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Annals of Oncology Advance Access originally published online on January 29, 2009
Annals of Oncology 2009 20(5):921-927; doi:10.1093/annonc/mdn752
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

head and neck cancer

Sequential therapy for the locally advanced larynx and hypopharynx cancer subgroup in TAX 324: survival, surgery, and organ preservation

M. R. Posner1,*, C. M. Norris2, L. J. Wirth1, D. M. Shin3, K. J. Cullen4, E. W. Winquist5, C. R. Blajman6, E. A. Mickiewicz7, G. P. Frenette8, L. F. Plinar9, R. B. Cohen10, L. M. Steinbrenner11, J. M. Freue12, V. A. Gorbunova13, S. A. Tjulandin14, L. E. Raez15, D. R. Adkins16, R. B. Tishler17, M. R. Roessner18, R. I. Haddad1 and for the TAX 324 Study Group

1 Division of Adult Oncology
2 Departments of Surgical Oncology and Adult Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Brigham and Women's Hospital, Boston
3 Department of Hematology and Medical Oncology, University of Pittsburgh Medical School, Pittsburgh
4 Department of Medical Oncology, Georgetown University Medical School, Washington, USA
5 Department of Oncology, London Regional Cancer Center, London, Canada
6 Servicio de Oncologia Clinica, Hospital JB Iturraspe, Santa Fe
7 Department of Oncology, Instituto Angel H Roffo, Buenos Aires, Argentina
8 General Oncology, Blumenthal Cancer Center, Charlotte
9 Division of Hematology and Oncology, University of Medicine and Dentistry of New Jersey, Newark
10 Division of Hematology–Oncology, University of Virginia, Charlottesville
11 Department of Hematology/Oncology, VA Western NY Health Care System, Buffalo, USA
12 Oncohematology, Hospital Evita, Buenos Aires, Argentina
13 Department of Oncology, Blokhin Cancer Research Center
14 Department of Clinical Pharmacology and Chemotherapy, Russian Cancer Research Center, Moscow, Russia
15 Department of Medicine, Sylvester Cancer Center, Miami
16 Medical Oncology/Internal Medicine, Washington University School of Medicine, St Louis
17 Department of Radiation Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Brigham and Women's Hospital, Boston
18 Biostatistics, Sanofi-aventis, Bridgewater, USA

* Correspondence to: Dr M. R. Posner, MD, Dana-Farber Cancer Institute, 44 Binney Street, SW430, Boston, MA 02115, USA. Tel: +1-617-582-7908; Fax: +1-617-632-4448; E-mail: marshall_posner{at}dfci.harvard.edu

Background: Locally advanced laryngeal and hypopharyngeal cancers (LHC) represent a group of cancers for which surgery, laryngectomy-free survival (LFS), overall survival (OS), and progression-free survival (PFS) are clinically meaningful end points.

Patients and methods: These outcomes were analyzed in the subgroup of assessable LHC patients enrolled in TAX 324, a phase III trial of sequential therapy comparing docetaxel plus cisplatin and fluorouracil (TPF) against cisplatin and fluorouracil (PF), followed by chemoradiotherapy.

Results: Among 501 patients enrolled in TAX 324, 166 had LHC (TPF, n = 90; PF, n = 76). Patient characteristics were similar between subgroups. Median OS for TPF was 59 months [95% confidence interval (CI): 31–not reached] versus 24 months (95% CI: 13–42) for PF [hazard ratio (HR) for death: 0.62; 95% CI: 0.41–0.94; P = 0.024]. Median PFS for TPF was 21 months (95% CI: 12–59) versus 11 months (95% CI: 8–14) for PF (HR: 0.66; 95% CI: 0.45–0.97; P = 0.032). Among operable patients (TPF, n = 67; PF, n = 56), LFS was significantly greater with TPF (HR: 0.59; 95% CI: 0.37–0.95; P = 0.030). Three-year LFS with TPF was 52% versus 32% for PF. Fewer TPF patients had surgery (22% versus 42%; P = 0.030).

Conclusions: In locally advanced LHC, sequential therapy with induction TPF significantly improved survival and PFS versus PF. Among operable patients, TPF also significantly improved LFS and PFS. These results support the use of sequential TPF followed by carboplatin chemoradiotherapy as a treatment option for organ preservation or to improve survival in locally advanced LHC.

Key words: chemotherapy, chemoradiotherapy, head and neck cancer, larynx cancer, hypopharynx cancer, organ preservation

Received for publication July 4, 2008. Revision received October 24, 2008. Accepted for publication October 27, 2008.


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