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 Gibson, M. K. Articles by Forastiere, A. A. Search for Related Content PubMed PubMed Citation Articles by Gibson, M. K. Articles by Forastiere, A. A. Social Bookmarking                            What's this?

Randomized Phase III Evaluation of Cisplatin Plus Fluorouracil Versus Cisplatin Plus Paclitaxel in Advanced Head and Neck Cancer (E1395): An Intergroup Trial of the Eastern Cooperative Oncology Group

From The Johns Hopkins University, Baltimore, MD; Dana-Farber Cancer Institute, Boston, MA; Vanderbilt-Ingram Cancer Center, Nashville, TN; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; and H. Lee Moffitt Cancer Center, Tampa, FL

Address reprint requests to Michael K. Gibson, MD, Department of Medical Oncology, Sidney Kimmell Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, CRB 345, Baltimore, MD 21231; e-mail: gibsomi{at}jhmi.edu

PURPOSE: To determine the response rate, survival and toxicity of infusional cisplatin plus fluorouracil (CF) versus cisplatin plus paclitaxel (CP) in patients with incurable squamous cell cancer of the head and neck, with the hypothesis that CP is superior.

PATIENTS AND METHODS: Two hundred eighteen patients with locally advanced, recurrent, or metastatic disease were randomly assigned to CF (cisplatin 100 mg/m² day 1 and fluorouracil 1,000 mg/m²/24 hours by continuous intravenous infusion day 1 through 4) or CP (cisplatin 75 mg/m² day 1 and paclitaxel 175 mg/m² over 3 hours on day 1). Cycles were repeated every 3 weeks until progression or a minimum of 6 cycles with complete response or stable disease. The primary outcome was overall survival. Secondary outcomes included response rate and toxicity.

RESULTS: No significant difference in overall survival or response rate was seen. Estimated median survival was 8.7 months in the CF group and 8.1 month in the CP group. Objective response rate (complete response plus partial response) was 27% in the CF group and 26% in the CP group. Toxicity was similar between groups, with the most frequent including myelosuppression, thrombocytopenia, anemia, nausea, vomiting, and stomatitis. A total of 12 deaths occurred (CF, seven; CP, five) during treatment; eight from infection, two from hemorrhage, one from cardiac causes and one from unknown causes. Gastrointestinal and hematologic toxicities were more common in the CF group, whereas neurotoxicity was equivalent between groups.

CONCLUSION: This phase III, randomized, multicenter trial showed no difference in survival between patients treated with CF or CP.

Supported in part by Public Health Service Grants CA23318, CA66636, CA21115, CA16116, CA49957, CA32102, CA27057, CA73590 from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services, Bethesda, MD.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

The Southwest Oncology Group also participated in the study.

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:

				C. H. Chung, J. Aulino, N. J. Muldowney, H. Hatakeyama, J. Baumann, B. Burkey, J. Netterville, R. Sinard, W. G. Yarbrough, A. J. Cmelak, et al. Nuclear factor-kappa B pathway and response in a phase II trial of bortezomib and docetaxel in patients with recurrent and/or metastatic head and neck squamous cell carcinoma Ann. Onc., October 22, 2009; (2009) mdp390v1. [Abstract] [Full Text] [PDF]

				D. J. Sher, R. B. Tishler, D. Annino, and R. S. Punglia Cost-effectiveness of CT and PET-CT for determining the need for adjuvant neck dissection in locally advanced head and neck cancer Ann. Onc., October 15, 2009; (2009) mdp405v1. [Abstract] [Full Text] [PDF]

				N. Kiyota, M. Tahara, S. Kadowaki, N. Fuse, T. Doi, H. Minami, and A. Ohtsu Systemic Chemotherapy with Cisplatin Plus 5-FU (PF) for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN): Efficacy and Safety of a Lower Dose of PF (80/800) at a Single Institution in Japan Jpn. J. Clin. Oncol., April 1, 2009; 39(4): 225 - 230. [Abstract] [Full Text] [PDF]

				T. YAMASHITA, S. SHINDEN, T. WATABE, and A. SHIOTANI Outpatient Chemotherapy with S-1 for Recurrent Head and Neck Cancer Anticancer Res, February 1, 2009; 29(2): 577 - 581. [Abstract] [Full Text] [PDF]

				B. A. Burtness, J. Manola, R. Axelrod, A. Argiris, and A. A. Forastiere A randomized phase II study of ixabepilone (BMS-247550) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study Ann. Onc., May 1, 2008; 19(5): 977 - 983. [Abstract] [Full Text] [PDF]

				T. Okabe, I. Okamoto, S. Tsukioka, J. Uchida, T. Iwasa, T. Yoshida, E. Hatashita, Y. Yamada, T. Satoh, K. Tamura, et al. Synergistic antitumor effect of S-1 and the epidermal growth factor receptor inhibitor gefitinib in non-small cell lung cancer cell lines: role of gefitinib-induced down-regulation of thymidylate synthase Mol. Cancer Ther., March 1, 2008; 7(3): 599 - 606. [Abstract] [Full Text] [PDF]

				C. J. Langer, J. Harris, E. M. Horwitz, N. Nicolaou, M. Kies, W. Curran, S. Wong, and K. Ang Phase II Study of Low-Dose Paclitaxel and Cisplatin in Combination With Split-Course Concomitant Twice-Daily Reirradiation in Recurrent Squamous Cell Carcinoma of the Head and Neck: Results of Radiation Therapy Oncology Group Protocol 9911 J. Clin. Oncol., October 20, 2007; 25(30): 4800 - 4805. [Abstract] [Full Text] [PDF]

				C. Elser, L. L. Siu, E. Winquist, M. Agulnik, G. R. Pond, S. F. Chin, P. Francis, R. Cheiken, J. Elting, A. McNabola, et al. Phase II Trial of Sorafenib in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Nasopharyngeal Carcinoma J. Clin. Oncol., August 20, 2007; 25(24): 3766 - 3773. [Abstract] [Full Text] [PDF]

				L. L. Siu, D. Soulieres, E. X. Chen, G. R. Pond, S. F. Chin, P. Francis, L. Harvey, M. Klein, W. Zhang, J. Dancey, et al. Phase I/II Trial of Erlotinib and Cisplatin in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: A Princess Margaret Hospital Phase II Consortium and National Cancer Institute of Canada Clinical Trials Group Study J. Clin. Oncol., June 1, 2007; 25(16): 2178 - 2183. [Abstract] [Full Text] [PDF]

				G Fountzilas, P Papakostas, U Dafni, T Makatsoris, M Karina, A Kalogera-Fountzila, N Maniadakis, G Aravantinos, K Syrigos, A Bamias, et al. Paclitaxel and gemcitabine vs. paclitaxel and pegylated liposomal doxorubicin in advanced non-nasopharyngeal head and neck cancer. An efficacy and cost analysis randomized study conducted by the Hellenic Cooperative Oncology Group Ann. Onc., October 1, 2006; 17(10): 1560 - 1567. [Abstract] [Full Text] [PDF]

				K. W. Yip, X. Mao, P.Y. B. Au, D. W. Hedley, S. Chow, S. Dalili, J. D. Mocanu, C. Bastianutto, A. Schimmer, and F.-F. Liu Benzethonium Chloride: A Novel Anticancer Agent Identified by Using a Cell-Based Small-Molecule Screen. Clin. Cancer Res., September 15, 2006; 12(18): 5557 - 5569. [Abstract] [Full Text] [PDF]

				M. Quintela-Fandino, R. Hitt, P. P. Medina, S. Gamarra, L. Manso, H. Cortes-Funes, and M. Sanchez-Cespedes DNA-Repair Gene Polymorphisms Predict Favorable Clinical Outcome Among Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Treated With Cisplatin-Based Induction Chemotherapy J. Clin. Oncol., September 10, 2006; 24(26): 4333 - 4339. [Abstract] [Full Text] [PDF]

				A. D. Colevas Chemotherapy Options for Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck J. Clin. Oncol., June 10, 2006; 24(17): 2644 - 2652. [Abstract] [Full Text] [PDF]

				S. J. Wong, M. Machtay, and Y. Li Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy, or Chemotherapy Alone? J. Clin. Oncol., June 10, 2006; 24(17): 2653 - 2658. [Abstract] [Full Text] [PDF]

				D. J. Adelstein Induction Redux: Once More With Taxanes J. Clin. Oncol., December 1, 2005; 23(34): 8556 - 8558. [Full Text] [PDF]

				G. H. Pantvaidya, A. K. D'cruz, and K. Prabhash Palliation in Incurable Head and Neck Cancers: Chemotherapy? J. Clin. Oncol., November 1, 2005; 23(31): 8128 - 8129. [Full Text] [PDF]

				M. K. Gibson, Y. Li, B. Murphy, M. H.A. Hussain, R. C. Deconti, J. Ensley, and A. A. Forastiere In Reply: J. Clin. Oncol., November 1, 2005; 23(31): 8129 - 8130. [Full Text] [PDF]

				M. R. Posner Paradigm Shift in the Treatment of Head and Neck Cancer: The Role of Neoadjuvant Chemotherapy Oncologist, October 1, 2005; 10(suppl_3): 11 - 19. [Abstract] [Full Text] [PDF]