Phase II clinical trial of chemotherapy-naïve patients ≥ 70 years of age treated with erlotinib for advanced non-small-cell lung cancer

Journal of Clinical Oncology

Volumn 25, Issue 7, 2007, Pages 760-766

  Jackman, David M ^a   Yeap, Beow Y ^a   Lindeman, Neal I ^a   Fidias, Panos ^a   Rabin, Michael S ^a   Temel, Jennifer ^a   Skarin, Arthur T ^a   Meyerson, Matthew ^a   Holmes, Alison J ^a   Borras, Ana M ^a   Freidlin, Boris ^a   Ostler, Patricia A ^a   Lucca, Joan ^a   Lynch, Thomas J ^a   Johnson, Bruce E ^a   Jänne, Pasi A ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; GEMCITABINE; K RAS PROTEIN; NAVELBINE; PACLITAXEL; PROTEIN KINASE INHIBITOR; QUINAZOLINE DERIVATIVE;

ACNE; AGED; ALOPECIA; AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTICLE; BILIRUBIN BLOOD LEVEL; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONFIDENCE INTERVAL; CORRELATION ANALYSIS; CREATININE BLOOD LEVEL; DEHYDRATION; DIARRHEA; DRUG DOSE REDUCTION; DRY EYE; DRY SKIN; EYE IRRITATION; FATIGUE; FEMALE; GASTROINTESTINAL HEMORRHAGE; HAND FOOT SYNDROME; HEMOPTYSIS; HUMAN; HUMAN TISSUE; HYPERKALEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPOPHOSPHATEMIA; INTERSTITIAL LUNG DISEASE; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAIL DISEASE; NAUSEA; PARTIAL THROMBOPLASTIN TIME; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTHROMBIN TIME; RASH; SIDE EFFECT; SKIN MANIFESTATION; SOMATIC MUTATION; SURVIVAL RATE; SURVIVAL TIME; TIME SERIES ANALYSIS; AGE; DRUG ANTAGONISM; GENETICS; LUNG TUMOR; MORTALITY; MUTATION; ONCOGENE RAS;

AGE FACTORS; AGED; AGED, 80 AND OVER; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; GENES, RAS; HUMANS; LUNG NEOPLASMS; MALE; MUTATION; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 33947504732     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2006.07.5754     Document Type: Article

References (35)

1. The Elderly Lung Cancer Vinorelbine Italian Study Group: Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 91:66-72, 1999
2. Gridelli C, Perrone F, Gallo C, et al: Chemotherapy for elderly patients with advanced non-small-cell lung cancer: The Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst 95:362-372, 2003
3. Langer CJ, Manola J, Bernardo P, et al: Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: Implications of Eastern Cooperative Oncology Group 5592, a randomized trial. J Natl Cancer Inst 94:173-181, 2002
4. Hillner BE, McDonald MK, Desch CE, et al: A comparison of patterns of care of nonsmall cell lung carcinoma patients in a younger and Medigap commercially insured cohort. Cancer 83:1930-1937, 1998
5. de Rijke JM, Schouten LJ, ten Velde GP, et al: Influence of age, comorbidity and performance status on the choice of treatment for patients with non-small cell lung cancer: Results of a population-based study. Lung Cancer 46:233-245, 2004
6. Earle CC, Venditti LN, Neumann PJ, et al: Who gets chemotherapy for metastatic lung cancer? Chest 117:1239-1246, 2000
7. Hutchins LF, Unger JM, Crowley JJ, et al: Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 341:2061-2067, 1999
8. Peake MD, Thompson S, Lowe D, et al: Ageism in the management of lung cancer. Age Ageing 32:171-177, 2003
9. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353:123-132, 2005
10. Lynch TJ, Bell DW, Sordella R, et al: 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
11. Paez JG, Janne PA, Lee JC, et al: EGFR mutations in lung cancer: Correlation with clinical response to gefitinib therapy. Science 304:1497-1500, 2004
12. Pao W, Miller V, Zakowski M, et al: EGF receptor 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 101:13306-13311, 2004
13. Eberhard DA, Johnson BE, Amler LC, et al: Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol 23:5900-5909, 2005
14. Pao W, Wang TY, Riely GJ, et al: KRAS mutations and primary resistance of lung adenocarcinomas to gefitinib or erlotinib. PLoS Med 2:e17, 2005
15. Hollen PJ, Gralla RJ, Kris MG, et al: Quality of life assessment in individuals with lung cancer: Testing the Lung Cancer Symptom Scale (LCSS). Eur J Cancer 29A:S51-S58, 1993 (suppl 1)
16. Travis WD, Colby TV, Corrin B, et al: World Health Organization: Histological Typing of Lung and Pleural Tumours (ed 3). Berlin, Germany, Springer-Verlag, 1999
17. National Cancer Institute: Common Toxicity Criteria (CTC) v2.0. http://ctep.cancer.gov/reporting/ctc.html
18. Freidlin B, Breathnach OS, Johnson BE: A model to select regimens for phase III trials for patients with advanced-stage non-small cell lung cancer. Clin Cancer Res 9:917-922, 2003
19. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors: European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216, 2000
20. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958
21. Cox DR: Regression models and life tables. J R Stat Soc B 34:187-220, 1972
22. Thatcher N, Chang A, Purvish P, et al: Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: Results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 366:1527-1537, 2005
23. Janne PA, Borras AM, Kuang Y, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006
24. Lilenbaum RC, Herndon JE II, List MA, et al: Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: The Cancer and Leukemia Group B (study 9730). J Clin Oncol 23:190-196, 2005
25. Fukuoka M, Yano S, Giaccone G, et al: Multiinstitutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial). J Clin Oncol 21:2237-2246, 2003
26. 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 290:2149-2158, 2003
27. Niho S, Kubota K, Goto K, et al: First-line single agent treatment with gefitinib in patients with advanced non-small-cell lung cancer: A phase II study. J Clin Oncol 24:64-69, 2006
28. Giaccone G, Lechevalier T, Thatcher N, et al: A phase II study of erlotinib as first-line treatment of advanced non-small cell lung cancer. J Clin Oncol 23:638s, 2005 (suppl, abstr 7073)
29. Cappuzzo F, Hirsch FR, Rossi E, et al: Epidermal growth factor receptor gene and protein and gefitinib sensitivity in non-small-cell lung cancer. J Natl Cancer Inst 97:643-655, 2005
30. Hirsch FR, Varella-Garcia M, McCoy J, et al: Increased epidermal growth factor receptor gene copy number detected by fluorescence in situ hybridization associates with increased sensitivity to gefitinib in patients with bronchioloalveolar carcinoma subtypes: A Southwest Oncology Group Study. J Clin Oncol 23:6838-6845, 2005
31. Tsao MS, Sakurada A, Cutz JC, et al: Erlotinib in lung cancer: Molecular and clinical predictors of outcome. N Engl J Med 353:133-144, 2005
32. Shigematsu H, Lin L, Takahashi T, et al: Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers. J Natl Cancer Inst 97:339-346, 2005
33. Riely GJ, Pao W, Pham DK, et al: Clinical course of patients with non-small cell lung cancer and epidermal growth factor receptor exon 19 and exon 21 mutations treated with gefitinib or erlotinib. Clin Cancer Res 12:839-844, 2006
34. Jackman DM, Yeap BY, Sequist LV, et al: Exon 19 deletion mutations of epidermal growth factor receptor are associated with prolonged survival in non-small cell lung cancer patients treated with gefitinib or erlotinib. Clin Cancer Res 12:3908-3914, 2006
35. West HL, Franklin WA, McCoy J, et al: Gefitinib therapy in advanced bronchioloalveolar carcinoma: Southwest Oncology Group Study S0126. J Clin Oncol 24:1807-1813, 2006