Randomized clinical trial of post-operative radiotherapy versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.
OBJECTIVE
Post-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.


METHODS
The study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54-72Gy, 30-40 fractions, 6-8 weeks) or identical treatment plus concomitant Carboplatin (50mg/m(2) administered by IV infusion twice weekly).


RESULTS
Between February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92-119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61-0.84) in the combined treatment group and 68% (95% CI: 0.57-0.80) in the radiotherapy group (p=0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69-1.60; p=0.81).


CONCLUSIONS
Twice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers.
Racadot
Séverine
S
Centre Léon Bérard, Department of Radiation Oncology, Lyon, France. racadot@lyon.fnclcc.fr
Mercier
Mariette
M
Dussart
Sophie
S
Dessard-Diana
Bernadette
B
Bensadoun
René-Jean
RJ
Martin
Michel
M
Malaurie
Emmanuelle
E
Favrel
Véronique
V
Housset
Martin
M
Durdux
Catherine
C
Journel
Catherine
C
Calais
Gilles
G
Huet
Jocelyne
J
Pillet
Gérard
G
Hennequin
Christophe
C
Haddad
Elias
E
Diana
Christian
C
Blaska-Jaulerry
Brigitte
B
Henry-Amar
Michel
M
Géhanno
Pierre
P
Baillet
François
F
Mazeron
Jean-Jacques
JJ
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D016016:Proportional Hazards Models; D011879:Radiotherapy Dosage; D015996:Survival Rate; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D016190:Carboplatin