Overview of the tolerability of gefitinib (IRESSA™) monotherapy: Clinical experience in non-small-cell lung cancer

Drug Safety

Volumn 27, Issue 14, 2004, Pages 1081-1092

  Forsythe, Beverley ^a   Faulkner, Karen ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE; GEFITINIB;

ACNE; ANOREXIA; ASTHENIA; BONE MARROW DEPRESSION; CANCER CHEMOTHERAPY; CANCER GROWTH; CELL SURVIVAL; CLINICAL TRIAL; DATA BASE; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; HUMAN; LUNG NON SMALL CELL CANCER; NAUSEA; NEPHROTOXICITY; NEUROTOXICITY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PRURITUS; RASH; REVIEW; SIGNAL TRANSDUCTION; VOMITING;

ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIALS, PHASE I; CLINICAL TRIALS, PHASE II; DRUG ADMINISTRATION SCHEDULE; HUMANS; LUNG NEOPLASMS; PRODUCT SURVEILLANCE, POSTMARKETING; PROTEIN-TYROSINE KINASES; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 10644261471     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200427140-00002     Document Type: Review

References (45)

1. Ries LAG, Eisner MP, Kosary CL, et al. SEER cancer statistics review, 1975-2001 [online]. Available from URL: http://seer.cancer.gov/csr/1975_2001/ [Accessed 2004 Apr]
2. Langer CJ, Leighton JC, Comis RL, et al. Paclitaxel and carboplatin in combination in the treatment of advanced non-small-cell lung cancer: a phase II toxicity, response, and survival analysis. J Clin Oncol 1995; 13 (8): 1860-70
3. Sandler AB, Nemunaitis J, Denham C, et al. Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 2000; 18 (1): 122-30
4. Zalcberg J, Millward M, Bishop J, et al. Phase II study of docetaxel and cisplatin in advanced non-small-cell lung cancer. J Clin Oncol 1998; 16 (5): 1948-53
5. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002; 346 (2): 92-8
6. Fossella FV, Devore R, Kerr RN, et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol 2000; 18 (12): 2354-62
7. Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000; 18 (10): 2095-103
8. Hanna NH, Shepherd FA, Resell R, et al. A phase III study of pemetrexed vs docetaxel in patients with recurrent non-small cell lung cancer (NSCLC) who were previously treated with chemotherapy [abstract 2503], Proc Am Soc Clin Oncol 2003; 22: 622
9. Silvestri G, Pritchard R, Welch HG. Preferences for chemotherapy in patients with advanced non-small cell lung cancer: descriptive study based on scripted interviews. BMJ 1998; 317 (7161): 771-5
10. Woodburn JR. The epidermal growth factor receptor and its inhibition in cancer therapy. Pharmacol Ther 1999; 82 (2-3): 241-50
11. Aaronson SA. Growth factors and cancer. Science 1991; 254 (5035): 1146-53
12. Wakeling AE, Guy SP, Woodburn JR, et al. ZD1839 (Iressa): an orally active inhibitor of epidermal growth factor signaling with potential for cancer therapy. Cancer Res 2002; 62 (20): 5749-54
13. National Cancer Institute Cancer Therapy Evaluation Program. Common toxicity criteria manual. Common toxicity criteria, version 2.0 [online]. Available from URL: http://ctep.info.nih.gov/1999 [Accessed 2004 Apr]
14. Schultz G, Cipolla L, Whitehouse A, et al. Growth factors and corneal endothelial cells: III. Stimulation of adult human corneal endothelial cell mitosis in vitro by defined mitogenic agents. Cornea 1992; 11 (1): 20-7
15. AstraZeneca studies TAD/876 (Jan 1997), TAR/2570 (Jan 1997), TPD/877 (Aug 1998). (Data on file)
16. AstraZeneca study TAD/876 (Jan 1997). (Data on file)
17. Nakagawa K, Tamura T, Negoro S, et al. Phase I pharmacokinetic trial of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor gefitinib ('Iressa', ZD1839) in Japanese patients with solid malignant tumours. Ann Oncol 2003; 14 (6): 922-30
18. Ranson M, Hammond LA, Ferry D, et al. ZD1839, a selective oral epidermal growth factor receptor-tyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: results of a phase I trial. J Clin Oncol 2002; 20 (9): 2240-50
19. Baselga J, Rischin D, Ranson M, et al. Phase I safety, pharmacokinetic, and pharmacodynamic trial of ZD1839, a selective oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with five selected solid tumor types. J Clin Oncol 2002; 20 (21): 4292-302
20. Herbst RS, Maddox AM, Rothenberg ML, et al. Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small-cell lung cancer and other solid tumors: results of a phase I trial. J Clin Oncol 2002; 20 (18): 3815-25
21. Swaisland HC, Ranson M, Smith RP, et al. Pharmacokinetic drug interactions with gefitinib (IRESSA, ZD1839) an epidermal growth factor receptor tyrosine kinase inhibitor, during co-administration with rifampicin, itraconazole and metoprolol. Clin Pharmacokinet. In press
22. Herbst R. Targeting the epidermal growth factor receptor: prognostic and clinical implications. Eur J Cancer Suppl 2003; 1 (8): 9-15
23. Fukuoka M, Yano S, Giaccone G, et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 2003; 21 (12): 2237-46
24. Kris MG, Natale RB, Herbst RS, et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. JAMA 2003; 290 (16): 2149-58
25. AstraZeneca Drug Safety, 1 Sep 2004. (Data on file)
26. Forsythe B, Faulkner K. Safety and tolerability of gefitinib ('IRESSA', ZD1839) in advanced NSCLC: overview of clinical experience poster P327. 13th European Respiratory Society Annual Congress; 2003 Sep 27-Oct 1; Vienna
27. Full prescribing information for IRESSA. AstraZeneca Pharmaceuticals LP, Wilmington (DE), USA
28. 14C]-ZD1839 ('Iressa') in healthy male volunteers [poster 95]. 26th European Society for Medical Oncology Congress; 2002 Oct 18-22; Nice
29. Twelves C, White J, Harris A, et al. A phase I pharmacokinetic and tolerability trial of ZD1839 ('Iressa') in hepatically impaired patients with solid tumors [poster 339]. 38th American Society of Clinical Oncology Annual Meeting; 2002 May 18-21; Orlando
30. Swaisland HC, Ranson M, Smith R, et al. Clinical drug interactions with ZD1839 ('Iressa'), a selective epidermal growth factor receptor tyrosine kinase inhibitor [poster 97]. 26th European Society for Medical Oncology Congress; 2002 Oct 18-22; Nice
31. AstraZeneca report: A combined population analysis of trials ZD1839IL/0016 and ZD1839IL/0039, Feb 2002. (Data on file)
32. Cappuzzo F, Bartolini S, Ceresoli GL, et al. Efficacy and tolerability of gefitinib in pretreated elderly patients with advanced non-small-cell lung cancer (NSCLC). Br J Cancer 2004; 90 (1): 82-6
33. Coplin MA, Kommareddy A, McLeod H, et al. Gefitinib ('Iressa', ZD1839) shows activity and is well tolerated in elderly patients with non-small-cell lung cancer (NSCLC) [poster 3048]. 39th American Society of Clinical Oncology Annual Meeting; 2003 May 31-Jun 3; Chicago
34. Gridelli C, Maione P, Castaldo V, et al. Gefitinib in elderly and unfit patients affected by advanced non-small-cell lung cancer. Br J Cancer 2003; 89 (10): 1827-9
35. Soto Parra H, Cavina R, Zucali P, et al. Gefitinib in elderly patients with progressive, pretreated, non-small-cell lung cancer: results from the Istituto Clinico Humanitas [poster]. 10th World Congress on Lung Cancer; 2003 Aug 10-14; Vancouver
36. Herbst RS, LoRusso PM, Purdom M, et al. Dermatologic side effects associated with gefitinib therapy: clinical experience and management. Clin Lung Cancer 2003; 4 (6): 366-9
37. Bhatia S, Hanna N, Ansari R, et al. A phase II study of weekly gemcitabine and paclitaxel in patients with previously untreated stage IIIb and IV non-small cell lung cancer. Lung Cancer 2002; 38(1): 73-7
38. Seto T, Yamamoto N. Interstitial lung diseases (ILD) induced by gefitinib in patients with advanced non-small cell lung cancer (NSCLC): results of a West Japan Thoracic Oncology Group (WJTOG) epidemiological survey [abstract 7064]. Proc Am Soc Clin Oncol 2004; 23: 629
39. Health Canada. Health Canada endorsed important safety information on ARAVA (leflunomide). Arava® (leflunomide) and interstitial lung disease [online]. Available from URL: www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/arava_hpc_e. html/2004 [Accessed 2004 Oct]
40. Koo L, Clark J, Higenbottam T, et al. National differences in reporting 'pneumonia' and 'pneumonia interstitial': an analysis of the WHO adverse events database on 15 drugs in 9 countries for 7 pulmonary conditions. Pharmacoepidemiol Drug Saf 2004; 13 Suppl. 1: S31-2
41. Ma Y, Seneviratne CK, Koss M. Idiopathic pulmonary fibrosis and malignancy. Curr Opin Pulm Med 2001; 7 (5): 278-82
42. Chen Y-M, Perng R-P, Yang K-Y, et al. A multicenter phase trial of vinorelbine plus gemcitabine in previously untreated inoperable (stage IIIB/IV) non-small cell lung cancer. Chest 2000; 117 (6): 1583-9
43. Rebattu P, Quantin X, Ardiet C, et al. Dose-finding, pharmacokinetic and phase II study of docetaxel in combination with gemcitabine in patients with inoperable non-small cell lung cancer. Lung Cancer 2001; 33 (2-3): 277-87
44. Thomas AL, Cox G, Sharma RA, et al. Gemcitabine and paclitaxel associated pneumonitis in non-small cell lung cancer: report of a phase I/II dose-escalating study. Eur J Cancer 2000; 36 (18): 2329-34
45. Willner J, Schmidt M, Kirschner J, et al. Sequential chemo- and radiochemotherapy with weekly paclitaxel (Taxol®) and 3D-conformal radiotherapy of stage III inoperable non small cell lung cancer: results of a dose escalation study. Lung Cancer 2001; 32 (2): 163-71