Phase III study of immediate compared with delayed docetaxel after front-line therapy with gemcitabine plus carboplatin in advanced non-small-cell lung cancer

Journal of Clinical Oncology

Volumn 27, Issue 4, 2009, Pages 591-598

  Fidias, Panos M ^a   Dakhil, Shaker R ^a   Lyss, Alan P ^a   Loesch, David M ^a   Waterhouse, David M ^a   Bromund, Jane L ^a   Chen, Ruqin ^a   Hristova Kazmierski, Maria ^a   Treat, Joseph ^a   Obasaju, Coleman K ^a   Marciniak, Martin ^a   Gill, John ^a   Schiller, Joan H ^a  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; DEXAMETHASONE; DOCETAXEL; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER SURVIVAL; CHRONOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; LARGE CELL CARCINOMA; LUNG ADENOCARCINOMA; LUNG ALVEOLUS CELL CARCINOMA; LUNG NON SMALL CELL CANCER; LUNG SQUAMOUS CELL CARCINOMA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; THERAPY DELAY; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; QUALITY OF LIFE; TAXOIDS; TREATMENT OUTCOME;

EID: 59149092945     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.17.1405     Document Type: Article

References (36)

1. Jemal A, Siegel R, Ward E, et al: Cancer statistics, 2007. CA Cancer J Clin 57:43-66, 2007
2. National Comprehensive Cancer Network: Clinical Practice Guidelines in Oncology: Non-small cell lung cancer. http://www.nccn.org/professionals/default. asp
3. Schiller JH, Harrington D, Belani CP, et al: Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346:92-98, 2002
4. Scagliotti GV, De Marainis F, Rinaldi M, et al: Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 20:4285-4291, 2002
5. Carrato A, Alberola V, Massuti B, et al: Combination of gemcitabine and carboplatin as first line treatment in non-small cell lung cancer. 23rd Congress of the European Society for Medical Oncology, Athens, Greece, November 6-10, 1998 (abstr 431P)
6. Parente B, Barroso A, Conde S, et al: A randomized phase III study of gemcitabine and carboplatinum versus vinorelbine and carboplatinum in advanced non small-cells lung cancer (NSCLC). Lung Cancer 29:61, 2000 (suppl 1)
7. Masters G, Argiris A, Hahn E, et al: A randomized phase II trial using two different treatment schedules of gemcitabine and carboplatin in patients with advanced non-small-cell lung cancer. J Thorac Oncol 1:19-24, 2006
8. Obasaju C, Ye Z, Bloss L, et al: Gemcitabine/carboplatin in patients with metastatic non-small cell lung cancer: Phase II study of 28-day and 21-day schedules. Clin Lung Cancer 7:202-207, 2005
9. Lustberg MB, Edelman MJ: Optimal duration of chemotherapy in advanced non-small cell lung cancer. Curr Treat Options Oncol 8:38-46, 2007
10. Socinski MA, Stinchcombe TE: Duration of first-line chemotherapy in advanced non-small-cell lung cancer: Less is more in the era of effective subsequent therapies. J Clin Oncol 25:5155-5157, 2007
11. 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
12. 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
13. Hanna N, Shepherd FA, Fossella FV, et al: Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22:1589-1597, 2004
14. Shepherd FA, Pereira JR, Ciuleanu T, et al: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353:123-132, 2005
15. Grossi F, Aita M, Follador A, et al: Sequential, alternating and maintenance/consolidation chemotherapy in advanced non-small cell lung cancer: A review of the literature. Oncologist 12:451-464, 2007
16. Therasse P, Arbuck S, Eisenhauer E, 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
17. Hollen PJ, Gralla RJ, Kris MG, et al: Measurement of quality of life in patients with lung cancer in multicenter trials of new therapies: Psychometric assessment of the Lung Cancer Symptom Scale. Cancer 73:2087-2098, 1994
18. Sankoh AJ: Interim analyses: An update of an FDA reviewer's experience and perspective. Drug Inform J 33:165-176, 1999
19. Kaplan E, Meier P: Nonparametric estimation of incomplete observations. J Am Stat Assoc 53:457-481, 1958
20. Bland JM, Altman DG: The logrank test. BMJ 328:1073, 2004
21. Agresti A: Categorical Data Analysis. New York, NY, John Wiley & Sons, Inc, 1990, pp 230-234
22. National Cancer Institute: National Cancer Institute Common Toxicity Criteria Version 2.0. http:ctep.cancer.gov/forms/CTCv20-4-30-992.pdf
23. Treat J, Belani CP, Schiller J, et al: Gemcitabine (G) plus carboplatin at AUC 5 demonstrates reduced grade 4 thrombocytopenia rate compared to AUC 5.5 in first-line therapy of patients with advanced stage NSCLC. J Clin Oncol 24:396s, 2006 (suppl; abstr 7130)
24. Chiappori A, Simon G, Williams C, et al: Phase II study of first-line sequential chemotherapy with gemcitabine-carboplatin followed by docetaxel in patients with advanced non-small cell lung cancer. Oncology 68:382-390, 2005
25. Smith IE, O'Brien ME, Talbot DC, et al: Duration of chemotherapy in advanced non-small-cell lung cancer: A randomized trial of three versus six courses of mitomycin, vinblastine, and cisplatin. J Clin Oncol 19:1336-1343, 2001
26. Socinski MA, Schell MJ, Peterman A, et al: Phase III trial comparing a defined duration of therapy versus continuous therapy followed by secondline therapy in advanced-stage IIIB/IV non-small-cell lung cancer. J Clin Oncol 20:1335-1343, 2002
27. Buccheri GF, Ferrigno D, Curcio A, et al: Continuation of chemotherapy versus supportive care alone in patients with inoperable non-small cell lung cancer and stable disease after two or three cycles of MACC. Cancer 63:428-432, 1989
28. Westeel V, Quoix E, Moro-Sibilot D, et al: Randomized study of maintenance vinorelbine in responders with advanced non-small-cell lung cancer. J Natl Cancer Inst 97:499-506, 2005
29. Brodowicz T, Krzakowski M, Zwitter M, et al: Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small cell lung cancer: A phase III trial. Lung Cancer 52:155-163, 2006
30. Edelman MJ, Gandara DR, Lau DHM, et al: Sequential chemotherapy in patients with advanced nonsmall cell lung carcinoma: Carboplatin and gemcitabine followed by paclitaxel. Cancer 92:146-152, 2001
31. Edelman MJ, Clark JI, Chansky K, et al: Randomized phase II trial of sequential chemotherapy in advanced non-small cell lung cancer (SWOG 9806): Carboplatin/gemcitabine followed by paclitaxel or cisplatin/vinorelbine followed by docetaxel. Clin Cancer Res 10:5022-5026, 2004
32. Belani CP, Barstis J, Perry MC, et al: Multicenter, randomized trial for stage IIB or IV non-small-cell lung cancer using weekly paclitaxel and carboplatin followed by maintenance weekly paclitaxel or observation. J Clin Oncol 21:2933-2939, 2003
33. Depierre A, Quoix E, Mercier M, et al: Maintenance chemotherapy in advanced non-small cell lung cancer (NSCLC): A randomized study of vinorelbine (V) versus observation (OB) in patients (pts) responding to induction therapy (French Cooperative Oncology Group). Proc Am Soc Clin Oncol 20:309a, 2001 (abstr 1231)
34. Sculier J, Lafitte J, Lecomte J, et al: A phase III randomized trial comparing sequential to standard chemotherapy in advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 24:367s, 2006 (suppl; abstr 7012)
35. Park JO, Kim SW, Ahn JS, et al: Phase III trial of two versus four additional cycles in patients who are nonprogressive after two cycles of platinumbased chemotherapy in non-small-cell lung cancer. J Clin Oncol 25:5233-5239, 2007
36. Ciuleanu T, Brodowicz T, Belani CP, et al: Maintenance pemetrexed plus best supportive care (BSC) versus placebo plus BSC: A phase III study. Proc Am Soc Clin Oncol 26:426s, 2008 (suppl; abstr 8011)