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In Reply:

Johns Hopkins University, Baltimore, MD

Yi Li

Dana-Farber Cancer Institute, Boston, MA

Barbara Murphy

Vanderbilt-Ingram Cancer Center, Nashville, TN

Maha H.A. Hussain

University of Michigan CCC, Ann Arbor, MI

Ronald C. Deconti

H. Lee Moffitt Cancer Center, Tampa, FL

John Ensley

Harper-Grace Hospitals, Detroit, MI

Arlene A. Forastiere

Johns Hopkins University, Baltimore, MD

We appreciate the interest that Dr Pantvaidya et al have in our study, "A Randomized phase III Evaluation of Paclitaxel + Cisplatin versus Cisplatin + 5-FU in Advanced Head and Neck Cancer (E1395): An Intergroup Trial of the Eastern Cooperative Oncology Group."¹ Their comments are welcome and helpful. We wish to reply as follows.

We designed this study to detect a 15% difference in 1-year survival between the two regimens, with the hypothesis that cisplatin plus paclitaxel is better than cisplatin plus fluorouracil. We agree that our survival curves indicate a higher than expected survival for both arms; however, we note that the result is counter to our hypothesis—cisplatin plus fluorouracil performed better than cisplatin plus paclitaxel. Choice of beta error, and thus power, is solely dependent on what outcome difference the investigators wish to detect and by inference what improvement they consider clinically relevant. Interpretation of the data is left to the reader.

96% of patients categorized as recurrent received radiation therapy as part of their initial therapy. All 25 patients with newly diagnosed disease presented with distant metastases.

The Eastern Cooperative Oncology Group is preparing a manuscript that will describe the quality of life and pain assessment data from this trial.

Authors' Disclosures of Potential Conflicts of Interest

The authors indicated no potential conflicts of interest.

REFERENCE

1. Gibson MK, Li Y, Murphy B, et al: 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. J Clin Oncol 23:3562-3567, 2005[Abstract/Free Full Text]

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Related Correspondence

• Palliation in Incurable Head and Neck Cancers: Chemotherapy?
  Gouri H. Pantvaidya, Anil K. D'cruz, and Kumar Prabhash
  JCO 2005 23: 8128-8129 [Full Text]

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