Randomized phase III trial of docetaxel plus carboplatin with or without levofloxacin prophylaxis in elderly patients with advanced non-small cell lung cancer: The apronta trial

Journal of Thoracic Oncology

Volumn 6, Issue 12, 2011, Pages 2090-2096

  Schuette, Wolfgang ^a   Nagel, Sylke ^a   Von Weikersthal, Ludwig Fischer ^b   Pabst, Stefan ^c   Schumann, Christian ^d   Deuss, Burkhard ^e   Salm, Thorsten ^f   Roscher, Katrin ^f   Dickgreber, Nicolas ^g  

^a Hospital Martha Maria Halle Dölau   (Germany)

^b Gesundheitszentrum St Marien GmbH   (Germany)

^c UNIVERSITY HOSPITAL BONN   (Germany)

^d UNIVERSITY HOSPITAL ULM   (Germany)

^e CLINASSESS GMBH   (Germany)

^f SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

^g HANNOVER MEDICAL SCHOOL   (Germany)

Author keywords

Chemotherapy; Elderly; Levofloxacin; NSCLC; Prophylaxis

Indexed keywords

CARBOPLATIN; DOCETAXEL; LEVOFLOXACIN; PLACEBO;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANTIBIOTIC THERAPY; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER STAGING; CANDIDIASIS; CHRONIC BRONCHITIS; CONTROLLED STUDY; DIARRHEA; DISEASE SURVEILLANCE; DOUBLE BLIND PROCEDURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FEBRILE NEUTROPENIA; FEMALE; FEVER; HUMAN; INFECTION; INFECTION PREVENTION; INFECTION RATE; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; THROMBOCYTOPENIA; URINARY TRACT INFECTION; UROSEPSIS; VOMITING;

EID: 81755174164     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e3182307e3c     Document Type: Article

References (20)

1. Jemal A, Siegel R, Ward E, et al. Cancer Statistics, 2009. CA Cancer J Clin 2009;59:225-249.
2. Ries LAG, Melbert D, Krapcho M, et al. (Eds.) SEER Cancer Statistics Review, 1975-2004. Bethesda, MD: National Cancer Institute, 2007. Available at:http://seer.cancer.gov/csr/1975-2004/results-merged/sect-15-lung-bronchus. pdf. Accessed January 5, 2011.
3. Azzoli CG, Baker S, Jr., Temin S, et al; American Society of Clinical Oncology. American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small cell lung cancer. J Clin Oncol 2009;27:6251-6266.
4. Gridelli C, Maione P, Rossi A, et al. Chemotherapy of advanced NSCLC in special patient population. Ann Oncol 2006;17(Suppl 5):v72-v78. (Pubitemid 43985210)
5. Minisini A, Spazzapan S, Crivellari D, et al. Incidence of febrile neutropenia and neutropenic infections in elderly patients receiving anthracycline-based chemotherapy for breast cancer without primary prophylaxis with colony-stimulating factors. Crit Rev Oncol Hematol 2005;53:125-131. (Pubitemid 40127530)
6. Fossella F, Pereira JR, von Pawel J, et al. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol 2003;21:3016-3024. (Pubitemid 46606280)
7. Belani CP, Pereira JR, von Pawel J, et al. Effect of chemotherapy for advanced non-small cell lung cancer on patients' quality of life. A randomized controlled trial. Lung Cancer 2006;53:231-239. (Pubitemid 44043122)
8. Belani CP, Fossella F. Elderly subgroup analysis of a randomized phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for first-line treatment of advanced non small cell lung carcinoma (TAX 326). Cancer 2005;104:2766-2774. (Pubitemid 41798287)
9. Fossella FV, Belani CP; The TAX 326 Study Group. Phase III study (TAX 326) of docetaxel-cisplatin (DC) and docetaxel-carboplatin (DCb) versus vinorelbine- cisplatin (VC) for the first-line treatment of advanced/metastatic non-small-cell lung cancer (NSCLC): analyses in elderly patients. Proc Am Soc Clin Oncol 2003;22(abstract 2528).
10. Anderson VR, Perry CM. Levofloxacin: a review of its use as a high-dose, short-course treatment for bacterial infection. Drugs 2008; 68:535-565. (Pubitemid 351342021)
11. Hughes WT, Armstrong D, Bodey GP, et al. 2002 Guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis 2002;34:730-751. (Pubitemid 34194843)
12. Bucaneve G, Micozzi A, Menichetti F, et al; Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Infection Program. Levofloxacin to prevent bacterial infection in patients with cancer and neutropenia. N Engl J Med 2005;353:977-987. (Pubitemid 41262332)
13. - Antibiotic in a Number of Tumours (SIGNIFICANT) Trial Group. Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas. N Engl J Med 2005;353:988-998. (Pubitemid 41262333)
14. Schiel X, Hebart H, Kern WV, et al; Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO). Sepsis in neutropenia- guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO). Ann Hematol 2003;82(Suppl 2):S158-S166. (Pubitemid 37265303)
15. 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 2000;92:205-216. (Pubitemid 30099779)
16. Fujiwara Y, Hotta K, Di Maio K, et al. Time trend in treatment-related deaths of patients with advanced non-small lung cell cancer enrolled into phase III trials of systemic treatment. Ann Oncol 2011;22:376-382.
17. Freifield A, McNabb J, Anderson J, et al. Low-risk patients with fever and neutropenia during chemotherapy; current clinical practice patterns. Proc Am Soc Clin Oncol 2004;23:747.
18. Imran H, Tleyjeh IM, Arndt CA, et al. Fluoroquinolone prophylaxis in patients with neutropenia: a meta-analysis of randomized placebocontrolled trials. Eur J Clin Microbiol Infect Dis 2008;27:53-63. (Pubitemid 350197874)
19. Kern WV, Klose K, Jellen-Ritter AS, et al. Fluoroquinolone resistance of Escherichia coli at a cancer center: epidemiological evolution and effects of discontinuing prophylactic fluoroquinolone use in neutropenic patients with leukemia. Eur J Clin Microbiol Infect Dis 2005;24:111-118. (Pubitemid 40487379)
20. Ramsey SD, Howlader N, Etzioni RD, et al. Chemotherapy use, outcomes, and costs for older persons with advanced non-small-cell lung cancer: evidence from surveillance, epidemiology and end results-Medicare. J Clin Oncol 2004;22:4971-4978. (Pubitemid 46638623)