Abstract
Advanced non-small-cell lung cancer (NSCLC) patients with poor performance status (PS) are less likely to respond to chemotherapy, or to have an improvement in survival, but more likely to experience toxicity. We retrospectively evaluated the efficacy and tolerability of gefitinib in patients with advanced NSCLC and very poor PS in Taiwan. Patients with stage IIIB, IV NSCLC with an Eastern Cooperative Oncology Group (ECOG) PS of 3–4 received oral gefitinib 250 mg once daily. Totally, 52 patients were included (25 men, 27 women). Forty-three patients (82.7%) were in a PS of 3. Tumor response rate was 25.0% (13/52). Tumor response rate to gefitinib was highest in chemonaive patients 38.1% (8/21) vs. failed 1 chemotherapy regimen 13.3% (2/15) vs. failed 2 or more chemotherapy regimens 18.8% (3/16), p = 0.015. The median overall survival was 2.5 months (response group 9.1 months, stable disease 3.1 months, and progressive group 0.8 month, p < 0.001). Adverse events, mainly skin reactions and diarrhea, were generally mild (grade 1 or 2) except paronychia and acne. Thus, gefitinib has clinically antitumor activity and good tolerability in {Taiwan} patients with advanced NSCLC and very poor performance status, with a higher response rate than that seen Europe or in European heritage Americans. Chemonaive patients responded better than patients with prior chemotherapy. Formal clinical trials are warranted to evaluate the role of gefitinib in this situation.
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Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH: Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346: 92-98, 2002
Fossella FV, Lee JS, Hong WK: Management strategies for recurrent non-small cell lung cancer. Semin Oncol 24: 455-462, 1997
Ruckdeschel JC, Finkelstein DM, Ettinger DS, Creech RH, Mason BA, Joss RA, Vogl S: A randomized trial of the four most active regimens for metastatic non-small-cell lung cancer. J Clin Oncol 4: 14-22, 1986
Fontanini G, Vignati S, Bigini D, Mussi A, Lucchi H, Angeletti CA, Pingitore R, Pepe S, Basolo F, Bevilacqua G: Epidermal growth factor receptor (EGFr) expression in non-small cell lung carcino-mas correlates with metastatic involvement of hilar and mediastinal lymph nodes in the squamous subtype. Eur J Cancer 31A: 178-183, 1995
Mukaida H, Toi M, Hirai T, Yamashita Y, Toge T: Clinical significance of the expression of epidermal growth factor and its receptor in esophageal cancer. Cancer 68: 142-148, 1991
Neal DE, Marsh C, Bennett MK, Abel PD, Hall RR, Sainsbury JR, Harris AL: Epidermal-growth-factor receptors in human bladder cancer: Comparison of invasive and superficial tumours. Lancet 1: 366-368, 1985
Sainsbury JR, Farndon JR, Needham GK, Malcolm AJ, Harris AL: Epidermal-growth-factor receptor status as predictor of early recurrence of and death from breast cancer. Lancet 1: 1398-1402, 1987
Woodburn JR: The epidermal growth factor receptor and its inhibition in cancer therapy. Pharmacol Ther 82: 241-250, 1999
Kris MG, Natale RB, Herbst RS, Lynch TJ, Jr., Prager D, Belani CP, Schiller JH, Kelly K, Spiridonidis H, Sandler A, Albain KS, Cella D, Wolf MK, Averbuch SD, Ochs JJ, Kay AC: 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 290: 2149-2158, 2003
Fukuoka M, Yano S, Giaccone G, Tamura T, Nakagawa K, Douillard JY, Nishiwaki Y, Vansteenkiste J, Kudoh S, Rischin D, Eek R, Horai T, Noda K, Takata I, Smit E, Averbuch S, Macleod A, Feyereislova A, Dong RP, Baselga J: Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 21: 2237-2246, 2003
Miller AB, Hoogstraten B, Staquet M, Winkler A: Reporting results of cancer treatment. Cancer 47: 207-214, 1981
Jiroutek M, Johnson D, Blum R, Bonomi P, Chang A, Ettinger D, Ruckdeschel J, Schiller J, Sandler A: Prognostic factors in advanced non-small cell lung cancer (NSCLC): Analysis of eastern cooperative oncology group (ECOG) trials from 1981-1992. Proc Am Soc Clin Oncol, 1998 (Abstract #1774)
Argiris A, Mittal N, Masters G: Gefitinib (ZD1839) as first-line, compassionate use therapy in patients with advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol, 2003 (Abstract #2729)
Kommareddy A, Coplin M, Behnken D, Romvari E, Trinkaus K, Read W, Govindan R: Gefitinib as a first line therapy for patients with advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol, 2003 (Abstract #2834)
Wong N, Lim TS, Lim WT, Leong SS, Tan EH: ZD1839 is more effective in patients (pts) with non-small cell lung cancer (NSCLC) who were lifetime non-tobacco users. Proc Am Soc Clin Oncol, 2003 (Abstract #2790)
Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, Harris PL, Haserlat SM, Supko JG, Haluska FG, Louis DN, Christiani DC, Settleman J, Haber DA: Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 350: 2129-2139, 2004
Paez JG, Janne PA, Lee JC, Tracy S, Greulich H, Gabriel S, Herman P, Kaye FJ, Lindeman N, Boggon TJ, Naoki K, Sasaki H, Fujii Y, Eck MJ, Sellers WR, Johnson BE, Meyerson M: EGFR mutations in lung cancer: Correlation with clinical response to gefitinib therapy. Science 304: 1497-1500, 2004.
Cohen MH, Williams GA, Sridhara R, Chen G, Pazdur R: FDAdrug approval summary: Gefitinib (ZD1839) (Iressa) tablets. Oncologist 8: 303-306, 2003
Fossella FV, DeVore R, Kerr RN, Crawford J, Natale RR, Dunphy F, Kalman L, Miller V, Lee JS, Moore M, Gandara D, Karp D, Vokes E, Kris M, Kim Y, Gamza F, Hammershaimb L: 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. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 18: 2354-2362, 2000
Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J: 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
Chang GC, Yang TY, Wang NS, Huang CM, Chiang CD: Successful treatment of multifocal bronchioloalveolar cell carcinoma with ZD1839 (Iressa) in two patients. J Formos Med Assoc 102: 407-411, 2003
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Chang, GC., Chen, KC., Yang, TY. et al. Activity of gefitinib in advanced non-small-cell lung cancer with very poor performance status. Invest New Drugs 23, 73–77 (2005). https://doi.org/10.1023/B:DRUG.0000047108.39129.7c
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DOI: https://doi.org/10.1023/B:DRUG.0000047108.39129.7c