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J Clin Oncol. 2014 Sep 1;32(25):2735-43. doi: 10.1200/JCO.2013.54.6309. Epub 2014 Jul 21.

Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer.

Author information

1
Ezra E.W. Cohen, Theodore G. Karrison, Masha Kocherginsky, Jeffrey Mueller, Robyn Egan, Tanguy Y. Seiwert, Victoria M. Villaflor, Daniel J. Haraf, and Everett E. Vokes, University of Chicago, Chicago; Bruce E. Brockstein, North Shore University Health System, Evanston; Mark B. Agulnik and Bharat B. Mittal, Northwestern University, Chicago, IL; Chao H. Huang, University of Kansas and Veterans Affairs Medical Center, Kansas City, KS; Furhan Yunus and Sandeep Samant, University of Tennessee, Memphis, TN; Luis E. Raez, University of Miami, Miami, FL; Ranee Mehra, Fox Chase Cancer Center, Philadelphia, PA; Priya Kumar and Frank Ondrey, University of Minnesota, Minneapolis, MN; and Patrice Marchand and Bettina Braegas, Nuvisan Oncology, Le Kremlin-Bicêtre, France. ecohen@ucsd.edu.
2
Ezra E.W. Cohen, Theodore G. Karrison, Masha Kocherginsky, Jeffrey Mueller, Robyn Egan, Tanguy Y. Seiwert, Victoria M. Villaflor, Daniel J. Haraf, and Everett E. Vokes, University of Chicago, Chicago; Bruce E. Brockstein, North Shore University Health System, Evanston; Mark B. Agulnik and Bharat B. Mittal, Northwestern University, Chicago, IL; Chao H. Huang, University of Kansas and Veterans Affairs Medical Center, Kansas City, KS; Furhan Yunus and Sandeep Samant, University of Tennessee, Memphis, TN; Luis E. Raez, University of Miami, Miami, FL; Ranee Mehra, Fox Chase Cancer Center, Philadelphia, PA; Priya Kumar and Frank Ondrey, University of Minnesota, Minneapolis, MN; and Patrice Marchand and Bettina Braegas, Nuvisan Oncology, Le Kremlin-Bicêtre, France.

Abstract

PURPOSE:

Induction chemotherapy (IC) before radiotherapy lowers distant failure (DF) rates in locally advanced squamous cell carcinoma of the head and neck (SCCHN). The goal of this phase III trial was to determine whether IC before chemoradiotherapy (CRT) further improves survival compared with CRT alone in patients with N2 or N3 disease.

PATIENTS AND METHODS:

Treatment-naive patients with nonmetastatic N2 or N3 SCCHN were randomly assigned to CRT alone (CRT arm; docetaxel, fluorouracil, and hydroxyurea plus radiotherapy 0.15 Gy twice per day every other week) versus two 21-day cycles of IC (docetaxel 75 mg/m(2) on day 1, cisplatin 75 mg/m(2) on day 1, and fluorouracil 750 mg/m(2) on days 1 to 5) followed by the same CRT regimen (IC + CRT arm). The primary end point was overall survival (OS). Secondary end points included DF-free survival, failure pattern, and recurrence-free survival (RFS).

RESULTS:

A total of 285 patients were randomly assigned. The most common grade 3 to 4 toxicities during IC were febrile neutropenia (11%) and mucositis (9%); during CRT (both arms combined), they were mucositis (49%), dermatitis (21%), and leukopenia (18%). Serious adverse events were more common in the IC arm (47% v 28%; P = .002). With a minimum follow-up of 30 months, there were no statistically significant differences in OS (hazard ratio, 0.91; 95% CI, 0.59 to 1.41), RFS, or DF-free survival.

CONCLUSION:

IC did not translate into improved OS compared with CRT alone. However, the study was underpowered because it did not meet the planned accrual target, and OS was higher than predicted in both arms. IC cannot be recommended routinely in patients with N2 or N3 locally advanced SCCHN.

PMID:
25049329
PMCID:
PMC4876357
DOI:
10.1200/JCO.2013.54.6309
[Indexed for MEDLINE]
Free PMC Article

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