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

Ann Oncol. 2009 May;20(5):921-7. doi: 10.1093/annonc/mdn752. Epub 2009 Jan 29.

Abstract

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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Squamous Cell / drug therapy
  • Carcinoma, Squamous Cell / mortality
  • Carcinoma, Squamous Cell / pathology
  • Carcinoma, Squamous Cell / radiotherapy
  • Carcinoma, Squamous Cell / therapy*
  • Chemotherapy, Adjuvant
  • Cisplatin / administration & dosage
  • Disease-Free Survival
  • Docetaxel
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Hypopharyngeal Neoplasms / drug therapy
  • Hypopharyngeal Neoplasms / mortality
  • Hypopharyngeal Neoplasms / pathology
  • Hypopharyngeal Neoplasms / radiotherapy
  • Hypopharyngeal Neoplasms / surgery
  • Hypopharyngeal Neoplasms / therapy*
  • Kaplan-Meier Estimate
  • Laryngeal Neoplasms / drug therapy
  • Laryngeal Neoplasms / mortality
  • Laryngeal Neoplasms / pathology
  • Laryngeal Neoplasms / radiotherapy
  • Laryngeal Neoplasms / surgery
  • Laryngeal Neoplasms / therapy*
  • Laryngectomy
  • Male
  • Middle Aged
  • Proportional Hazards Models
  • Radiotherapy, Adjuvant
  • Risk Assessment
  • Taxoids / administration & dosage
  • Time Factors
  • Treatment Outcome

Substances

  • Taxoids
  • Docetaxel
  • Cisplatin
  • Fluorouracil