Concomitant cisplatin significantly improves locoregional control in advanced head and neck cancers treated with hyperfractionated radiotherapy.
OBJECTIVE
To determine whether the application of two courses of cisplatin simultaneously with hyperfractionated radiotherapy improves the outcome in locally advanced and/or node-positive nonmetastatic carcinomas of the head and neck, compared with hyperfractionated radiotherapy alone.


METHODS
From July 1994 to July 2000, 224 patients with squamous cell carcinomas of the head and neck (excluding nasopharynx and paranasal sinus) were randomly assigned to hyperfractionated radiotherapy (median dose, 74.4 Gy; 1.2 Gy twice daily) or the same radiotherapy combined with two cycles of concomitant cisplatin (20 mg/m2 on 5 days of weeks 1 and 5). The primary end point was time to any treatment failure; secondary end points were locoregional failure, metastatic relapse, overall survival, and late toxicity.


RESULTS
There was no difference in radiotherapy between both treatment arms (74.4 Gy in 44 days). The full cisplatin dose was applied in 93% and 71% of patients during the first and second treatment cycles, respectively. Acute toxicity was similar in both arms. Median time to any treatment failure was not significantly different between treatment arms (19 months for combined treatment and 16 months for radiotherapy only, respectively) and the failure-free rate at 2.5 years was 45% and 33%, respectively. Locoregional control and distant disease-free survival were significantly improved with cisplatin (log-rank test, P = .039 and .011, respectively). The difference in overall survival did not reach significance (log-rank test, P = .147). Late toxicity was comparable in both treatment groups.


CONCLUSIONS
The therapeutic index of hyperfractionated radiotherapy is improved by concomitant cisplatin.
Huguenin
Pia
P
Department of Radiation Oncology, University Hospital Zurich, Zurich, Switzerland. pia.huguenin@usz.ch
Beer
Karl T
KT
Allal
Abdelkarim
A
Rufibach
Kaspar
K
Friedli
Corinne
C
Davis
Jacques Bernard
JB
Pestalozzi
Bernhard
B
Schmid
Stephan
S
Thöni
Armin
A
Ozsahin
Mahmut
M
Bernier
Jacques
J
Töpfer
Michael
M
Kann
Roger
R
Meier
Urs Richard
UR
Thum
Peter
P
Bieri
Sabine
S
Notter
Markus
M
Lombriser
Norbert
N
Glanzmann
Christoph
C
D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004307:Dose-Response Relationship, Radiation; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology*; D009367:Neoplasm Staging; D011336:Probability; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D012016:Reference Values; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D013557:Switzerland; D016896:Treatment Outcome
D002945:Cisplatin