title: Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer.
abstract: OBJECTIVE
  To report the long-term results of the Intergroup Radiation Therapy Oncology Group 91-11 study evaluating the contribution of chemotherapy added to radiation therapy (RT) for larynx preservation.
  
  
  METHODS
  Patients with stage III or IV glottic or supraglottic squamous cell cancer were randomly assigned to induction cisplatin/fluorouracil (PF) followed by RT (control arm), concomitant cisplatin/RT, or RT alone. The composite end point of laryngectomy-free survival (LFS) was the primary end point.
  
  
  RESULTS
  Five hundred twenty patients were analyzed. Median follow-up for surviving patients is 10.8 years. Both chemotherapy regimens significantly improved LFS compared with RT alone (induction chemotherapy v RT alone: hazard ratio [HR], 0.75; 95% CI, 0.59 to 0.95; P = .02; concomitant chemotherapy v RT alone: HR, 0.78; 95% CI, 0.78 to 0.98; P = .03). Overall survival did not differ significantly, although there was a possibility of worse outcome with concomitant relative to induction chemotherapy (HR, 1.25; 95% CI, 0.98 to 1.61; P = .08). Concomitant cisplatin/RT significantly improved the larynx preservation rate over induction PF followed by RT (HR, 0.58; 95% CI, 0.37 to 0.89; P = .0050) and over RT alone (P < .001), whereas induction PF followed by RT was not better than treatment with RT alone (HR, 1.26; 95% CI, 0.88 to 1.82; P = .35). No difference in late effects was detected, but deaths not attributed to larynx cancer or treatment were higher with concomitant chemotherapy (30.8% v 20.8% with induction chemotherapy and 16.9% with RT alone).
  
  
  CONCLUSIONS
  These 10-year results show that induction PF followed by RT and concomitant cisplatin/RT show similar efficacy for the composite end point of LFS. Locoregional control and larynx preservation were significantly improved with concomitant cisplatin/RT compared with the induction arm or RT alone. New strategies that improve organ preservation and function with less morbidity are needed.
authors.affiliation: Sydney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA. af@jhmi.edu
authors.forename: Arlene A
authors.initials: AA
authors.lastname: Forastiere
authors.forename: Qiang
authors.initials: Q
authors.lastname: Zhang
authors.forename: Randal S
authors.initials: RS
authors.lastname: Weber
authors.forename: Moshe H
authors.initials: MH
authors.lastname: Maor
authors.forename: Helmuth
authors.initials: H
authors.lastname: Goepfert
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Pajak
authors.forename: William
authors.initials: W
authors.lastname: Morrison
authors.forename: Bonnie
authors.initials: B
authors.lastname: Glisson
authors.forename: Andy
authors.initials: A
authors.lastname: Trotti
authors.forename: John A
authors.initials: JA
authors.lastname: Ridge
authors.forename: Wade
authors.initials: W
authors.lastname: Thorstad
authors.forename: Henry
authors.initials: H
authors.lastname: Wagner
authors.forename: John F
authors.initials: JF
authors.lastname: Ensley
authors.forename: Jay S
authors.initials: JS
authors.lastname: Cooper
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D003679:Deglutition / Q000187:drug effects / Q000528:radiation effects; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D007822:Laryngeal Neoplasms / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D007825:Laryngectomy; D007830:Larynx / Q000187:drug effects / Q000528:radiation effects; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D059351:Organ Sparing Treatments / Q000379:methods*; D018714:Radiotherapy, Adjuvant; D012074:Remission Induction; D016879:Salvage Therapy / Q000379:methods; D013060:Speech / Q000187:drug effects / Q000528:radiation effects; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin; D005472:Fluorouracil