toxicity probability interval design for phase I clinical trials

Yan, F., Mandrekar, S. J. & Yuan, Y., Aug 1 2017, In : Clinical Cancer Research. 23, 15, p. 3994-4003 10 p.

Research output: Contribution to journalArticle

22 Scopus citations

Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 Mutation

Stone, R. M., Mandrekar, S. J., Sanford, B. L., Laumann, K., Geyer, S., Bloomfield, C. D., Thiede, C., Prior, T. W., Dohner, K., Marcucci, G., Lo-Coco, F., Klisovic, R. B., Wei, A., Sierra, J., Sanz, M. A., Brandwein, J. M., De Witte, T., Niederwieser, D., Appelbaum, F. R., Medeiros, B. C. & 9 others, Tallman, M. S., Krauter, J., Schlenk, R. F., Ganser, A., Serve, H., Ehninger, G., Amadori, S., Larson, R. A. & Dohner, H., Aug 3 2017, In : New England Journal of Medicine. 377, 5, p. 454-464 11 p.

Research output: Contribution to journalArticle

498 Scopus citations

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

Yin, J., Paoletti, X., Sargent, D. J. & Mandrekar, S. J., Dec 1 2017, In : Clinical Trials. 14, 6, p. 611-620 10 p.

Research output: Contribution to journalArticle

2 Scopus citations
5 Scopus citations
2016

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

Yin, J., Qin, R., Ezzalfani, M., Sargent, D. J. & Mandrekar, S. J., 2016, (Accepted/In press) In : Statistics in Medicine.

Research output: Contribution to journalArticle

3 Scopus citations

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

Stock, W., Diouf, B., Crews, K., Pei, D., Cheng, C., Laumann, K., Mandrekar, S. J., Luger, S., Advani, A., Stone, R., Larson, R. & Evans, W., 2016, (Accepted/In press) In : Clinical Pharmacology and Therapeutics.

Research output: Contribution to journalArticle

21 Scopus citations

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, M. S., Mandrekar, S. J., Landreneau, R., Nichols, F., Foster, N. R., DiPetrillo, T. A., Meyers, B., Heron, D. E., Jones, D. R., Tan, A. D., Starnes, S., Putnam, J. B. & Fernando, H. C., 2016, (Accepted/In press) In : Annals of Thoracic Surgery.

Research output: Contribution to journalArticle

22 Scopus citations

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

Lam, S., Mandrekar, S. J., Gesthalter, Y., Allen Ziegler, K. L., Seisler, D. K., Midthun, D. E., Mao, J. T., Aubry, M. C., McWilliams, A., Sin, D. D., Shaipanich, T., Liu, G., Johnson, E., Bild, A., Lenburg, M. E., Ionescu, D. N., Mayo, J., Yi, J., Tazelaar, H., Harmsen, W. S. & 5 others, Smith, J., Spira, A. E., Beane, J., Limburg, P. J. & Szabo, E., Dec 2016, In : Cancer Prevention Research. 9, 12, p. 906-914 9 p.

Research output: Contribution to journalArticle

13 Scopus citations

Clinical trial designs incorporating predictive biomarkers

Renfro, L. A., Mallick, H., An, M. W., Sargent, D. J. & Mandrekar, S. J., 2016, In : Cancer Treatment Reviews. 43, p. 74-82 9 p.

Research output: Contribution to journalArticle

23 Scopus citations

Difference in restricted mean survival time for cost-effectiveness analysis using individual patient data meta-analysis: Evidence from a case study

MAR-LC Collaborative Group, Mar 2016, In : PloS one. 11, 3, e0150032.

Research output: Contribution to journalArticle

7 Scopus citations

Enrollment trends and disparity among patients with lung cancer in national clinical trials, 1990 to 2012

Pang, H. H., Wang, X., Stinchcombe, T. E., Wong, M. L., Cheng, P., Ganti, A. K., Sargent, D. J., Zhang, Y., Hu, C., Mandrekar, S. J., Redman, M. W., Manola, J. B., Schilsky, R. L., Cohen, H. J., Bradley, J. D., Adjei, A., Gandara, D., Ramalingam, S. S. & Vokes, E. E., Nov 20 2016, In : Journal of Clinical Oncology. 34, 33, p. 3992-3999 8 p.

Research output: Contribution to journalArticle

34 Scopus citations

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

Kent, M. S., Mandrekar, S. J., Landreneau, R., Nichols, F., DiPetrillo, T. A., Meyers, B., Heron, D. E., Jones, D. R., Tan, A. D., Starnes, S., Putnam, J. B. & Fernando, H. C., 2016, (Accepted/In press) In : Annals of Thoracic Surgery.

Research output: Contribution to journalArticle

7 Scopus citations

Precision oncology: A new era of cancer clinical trials

Renfro, L. A., An, M. W. & Mandrekar, S. J., 2016, (Accepted/In press) In : Cancer Letters.

Research output: Contribution to journalArticle

25 Scopus citations

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

Schwartz, L. H., Seymour, L., Litière, S., Ford, R., Gwyther, S., Mandrekar, S. J., Shankar, L., Bogaerts, J., Chen, A., Dancey, J., Hayes, W., Hodi, F. S., Hoekstra, O. S., Huang, E. P., Lin, N., Liu, Y., Therasse, P., Wolchok, J. D. & de Vries, E., Mar 25 2016, (Accepted/In press) In : European Journal of Cancer.

Research output: Contribution to journalArticle

51 Scopus citations

RECIST 1.1-Update and clarification: From the RECIST committee

Schwartz, L. H., Litière, S., de Vries, E., Ford, R., Gwyther, S., Mandrekar, S. J., Shankar, L., Bogaerts, J., Chen, A., Dancey, J., Hayes, W., Hodi, F. S., Hoekstra, O. S., Huang, E. P., Lin, N., Liu, Y., Therasse, P., Wolchok, J. D. & Seymour, L., Mar 25 2016, (Accepted/In press) In : European Journal of Cancer.

Research output: Contribution to journalArticle

144 Scopus citations
2015

Alchemist trials: A golden opportunity to transform outcomes in early-stage non-small cell lung cancer

Govindan, R., Mandrekar, S. J., Gerber, D. E., Oxnard, G. R., Dahlberg, S. E., Chaft, J., Malik, S., Mooney, M., Abrams, J. S., Jänne, P. A., Gandara, D. R., Ramalingam, S. S. & Vokes, E. E., Dec 15 2015, In : Clinical Cancer Research. 21, 24, p. 5439-5444 6 p.

Research output: Contribution to journalArticle

41 Scopus citations

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, H. C., Landreneau, R. J., Mandrekar, S. J., Nichols, F. C., Dipetrillo, T. A., Meyers, B. F., Heron, D. E., Hillman, S. L., Jones, D. R., Starnes, S. L., Tan, A. D., Daly, B. D. T. & Putnam, J. B., Mar 1 2015, In : Journal of Thoracic and Cardiovascular Surgery. 149, 3, p. 718-726 9 p.

Research output: Contribution to journalArticle

32 Scopus citations

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, M. W., Han, Y., Meyers, J. P., Bogaerts, J., Sargent, D. J. & Mandrekar, S. J., Dec 1 2015, In : Journal of Clinical Oncology. 33, 34, p. 4048-4057 10 p.

Research output: Contribution to journalArticle

4 Scopus citations

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

Alden, R. S., Mandrekar, S. J. & Oxnard, G. R., 2015, In : Chinese Clinical Oncology. 4, 3, 37.

Research output: Contribution to journalArticle

10 Scopus citations

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

Response Evaluation Criteria in Solid Tumors Steering Committee & Sargent, D. J., Nov 1 2015, In : Journal of the National Cancer Institute. 107, 11

Research output: Contribution to journalArticle

9 Scopus citations

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

Sargent, D. J., Mandrekar, S. J. & Grothey, A. F., 2015, In : Chinese Clinical Oncology. 4, 3, 28.

Research output: Contribution to journalArticle

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

Chak, A., Buttar, N. S., Foster, N. R., Seisler, D. K., Marcon, N. E., Schoen, R., Cruz-Correa, M. R., Falk, G. W., Sharma, P., Hur, C., Katzka, D. A., Rodriguez, L. M., Richmond, E., Sharma, A. N., Smyrk, T. C., Mandrekar, S. J. & Limburg, P. J., Apr 1 2015, In : Clinical Gastroenterology and Hepatology. 13, 4, p. 665-672.e4

Research output: Contribution to journalArticle

26 Scopus citations

Molecular and clinical implementations of ovarian cancer mouse avatar models

Zayed, A. A., Mandrekar, S. J. & Haluska, P., 2015, In : Chinese Clinical Oncology. 4, 3, 30.

Research output: Contribution to journalArticle

9 Scopus citations

Multitrial evaluation of progression-free survival as a surrogate end point for overall survival in first-line extensive-stage small-cell lung cancer

Foster, N. R., Renfro, L. A., Schild, S. E., Redman, M. W., Wang, X. F., Dahlberg, S. E., Ding, K., Bradbury, P. A., Ramalingam, S. S., Gandara, D. R., Shibata, T., Saijo, N., Vokes, E. E., Adjei, A. & Mandrekar, S. J., Jul 4 2015, In : Journal of Thoracic Oncology. 10, 7, p. 1099-1106 8 p.

Research output: Contribution to journalArticle

20 Scopus citations

Radiotherapy for extensive stage small-cell lung cancer

Mansfield, A. & Mandrekar, S. J., Apr 4 2015, In : The Lancet. 385, 9975, p. 1291 1 p.

Research output: Contribution to journalArticle

1 Scopus citations

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

An, M. W., Lu, X., Sargent, D. J. & Mandrekar, S. J., Jan 15 2015, In : Computational and Mathematical Methods in Medicine. 2015, 210817.

Research output: Contribution to journalArticle

2 Scopus citations
2014

A Phase I/II Study of Bortezomib in Combination with Paclitaxel, Carboplatin and Concurrent Thoracic Radiation Therapy for Non-Small Cell Lung Cancer: NCCTG-N0321

Zhao, Y., Foster, N. R., Meyers, J. P., Thomas, S. P., Northfelt, D. W., Rowland, K. M., Mattar, B. I., Johnson, D. B., Molina, J. R., Mandrekar, S. J., Schild, S. E., Bearden, J. D., Aubry, M. C. & Adjei, A., Sep 22 2014, (Accepted/In press) In : Journal of Thoracic Oncology.

Research output: Contribution to journalArticle

21 Scopus citations
2 Scopus citations

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

Mandrekar, S. J., An, M. W., Meyers, J., Grothey, A., Bogaerts, J. & Sargent, D. J., Mar 10 2014, In : Journal of Clinical Oncology. 32, 8, p. 841-850 10 p.

Research output: Contribution to journalArticle

27 Scopus citations

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

An, M. W., Mandrekar, S. J., Edelman, M. J. & Sargent, D. J., Jul 2014, In : Contemporary Clinical Trials. 38, 2, p. 157-162 6 p.

Research output: Contribution to journalArticle

1 Scopus citations

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, H. C., Landreneau, R. J., Mandrekar, S. J., Nichols, F. C., Hillman, S. L., Heron, D. E., Meyers, B. F., DiPetrillo, T. A., Jones, D. R., Starnes, S. L., Tan, A. D., Daly, B. D. T. & Putnam, J. B., Aug 10 2014, In : Journal of Clinical Oncology. 32, 23, p. 2456-2462 7 p.

Research output: Contribution to journalArticle

56 Scopus citations

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

Millen, B. A., Dmitrienko, A., Mandrekar, S. J., Zhang, Z. & Williams, D., Jul 2014, In : Therapeutic Innovation and Regulatory Science. 48, 4, p. 453-462 10 p.

Research output: Contribution to journalArticle

5 Scopus citations

NCCTG N0821 (Alliance): A phase ii first-line study of pemetrexed, carboplatin, and bevacizumab in elderly patients with advanced nonsquamous non-small-cell lung cancer with good performance status

Dy, G. K., Molina, J. R., Qi, Y., Ansari, R., Thomas, S., Ross, H. J., Soori, G., Anderson, D., Christine Aubry, M., Meyers, J., Adjei, A. A., Mandrekar, S. & Adjei, A. A., Aug 2014, In : Journal of Thoracic Oncology. 9, 8, p. 1146-1153 8 p.

Research output: Contribution to journalArticle

8 Scopus citations
2013

A phase III randomized trial of thalidomide plus zoledronic acid versus zoledronic acid alone in patients with asymptomatic multiple myeloma

Witzig, T. E., Laumann, K. M., Lacy, M. Q., Hayman, S. R., Dispenzieri, A., Kumar, S., Reeder, C. B., Roy, V., Lust, J. A., Gertz, M. A., Greipp, P. R., Hassoun, H., Mandrekar, S. J. & Rajkumar, S. V., Jan 1 2013, In : Leukemia. 27, 1, p. 220-225 6 p.

Research output: Contribution to journalArticle

54 Scopus citations

A randomized phase II study of gemcitabine and carboplatin with or without cediranib as first-line therapy in advanced non-small-cell lung cancer: North central cancer treatment group study N0528

Adjei, A. A., Dy, G. K., Mandrekar, S. J., Nelson, G. D., Meyers, J. P., Adjei, A. A., Ross, H. J., Ansari, R. H., Lyss, A. P., Stella, P. J., Schild, S. E. & Molina, J. R., Jan 2013, In : Journal of Thoracic Oncology. 8, 1, p. 79-88 10 p.

Research output: Contribution to journalArticle

34 Scopus citations

A review of phase II trial designs for initial marker validation

Mandrekar, S. J., An, M. W. & Sargent, D. J., Nov 1 2013, In : Contemporary Clinical Trials. 36, 2, p. 597-604 8 p.

Research output: Contribution to journalArticle

16 Scopus citations

Cost effectiveness of modified fractionation radiotherapy versus conventional radiotherapy for unresected non-small-cell lung cancer patients

Ramaekers, B. L. T., Joore, M. A., Lueza, B., Bonastre, J., Mauguen, A., Pignon, J. P., Le Pechoux, C., De Ruysscher, D. K. M., Arriagada, R., Bae, K., Ball, D., Baumann, M., Behrendt, K., Belani, C. P., Beresford, J., Bishop, J., Bonner, J. A., Choy, H., Dahlberg, S. E., De Ruysscher, D. & 17 others, Dische, S., Fournel, P., Koch, R., Le Péchoux, C., Mandrekar, S. J., Mornex, F., Nankivell, M., Nelson, G., Parmar, M. K., Paulus, R., Pignon, J. P., Saunders, M. I., Sause, W., Schild, S. E., Turrisi, A. T., Zajusz, A. & Grutters, J. P. C., Jan 1 2013, In : Journal of Thoracic Oncology. 8, 10, p. 1295-1307 13 p.

Research output: Contribution to journalArticle

13 Scopus citations

Dose-finding designs using a novel quasi-continuous endpoint for multiple toxicities

Ezzalfani, M., Zohar, S., Qin, R., Mandrekar, S. J. & Deley, M. C. L., Jul 20 2013, In : Statistics in Medicine. 32, 16, p. 2728-2746 19 p.

Research output: Contribution to journalArticle

18 Scopus citations

Missing data and measurement variability in assessing progression-free survival endpoint in randomized clinical trials

Sridhara, R., Mandrekar, S. J. & Dodd, L. E., May 15 2013, In : Clinical Cancer Research. 19, 10, p. 2613-2620 8 p.

Research output: Contribution to journalArticle

20 Scopus citations