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Accelerating anticancer drug development - opportunities and trade-offs.

Nass SJ, Rothenberg ML, Pentz R, Hricak H, Abernethy A, Anderson K, Gee AW, Harvey RD, Piantadosi S, Bertagnolli MM, Schrag D, Schilsky RL.

Nat Rev Clin Oncol. 2018 Dec;15(12):777-786. doi: 10.1038/s41571-018-0102-3. Review.


Myocarditis Associated with Immune Checkpoint Inhibitors: An Expert Consensus on Data Gaps and a Call to Action.

Neilan TG, Rothenberg ML, Amiri-Kordestani L, Sullivan RJ, Steingart RM, Gregory W, Hariharan S, Hammad TA, Lindenfeld J, Murphy MJ, Moslehi JJ; Checkpoint Inhibitor Safety Working Group.

Oncologist. 2018 Aug;23(8):874-878. doi: 10.1634/theoncologist.2018-0157. Epub 2018 May 25.


Advantages of a Truly Open-Access Data-Sharing Model.

Bertagnolli MM, Sartor O, Chabner BA, Rothenberg ML, Khozin S, Hugh-Jones C, Reese DM, Murphy MJ.

N Engl J Med. 2017 Mar 23;376(12):1178-1181. doi: 10.1056/NEJMsb1702054. No abstract available.


Pragmatic randomized clinical trials: a proposal to enhance evaluation of new cancer therapies with early signs of exceptional activity.

Koehler M, Donnelly ET, Kalanovic D, Dagher R, Rothenberg ML.

Ann Oncol. 2016 Jul;27(7):1342-8. doi: 10.1093/annonc/mdw143. Epub 2016 Mar 30. No abstract available.


Factors affecting the pharmacokinetics and pharmacodynamics of PEGylated liposomal irinotecan (IHL-305) in patients with advanced solid tumors.

Wu H, Infante JR, Keedy VL, Jones SF, Chan E, Bendell JC, Lee W, Kirschbrown WP, Zamboni BA, Ikeda S, Kodaira H, Rothenberg ML, Burris HA 3rd, Zamboni WC.

Int J Nanomedicine. 2015 Feb 10;10:1201-9. doi: 10.2147/IJN.S62911. eCollection 2015. Erratum in: Int J Nanomedicine. 2019 Jul 24;14:5751-5752.


The role of nonrandomized trials in the evaluation of oncology drugs.

Simon R, Blumenthal GM, Rothenberg ML, Sommer J, Roberts SA, Armstrong DK, LaVange LM, Pazdur R.

Clin Pharmacol Ther. 2015 May;97(5):502-7. doi: 10.1002/cpt.86. Epub 2015 Apr 7.


Population pharmacokinetics of PEGylated liposomal CPT-11 (IHL-305) in patients with advanced solid tumors.

Wu H, Infante JR, Keedy VL, Jones SF, Chan E, Bendell JC, Lee W, Zamboni BA, Ikeda S, Kodaira H, Rothenberg ML, Burris HA 3rd, Zamboni WC.

Eur J Clin Pharmacol. 2013 Dec;69(12):2073-81. doi: 10.1007/s00228-013-1580-y. Epub 2013 Aug 30.


Analysis of neurosensory adverse events induced by FOLFOX4 treatment in colorectal cancer patients: a comparison between two Asian studies and four Western studies.

Sugihara K, Ohtsu A, Shimada Y, Mizunuma N, Gomi K, Lee PH, Gramont A, Rothenberg ML, André T, Brienza S, Goldberg RM.

Cancer Med. 2012 Oct;1(2):198-206. doi: 10.1002/cam4.25. Epub 2012 Aug 6.


Phase I and pharmacokinetic study of IHL-305 (PEGylated liposomal irinotecan) in patients with advanced solid tumors.

Infante JR, Keedy VL, Jones SF, Zamboni WC, Chan E, Bendell JC, Lee W, Wu H, Ikeda S, Kodaira H, Rothenberg ML, Burris HA 3rd.

Cancer Chemother Pharmacol. 2012 Nov;70(5):699-705. doi: 10.1007/s00280-012-1960-5. Epub 2012 Sep 2.


Safety analysis of FOLFOX4 treatment in colorectal cancer patients: a comparison between two Asian studies and four Western studies.

Sugihara K, Ohtsu A, Shimada Y, Mizunuma N, Lee PH, de Gramont A, Goldberg RM, Rothenberg ML, André T, Brienza S, Gomi K.

Clin Colorectal Cancer. 2012 Jun;11(2):127-37. doi: 10.1016/j.clcc.2011.09.001. Epub 2011 Nov 17.


A phase I study of subcutaneously administered aflibercept (VEGF trap) in a new formulation in patients with advanced solid tumors.

Wang-Gillam A, Tew WP, Rothenberg ML, Dupont J, Cooper W, Sternas L, Buzenet G, Sosman JA, Spriggs DR, Lockhart AC.

Invest New Drugs. 2012 Oct;30(5):1958-61. doi: 10.1007/s10637-011-9753-y. Epub 2011 Oct 15.


Phase I pharmacokinetic and pharmacodynamic study of SJG-136, a novel DNA sequence selective minor groove cross-linking agent, in advanced solid tumors.

Puzanov I, Lee W, Chen AP, Calcutt MW, Hachey DL, Vermeulen WL, Spanswick VJ, Liao CY, Hartley JA, Berlin JD, Rothenberg ML.

Clin Cancer Res. 2011 Jun 1;17(11):3794-802. doi: 10.1158/1078-0432.CCR-10-2056. Epub 2011 Feb 23.


Dual blockade of the EGFR and COX-2 pathways: a phase II trial of cetuximab and celecoxib in patients with chemotherapy refractory metastatic colorectal cancer.

Chan E, Lafleur B, Rothenberg ML, Merchant N, Lockhart AC, Trivedi B, Chung CH, Coffey RJ, Berlin JD.

Am J Clin Oncol. 2011 Dec;34(6):581-6. doi: 10.1097/COC.0b013e3181fe46a1.


Phase I study of oral irinotecan as a single-agent and given sequentially with capecitabine.

Goff LW, Benson AB 3rd, LoRusso PM, Tan AR, Berlin JD, Denis LJ, Benner RJ, Yin D, Rothenberg ML.

Invest New Drugs. 2012 Feb;30(1):290-8. doi: 10.1007/s10637-010-9528-x. Epub 2010 Sep 21.


A phase I dose escalation study of TTI-237 in patients with advanced malignant solid tumors.

Wang-Gillam A, Arnold SM, Bukowski RM, Rothenberg ML, Cooper W, Wang KK, Gauthier E, Lockhart AC.

Invest New Drugs. 2012 Feb;30(1):266-72. doi: 10.1007/s10637-010-9506-3. Epub 2010 Aug 10.


Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031.

Picozzi VJ, Abrams RA, Decker PA, Traverso W, O'Reilly EM, Greeno E, Martin RC, Wilfong LS, Rothenberg ML, Posner MC, Pisters PW; American College of Surgeons Oncology Group.

Ann Oncol. 2011 Feb;22(2):348-54. doi: 10.1093/annonc/mdq384. Epub 2010 Jul 29.


Insulin-like growth factor-1 receptor inhibitor, AMG-479, in cetuximab-refractory head and neck squamous cell carcinoma.

Chung CH, Pohlmann PR, Rothenberg ML, Burkey BB, Parker J, Palka K, Aulino J, Puzanov I, Murphy B.

Head Neck. 2011 Dec;33(12):1804-8. doi: 10.1002/hed.21478. Epub 2010 Jul 22.


Phase I study of intravenous vascular endothelial growth factor trap, aflibercept, in patients with advanced solid tumors.

Lockhart AC, Rothenberg ML, Dupont J, Cooper W, Chevalier P, Sternas L, Buzenet G, Koehler E, Sosman JA, Schwartz LH, Gultekin DH, Koutcher JA, Donnelly EF, Andal R, Dancy I, Spriggs DR, Tew WP.

J Clin Oncol. 2010 Jan 10;28(2):207-14. doi: 10.1200/JCO.2009.22.9237. Epub 2009 Nov 30.


Incidence and evolution of oxaliplatin-induced peripheral sensory neuropathy in diabetic patients with colorectal cancer: a pooled analysis of three phase III studies.

Ramanathan RK, Rothenberg ML, de Gramont A, Tournigand C, Goldberg RM, Gupta S, André T.

Ann Oncol. 2010 Apr;21(4):754-8. doi: 10.1093/annonc/mdp509. Epub 2009 Nov 3.


Analysis and variability of TGFbeta measurements in cancer patients with skeletal metastases.

O'Brien PJ, Ramanathan R, Yingling JM, Baselga J, Rothenberg ML, Carducci M, Daly T, Adcock D, Lahn M.

Biologics. 2008 Sep;2(3):563-9.


Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group.

Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson AB 3rd.

J Clin Oncol. 2009 Aug 10;27(23):3778-85. doi: 10.1200/JCO.2008.20.9007. Epub 2009 Jul 6. Erratum in: J Clin Oncol. 2009 Dec 1;27(34):5859.


Phase III trial of FOLFOX plus bevacizumab or cediranib (AZD2171) as first-line treatment of patients with metastatic colorectal cancer: HORIZON III.

Robertson JD, Botwood NA, Rothenberg ML, Schmoll HJ.

Clin Colorectal Cancer. 2009 Jan;8(1):59-60. doi: 10.3816/CCC.2009.n.010.


A phase I dose-escalation study of SR271425, an intravenously dosed thioxanthone analog, administered weekly in patients with refractory solid tumors.

Lockhart AC, Calvo E, Tolcher AW, Rowinsky EK, Shackleton G, Morrison JG, Rafi R, VerMeulen W, Rothenberg ML.

Am J Clin Oncol. 2009 Feb;32(1):9-14. doi: 10.1097/COC.0b013e318178331b.


Phase I, pharmacokinetic and biological correlative study of OSI-7904L, a novel liposomal thymidylate synthase inhibitor, and cisplatin in patients with solid tumors.

Ricart AD, Berlin JD, Papadopoulos KP, Syed S, Drolet DW, Quaratino-Baker C, Horan J, Chick J, Vermeulen W, Tolcher AW, Rowinsky EK, Rothenberg ML.

Clin Cancer Res. 2008 Dec 1;14(23):7947-55. doi: 10.1158/1078-0432.CCR-08-0864.


Molecular imaging of therapeutic response to epidermal growth factor receptor blockade in colorectal cancer.

Manning HC, Merchant NB, Foutch AC, Virostko JM, Wyatt SK, Shah C, McKinley ET, Xie J, Mutic NJ, Washington MK, LaFleur B, Tantawy MN, Peterson TE, Ansari MS, Baldwin RM, Rothenberg ML, Bornhop DJ, Gore JC, Coffey RJ.

Clin Cancer Res. 2008 Nov 15;14(22):7413-22. doi: 10.1158/1078-0432.CCR-08-0239.


A phase I trial of irinotecan alternating with epirubicin in patients with advanced malignancies.

Goff LW, Rothenberg ML, Lockhart AC, Roth BJ, VerMeulen WL, Chan E, Berlin JD.

Am J Clin Oncol. 2008 Oct;31(5):413-6. doi: 10.1097/COC.0b013e318168ef2a.


Oxaliplatin plus irinotecan compared with irinotecan alone as second-line treatment after single-agent fluoropyrimidine therapy for metastatic colorectal carcinoma.

Haller DG, Rothenberg ML, Wong AO, Koralewski PM, Miller WH Jr, Bodoky G, Habboubi N, Garay C, Olivatto LO.

J Clin Oncol. 2008 Oct 1;26(28):4544-50. doi: 10.1200/JCO.2008.17.1249.


A phase I and pharmacokinetic study of the oral histone deacetylase inhibitor, MS-275, in patients with refractory solid tumors and lymphomas.

Gore L, Rothenberg ML, O'Bryant CL, Schultz MK, Sandler AB, Coffin D, McCoy C, Schott A, Scholz C, Eckhardt SG.

Clin Cancer Res. 2008 Jul 15;14(14):4517-25. doi: 10.1158/1078-0432.CCR-07-1461. Epub 2008 Jun 25.


Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer: a randomized phase III noninferiority study.

Rothenberg ML, Cox JV, Butts C, Navarro M, Bang YJ, Goel R, Gollins S, Siu LL, Laguerre S, Cunningham D.

Ann Oncol. 2008 Oct;19(10):1720-6. doi: 10.1093/annonc/mdn370. Epub 2008 Jun 10.


Phase I trial of pemetrexed plus oxaliplatin administered every other week in patients with metastatic cancer.

Stover DG, Lockhart AC, Berlin JD, Chan E, Sandler AB, Sosman JA, Middlebrook V, Nicol S, Rothenberg ML.

Invest New Drugs. 2008 Aug;26(4):339-45. doi: 10.1007/s10637-008-9133-4. Epub 2008 May 8.


Potential regional differences for the tolerability profiles of fluoropyrimidines.

Haller DG, Cassidy J, Clarke SJ, Cunningham D, Van Cutsem E, Hoff PM, Rothenberg ML, Saltz LB, Schmoll HJ, Allegra C, Bertino JR, Douillard JY, Gustavsson BG, Milano G, O'Connell M, Rustum Y, Tabernero J, Gilberg F, Sirzén F, Twelves C.

J Clin Oncol. 2008 May 1;26(13):2118-23. doi: 10.1200/JCO.2007.15.2090.


TACE/ADAM-17: a component of the epidermal growth factor receptor axis and a promising therapeutic target in colorectal cancer.

Merchant NB, Voskresensky I, Rogers CM, Lafleur B, Dempsey PJ, Graves-Deal R, Revetta F, Foutch AC, Rothenberg ML, Washington MK, Coffey RJ.

Clin Cancer Res. 2008 Feb 15;14(4):1182-91. doi: 10.1158/1078-0432.CCR-07-1216.


TGF-beta signalling-related markers in cancer patients with bone metastasis.

Baselga J, Rothenberg ML, Tabernero J, Seoane J, Daly T, Cleverly A, Berry B, Rhoades SK, Ray CA, Fill J, Farrington DL, Wallace LA, Yingling JM, Lahn M, Arteaga C, Carducci M.

Biomarkers. 2008 Mar;13(2):217-36. doi: 10.1080/13547500701676019 .


Intraperitoneal chemotherapy for ovarian cancer: overview and perspective.

Rao G, Crispens M, Rothenberg ML.

J Clin Oncol. 2007 Jul 10;25(20):2867-72. Review.


Inhibition of poly(ADP-ribose) polymerase enhances cell death and improves tumor growth delay in irradiated lung cancer models.

Albert JM, Cao C, Kim KW, Willey CD, Geng L, Xiao D, Wang H, Sandler A, Johnson DH, Colevas AD, Low J, Rothenberg ML, Lu B.

Clin Cancer Res. 2007 May 15;13(10):3033-42.


The continuum of care: a paradigm for the management of metastatic colorectal cancer.

Goldberg RM, Rothenberg ML, Van Cutsem E, Benson AB 3rd, Blanke CD, Diasio RB, Grothey A, Lenz HJ, Meropol NJ, Ramanathan RK, Becerra CH, Wickham R, Armstrong D, Viele C.

Oncologist. 2007 Jan;12(1):38-50. Review.


Phase I trial of oral MAC-321 in subjects with advanced malignant solid tumors.

Lockhart AC, Bukowski R, Rothenberg ML, Wang KK, Cooper W, Grover J, Appleman L, Mayer PR, Shapiro M, Zhu AX.

Cancer Chemother Pharmacol. 2007 Jul;60(2):203-9. Epub 2006 Nov 8.


Pooled analysis of safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer.

Goldberg RM, Tabah-Fisch I, Bleiberg H, de Gramont A, Tournigand C, Andre T, Rothenberg ML, Green E, Sargent DJ.

J Clin Oncol. 2006 Sep 1;24(25):4085-91. Erratum in: J Clin Oncol. 2008 Jun 10;26(17):2925-6.


Phase 1 and pharmacokinetic study of intravenous irinotecan in refractory solid tumor patients with hepatic dysfunction.

Schaaf LJ, Hammond LA, Tipping SJ, Goldberg RM, Goel R, Kuhn JG, Miller LL, Compton LD, Cisar LA, Elfring GL, Gruia G, McGovren JP, Pirotta N, Yin D, Sharma A, Duncan BA, Rothenberg ML.

Clin Cancer Res. 2006 Jun 15;12(12):3782-91.


The pharmacokinetics and safety of ABT-751, a novel, orally bioavailable sulfonamide antimitotic agent: results of a phase 1 study.

Hande KR, Hagey A, Berlin J, Cai Y, Meek K, Kobayashi H, Lockhart AC, Medina D, Sosman J, Gordon GB, Rothenberg ML.

Clin Cancer Res. 2006 May 1;12(9):2834-40.


Phase I/pilot study of SU5416 (semaxinib) in combination with irinotecan/bolus 5-FU/LV (IFL) in patients with metastatic colorectal cancer.

Lockhart AC, Cropp GF, Berlin JD, Donnelly E, Schumaker RD, Schaaf LJ, Hande KR, Fleischer AC, Hannah AL, Rothenberg ML.

Am J Clin Oncol. 2006 Apr;29(2):109-15.


Pretreatment CA-125 and risk of relapse in advanced ovarian cancer.

Markman M, Liu PY, Rothenberg ML, Monk BJ, Brady M, Alberts DS.

J Clin Oncol. 2006 Mar 20;24(9):1454-8.


Randomized phase II trial of the clinical and biological effects of two dose levels of gefitinib in patients with recurrent colorectal adenocarcinoma.

Rothenberg ML, LaFleur B, Levy DE, Washington MK, Morgan-Meadows SL, Ramanathan RK, Berlin JD, Benson AB 3rd, Coffey RJ.

J Clin Oncol. 2005 Dec 20;23(36):9265-74.


Safety and pharmacokinetic study of RPI.4610 (ANGIOZYME), an anti-VEGFR-1 ribozyme, in combination with carboplatin and paclitaxel in patients with advanced solid tumors.

Kobayashi H, Eckhardt SG, Lockridge JA, Rothenberg ML, Sandler AB, O'Bryant CL, Cooper W, Holden SN, Aitchison RD, Usman N, Wolin M, Basche ML.

Cancer Chemother Pharmacol. 2005 Oct;56(4):329-36. Epub 2005 May 20.


Treatment for pancreatic cancer: current therapy and continued progress.

Lockhart AC, Rothenberg ML, Berlin JD.

Gastroenterology. 2005 May;128(6):1642-54. Review.


Silatecan DB-67 is a novel DNA topoisomerase I-targeted radiation sensitizer.

Chen AY, Shih SJ, Garriques LN, Rothenberg ML, Hsiao M, Curran DP.

Mol Cancer Ther. 2005 Feb;4(2):317-24.


Cancer pharmacogenomics: powerful tools in cancer chemotherapy and drug development.

Lee W, Lockhart AC, Kim RB, Rothenberg ML.

Oncologist. 2005 Feb;10(2):104-11. Review.


Phase II trial of vinorelbine for relapsed ovarian cancer: a Southwest Oncology Group study.

Rothenberg ML, Liu PY, Wilczynski S, Nahhas WA, Winakur GL, Jiang CS, Moinpour CM, Lyons B, Weiss GR, Essell JH, Smith HO, Markman M, Alberts DS.

Gynecol Oncol. 2004 Dec;95(3):506-12.


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