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Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy

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Part 1. Gefitinib and Erlotinib for Non-Small Cell Lung Cancer (continued)


Excluded Articles

Anonymous. Keeping pace with innovation. Lancet Oncology 2005;6(2):65.

Ardizzoni A, Tiseo M. Second-line chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC). Journal of Chemotherapy 2004;16(Suppl 4):104-7.

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. Journal of Clinical Oncology 2002;20(21):4292-302.

Belani CP, Ramalingam S. Implications of the Iressa Survival Evaluation in Lung Cancer trial and the future of gefitinib. Clinical Lung Cancer 2005;6(4):203-4.

Betta P, Trombino S, Angelini C, et al. Codon 12 K-ras mutations in plasma DNA are not an indicator of disease in non-small-cell lung cancer (NSCLC) patients. 2005 ASCO Annual Meetings 2005; Abstract #7204.

Birnbaum A, Ready N. Gefitinib therapy for non-small cell lung cancer. Current Treatment Options In Oncology 2005;6(1):75-81.

Blackledge G, Averbuch S. Gefitinib ('Iressa', ZD1839) and new epidermal growth factor receptor inhibitors. British Journal of Cancer 2004;90(3):566-72.

Bonomi P. Clinical studies with non-iressa EGFR tyrosine kinase inhibitors. Lung Cancer 2003;41(Suppl 1):S43-8.

Bonomi PD. Therapeutic advances in second-line treatment of advanced non-small-cell lung cancer. Clinical Lung Cancer 2004;6(3):154-61.

Canadian Coordinating Office for Health Technology Assessment. 2004.

Cappuzzo F. Erlotinib in gliomas: should selection be based on EGFR and Akt analyses? Journal of the National Cancer Institute 2005;97(12):868-9.

Cella D. Impact of ZD1839 on non-small cell lung cancer-related symptoms as measured by the functional assessment of cancer therapy-lung scale. Seminars in Oncology 2003;30(1 Suppl 1):39-48.

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 2005;23(1):73-7.

Chinnaiyan P, Huang S, Vallabhaneni G, et al. Mechanisms of enhanced radiation response following epidermal growth factor receptor signaling inhibition by erlotinib (Tarceva). Cancer Res 2005;65(8):3328-35.

Chiu CH, Tsai CM, Chen YM, et al. Gefitinib is active in patients with brain metastases from non-small cell lung cancer and response is related to skin toxicity. Lung Cancer 2005;47(1):129-38.

Cohen MH, Williams GA, Sridhara R, et al. FDA drug approval summary: gefitinib (ZD1839) (Iressa) tablets. Oncologist 2003;8(4):303-6.

Culy CR, Faulds D. Gefitinib. Drugs 2002;62(15):2237-48.

Dacic S, Ramalingam S, Flanagan M, et al. Correlation between epidermal growth factor receptor (EGFR) protein expression (PE) and gene amplification (GA) in non-small cell lung carcinoma (NSCLC). 2005 ASCO Annual Meetings 2005; Abstract #7079.

Dainichi T, Tanaka M, Tsuruta N, et al. Development of multiple paronychia and periungual granulation in patients treated with gefitinib, an inhibitor of epidermal growth factor receptor. Dermatology 2003;207(3):324-5.

del Giglio A, Ito C. Gefitinib (Iressa) in metastatic patients with non-small cell lung cancer: preliminary experience in a Brazilian center. Sao Paulo Medical Journal 2004;122(3):128-30.

Dowell J, Minna JD, Kirkpatrick P. Erlotinib hydrochloride. Nature Reviews: Drug Discovery 2005;4(1):13-4.

Ettinger DS. An overview of eastern cooperative oncology group stage III non-small cell lung cancer studies. Seminars in Oncology 2005;32(2 Suppl 3):S109-10.

Frampton JE, Easthope SE. Gefitinib: a review of its use in the management of advanced non-small-cell lung cancer. Drugs 2004;64(21):2475-92.

Frantz S. Iressa failure raises fears about accelerated approvals. Nature Reviews: Drug Discovery 2005;4(2):94-5.

Fujiwara K, Kiura K, Gemba K, et al. Gefitinib ('Iressa', ZD1839) may restore chemosensitivity in NSCLC patients? Anticancer Research 2005;25(1B):547-9.

Fuster LM, Sandler AB. Select clinical trials of erlotinib (OSI-774) in non-small-cell lung cancer with emphasis on phase III outcomes. Clinical Lung Cancer 2004;6(Suppl 1):S24-9.

Golsteyn RM. Gefitinib does not increase survival in lung cancer patients. Drug Discov Today 2005;10(6):381.

Harita S, Mizuta A, Kuyama S, et al. Long-term survival following concurrent chemoradiotherapy in patients with non-small-cell lung cancer with concomitant brain metastases only. International Journal of Clinical Oncology 2005;10(1):63-8.

Haura EB, Zheng Z, Cantor A, et al. Small tumor size and limited smoking history predicts activated EGFR-Stat3 in early stage non-small cell lung cancer. 2005 ASCO Annual Meetings 2005; Abstract #7075.

Herbst RS, Johnson DH, Mininberg E, et al. Phase I/II trial evaluating the anti-vascular endothelial growth factor monoclonal antibody bevacizumab in combination with the HER-1/epidermal growth factor receptor tyrosine kinase inhibitor erlotinib for patients with recurrent non-small-cell lung cancer. Journal of Clinical Oncology 2005;23(11):2544-55.

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. Journal of Clinical Oncology 2002;20(18):3815-25.

Herbst RS, Sandler AB. Overview of the current status of human epidermal growth factor receptor inhibitors in lung cancer. Clinical Lung Cancer 2004;6(Suppl 1):S7-19.

Heymach JV. ZD6474--clinical experience to date. British Journal of Cancer 2005;92(Suppl 1):S14-20.

Hirsch FR, Witta S. Biomarkers for prediction of sensitivity to EGFR inhibitors in non-small cell lung cancer. Current Opinion in Oncology 2005;17(2):118-22.

Ieki R, Saitoh E, Shibuya M. Acute lung injury as a possible adverse drug reaction related to gefitinib. European Respiratory Journal 2003;22(1):179-81.

Inoue A, Saijo Y, Maemondo M, et al. Severe acute interstitial pneumonia and gefitinib. Lancet 2003;361:137-9.

Janne PA, Engelman JA, Johnson BE. Epidermal growth factor receptor mutations in non-small-cell lung cancer: implications for treatment and tumor biology. Journal of Clinical Oncology 2005;23(14):3227-34.

Johnson BE, Lucca J, Rabin MS, et al. Preliminary results from a phase II study of the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib in patients > 70 years of age with previously untreated advanced non-small cell lung carcinoma. Journal of Clinical Oncology 2004;22(14):080.

Johnson BE, Ma P, West H, et al. Preliminary phase II safety evaluation of ZD6474, in combination with carboplatin and paclitaxel, as 1st-line treatment in patients with NSCLC. 2005 ASCO Annual Meetings 2005; Abstract #7102.

Knight LA, Di Nicolantonio F, Whitehouse P, et al. The in vitro effect of gefitinib ('Iressa') alone and in combination with cytotoxic chemotherapy on human solid tumours. BMC Cancer 2004;4(1):83.

Kobayashi S, Boggon TJ, Dayaram T, et al. EGFR mutation and resistance of non-small-cell lung cancer to gefitinib. New England Journal of Medicine 2005;352(8):786-92.

Kwak EL, Sordella R, Bell DW, et al. Irreversible inhibitors of the EGF receptor may circumvent acquired resistance to gefitinib. Proc Natl Acad Sci USA 2005;102(21):7665-70.

Lilenbaum RC. Treatment of patients with advanced lung cancer and poor performance status. Clinical Lung Cancer 2004;6(Suppl 1):S71-4.

LoRusso PM, Herbst RS, Rischin D, et al. Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors. Clinical Cancer Research 2003;9(6):2040-8.

Miller VA, Hirsch FR, Johnson DH. Systemic therapy of advanced bronchioloalveolar cell carcinoma: challenges and opportunities. Journal of Clinical Oncology 2005;23(14):3288-93.

Miller VA, Johnson DH, Krug LM, et al. Pilot trial of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib plus carboplatin and paclitaxel in patients with stage IIIB or IV non-small-cell lung cancer. Journal of Clinical Oncology 2003;21(11):2094-100.

Milton DT, Kris MG, Gomez JE, et al. Prompt control of bronchorrhea in patients with bronchioloalveolar carcinoma treated with gefitinib (Iressa™). Support Care In Cancer 2005;13(1):70-2.

Minna JD, Dowell J. Erlotinib hydrochloride. Nature Reviews: Drug Discovery 2005;Supplemental:S14-5.

Minna JD, Gazdar AF, Sprang SR, et al. Cancer. A bull's eye for targeted lung cancer therapy. Science 2004;304:1458-61.

Nakamura Y, Oka M, Soda H, et al. Gefitinib ("Iressa", ZD1839), an epidermal growth factor receptor tyrosine kinase inhibitor, reverses breast cancer resistance protein/ABCG2-mediated drug resistance. Cancer Res 2005;65(4):1541-6.

Nakano J, Nakamura M. Paronychia induced by gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor. Journal of Dermatology 2003;30(3):261-2.

National Institute for Clinical Excellence. Gefitinib for non-small cell lung cancer—appraisal (project). London: National Institute for Clinical Excellence 2003.

Nishio M, Ohyanagi F, Horiike A, et al. Gefitinib treatment affects androgen levels in non-small-cell lung cancer patients. British Journal of Cancer 2005;92(10):1877-80.

Normanno N. Gefitinib and cisplatin-based chemotherapy in non-small-cell lung cancer: simply a bad combination? Journal of Clinical Oncology 2005;23(4):928-30; author reply 930-1.

Ohe Y. Chemoradiotherapy for lung cancer: current status and perspectives. International Journal of Clinical Oncology 2004;9(6):435-43.

Omuro AM, Kris MG, Miller VA, et al. High incidence of disease recurrence in the brain and leptomeninges in patients with nonsmall cell lung carcinoma after response to gefitinib. Cancer 2005;103(11):2344-8.

Pao W, Miller VA. Epidermal growth factor receptor mutations, small-molecule kinase inhibitors, and non-small-cell lung cancer: current knowledge and future directions. Journal of Clinical Oncology 2005;23(11):2556-68.

Pao W, Miller 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;2(3):e73.

Patel JD. Role of epidermal growth factor receptor tyrosine kinase inhibitors in the treatment of bronchoalveolar carcinoma. Clinical Lung Cancer 2004;6(Suppl 1):S433-7.

Patrick-Miller LJ. Is there a role for the assessment of health-related quality of life in the clinical evaluation of novel cytostatic agents?: Commentary re: P. M. LoRusso, Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors. Clinical Cancer Research 2003;9(6):1990-4.

Perrone F, Di Maio M, Budillon A, et al. Targeted therapies and non-small cell lung cancer: methodological and conceptual challenge for clinical trials. Current Opinion in Oncology 2005;17(2):123-9.

Pham D, Kris MG, McDonough T, et al. Estimation of the likelihood of epidermal growth factor receptor (EGFR) mutations based on cigarette smoking history in patients with adenocarcinoma of the lung. 2005 ASCO Annual Meetings 2005; Abstract #7069.

Price DK, Figg WD. Mutations in the EGFR: the importance of genotyping. Cancer Biology & Therapy 2004;3(5):434-5.

Price N, Belani C. Clinical development of gefitinib in non-small-cell lung cancer and the Iressa Survival Evaluation in Lung Cancer trial. Clinical Lung Cancer 2005;6(4):214-6.

Ready N. Inhibition of the epidermal growth factor receptor in combined modality treatment for locally advanced non-small cell lung cancer. Seminars in Oncology 2005;32(2 Suppl 3):S35-41.

Reck M, Gatzemeier U. Gefitinib ("Iressa"): a new therapy for advanced non-small-cell lung cancer. Respiratory Medicine 2005;99(3):298-307.

Reckamp KL, Dubinett SM, Krysan K, et al. A phase I trial of targeted COX-2 and EGFR TK inhibition in advanced NSCLC. 2005 ASCO Annual Meetings 2005; Abstract #7112.

Riely GJ, Miller VA, Pao W, et al. Clinical characteristics and natural history of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations treated with erlotinib or gefitinib. 2005 ASCO Annual Meetings 2005; Abstract #7085.

Ross HJ, Blumenschein GR, Dowlati A, et al. Preliminary safety results of a phase II trial comparing two schedules of lapatinib (GW572016) as first line therapy for advanced or metastatic non-small cell lung cancer. 2005 ASCO Annual Meetings 2005; Abstract #7099.

Schutte W, Nagel S, Schaedlich S, et al. Clinical benefit in NSCLC: advanced-stage patients require symptom-improving palliation. Experiences from the 'Iressa' expanded access program. Onkologie 2005;28(4):195-8.

Shah NT, Miller VA. Antitumor activity and tolerability of gefitinib in patients with non-small-cell lung cancer treated in an expanded access program. Clinical Lung Cancer 2003;5(3):182-6.

Shih YN, Chiu CH, Tsai CM, et al. Interstitial pneumonia during gefitinib treatment of non-small-cell lung cancer. Journal of the Chinese Medical Association 2005;68(4):183-6.

Singer E. Iressa's fall from grace points to need for better clinical trials. Nature Medicine 2005;11(2):107.

Sonobe M, Katakura H, Adachi T, et al. Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene in Non-Small Cell Lung Cancer (NSCLC). 2005 ASCO Annual Meetings 2005; Abstrract #7070.

Soulieres D, Senzer NN, Vokes EE, et al. Multicenter phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. Journal of Clinical Oncology 2004;22(1):77-85.

Stabile LP, Lyker JS, Gubish CT, et al. Combined targeting of the estrogen receptor and the epidermal growth factor receptor in non-small cell lung cancer shows enhanced antiproliferative effects. Cancer Res 2005;65(4):1459-70.

Stahel R, Rossi A, Petruzelka L, et al. Lessons from the ("Iressa" Expanded Access Programme: gefitinib in special non-small-cell lung cancer patient populations. British Journal of Cancer 2003;89(Suppl 2):S19-23.

Twombly R. Failing survival advantage in crucial trial, future of Iressa is in jeopardy. Journal of the National Cancer Institute 2005;97(4):249-50.

Witta SE, Helfrich B, Chan D, et al. Overcomming Resistance to EGFR Inhibitors in NSCLC Cell lines by Sequential Treatment with Histone Deacetylase Inhibitors. 2005 ASCO Annual Meetings 2005; Abstract #7083.

Yang CH. Third-line chemotherapy for advanced non-small-cell lung cancer--is there enough evidence to support its use? Journal of the Chinese Medical Association 2005;68(4):160-1.

Yoshimoto A, Kasahara K, Nishio M, et al. Changes in angiogenic growth factor levels after gefitinib treatment in non-small cell lung cancer. Japanese Journal of Clinical Oncology 2005;35(5):233-8.

Zhang L, Zhang X, Wang X, et al. The status of epidermal growth factor receptor (EGFR) mutations at Exon 19 and 21 in Chinese Patients with NSCLC. 2005 ASCO Annual Meetings 2005; Abstract #7097.

Zhou C. Epidermal growth factor receptor mutations in Chinese patients with non-small cell lung cancer. 2005 ASCO Annual Meetings 2005; Abstract #7101.

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