Docetaxel versus docetaxel plus gemcitabine as front-line treatment of patients with advanced non-small cell lung cancer: A randomized, multicenter phase III trial

Lung Cancer

Volumn 59, Issue 1, 2008, Pages 57-63

  Georgoulias, Vassilis ^a   Androulakis, Nikolaos ^a   Kotsakis, Athanasios ^a   Hatzidaki, Dora ^a   Syrigos, Kostas ^a   Polyzos, Aris ^a   Agelidou, Athina ^a   Varthalitis, Ioannis ^a   Ziras, Nikoalos ^a   Agelidou, Maria ^a   Chandrinos, Vassilis ^a   Boukovinas, Ioannis ^a   Geroyianni, Alexandra ^a   Vamvakas, Lambros ^a   Mavroudis, Dimitris ^a  

^a Hellenic Oncology Research Group HORG   (Greece)

Author keywords

Docetaxel; Gemcitabine; NSCLC; Phase III trial

Indexed keywords

DOCETAXEL; GEMCITABINE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANAPHYLACTIC SHOCK; ANEMIA; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG RESPONSE; EDEMA; FEMALE; FLUID RETENTION; HUMAN; HYPERSENSITIVITY REACTION; INFECTION; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAIL DISEASE; NAIL LESION; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; DEOXYCYTIDINE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; QUALITY OF LIFE; TAXOIDS;

EID: 37549069291     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lungcan.2007.07.021     Document Type: Article

References (34)

1. Souquet P.J., Chauvin F., Boissel J.P., Cellerino R., Cormier Y., Ganz P.A., et al. Polychemotherapy in advanced non-small cell lung cancer: a meta-analysis. Lancet 342 (1993) 19-21
2. Non-Small Cell Lung Cancer Collaborative Group. Chemotherapy in non-small cell lung cancer: a meta-analysis using update data on individual patients from 52 randomized trials. Br Med J 311 (1995) 899-909
3. Albain K.S., Crowley J.J., LeBlanc M., and Livingston R.B. Survival determinants in extensive disease non-small cell lung cancer: the Southwest Oncology Group experience. J Clin Oncol 9 (1991) 1618-1626
4. Kelly K., Crowley J., Bunn P.A., Presant C.A., Grevstad P.K., Moinpour C.M., et al. Randomized phase III truial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small cell lung cancer: a Southwest Oncology Group trial. J Clin Oncol 19 (2001) 3210-3218
5. Schiller J.H., Harrington D., Belani C.P., Langer C., Sandler A., Krook J., et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med 346 (2002) 92-98
6. Rodriguez J., Pawel J., Pluzanska A., Gorbounova V., Fossella F., Kaukel E., et al. A multicenter, randomized phase III study of docetaxel + cisplatin (DC) and docetaxel + carboplatin (DCb) vs. vinorelbine + cisplatin (VC) in chemotherapy-naïve patients with advanced and metastatic non-small cell lung cancer. Proc Am Soc Clin Oncol 20 20a (2001) (abstr 1252)
7. Gueritte-Voegelein F., Guenard D., Lavelle F., Le Goff M.T., and Mangatal L. Potier P. Relationships between the structure of taxol analogues and their antimitotic activity. J Med Chem 34 (1991) 992-998
8. Cerny T., Kaplan S., Pavlidis N., Schoffski P., Epelbaum R., van Meerbeek J., et al. Docetaxel (Taxotere) is active in non-small cell lung cancer: a phase II trial of the EORTC Early Clinical Trials Group (ECTG). Br J Cancer 70 (1994) 384-387
9. Fossella F.V., Lee J.S., Murphy W.K., Lippman S.M., Calayag M., Pang A., et al. Phase II study of docetaxel for recurrent or metastatic non-small cell lung cancer. J Clin Oncol 12 (1994) 1238-1244
10. Francis P.A., Rigas J.R., Kris M.G., Pisters K.M., Orazem J.P., Woolley K.J., et al. Phase II trial of docetaxel in patients with stage III and IV non-small cell lung cancer. J Clin Oncol 12 (1994) 1232-1237
11. Miller V.A., Rigas J.R., Francis P., Grant S.C., Pisters K.M., Venkatraman E.S., et al. Phase II trial of docetaxel with prednisone premedication for patients with advanced non-small cell lung cancer. Cancer 75 (1995) 968-972
12. Roszkowski K., Pluzanska A., Krazakofwski M., Smith A.P., Saigi E., Aasebo U., et al. A multicenter, randomized phase III study of docetaxel plus best supportive care versus supportive care in chemotherapy-naive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC). Lung Cancer 27 (2000) 145-157
13. Georgoulias V., Androulakis N., Dimopoulos A.M., Kourousis C., Kakolyris S., Papadakis E., et al. First-line treatment of advanced non-small cell lung cancer with docetaxel and cisplatin: a multicenter phase II study. Ann Oncol 9 (1998) 331-334
14. Zalcberg J., Milward M., Bishop J., McKeage M., Zimet A., Toner G., et al. Phase II study of docetaxel and cisplatin in advanced non-small cell lung cancer. J Clin Oncol 16 (1998) 1948-1953
15. Le Chevalier T., Monnier A., Douillard J.Y., Ruffie P., Sun X.S., Belli L., et al. Docetaxel (Taxotere) plus cisplatin: an active and well-tolerated combination in patients with advanced non-small cell lung cancer. Eur J Cancer 34 (1998) 2032-2036
16. Georgoulias V., Papadakis E., Alexopoulos A., Tsiafaki X., Rapti A., Veslemes M., et al. Platinum-based or non-platinum-based chemotherapy in advanced non-small cell lung cancer? Results of a randomised multicenter trial. Lancet 357 (2001) 1478-1484
17. Kosmidis P., Mylonakis N., Nicolaides C., Kalophonos C., Samantas E., Boukovinas J., et al. Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small cell lung cancer: a phase III randomized trial. J Clin Oncol 20 (2002) 3578-3585
18. Smit E.F., van Meerbeeck J.P.A.M., lianes P., Debruyne C., Legrand C., Schramel F., et al. Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group-EORTC 08975. J Clin Oncol 21 (2003) 3909-3917
19. Georgoulias V., Ardavanis A., Tsiafaki X., Agelidou A., Mixalopoulou P., Anagnostopoulou O., et al. Vinorelbine plus cisplatin versus docetaxel plus gemcitabine in advanced non-small cell lung cancer: a phase III randomized trial. J Clin Oncol 23 (2005) 2937-2945
20. D'Addario G., Pintilie M., Leighl N.B., D'Addario G., Pintilie M., Leighl N.B., et al. Platinum-based versus non-platinum-based chemotherapy in advanced non-small cell lung cancer: a meta-analysis of the published literature. J Clin Oncol 23 (2005) 2926-2936
21. Pujol J.L., Barlesi F., and Daures J.P. Should chemotherapy combinations for advanced non-small cell lung cancer be platinum-based? A meta analysis of phase III randomized trials. Lung Cancer 51 (2006) 335-345
22. Lilenbaum R., Langenberg P., and Dickersin K. Single agent versus combination chemotherapy in patients with advanced non-small cell lung carcinoma: a meta-analysis of response, toxicity, and survival. Cancer 82 (1998) 116-126
23. Georgoulias V., Ardavanis A., Agelidou A., Agelidou M., Chandrinos V., Tsaroucha E., et al. Docetaxel versus docetaxel plus cisplatin as front-line treatment of patients with advanced non-small cell lung cancer: a randomized, multicenter phase III trial. J Clin Oncol 22 (2004) 2602-2609
24. Lilenbaum R.C., Herndon II J.E., List M.A., Desch C., Watson D.M., Miller A.A., 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 (2005) 190-196
25. Sederholm C., Hillerdal G., Lamberg K., Kolbeck K., Dufmats M., Westberg R., et al. Phase III trial of gemcitabine plus carboplatin versus single-agent gemcitabine in the treatment of locally advanced or metastatic non-small cell lung cancer: the Swedish Lung Cancer Group. J Clin Oncol 23 (2005) 8380-8388
26. NCI Toxicities Criteria, version 2, 1999; April 30.
27. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. New guidelines to evaluate the response to treatment in solid tumors. J Nat Cancer Inst 92 (2000) 205-216
28. Miller A.B., Hoogstraten B., Staquet M., and Winkler A. Reporting results of cancer treatment. Cancer 47 (1981) 207-214
29. Hollen P.J., Gralla R.J., Kris R.G., and Cox C. Quality of life during clinical trials: conceptual model for the lung cancer symptom score (LCSS). Support Care Cancer 2 (1994) 213-222
30. Hollen P.J., and Gralla R.J. Comparison of instruments for measuring quality of life in patients with lung cancer. Sem Oncol 23 (1996) 53-55 2 suppl. 5
31. Altman G.D. Practical statistics for medical research (1991), Chapman and Hall, London, UK
32. Armitage P., and Berry G. Statistical methods in medical research. 3rd ed. (1994), Blackwell Scientific, Oxford, UK
33. Collet D. Modelling survival data in medical research (1994), Chapman and Hall, London, UK
34. Cox D. The analysis of binary data (1970), Methuen, London, UK