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A Pharmacometric Analysis of Patient-Reported Outcomes in Breast Cancer Patients Through Item Response Theory.

Schindler E, Friberg LE, Lum BL, Wang B, Quartino A, Li C, Girish S, Jin JY, Karlsson MO.

Pharm Res. 2018 Apr 19;35(6):122. doi: 10.1007/s11095-018-2403-8.


Pharmacokinetic and exposure-response analyses of pertuzumab in combination with trastuzumab and docetaxel during neoadjuvant treatment of HER2+ early breast cancer.

Quartino AL, Li H, Jin JY, Wada DR, Benyunes MC, McNally V, Viganò L, Nijem I, Lum BL, Garg A.

Cancer Chemother Pharmacol. 2017 Feb;79(2):353-361. doi: 10.1007/s00280-016-3218-0. Epub 2017 Jan 10.


Antitherapeutic antibody-mediated hepatotoxicity of recombinant human Apo2L/TRAIL in the cynomolgus monkey.

Zuch de Zafra CL, Ashkenazi A, Darbonne WC, Cheu M, Totpal K, Ortega S, Flores H, Walker MD, Kabakoff B, Lum BL, Mounho-Zamora BJ, Marsters SA, Dybdal NO.

Cell Death Dis. 2016 Aug 11;7(8):e2338. doi: 10.1038/cddis.2016.241.


Should Therapeutic Drug Monitoring for Monoclonal Antibodies Remain the Exception or Become the Norm?

Stroh M, Lum BL.

Clin Pharmacol Ther. 2016 Sep;100(3):215-7. doi: 10.1002/cpt.365. Epub 2016 May 3.


A survey of new oncology drug approvals in the USA from 2010 to 2015: a focus on optimal dose and related postmarketing activities.

Lu D, Lu T, Stroh M, Graham RA, Agarwal P, Musib L, Li CC, Lum BL, Joshi A.

Cancer Chemother Pharmacol. 2016 Mar;77(3):459-76. doi: 10.1007/s00280-015-2931-4. Epub 2016 Jan 25. Review.


Population pharmacokinetic and exposure-response analysis for trastuzumab administered using a subcutaneous "manual syringe" injection or intravenously in women with HER2-positive early breast cancer.

Quartino AL, Hillenbach C, Li J, Li H, Wada RD, Visich J, Li C, Heinzmann D, Jin JY, Lum BL.

Cancer Chemother Pharmacol. 2016 Jan;77(1):77-88. doi: 10.1007/s00280-015-2922-5. Epub 2015 Dec 8.


Effect of gastric pH on erlotinib pharmacokinetics in healthy individuals: omeprazole and ranitidine.

Kletzl H, Giraudon M, Ducray PS, Abt M, Hamilton M, Lum BL.

Anticancer Drugs. 2015 Jun;26(5):565-72. doi: 10.1097/CAD.0000000000000212.


Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study.

Jackisch C, Kim SB, Semiglazov V, Melichar B, Pivot X, Hillenbach C, Stroyakovskiy D, Lum BL, Elliott R, Weber HA, Ismael G.

Ann Oncol. 2015 Feb;26(2):320-5. doi: 10.1093/annonc/mdu524. Epub 2014 Nov 17.


Trastuzumab, in combination with carboplatin and docetaxel, does not prolong the QT interval of patients with HER2-positive metastatic or locally advanced inoperable solid tumors: results from a phase Ib study.

Xu N, Redfern CH, Gordon M, Eppler S, Lum BL, Trudeau C.

Cancer Chemother Pharmacol. 2014 Dec;74(6):1251-60. doi: 10.1007/s00280-014-2603-9. Epub 2014 Oct 26.


Effect of erlotinib on CYP3A activity, evaluated in vitro and by dual probes in patients with cancer.

Calvert H, Twelves C, Ranson M, Plummer R, Fettner S, Pantze M, Ling J, Hamilton M, Lum BL, Rakhit A.

Anticancer Drugs. 2014 Aug;25(7):832-40. doi: 10.1097/CAD.0000000000000099.


Population pharmacokinetics and exposure-response analyses of trastuzumab in patients with advanced gastric or gastroesophageal junction cancer.

Cosson VF, Ng VW, Lehle M, Lum BL.

Cancer Chemother Pharmacol. 2014 Apr;73(4):737-47. doi: 10.1007/s00280-014-2400-5. Epub 2014 Feb 12.


The effect of rifampicin, a prototypical CYP3A4 inducer, on erlotinib pharmacokinetics in healthy subjects.

Hamilton M, Wolf JL, Drolet DW, Fettner SH, Rakhit AK, Witt K, Lum BL.

Cancer Chemother Pharmacol. 2014 Mar;73(3):613-21. doi: 10.1007/s00280-014-2390-3. Epub 2014 Jan 29.


Comparative pharmacokinetics of subcutaneous trastuzumab administered via handheld syringe or proprietary single-use injection device in healthy males.

Wynne CJ, Ellis-Pegler RB, Waaka DS, Schwabe C, Lehle M, Heinzmann D, Mangat R, Li C, Dick AE, Cranshaw NA, Lum BL.

Cancer Chemother Pharmacol. 2013 Nov;72(5):1079-87. doi: 10.1007/s00280-013-2273-z. Epub 2013 Sep 22.


Prevalence of acid-reducing agents (ARA) in cancer populations and ARA drug-drug interaction potential for molecular targeted agents in clinical development.

Smelick GS, Heffron TP, Chu L, Dean B, West DA, Duvall SL, Lum BL, Budha N, Holden SN, Benet LZ, Frymoyer A, Dresser MJ, Ware JA.

Mol Pharm. 2013 Nov 4;10(11):4055-62. doi: 10.1021/mp400403s. Epub 2013 Oct 24.


Absence of pharmacokinetic drug-drug interaction of pertuzumab with trastuzumab and docetaxel.

Cortés J, Swain SM, Kudaba I, Hauschild M, Patel T, Grincuka E, Masuda N, McNally V, Ross G, Brewster M, Marier JF, Trinh MM, Garg A, Nijem I, Visich J, Lum BL, Baselga J.

Anticancer Drugs. 2013 Nov;24(10):1084-92. doi: 10.1097/CAD.0000000000000016.


Antibody delivery of drugs and radionuclides: factors influencing clinical pharmacology.

Prabhu S, Boswell CA, Leipold D, Khawli LA, Li D, Lu D, Theil FP, Joshi A, Lum BL.

Ther Deliv. 2011 Jun;2(6):769-91. Review.


Single and multiple dose intravenous and oral pharmacokinetics of the hedgehog pathway inhibitor vismodegib in healthy female subjects.

Graham RA, Hop CE, Borin MT, Lum BL, Colburn D, Chang I, Shin YG, Malhi V, Low JA, Dresser MJ.

Br J Clin Pharmacol. 2012 Nov;74(5):788-96. doi: 10.1111/j.1365-2125.2012.04281.x.


A single dose mass balance study of the Hedgehog pathway inhibitor vismodegib (GDC-0449) in humans using accelerator mass spectrometry.

Graham RA, Lum BL, Morrison G, Chang I, Jorga K, Dean B, Shin YG, Yue Q, Mulder T, Malhi V, Xie M, Low JA, Hop CE.

Drug Metab Dispos. 2011 Aug;39(8):1460-7. doi: 10.1124/dmd.111.039339. Epub 2011 May 20.


Identification, characterization, and implications of species-dependent plasma protein binding for the oral Hedgehog pathway inhibitor vismodegib (GDC-0449).

Giannetti AM, Wong H, Dijkgraaf GJ, Dueber EC, Ortwine DF, Bravo BJ, Gould SE, Plise EG, Lum BL, Malhi V, Graham RA.

J Med Chem. 2011 Apr 28;54(8):2592-601. doi: 10.1021/jm1008924. Epub 2011 Mar 25.


Pharmacokinetics of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with locally advanced or metastatic solid tumors: the role of alpha-1-acid glycoprotein binding.

Graham RA, Lum BL, Cheeti S, Jin JY, Jorga K, Von Hoff DD, Rudin CM, Reddy JC, Low JA, Lorusso PM.

Clin Cancer Res. 2011 Apr 15;17(8):2512-20. doi: 10.1158/1078-0432.CCR-10-2736. Epub 2011 Feb 7.


Phase I dose-escalation study of recombinant human Apo2L/TRAIL, a dual proapoptotic receptor agonist, in patients with advanced cancer.

Herbst RS, Eckhardt SG, Kurzrock R, Ebbinghaus S, O'Dwyer PJ, Gordon MS, Novotny W, Goldwasser MA, Tohnya TM, Lum BL, Ashkenazi A, Jubb AM, Mendelson DS.

J Clin Oncol. 2010 Jun 10;28(17):2839-46. doi: 10.1200/JCO.2009.25.1991. Epub 2010 May 10.


Phase I study of valspodar (PSC-833) with mitoxantrone and etoposide in refractory and relapsed pediatric acute leukemia: a report from the Children's Oncology Group.

O'Brien MM, Lacayo NJ, Lum BL, Kshirsagar S, Buck S, Ravindranath Y, Bernstein M, Weinstein H, Chang MN, Arceci RJ, Sikic BI, Dahl GV.

Pediatr Blood Cancer. 2010 May;54(5):694-702. doi: 10.1002/pbc.22366.


Determination of GDC-0449, a small-molecule inhibitor of the Hedgehog signaling pathway, in human plasma by solid phase extraction-liquid chromatographic-tandem mass spectrometry.

Ding X, Chou B, Graham RA, Cheeti S, Percey S, Matassa LC, Reuschel SA, Meng M, Liu S, Voelker T, Lum BL, Rudewicz PJ, Hop CE.

J Chromatogr B Analyt Technol Biomed Life Sci. 2010 Mar 15;878(9-10):785-90. doi: 10.1016/j.jchromb.2010.01.039. Epub 2010 Feb 1.


Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC).

Tran HT, Zinner RG, Blumenschein GR Jr, Oh YW, Papadimitrakopoulou VA, Kim ES, Lu C, Malik M, Lum BL, Herbst RS.

Invest New Drugs. 2011 Jun;29(3):499-505. doi: 10.1007/s10637-009-9380-z. Epub 2010 Jan 22.


Inhibition of the hedgehog pathway in advanced basal-cell carcinoma.

Von Hoff DD, LoRusso PM, Rudin CM, Reddy JC, Yauch RL, Tibes R, Weiss GJ, Borad MJ, Hann CL, Brahmer JR, Mackey HM, Lum BL, Darbonne WC, Marsters JC Jr, de Sauvage FJ, Low JA.

N Engl J Med. 2009 Sep 17;361(12):1164-72. doi: 10.1056/NEJMoa0905360. Epub 2009 Sep 2.


A phase I/II trial of trastuzumab plus erlotinib in metastatic HER2-positive breast cancer: a dual ErbB targeted approach.

Britten CD, Finn RS, Bosserman LD, Wong SG, Press MF, Malik M, Lum BL, Slamon DJ.

Clin Breast Cancer. 2009 Feb;9(1):16-22. doi: 10.3816/CBC.2009.n.003.


Effect of food on the pharmacokinetics of erlotinib, an orally active epidermal growth factor receptor tyrosine-kinase inhibitor, in healthy individuals.

Ling J, Fettner S, Lum BL, Riek M, Rakhit A.

Anticancer Drugs. 2008 Feb;19(2):209-16. doi: 10.1097/CAD.0b013e3282f2d8e4.


The effects of CYP3A4 inhibition on erlotinib pharmacokinetics: computer-based simulation (SimCYP) predicts in vivo metabolic inhibition.

Rakhit A, Pantze MP, Fettner S, Jones HM, Charoin JE, Riek M, Lum BL, Hamilton M.

Eur J Clin Pharmacol. 2008 Jan;64(1):31-41. Epub 2007 Nov 14.


Pharmacokinetics and safety of bevacizumab administered in combination with cisplatin and paclitaxel in cynomolgus monkeys.

Xu L, Zuch CL, Lin YS, Modi NB, Lum BL.

Cancer Chemother Pharmacol. 2008 Apr;61(4):607-14. Epub 2007 Jun 5.


Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer.

Lu JF, Eppler SM, Wolf J, Hamilton M, Rakhit A, Bruno R, Lum BL.

Clin Pharmacol Ther. 2006 Aug;80(2):136-45.


Rationale for fixed dosing of pertuzumab in cancer patients based on population pharmacokinetic analysis.

Ng CM, Lum BL, Gimenez V, Kelsey S, Allison D.

Pharm Res. 2006 Jun;23(6):1275-84. Epub 2006 May 26.


Metabolism and excretion of erlotinib, a small molecule inhibitor of epidermal growth factor receptor tyrosine kinase, in healthy male volunteers.

Ling J, Johnson KA, Miao Z, Rakhit A, Pantze MP, Hamilton M, Lum BL, Prakash C.

Drug Metab Dispos. 2006 Mar;34(3):420-6. Epub 2005 Dec 28.


A phase I trial of aprinocarsen (ISIS 3521/LY900003), an antisense inhibitor of protein kinase C-alpha administered as a 24-hour weekly infusion schedule in patients with advanced cancer.

Advani R, Lum BL, Fisher GA, Halsey J, Geary RS, Holmlund JT, Kwoh TJ, Dorr FA, Sikic BI.

Invest New Drugs. 2005 Oct;23(5):467-77.


A phase I trial of liposomal doxorubicin, paclitaxel and valspodar (PSC-833), an inhibitor of multidrug resistance.

Advani R, Lum BL, Fisher GA, Halsey J, Chin DL, Jacobs CD, Sikic BI.

Ann Oncol. 2005 Dec;16(12):1968-73. Epub 2005 Aug 26.


Phase I trial of irinotecan, infusional 5-fluorouracil, and leucovorin (FOLFIRI) with erlotinib (OSI-774): early termination due to increased toxicities.

Messersmith WA, Laheru DA, Senzer NN, Donehower RC, Grouleff P, Rogers T, Kelley SK, Ramies DA, Lum BL, Hidalgo M.

Clin Cancer Res. 2004 Oct 1;10(19):6522-7.


A Phase II trial of aprinocarsen, an antisense oligonucleotide inhibitor of protein kinase C alpha, administered as a 21-day infusion to patients with advanced ovarian carcinoma.

Advani R, Peethambaram P, Lum BL, Fisher GA, Hartmann L, Long HJ, Halsey J, Holmlund JT, Dorr A, Sikic BI.

Cancer. 2004 Jan 15;100(2):321-6.


Phase I trial of uracil-ftorafur, leucovorin, and etoposide: an active all-oral regimen for metastatic breast cancer.

Hartman AR, Grekowicz A, Lum BL, Carlson RW, Schurman C, Sikic BI, Shapiro R, Stockdale FE.

Breast Cancer Res Treat. 2003 Nov;82(1):61-9.


Phase I and pharmacokinetic study of BMS-188797, a new taxane analog, administered on a weekly schedule in patients with advanced malignancies.

Advani R, Fisher GA, Lum BL, Jambalos C, Cho CD, Cohen M, Gollerkeri A, Sikic BI.

Clin Cancer Res. 2003 Nov 1;9(14):5187-94.


Pharmacokinetic interactions of cyclosporine with etoposide and mitoxantrone in children with acute myeloid leukemia.

Lacayo NJ, Lum BL, Becton DL, Weinstein H, Ravindranath Y, Chang MN, Bomgaars L, Lauer SJ, Sikic BI, Dahl GV.

Leukemia. 2002 May;16(5):920-7.


Long-term results of irradiation for patients with progressive Graves' ophthalmopathy.

Marquez SD, Lum BL, McDougall IR, Katkuri S, Levin PS, MacManus M, Donaldson SS.

Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):766-74.


A phase I trial of doxorubicin, paclitaxel, and valspodar (PSC 833), a modulator of multidrug resistance.

Advani R, Fisher GA, Lum BL, Hausdorff J, Halsey J, Litchman M, Sikic BI.

Clin Cancer Res. 2001 May;7(5):1221-9.


Primary leiomyosarcoma of the vagina. A case report and literature review.

Ciaravino G, Kapp DS, Vela AM, Fulton RS, Lum BL, Teng NN, Roberts JA.

Int J Gynecol Cancer. 2000 Jul;10(4):340-347.


Effect of high-dose cyclosporine on etoposide pharmacodynamics in a trial to reverse P-glycoprotein (MDR1 gene) mediated drug resistance.

Lum BL, Kaubisch S, Fisher GA, Brown BW, Sikic BI.

Cancer Chemother Pharmacol. 2000;45(4):305-11.


A phase I single-dose trial of gadolinium texaphyrin (Gd-Tex), a tumor selective radiation sensitizer detectable by magnetic resonance imaging.

Rosenthal DI, Nurenberg P, Becerra CR, Frenkel EP, Carbone DP, Lum BL, Miller R, Engel J, Young S, Miles D, Renschler MF.

Clin Cancer Res. 1999 Apr;5(4):739-45.

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