Randomized phase III trial comparing induction chemotherapy followed by radiotherapy to concomitant chemoradiotherapy for laryngeal preservation in T3M0 pyriform sinus carcinoma.
CONCLUSIONS
Conventional radiotherapy with concurrent cisplatin is significantly superior to induction cisplatin fluorouracil chemotherapy followed by radiotherapy in terms of laryngeal preservation in patients with T3 hypopharyngeal carcinoma. Despite a high rate of laryngeal preservation no survival benefit was recorded in this selected population.


OBJECTIVE
To compare conventional radiotherapy with concurrent cisplatin to induction chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary end point was the preservation of the larynx. The secondary end points included toxicity, causes of death, and survival rates.


METHODS
Seventy-one adult patients with previously untreated resectable T3 pyriform sinus squamous cell carcinoma were enrolled in the multicenter prospective randomized phase III trial. They were evaluated for organ preservation, survival rates, and toxic reactions.


RESULTS
The rates of laryngeal preservation at 2 years were 68% for the induction chemotherapy (IC) group and 92% for the chemoradiotherapy (CR) group (p = 0.016). At 2 years, the event-free survival rates were 36% and 41% for the IC group and CR group, respectively.
Prades
Jean-Michel
JM
Department of Otolaryngology - Head and Neck Surgery, Saint-Etienne University Hospital Center, Loire Cancer Institute, Saint-Etienne, France.
Lallemant
Benjamin
B
Garrel
Renaud
R
Reyt
Emile
E
Righini
Christian
C
Schmitt
Thierry
T
Remini
Nagib
N
Saban-Roche
Lea
L
Timoshenko
Andrei P
AP
Trombert
Beatrice
B
Guerrier
Bernard
B
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D002423:Cause of Death; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D007825:Laryngectomy; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D056144:Pyriform Sinus
D002945:Cisplatin; D005472:Fluorouracil