This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Georgoulias, V. Articles by Alegakis, A. Search for Related Content PubMed PubMed Citation Articles by Georgoulias, V. Articles by Alegakis, A. Social Bookmarking                            What's this?

Docetaxel Versus Docetaxel Plus Cisplatin As Front-Line Treatment of Patients With Advanced Non—Small-Cell Lung Cancer: A Randomized, Multicenter Phase III Trial

From the Department of Medical Oncology, University General Hospital of Heraklion, Crete; 1st Department of Medical Oncology, Agios Savas Anticancer Hospital; 1st, 8th, and 7th Departments of Pulmonary Diseases, Sotiria Hospital; 1st and 2nd Departments of Pulmonary Diseases, Sismanoglion Hospital; Medical Oncology Unit, 3rd Department of Internal Medicine and Oncology Unit, Department of Propedeutic Medicine, School of Medicine, University of Athens; Medical Oncology Unit, 401 Military Hospital; 2nd Department of Medical Oncology, Metaxa Anticancer Hospital of Athens, Athens; 2nd Department of Pulmonary Diseases, Papanikolaou Hospital, Thessaloniki; 2nd Department of Medical Oncology, Theagenion Anticancer Hospital, Thessaloniki; Department of Medical Statistics, School of Medicine, University of Crete, Heraklion, Greece

Address reprint requests to V. Georgoulias, MD, PhD, Department of Medical Oncology, University General Hospital of Heraklion, PO Box 1352, 711 10 Heraklion, Crete, Greece; e-mail: georgoul{at}med.uoc.gr

PURPOSE: To compare the overall survival (OS) of patients with advanced non–small-cell lung cancer (NSCLC) treated with docetaxel plus cisplatin (DC) or docetaxel (D) alone.

PATIENTS AND METHODS: Chemotherapy-naïve patients with advanced/metastatic NSCLC were randomly assigned to receive either DC (n = 167; docetaxel 100 mg/m² on day 1, cisplatin 80 mg/m² on day 2, and recombinant human granulocyte colony-stimulating factor (rhG-CSF) 150 µg/m²/d on days 3 to 9) or D (n = 152; 100 mg/m² on day 1 without rhG-CSF) every 3 weeks.

RESULTS: The overall response rates were 36.5% for DC (three complete responses and 58 partial responses) and 21.7% for D (one complete response and 32 partial responses; P = .004). The median OS was 10.5 months (range, 0.5 to 41 months) and 8.0 months (range, 0.5 to 41 months) for DC and D, respectively (P = .200). The 1- and 2-year survival rates were 44% and 19% for DC and 43% and 15% for D, respectively. Median times to tumor progression were 4.0 and 2.5 months for DC and D, respectively (P = .580). Grade 2/3 anemia was significantly higher with DC than with D (33% v 16%; P = .0001). Fifteen (9%) DC and 12 (8%) D patients developed febrile neutropenia. Grade 3/4 nausea/vomiting (P = .0001), diarrhea (P = .007), neurotoxicity (P = .017), and nephroroxicity (P = .006) were significantly more common with DC than with D. There were five treatment-related deaths in the DC group and one in the D (P = .098).

CONCLUSION: DC regimen resulted in a higher response rate but without improvement in median time to tumor progession or OS compared with D. D could be a reasonable front-line chemotherapy for patients who cannot tolerate cisplatin.

Supported partly by a grant from the Cretan Association for Biomedical Research.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				F. Grossi, M. Aita, C. Defferrari, F. Rosetti, A. Brianti, G. Fasola, O. Vinante, P. Pronzato, and G. Pappagallo Impact of Third-Generation Drugs on the Activity of First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Meta-Analytical Approach Oncologist, May 1, 2009; 14(5): 497 - 510. [Abstract] [Full Text] [PDF]

				M. A. Socinski, R. Crowell, T. E. Hensing, C. J. Langer, R. Lilenbaum, A. B. Sandler, and D. Morris Treatment of Non-small Cell Lung Cancer, Stage IV: ACCP Evidence-Based Clinical Practice Guidelines (2nd Edition) Chest, September 1, 2007; 132(3_suppl): 277S - 289S. [Abstract] [Full Text] [PDF]

				A. K. Malani, R. M. Abou-Jawde, J. Singh, and S. A. Taylor Docetaxel As Monotherapy in the Treatment of Advanced Non-Small-Cell Lung Cancer in Elderly Patients J. Clin. Oncol., March 20, 2007; 25(9): 1143 - 1144. [Full Text] [PDF]

				T. Y. Seiwert, P. P. Connell, A. M. Mauer, P. C. Hoffman, C. M. George, L. Szeto, R. Salgia, K. E. Posther, B. Nguyen, D. J. Haraf, et al. A Phase I Study of Pemetrexed, Carboplatin, and Concurrent Radiotherapy in Patients with Locally Advanced or Metastatic Non-Small Cell Lung or Esophageal Cancer Clin. Cancer Res., January 15, 2007; 13(2): 515 - 522. [Abstract] [Full Text] [PDF]

				G. Giaccone, M. Gallegos Ruiz, T. Le Chevalier, N. Thatcher, E. Smit, J. A. Rodriguez, P. Janne, D. Oulid-Aissa, and J.-C. Soria Erlotinib for Frontline Treatment of Advanced Non-Small Cell Lung Cancer: a Phase II Study. Clin. Cancer Res., October 15, 2006; 12(20): 6049 - 6055. [Abstract] [Full Text] [PDF]

				R. Booton, P. Lorigan, H. Anderson, S. Baka, L. Ashcroft, M. Nicolson, M. O'Brien, D. Dunlop, K. O'Byrne, V. Laurence, et al. A phase III trial of docetaxel/carboplatin versus mitomycin C/ifosfamide/cisplatin (MIC) or mitomycin C/vinblastine/cisplatin (MVP) in patients with advanced non-small-cell lung cancer: a randomised multicentre trial of the British Thoracic Oncology Group (BTOG1) Ann. Onc., July 1, 2006; 17(7): 1111 - 1119. [Abstract] [Full Text] [PDF]

				M. G. Fakih, P. J. Creaven, N. Ramnath, D. Trump, M. Javle, S. Strychor, T. V.W. Repinski, B. A. Zamboni, J. K. Schwarz, R. A. French, et al. Phase I and Pharmacokinetic Study of Weekly Docetaxel, Cisplatin, and Daily Capecitabine in Patients with Advanced Solid Tumors Clin. Cancer Res., August 15, 2005; 11(16): 5942 - 5949. [Abstract] [Full Text] [PDF]

				M. Taron, R. Rosell, E. Felip, P. Mendez, J. Souglakos, M. S. Ronco, C. Queralt, J. Majo, J. M. Sanchez, J. J. Sanchez, et al. BRCA1 mRNA expression levels as an indicator of chemoresistance in lung cancer Hum. Mol. Genet., October 1, 2004; 13(20): 2443 - 2449. [Abstract] [Full Text] [PDF]