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 Thuss-Patience, P. C. Articles by Reichardt, P. Search for Related Content PubMed PubMed Citation Articles by Thuss-Patience, P. C. Articles by Reichardt, P. Social Bookmarking                            What's this?

Docetaxel and Continuous-Infusion Fluorouracil Versus Epirubicin, Cisplatin, and Fluorouracil for Advanced Gastric Adenocarcinoma: A Randomized Phase II Study

From the Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Charité, Universitätsmedizin Berlin, Campus Virchow-Klinkum; HELIOS-Klinikum Berlin, Robert-Rössle-Klink, Charité Campus Buch; and Onkologische Schwerpunktpraxis Tiergarten, Berlin; Städtisches Klinikum St. Georg, Leipzig; and Vinzenz-Pallotti-Krankenhaus, Hämato-onkologische Ambulanz, Bergisch-Gladbach, Germany

Address reprint requests to P. Thuss-Patience, MD, Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Charité, Universitätsmedizin Berlin, Campus Virchow-Klinkum, Augustenburger Platz 1, 13353 Berlin, Germany; e-mail: peter.thuss{at}charite.de

PURPOSE: A combination of docetaxel and fluorouracil (DF) was evaluated in an outpatient setting and compared with epirubicin, cisplatin, and fluorouracil (ECF), which served as an internal control arm to avoid selection bias.

PATIENTS AND METHODS: Patients with metastatic or locally advanced gastric adenocarcinoma without prior chemotherapy were randomly assigned to receive either ECF (epirubicin 50 mg/m² day 1, cisplatin 60 mg/m² day 1, and fluorouracil 200 mg/m² days 1 through 21, every 3 weeks) or DF (docetaxel 75 mg/m² day 1, and fluorouracil 200 mg/m² days 1 through 21, every 3 weeks).

RESULTS: Ninety patients were randomly assigned. Toxicity was rarely severe. Major toxic effects included diarrhea, stomatitis, and leukopenia in the DF arm and nausea, vomiting, and leukopenia in the ECF arm. Forty-three of 45 patients in each arm were assessable. In the DF arm, two patients (4.4%, intent to treat) experienced a confirmed complete tumor remission as best response, and 15 patients (33.3%) experienced a confirmed partial remission (overall response rate [ORR], 37.8%; 95% CI, 25.9% to 51.9%). Two patients (4.4%) in the ECF arm showed confirmed complete remission, and 14 (31.1%) showed confirmed partial remission (ORR, 35.6%; 95% CI, 24.8% to 48.7%). For the DF and ECF arms, the median survival was 9.5 and 9.7 months, and the median time to tumor progression 5.5 and 5.3 months, respectively.

CONCLUSION: DF can be safely given in an ambulant setting. Compared with ECF, the dual combination of DF shows promising efficacy and may be an alternative treatment option that avoids cisplatin.

Supported by a research grant from Aventis Pharma Deutschland GmbH, Bad Soden, Germany.

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002.

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:

				S. Lorenzen, M. Hentrich, C. Haberl, V. Heinemann, T. Schuster, T. Seroneit, N. Roethling, C. Peschel, and F. Lordick Split-dose docetaxel, cisplatin and leucovorin/fluorouracil as first-line therapy in advanced gastric cancer and adenocarcinoma of the gastroesophageal junction: results of a phase II trial Ann. Onc., October 1, 2007; 18(10): 1673 - 1679. [Abstract] [Full Text] [PDF]

				D. H. Ilson Docetaxel, Cisplatin, and Fluorouracil in Gastric Cancer: Does the Punishment Fit the Crime? J. Clin. Oncol., August 1, 2007; 25(22): 3188 - 3190. [Full Text] [PDF]

				A. D. Wagner, W. E. Fleig, and J. Haerting In Reply J. Clin. Oncol., February 20, 2007; 25(6): 730 - 730. [Full Text] [PDF]

				W Ichikawa and Y Sasaki Correlation between tumor response to first-line chemotherapy and prognosis in advanced gastric cancer patients Ann. Onc., November 1, 2006; 17(11): 1665 - 1672. [Abstract] [Full Text] [PDF]

				K. Yoshida, M. Ninomiya, N. Takakura, N. Hirabayashi, W. Takiyama, Y. Sato, S. Todo, M. Terashima, M. Gotoh, J. Sakamoto, et al. Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer. Clin. Cancer Res., June 1, 2006; 12(11): 3402 - 3407. [Abstract] [Full Text] [PDF]

				K. F. Giordano, A. Jatoi, P. J. Stella, N. Foster, L. K. Tschetter, S. R. Alberts, S. R. Dakhil, J. A. Mailliard, P. J. Flynn, and D. A. Nikcevich Docetaxel and capecitabine in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction: a phase II study from the North Central Cancer Treatment Group Ann. Onc., April 1, 2006; 17(4): 652 - 656. [Abstract] [Full Text] [PDF]

				D. Ilson Just When You Thought the Fluorouracil Debate Was Over: S-1 and Gastric Cancer J. Clin. Oncol., October 1, 2005; 23(28): 6826 - 6828. [Full Text] [PDF]

				J. A. Ajani Evolving Chemotherapy for Advanced Gastric Cancer Oncologist, October 1, 2005; 10(suppl_3): 49 - 58. [Abstract] [Full Text] [PDF]

				O. Bouche, M. Ychou, P. Burtin, L. Bedenne, M. Ducreux, G. Lebreton, J. Baulieux, B. Nordlinger, C. Martin, J. F. Seitz, et al. Adjuvant chemotherapy with 5-fluorouracil and cisplatin compared with surgery alone for gastric cancer: 7-year results of the FFCD randomized phase III trial (8801) Ann. Onc., September 1, 2005; 16(9): 1488 - 1497. [Abstract] [Full Text] [PDF]

				W. P. Tew, D. P. Kelsen, and D. H. Ilson Targeted Therapies for Esophageal Cancer Oncologist, September 1, 2005; 10(8): 590 - 601. [Abstract] [Full Text] [PDF]