A phase II trial of erlotinib in patients with recurrent malignant gliomas and nonprogressive glioblastoma multiforme postradiation therapy

Neuro-Oncology

Volumn 12, Issue 1, 2010, Pages 95-103

  Raizer, Jeffrey J ^a   Abrey, Lauren E ^b   Lassman, Andrew B ^b   Chang, Susan M ^c   Lamborn, Kathleen R ^c   Kuhn, John G ^d   Yung, W K Alfred ^e   Gilbert, Mark R ^e   Aldape, Kenneth A ^e   Wen, Patrick Y ^f   Fine, Howard A ^g   Mehta, Minesh ^h   DeAngelis, Lisa M ^b   Lieberman, Frank ⁱ   Cloughesy, Timothy F ^j   Robins, H Ian ^h   Dancey, Janet ^k   Prados, Michael D ^c  

^a NORTHWESTERN UNIVERSITY   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^e UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^f BRIGHAM AND WOMEN S HOSPITAL   (United States)

^g NATIONAL CANCER INSTITUTE   (United States)

^h University of Wisconsin Health   (United States)

ⁱ UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^j UNIVERSITY OF CALIFORNIA   (United States)

^k ONTARIO INSTITUTE FOR CANCER RESEARCH   (Canada)

more..

Author keywords

Erlotinib; Glioblastoma; Glioma; Meningioma; Pharmacokinetics

Indexed keywords

ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; OSI 420; TEMOZOLOMIDE; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; BILIRUBIN BLOOD LEVEL; BLOOD SAMPLING; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; FATIGUE; FEMALE; GLIOBLASTOMA; HUMAN; HYPOCALCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPOPHOSPHATEMIA; INFECTION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; MUSCLE WEAKNESS; MYALGIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; RECURRENT CANCER; SEIZURE; SIDE EFFECT; SURVIVAL TIME; THERAPY EFFECT; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT OUTCOME; TREATMENT RESPONSE; WEIGHT REDUCTION;

ADULT; AGED; ANTINEOPLASTIC AGENTS; BRAIN NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; GLIOBLASTOMA; GLIOMA; HUMANS; KAPLAN-MEIERS ESTIMATE; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; QUINAZOLINES; TISSUE DISTRIBUTION;

EID: 75749122223     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1093/neuonc/nop015     Document Type: Article

References (43)

1. DeAngelis LM. Chemotherapy for brain tumors-a new beginning. N Engl J Med. 2005;352:1036-1038.
2. Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352:987-996.
3. Nagane M, Coufal F, Lin H, et al. A common mutant epidermal growth factor receptor confers enhanced tumorigenicity on human glioblastoma cells by increasing proliferation and reducing apoptosis. Cancer Res. 1996;56:5079-5086.
4. Nishikawa R, Ji XD, Harmon RC, et al. A mutant epidermal growth factor receptor common in human glioma confers enhanced tumorigenicity. Proc Natl Acad Sci USA. 1994;91: 7727-7731.
5. Rasheed BK, Wiltshire RN, Bigner SH, et al. Molecular pathogenesis of malignant gliomas. Curr Opin Oncol. 1999;11:162-167.
6. Sehgal A. Molecular changes during the genesis of human gliomas. Semin Surg Oncol. 1998;14:3-12.
7. Han Y, Caday CG, Umezawa K, et al. Preferential inhibition of glioblastoma cells with wild-type epidermal growth factor receptors by a novel tyrosine kinase inhibitor ethyl-2,5-dihydroxycinnamate. Oncol Res. 1997;9:581-587.
8. Penar PL, Khoshyomn S, Bhushan A, et al. Inhibition of epidermal growth factor receptor-associated tyrosine kinase blocks glioblastoma invasion of the brain. Neurosurgery. 1997;40:141-151.
9. Mishima K, Johns TG, Luwor RB, et al. Growth suppression of intracranial xenografted glioblastomas overexpressing mutant epidermal growth factor receptors by systemic administration of monoclonal antibody (mAb) 806, a novel monoclonal antibody directed to the receptor. Cancer Res. 2001;61:5349-5354.
10. Iwata KK, Provoncha K, Gibson N. Inhibition of mutant EGFRvIII transformed cells by tyrosine kinase inhibitor OSI-774 (Tarceva). Proc Am Soc Clin Oncol. 2002;21:abstract 79.
11. Vogelbaum MA, Goldlust S, Kanner A. The EGFR tyrosine kinase inhibitor TarcevaTM (OSI-774) shows activity against both wild-type and mutant EGFR. Neuro-Oncology. 2003;3:abstract ET-47.
12. Lal A, Glazer CA, Martinson HM, et al. Mutant epidermal growth factor receptor up-regulates molecular effectors of tumor invasion. Cancer Res. 2002;62:3335-3339.
13. Lassman AB, Rossi MR, Raizer JJ, et al. Molecular study of malignant gliomas treated with epidermal growth factor receptor inhibitors: tissue analysis from North American Brain Tumor Consortium Trials 01-03 and 00-01. Clin Cancer Res. 2005;11:7841-7850.
14. Macdonald DR, Cascino TL, Schold SC, Jr, et al. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol. 1990;8:1277-1280.
15. Mellinghoff IK, Wang MY, Vivanco I, et al. Molecular determinants of the response of glioblastomas to EGFR kinase inhibitors. N Engl J Med. 2005;353:2012-2024.
16. Haas-Kogan DA, Prados MD, Tihan T, et al. Epidermal growth factor receptor, protein kinase B/Akt, and glioma response to erlotinib. J Natl Cancer Inst. 2005;97:880-887.
17. Rich JN, Reardon DA, Peery T, et al. Phase II trial of gefitinib in recurrent glioblastoma. J Clin Oncol. 2004;22:133-142.
18. Uhm JH, Ballman KV, Giannini C, et al. Phase II study of ZD1839 in patients with newly diagnosed grade 4 astrocytoma. J Clin Oncol. 2004;22:abstract 1505.
19. Franceschi E, Cavallo G, Lonardi S, et al. Gefitinib in patients with progressive high-grade gliomas: a multicentre phase II study by Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO). Br J Cancer. 2007;96:1047-1051.
20. Vogelbaum MA, Peereboom D, Stevens G, et al. Phase II trial of the EGFR tyrosine kinase inhibitor erlotinib for single agent therapy of recurrent glioblastoma multiforme: interim results. J Clin Oncol. 2004;22:abstract 1558.
21. Van Den Bent MJ, Brandes A, Rampling R, et al. Randomized phase II trial of erlotinib (E) versus temozolomide (TMZ) or BCNU in recurrent glioblastoma multiforme (GBM): EORTC 26034. J Clin Oncol. 2007;25:abstract 2005 (Meeting Abstracts).
22. Prados MD, Lamborn KR, Chang S, et al. Phase 1 study of erlotinib HCl alone and combined with temozolomide in patients with stable or recurrent malignant glioma. Neuro-Oncology 2006;8:67-78.
23. Neyns BSJ, Joosens E, Bouttens F, et al. A multicenter stratified phase II study of cetuximab for the treatment of patients with recurrent highgrade glioma. J Clin Oncol. 2008;26:abstract 2017.
24. Krishnan S, Brown PD, Ballman KV, et al. Phase I trial of erlotinib with radiation therapy in patients with glioblastoma multiforme: results of North Central Cancer Treatment Group protocol N0177. Int J Radiat Oncol Biol Phys. 2006;65:1192-1199.
25. Brewer CJ, Suh JH, Stevens GHJ, et al. Phase II trial of erlotinib with temozolomide and concurrent radiation therapy in patients with newlydiagnosed glioblastoma multiforme. J Clin Oncol. 2005;23:abstract 1567 (Meeting Abstracts).
26. Prados M, DeBoer R, Chang S, et al. Phase II study of tarceva plus temodar during and following radiotherapy in patients newly diagnosed with glioblastoma or gliosarcoma. Neuro-Oncology. 2007;9:528:abstract MA-50.
27. Brown PD, Krishnan S, Sarkaria JN, et al. Phase I/II trial of erlotinib and temozolomide with radiation therapy in the treatment of newly diagnosed glioblastoma multiforme: North Central Cancer Treatment Group Study N0177. J Clin Oncol. 2008;26:5603-5609.
28. Combs SE, Schulz-Ertner D, Hartmann C, et al. Phase I/II study of cetuximab plus temozolomide as radiochemotherapy for primary glioblastoma (GERT). J Clin Oncol. 2008;26:abstract 2077.
29. Perez-Soler R, Chachoua A, Hammond LA, et al. Determinants of tumor response and survival with erlotinib in patients with nonsmall-cell lung cancer. J Clin Oncol. 2004;22:3238-3247.
30. Dudek AZ, Kmak KL, Koopmeiners J, et al. Skin rash and bronchoalveolar histology correlates with clinical benefit in patients treated with gefitinib as a therapy for previously treated advanced or metastatic nonsmall cell lung cancer. Lung Cancer. 2006; 51:89-96.
31. Herbst RS, Johnson DH, Mininberg E, et al. Phase I/II trial evaluating the anti-vascular endothelial growth factor monoclonal antibody bevacizumab in combination with the HER-1/epidermal growth factor receptor tyrosine kinase inhibitor erlotinib for patients with recurrent nonsmall-cell lung cancer. J Clin Oncol. 2005;23: 2544-2555.
32. Meany HJ, Fox E, McCully C, et al. The plasma and cerebrospinal fluid pharmacokinetics of erlotinib and its active metabolite (OSI-420) after intravenous administration of erlotinib in nonhuman primates. Cancer Chemother Pharmacol. 2008;63(3):387-392.
33. Buie LW, Lindley C, Shih T, et al. Plasma pharmacokinetics and cerebrospinal fluid concentrations of erlotinib in high-grade gliomas: a novel, phase I, dose escalation study. J Clin Oncol. 2007;25:abstract 2054.
34. Hofer S, Frei K. Gefitinib concentrations in human glioblastoma tissue. J Neurooncol. 2007;82:175-176.
35. Feldkamp MM, Lala P, Lau N, et al. Expression of activated epidermal growth factor receptors, Ras-guanosine triphosphate, and mitogenactivated protein kinase in human glioblastoma multiforme specimens. Neurosurgery. 1999;45:1442-1453.
36. Chakravarti A, Seiferheld W, Tu X, et al. Immunohistochemically determined total epidermal growth factor receptor levels not of prognostic value in newly diagnosed glioblastoma multiforme: report from the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 2005;62:318-327.
37. Lee JC, Vivanco I, Beroukhim R, et al. Epidermal growth factor receptor activation in glioblastoma through novel missense mutations in the extracellular domain. PLoS Med. 2006;3:e485.
38. Li D, Ambrogio L, Shimamura T, et al. BIBW2992, an irreversible EGFR/ HER2 inhibitor highly effective in preclinical lung cancer models. Oncogene. 2008;27:4702-4711.
39. Marie Y, Carpentier AF, Omuro AM, et al. EGFR tyrosine kinase domain mutations in human gliomas. Neurology. 2005;64:1444-1445.
40. Preusser M, Gelpi E, Rottenfusser A, et al. Epithelial growth factor receptor inhibitors for treatment of recurrent or progressive high grade glioma: an exploratory study. J Neurooncol. 2008;89:211-218.
41. Riely GJ, Politi KA, Miller VA, et al. Update on epidermal growth factor receptor mutations in nonsmall cell lung cancer. Clin Cancer Res. 2006;12:7232-7241.
42. Mellinghoff IK, Cloughesy TF, Mischel PS. PTEN-mediated resistance to epidermal growth factor receptor kinase inhibitors. Clin Cancer Res. 2007;13:378-381.
43. Stommel JM, Kimmelman AC, Ying H, et al. Coactivation of receptor tyrosine kinases affects the response of tumor cells to targeted therapies. Science. 2007;318:287-290.