Dose-comparative monotherapy trials of ZD1839 in previously treated non-small cell lung cancer patients

Seminars in Oncology

Volumn 30, Issue 1 SUPPL. 1, 2003, Pages 30-38

  Herbst, Roy S ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; GEFITINIB; PLATINUM DERIVATIVE; PROTEIN KINASE INHIBITOR; UNCLASSIFIED DRUG;

ACNE; ADVANCED CANCER; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; DIARRHEA; DOSE RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; HUMAN; LUNG NON SMALL CELL CANCER; MONOTHERAPY; PRIORITY JOURNAL; PRURITUS; QUESTIONNAIRE; RASH; RELAPSE; REVIEW; SOLID TUMOR; TREATMENT OUTCOME; VOMITING;

EID: 0037296417     PISSN: 00937754     EISSN: None     Source Type: Journal    
DOI: 10.1053/sonc.2003.50030     Document Type: Review

References (39)

1. Cancer Facts & Figures 2002. Atlanta, GA, American Cancer Society, 2002
2. Schiller JH: Current standards of care in small-cell and non-small-cell lung cancer. Oncology 61:3-13, 2001 (suppl 1)
3. Haura EB: Treatment of advanced non-small-cell lung cancer: A review of current randomized clinical trials and an examination of emerging therapies. Cancer Control 8:326-336, 2001
4. Lara PN Jr, Lau DHM, Davies A, et al: Current status and future directions in advanced non-small cell lung cancer. Oncology Special Edition 4:129-135, 2001
5. Schiller JH, Harrington D, Sandler A, et al: A randomized phase III trial of four chemotherapy regimens in advanced non-small cell lung cancer (NSCLC). Presented at the Thirty-Sixth Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, May 22, 2000
6. Schiller JH, Harrington D, Belani CP, et al for the Eastern Cooperative Oncology Group: Comparison of four chemotherapy regimes for advanced non-small-cell lung cancer. N Engl J Med 346:92-98, 2002
7. Taxotere (docetaxal) for injection concentrate: prescribing information, in Physicians' Desk Reference (55th ed). Montvale, NJ, Medical Economics Co, 2001, pp 748-753
8. Massarelli E, Andre F, Liu DD, et al: A retrospective analysis of the outcome of patients, who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer. Lung Cancer 39:55-61, 2003
9. Fukuoka M: State of the art of non-small-cell lung cancer in the new millennium. Oncology (Huntingt) 15:9-11, 2001 (suppl)
10. Shepherd FA: Chemotherapy for non-small cell lung cancer: Have we reached a new plateau? Semin Oncol 26:3-11, 1999 (suppl 4)
11. American Society of Clinical Oncology: Clinical practice guidelines for the treatment of unresectable non-small-cell lung cancer: Adopted on May 16, 1997 by the American Society of Clinical Oncology. J Clin Oncol 15:2996-3018, 1997
12. Jacobsen PB, Weitzer MA: Evaluation of palliative endpoints in oncology clinical trials. Cancer Control 6:471-477, 1999
13. Shin DM, Ro JY, Hong WK, et al: Dysregulation of epidermal growth factor receptor expression in premalignant lesions during head and neck tumorigenesis. Cancer Res 54: 3153-3159, 1994
14. Carney DN: Lung cancer-Time to move on from chemotherapy. N Engl J Med 346:126-128, 2002
15. Salomon DS, Brandt R, Ciardiello F, et al: Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 19:183-232, 1995
16. Kelloff GJ, Fay JR, Steele VE, et al: Epidermal growth factor receptor tyrosine kinase inhibitors as potential cancer chemopreventives. Cancer Epidemiol Biomarkers Prev 5:657-666, 1996
17. Lei W, Mayotte JE, Levitt ML: Enhancement of chemosensitivity and programmed cell death by tyrosine kinase inhibitors correlates with EGFR expression in non-small cell lung cancer cells. Anticancer Res 19:221-228, 1999
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 20:2240-2250, 2002
19. Kris M, Ranson M, Ferry D, et al: Phase I study of oral ZD1839 ('Iressa'), a novel inhibitor of epidermal growth factor receptor tyrosine kinase (EGFR-TK): Evidence of good tolerability and activity. Presented at American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer, Washington, DC, November 16-19, 1999
20. 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 20:4292-4302, 2002
21. Baselga J, Herhst R, LoRusso P, et al: Continuous administration of ZD1839 (Iresa), a novel oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), in patients with five selected tumor types: Evidence of activity and good tolerability. Proc Am Soc Clin Oncol 19:177a, 2000 (abstr 686)
22. Hirte H, Miller WH, Major P, et al: Initial results of part 2 of a phase I/II pharmacokinetic, pharmacodynamic and biological activity study of ZD1839 ('Iressa'): NCIC CTG IND.122. Presented at American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer, Miami Beach, FL, October 29-November 2, 2001
23. Negoro S, Nakagawa K, Fukuoka M, et al: Final results of a phase I intermittent dose-escalation trial of ZD1839 ('Iressa') in Japanese patients with various solid tumors. Proc Am Sac Clin Oncol 20:324a, 2001 (abstr 1292)
24. Hetbst RS, Maddox A-M, 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 20:3815-3825, 2002
25. Fukuoka M, Yano S, Giaccone G, et al: Final results from a phase II trial of ZD1839 ('Iressa') for patients with advanced non-small-cell lung cancer (IDEAL 1). Proc Am Soc Clin Oncol 21:298a, 2002 (abstr 1188)
26. Kris MG, Natale RB, Herbst RS, et al: A phase II trial of ZD1839 ('Iressa') in advanced non-small cell lung cancer (NSCLC) patients who had failed platinum- and docetaxelbased regimens (IDEAL 2). Proc Am Soc Clin Oncol 21:292a, 2002 (abstr 1166)
27. Green S, Weiss GR: Southwest Oncology Group standard response criteria, endpoint definitions and toxicity criteria. Invest New Drugs 10:239-253, 1992
28. Cella DF, Bonomi AE, Lloyd SR, et al: Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Cancer 12:199-220, 1995
29. Cella D, Eton UT, Fairclough DL, et al: What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol 55:285-295, 2002
30. Douillard J-Y, Giaccone G, Horai T, et al: Improvement in disease-related symptoms and quality of life in patients with advanced non-small-cell lung cancer (NSCLC) treated with ZD1839 ('Iressa') (IDEAL 1). Proc Am Soc Clin Oncol 21: 299a, 2002 (abstr 1195)
31. Baselga J, Yano S, Giaccone G, et al: Initial results from a phase II trial of ZD1839 ('Iressa') as second- and third-line monotherapy for patients with advanced non-small-cell lung cancer (IDEAL 1). Presented at American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer International Conference, Miami Beach, FL, October 29-November 2, 2001
32. Baselga J, Yano, S, Giaccone G, et al. Initial results from a phase II trial of ZD1839 (Iressa) as second- and third-line monotherapy for patients with advanced non-small-cell lung cancer (IDEAL 1). Presented at American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer International Conference, Miami Beach, FL, October 29-November 2, 2000
33. Natale R, Skarin A, Maddox A, et al: Improvement in symptoms and quality of life for advanced non-small-cell lung cancer patients receiving ZD1839 ('Iressa') in IDEAL 2. Presented at the Thirty-Eighth Annual Meeting of the American Society of Clinical Oncology. Orlando, FL, May 18-21, 2002
34. Natale RB, Skarin AT, Maddox A-M, et al. Improvement in symptoms and quality of life for advanced non-small-cell lung cancer patients receiving ZD1839 ('Iressa') in IDEAL 2. Proc Am Soc Clin Oncol 21:292a, 2002 (abstr 1167)
35. Kris M: A phase II trial of ZD1839 ('Iressa') in advanced non-small-cell lung cancer (NSCLC) patients who had failed platinum- and docetaxal-based regimens (IDEAL 2). Presented at the Thirty-Eighth Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002
36. 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 18:2354-2362, 2000
37. 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 18:2095-2103, 2000
38. Gridelli C: Chemotherapy of advanced non small cell lung cancer in the elderly: An update. Crit Rev Oncol Hematol 35:219-225, 2000
39. Herbst RS, Khuri FR, Fossella FV, et al: ZD1839 (Iressa) in non-small-cell lung cancer. Clin Lung Cancer 3:27-32, 2001