title: Sequential therapy for the locally advanced larynx and hypopharynx cancer subgroup in TAX 324: survival, surgery, and organ preservation.
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.
  
  
  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.
authors.affiliation: Division of Adult Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Brigham and Women's Hospital, Boston, MA 02115, USA. marshall_posner@dfci.harvard.edu
authors.forename: M R
authors.initials: MR
authors.lastname: Posner
authors.forename: C M
authors.initials: CM
authors.lastname: Norris
authors.forename: L J
authors.initials: LJ
authors.lastname: Wirth
authors.forename: D M
authors.initials: DM
authors.lastname: Shin
authors.forename: K J
authors.initials: KJ
authors.lastname: Cullen
authors.forename: E W
authors.initials: EW
authors.lastname: Winquist
authors.forename: C R
authors.initials: CR
authors.lastname: Blajman
authors.forename: E A
authors.initials: EA
authors.lastname: Mickiewicz
authors.forename: G P
authors.initials: GP
authors.lastname: Frenette
authors.forename: L F
authors.initials: LF
authors.lastname: Plinar
authors.forename: R B
authors.initials: RB
authors.lastname: Cohen
authors.forename: L M
authors.initials: LM
authors.lastname: Steinbrenner
authors.forename: J M
authors.initials: JM
authors.lastname: Freue
authors.forename: V A
authors.initials: VA
authors.lastname: Gorbunova
authors.forename: S A
authors.initials: SA
authors.lastname: Tjulandin
authors.forename: L E
authors.initials: LE
authors.lastname: Raez
authors.forename: D R
authors.initials: DR
authors.lastname: Adkins
authors.forename: R B
authors.initials: RB
authors.lastname: Tishler
authors.forename: M R
authors.initials: MR
authors.lastname: Roessner
authors.forename: R I
authors.initials: RI
authors.lastname: Haddad
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D007822:Laryngeal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D007825:Laryngectomy; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D018714:Radiotherapy, Adjuvant; D018570:Risk Assessment; D043823:Taxoids / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil