Erlotinib: As maintenance monotherapy in non-small-cell lung cancer

BioDrugs

Volumn 25, Issue 3, 2011, Pages 139-146

  Muir, Victoria J ^a   Dhillon, Sohita ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Profiles; Erlotinib; Non small cell lung cancer

Indexed keywords

CIPROFLOXACIN; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; GEMCITABINE; KETOCONAZOLE; OMEPRAZOLE; PEMETREXED; PLACEBO; RANITIDINE; RIFAMPICIN;

ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER RESISTANCE; CANCER SURVIVAL; CREATININE CLEARANCE; DIARRHEA; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG EXCRETION; DRUG FATALITY; DRUG HALF LIFE; DRUG MEGADOSE; DRUG METABOLISM; DRUG PROTEIN BINDING; DRUG SOLUBILITY; DRUG TOLERABILITY; GENE MUTATION; HEMODIALYSIS PATIENT; HUMAN; IC 50; IMMUNOHISTOCHEMISTRY; INTERSTITIAL LUNG DISEASE; KIDNEY FUNCTION; LUNG NON SMALL CELL CANCER; MAINTENANCE THERAPY; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NONHUMAN; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 2 CLINICAL TRIAL (TOPIC); PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; QUALITY OF LIFE; RASH; REPEATED DRUG DOSE; SINGLE DRUG DOSE; SMOKING; SOLID TUMOR; STEADY STATE; TREATMENT RESPONSE; WILD TYPE;

ANIMALS; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; LUNG NEOPLASMS; PROTEIN KINASE INHIBITORS; QUALITY OF LIFE; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 79957918829     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.2165/11206910-000000000-00000     Document Type: Article

References (52)

1. Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 2010 Mar; 46 (4): 765-81
2. Ferlay J, Shin H-R, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; 127 (12): 2893-917
3. Ramalingam S, Belani C. Systemic chemotherapy for advanced non-small cell lung cancer: recent advances and future directions.Oncologist 2008; 13 Suppl. 1: 5-13
4. Dancey JE. Epidermal growth factor receptor inhibitors in non-small cell lung cancer. Drugs 2007; 67 (8): 1125-38 (Pubitemid 46871023)
5. Cappuzzo F, Ciuleanu T, Stelmakh L, et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebocontrolled phase 3 study. Lancet Oncol 2010 Jun; 11 (6): 521-9
6. Coate LE, Shepherd FA. Maintenance therapy in advanced non-small cell lung cancer. J Thorac Oncol 2010 May; 5 (5): 723-34
7. Triano LR, Deshpande H, Gettinger SN. Management of patients with advanced non-small cell lung cancer: current and emerging options. Drugs 2010; 70 (2): 167-79
8. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Non-Small Cell Lung Cancer, version 3.2011 [online]. Available from URL: http://www.nccn.org/professionals/physician-gls/ pdf/nscl.pdf [Accessed 2011 Mar 22]
9. D'Addario G, Fruh M, Reck M, et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010 May; 21 Suppl. 5: v116-9
10. Owonikoko TK, Ramalingam SS, Belani CP. Maintenance therapy for advanced non-small cell lung cancer: current status, controversies, and emerging consensus. Clin Cancer Res 2010 May 1; 16 (9): 2496-504
11. Roche. Summary of ProductCharacteristics: Tarceva 25 mg film-coated tablets [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/ document-library/EPAR-Product-Information/human/000618/WC500033994.pdf [Accessed 2010 Nov 10]
12. Robinson DM, Keating GM, Perry CM. Erlotinib. Am J Cancer 2005; 4 (4): 247-52 (Pubitemid 41306476)
13. Hidalgo M, Bloedow D. Pharmacokinetics and pharmacodynamics: maximizing the clinical potential of erlotinib (Tarceva). Semin Oncol 2003 Jun; 30 (3 Suppl. 7): 25-33 (Pubitemid 36828625)
14. Ciardiello F, Tortora G.Anovel approach in the treatment of cancer: targeting the epidermal growth factor receptor. Clin Cancer Res 2001 Oct; 7 (10): 2958-70 (Pubitemid 32963812)
15. Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat Rev Mol Cell Biol 2001 Feb; 2 (2): 127-37 (Pubitemid 33674041)
16. Genentech Inc. Tarceva : US prescribing information [online]. Available from URL: http://www.gene.com/gene/products/information/pdf/tarceva-prescri bing.pdf [Accessed 2010 Nov 25]
17. Pao W, Miller VA. Epidermal growth factor receptor mutations, smallmolecule kinase inhibitors, and non-small-cell lung cancer: current knowledge and future directions. J Clin Oncol 2005 Apr 10; 23 (11): 2556-68
18. Moyer JD, Barbacci EG, Iwata KK, et al. Induction of apoptosis and cell cycle arrest by CP-358,774, an inhibitor of epidermal growth factor receptor tyrosine kinase. Cancer Res 1997 Nov 1; 57 (21): 4838-48
19. Pollack VA, Savage DM, Baker DA, et al. Inhibition of epidermal growth factor receptor-associated tyrosine phosphorylation in human carcinomas with CP-358,774: dynamics of receptor inhibition in situ and antitumor effects in athymic mice. J Pharmacol Exp Ther 1999 Nov; 291 (2): 739-48 (Pubitemid 29503548)
20. Ling YH, Li T, Yuan Z, et al. Erlotinib, an effective epidermal growth factor receptor tyrosine kinase inhibitor, induces p27KIP1 up-regulation and nuclear translocation in association with cell growth inhibition and G1/S phase arrest in human non-small-cell lung cancer cell lines. Mol Pharmacol 2007 Aug; 72 (2): 248-58 (Pubitemid 47124105)
21. Qian X, Li J, Ding J, et al. Erlotinib activates mitochondrial death pathways related to the production of reactive oxygen species in the human non-small cell lung cancer cell line A549. Clin Exp Pharmacol Physiol 2009 May; 36 (5-6): 487-94
22. Schaefer G, Shao L, Totpal K, et al. Erlotinib directly inhibits HER2 kinase activation and downstream signaling events in intact cells lacking epidermal growth factor receptor expression. Cancer Res 2007 Feb 1; 67 (3): 1228-38
23. Ling YH, Lin R, Perez-Soler R. Erlotinib induces mitochondrial-mediated apoptosis in human H3255 non-small-cell lung cancer cells with epidermal growth factor receptor L858R mutation through mitochondrial oxidative phosphorylation-dependent activation of BAX and BAK. Mol Pharmacol 2008 Sep; 74 (3): 793-806
24. Higgins B, Kolinsky K, Smith M, et al. Antitumor activity of erlotinib (OSI-774, Tarceva) alone or in combination in human non-small cell lung cancer tumor xenograft models. Anticancer Drugs 2004 Jun; 15 (5): 503-12 (Pubitemid 38736950)
25. Dai Q, Ling Y-H, Lia M, et al. Enhanced sensitivity to the HER1/epidermal growth factor receptor tyrosine kinase inhibitor erlotinib hydrochloride in chemotherapy-resistant tumor cell lines. Clin Cancer Res 2005 Feb 15; 11 (4): 1572-8 (Pubitemid 40315242)
26. Amann J, Kalyankrishna S, Massion PP, et al. Aberrant epidermal growth factor receptor signaling and enhanced sensitivity to EGFR inhibitors in lung cancer. Cancer Res 2005 Jan 1; 65 (1): 226-35 (Pubitemid 40070814)
27. Gong Y, Somwar R, Politi K, et al. Induction of BIM is essential for apoptosis triggered by EGFR kinase inhibitors in mutant EGFR-dependent lung adenocarcinomas. PLoS Med 2007 Oct 9; 4 (10): e294
28. Pao W, Miller V, ZakowskiM, et al.EGFreceptor gene mutations are common in lung cancers from never smokers and are associated with sensitivity of tumors to gefitinib and erlotinib. Proc Natl Acad Sci U S A 2004 Sep 7; 101 (36): 13306-11 (Pubitemid 39209661)
29. Tsao MS, Sakurada A, Cutz JC, et al. Erlotinib in lung cancer: molecular and clinical predictors of outcome. N Engl J Med 2005 Jul 14; 353 (2): 133-44 (Pubitemid 41058345)
30. Zhu CQ, da Cunha Santos G, Ding K, et al. Role of KRAS and EGFR as biomarkers of response to erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 2008 Sep 10; 26 (26): 4268-75
31. Paz-Ares L, Soulieres D, Melezinek I, et al. Clinical outcomes in non-small-cell lung cancer patients with EGFR mutations: pooled analysis. J Cell MolMed 2010 Jan; 14 (1-2): 51-69
32. Rosell R, Moran T, Queralt C, et al. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl JMed 2009 Sep 3; 361 (10): 958-67
33. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005 Jul 14; 353 (2): 123-32 (Pubitemid 41058344)
34. Pao W, Miler VA, Politi KA, et al. Acquired resistance of lung adenocarcinomas to gefitinib or erlotinib is associated with a second mutation in the EGFR kinase domain. PLoS Med 2005 Mar; 2 (3): e73
35. Nguyen KS, Kobayashi S, Costa DB. Acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancers dependent on the epidermal growth factor receptor pathway. Clin Lung Cancer 2009 Jul; 10 (4): 281-9
36. Morgillo F, Woo JK, Kim ES, et al. Heterodimerization of insulin-like growth factor receptor/epidermal growth factor receptor and induction of survivin expression counteract the antitumor action of erlotinib. Cancer Res 2006 Oct 15; 66 (20): 10100-11 (Pubitemid 44672064)
37. Ling J, Johnson KA, Miao Z, et al. Metabolism and excretion of erlotinib, a small molecule inhibitor of epidermal growth factor receptor tyrosine kinase, in healthy male volunteers. Drug Metab Dispos 2006 Mar; 34 (3): 420-6 (Pubitemid 43290900)
38. Frohna P, Lu J, Eppler S, et al. Evaluation of the absolute oral bioavailability and bioequivalence of erlotinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in a randomized, crossover study in healthy subjects. J Clin Pharmacol 2006 Mar; 46 (3): 282-90 (Pubitemid 43260315)
39. Hidalgo M, Siu LL, Nemunaitis J, et al. Phase I and pharmacologic study of OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced solid malignancies. J Clin Oncol 2001 Jul; 19: 3267-79 (Pubitemid 32591445)
40. Lu JF, Eppler SM, Wolf J, et al. Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer. Clin Pharmacol Ther 2006 Aug; 80 (2): 136-45 (Pubitemid 44160689)
41. Togashi Y, Masago K, Fukudo M, et al. Cerebrospinal fluid concentration of erlotinib and its active metabolite OSI-420 in patients with central nervous system metastases of non-small cell lung cancer. J Thorac Oncol 2010; 5 (7): 950-5
42. Li J, ZhaoM, He P, et al. Differential metabolism of gefitinib and erlotinib by human cytochrome P450 enzymes. Clin Cancer Res 2007 Jun 15; 13 (12): 3731-7 (Pubitemid 46955138)
43. Hughes AN, OBrien ME, Petty WJ, et al. Overcoming CYP1A1/1A2 mediated induction of metabolism by escalating erlotinib dose in current smokers. J Clin Oncol 2009 Mar 10; 27 (8): 1220-6
44. Hamilton M, Wolf JL, Rusk J, et al. Effects of smoking on the pharmacokinetics of erlotinib. Clin Cancer Res 2006 Apr 1; 12 (7 Pt 1): 2166-71
45. Hamilton M, Wolf JL, Zborowski D, et al. Tarceva (erlotinib) exposure/effects (EE) analysis from a phase III study in advanced NSCLC: effect of smoking on the PK of erlotinib [abstract no. 6165]. Proc Am Assoc Cancer Res 2005; 46: 1451
46. Miller AA, Murry DJ, Owzar K, et al. Phase I and pharmacokinetic study of erlotinib for solid tumors in patients with hepatic or renal dysfunction: CALGB 60101. J Clin Oncol 2007 Jul 20; 25 (21): 3055-60 (Pubitemid 47218052)
47. Togashi Y,Masago K, FukudoM, et al. Pharmacokinetics of erlotinib and its active metabolite OSI-420 in patients with non-small cell lung cancer and chronic renal failure who are undergoing hemodialysis. J Thorac Oncol 2010 May; 5 (5): 601-5
48. Brugger W, Kim JH, Hansen O, et al. Molecular markers and clinical outcome with erlotinib: results from the phase III placebo-controlled SATURN study of maintenance therapy for advanced NSCLC [abstract no. B9.1]. J Thorac Oncol 2009; 4 (9 Suppl. 1): S348-9
49. Juhasz E, Kim J-H, Stelmakh L, et al. Maintenance therapy of non-small cell lung cancer with erlotinib preserves quality of life [abstract no. 439P]. Ann Oncol 2010; 21 Suppl. 8: viii147
50. Cappuzzo F, Ciuleanu T-E, Park K, et al. Erlotinib maintenance therapy in patients with stable disease after first-line platinum-doublet chemotherapy for advanced NSCLC [abstract no. 369PD]. Ann Oncol 2010; 21 Suppl. 8: viii124
51. PerolM, Zalcman G, Monnet I, et al. Final results from the IFCT-GFPC 0502 phase III study: maintenance therapy in advanced NSCLC with either gemcitabine (G) or erlotinib (E) versus observation (O) after cisplatin-gemcitabine induction chemotherapy (CT), with a predefined second-line treatment [abstract no. 370PD]. Ann Oncol 2010; 21 Suppl. 8: viii124. Plus poster presented at the 35th ESMO Congress; 2010 Oct 8-12; Milan
52. European Medicines Agency. Assessment report for Tarceva [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR- Assessment-Report-Variation/human/000618/WC500090680.pdf [Accessed 2011 Jan 24]