Phase I/randomized phase II study of afatinib, an irreversible ErbB family blocker, with or without protracted temozolomide in adults with recurrent glioblastoma

Neuro-Oncology

Volumn 17, Issue 3, 2015, Pages 430-439

  Reardon, David A ^a   Nabors, Louis B ^b   Mason, Warren P ^c   Perry, James R ^d   Shapiro, William ^e,s   Kavan, Petr ^f   Mathieu, David ^g   Phuphanich, Surasak ^h   Cseh, Agnieszka ^h,i   Fu, Yali ^j   Cong, Julie ^j   Wind, Sven ^k   Eisenstat, David D ^l,m   Wen, Patrick ^a   Mikkelson, Tom ⁿ   Portnow, Jana ^o   Giglio, Pierre ^p   Lai, Rose ^q   New, Pamela ^r   Fink, Karen ^t   Chowdhary, Sajeel ^u   Madison, Michael ^v   Taylor, Lynn ^w   Hadjipanayis, Constantinos ^x   Madarnas, Yolanda ^y   Easaw, Jacob ^z   Vallières, Isabelle ^aa   Hirte, Hal ^ab   Whitlock, Pierre ^ac   MacNeil, Mary V ^ad   more..

^a DANA FARBER CANCER INSTITUTE   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c PRINCESS MARGARET HOSPITAL   (Canada)

^d UNIVERSITY OF TORONTO   (Canada)

^e BARROW NEUROLOGICAL INSTITUTE   (United States)

^f MCGILL UNIVERSITY   (Canada)

^g CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE   (Canada)

^h CEDARS SINAI MEDICAL CENTER   (United States)

ⁱ BOEHRINGER INGELHEIM RCV GMBH AND CO KG   (Austria)

^j BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^k BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^l CANCERCARE MANITOBA   (Canada)

^m UNIVERSITY OF ALBERTA   (Canada)

ⁿ HENRY FORD HEALTH SYSTEM   (United States)

^o CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^p MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^q Department of Medicine   (United States)

^r HOUSTON METHODIST RESEARCH INSTITUTE   (United States)

^s ST JOSEPH'S HOSPITAL AND MEDICAL CENTER   (United States)

^t Neuro Oncology Assocs   (United States)

^u FLORIDA HOSPITAL CANCER INSTITUTE   (United States)

^v METHODIST UNIVERSITY HOSPITAL   (United States)

^w VIRGINIA MASON MEDICAL CENTER   (United States)

^x EMORY CLINIC   (United States)

^y KINGSTON GENERAL HOSPITAL   (Canada)

^z TOM BAKER CANCER CENTRE   (Canada)

^aa LAVAL UNIVERSITY   (Canada)

^ab JURAVINSKI CANCER CENTRE   (Canada)

^ac Dr Georges L Dumont Regional Hospital   (Canada)

^ad QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

more..

Author keywords

Afatinib; EGFRvIII; ErbB family; Glioblastoma; Temozolomide

Indexed keywords

AFATINIB; BEVACIZUMAB; ENOXAPARIN; EPIDERMAL GROWTH FACTOR RECEPTOR 3; TEMOZOLOMIDE; ANTINEOPLASTIC AGENT; DACARBAZINE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; QUINAZOLINE DERIVATIVE;

ACNE; ACUTE KIDNEY FAILURE; ACUTE PRE RENAL FAILURE; ADULT; AGE DISTRIBUTION; AGED; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLOOD EXAMINATION; BLOOD TOXICITY; BRAIN HEMORRHAGE; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER RECURRENCE; COHORT ANALYSIS; CONNECTIVE TISSUE DISEASE; CONTINUOUS INFUSION; CONTROLLED STUDY; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DISEASE COURSE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; ELECTROCARDIOGRAPHY; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL DISEASE; GLIOBLASTOMA; HEART LEFT VENTRICLE FUNCTION; HUMAN; HUMAN TISSUE; HYPOKALEMIA; INFECTION; LABORATORY TEST; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; NAUSEA; NEUTROPENIA; PANCREATITIS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RECOMMENDED DRUG DOSE; RECURRENT GLIOBLASTOMA; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; BRAIN NEOPLASMS; CLINICAL TRIAL; COMBINATION DRUG THERAPY; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC AGENTS; BRAIN NEOPLASMS; DACARBAZINE; DRUG THERAPY, COMBINATION; FEMALE; GLIOBLASTOMA; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; QUINAZOLINES; RECEPTOR, ERBB-2; TREATMENT OUTCOME;

EID: 84987616093     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1093/neuonc/nou160     Document Type: Article

References (45)

1. Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987-996.
2. Chinot OL, Wick W, Mason W, et al. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014;370(8):709-722.
3. Gilbert MR, Dignam JJ, Armstrong TS, et al. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014;370(8):699-708.
4. Stupp R, Hegi ME, Gorlia T, et al. Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma and methylated O6-methylguanine-DNA methyltransferase (MGMT) gene promoter: Key results of the multicenter, randomized, open-label, controlled, phase III CENTRIC study. ASCO Meeting Abstracts. 2013;31(18 suppl):LBA2009.
5. Weller M, Cloughesy T, Perry JR, et al. Standards of care for treatment of recurrent glioblastoma-are we there yet? Neuro Oncol. 2013;15(1):4-27.
6. Silber JR, Bobola MS, Blank A, et al. O(6)-methylguanine-DNA methyltransferase in glioma therapy: promise and problems. Biochim Biophys Acta. 2012;1826(1):71-82.
7. Perry JR, Belanger K, Mason WP, et al. Phase II trial of continuous dose-intense temozolomide in recurrent malignant glioma: RESCUE study. J Clin Oncol. 2010;28(12):2051-2057.
8. Perry JR, Rizek P, Cashman R, et al. Temozolomide rechallenge in recurrent malignant glioma by using a continuous temozolomide schedule: the "rescue" approach. Cancer. 2008; 113(8):2152-2157.
9. Tolcher AW, Gerson SL, Denis L, et al. Marked inactivation of O6-alkylguanine-DNA alkyltransferase activity with protracted temozolomide schedules. Br J Cancer. 2003;88(7):1004-1011.
10. Citri A, Yarden Y. EGF-ERBB signalling: towards the systems level. Nat Rev Mol Cell Biol. 2006;7(7):505-516.
11. Andersson U, Schwartzbaum J, Wiklund F, et al. A comprehensive study of the association between the EGFR and ERBB2 genes and glioma risk. Acta Oncol. 2010;49(6):767-775.
12. Frederick L, Wang XY, Eley G, et al. Diversity and frequency of epidermal growth factor receptor mutations in human glioblastomas. Cancer Res. 2000;60(5):1383-1387.
13. Pelloski CE, Ballman KV, Furth AF, et al. Epidermal growth factor receptor variant III status defines clinically distinct subtypes of glioblastoma. J Clin Oncol. 2007;25(16):2288-2294.
14. Kreisl TN, Lassman AB, Mischel PS, et al. A pilot study of everolimus and gefitinib in the treatment of recurrent glioblastoma (GBM). J Neurooncol. 2009;92(1):99-105.
15. Reardon DA, Desjardins A, Vredenburgh JJ, et al. Phase 2 trial of erlotinib plus sirolimus in adults with recurrent glioblastoma. J Neurooncol. 2010;96(2):219-230.
16. 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 ClinOncol. 2008;26(34):5603-5609.
17. de Groot JF, Gilbert MR, Aldape K, et al. Phase II study of carboplatin and erlotinib (Tarceva, OSI-774) in patients with recurrent glioblastoma. J Neurooncol. 2008;90(1):89-97.
18. 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(7):1047-1051.
19. Hegi ME, Diserens AC, Bady P, et al. Pathway analysis of glioblastoma tissue after preoperative treatment with the EGFR tyrosine kinase inhibitor gefitinib-a phase II trial. Mol Cancer Ther. 2011;10(6):1102-1112.
20. Norden AD, Raizer JJ, Abrey LE, et al. Phase II trials of erlotinib or gefitinib in patients with recurrent meningioma. J Neurooncol. 2010;96(2):211-217.
21. Peereboom DM, Shepard DR, Ahluwalia MS, et al. Phase II trial of erlotinib with temozolomide and radiation in patients with newly diagnosed glioblastoma multiforme. J Neurooncol. 2010;98(1): 93-99.
22. Prados MD, Chang SM, Butowski N, et al. Phase II study of erlotinib plus temozolomide during and after radiation therapy in patients with newly diagnosed glioblastoma multiforme or gliosarcoma. J Clin Oncol. 2009;27(4):579-584.
23. Raizer JJ, Abrey LE, Lassman AB, et al. A phase II trial of erlotinib in patients with recurrent malignant gliomas and nonprogressive glioblastoma multiforme postradiation therapy. Neuro Oncol. 2010;12(1):95-103.
24. Rich JN, Reardon DA, Peery T, et al. Phase II trial of gefitinib in recurrent glioblastoma. J Clin Oncol. 2004;22(1):133-142.
25. van den Bent MJ, Brandes AA, Rampling R, et al. Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034. J Clin Oncol. 2009;27(8):1268-1274.
26. Yung WK, Vredenburgh JJ, Cloughesy TF, et al. Safety and efficacy of erlotinib in first-relapse glioblastoma: a phase II open-label study. Neuro Oncol. 2010;12(10):1061-1070.
27. Solca F, Dahl G, Zoephel A, et al. Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker. J Pharmacol Exp Ther. 2012;343(2):342-350.
28. Li D, Ambrogio L, Shimamura T, et al. BIBW2992, an irreversible EGFR/HER2 inhibitor highly effective in preclinical lung cancer models. Oncogene. 2008;27(34):4702-4711.
29. Miller VA, Hirsh V, Cadranel J, et al. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol. 2012;13(5):528-538.
30. Wu YL, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(2):213-222.
31. Yang JC, Shih JY, Su WC, et al. Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial. Lancet Oncol. 2012; 13(5):539-548.
32. 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(12): e485.
33. Stopfer P, Marzin K, Narjes H, et al. Afatinib pharmacokinetics and metabolism after oral administration to healthy male volunteers. Cancer Chemother Pharmacol. 2012;69(4):1051-1061.
34. Wen PY, Macdonald DR, Reardon DA, et al. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010;28(11):1963-1972.
35. Chien AJ, Illi JA, Ko AH, et al. A phase I study of a 2-day lapatinib chemosensitization pulse preceding nanoparticle albumin-bound paclitaxel for advanced solid malignancies. Clin Cancer Res. 2009; 15(17):5569-5575.
36. Alshami J, Lecavalier-Barsoum M, Guiot M-C, et al. Glioblastoma recurrence: impact of the molecular profile. Neuro Ooncol. 2013; 15(3-suppl):iii98-iii135 [abstract].
37. Brandes AA, Tosoni A, Cavallo G, et al. Temozolomide 3 weeks on and 1 week off as first-line therapy for recurrent glioblastoma: phase II study from Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO). Br J Cancer. 2006;95(9):1155-1160.
38. Gilbert MR, Wang M, Aldape KD, et al. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013;31(32):4085-4091.
39. Rosso L, Brock CS, Gallo JM, et al. A new model for prediction of drug distribution in tumor and normal tissues: pharmacokinetics of temozolomide in glioma patients. Cancer Res. 2009;69(1): 120-127.
40. Marshall J, Hwang J, Eskens FA, et al. A Phase I, open-label, dose escalation study of afatinib, in a 3-week-on/1-week-off schedule in patients with advanced solid tumors. Invest New Drugs. 2013; 31(2):399-408.
41. Thiessen B, Stewart C, Tsao M, et al. A phase I/II trial of GW572016 (lapatinib) in recurrent glioblastoma multiforme: clinical outcomes, pharmacokinetics and molecular correlation. Cancer Chemother Pharmacol. 2010;65(2):353-361.
42. Vivanco I, Robins HI, Rohle D, et al. Differential sensitivity of glioma-versus lung cancer-specific EGFR mutations to EGFR kinase inhibitors. Cancer Discov. 2012;2(5):458-471.
43. Shinojima N, Tada K, Shiraishi S, et al. Prognostic value of epidermal growth factor receptor in patients with glioblastoma multiforme. Cancer Res. 2003;63(20):6962-6970.
44. Heimberger AB, Hlatky R, Suki D, et al. Prognostic effect of epidermal growth factor receptor and EGFRvIII in glioblastoma multiforme patients. Clin Cancer Res. 2005;11(4):1462-1466.
45. 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(19):2012-2024.