Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer.
BACKGROUND
A randomized phase 3 trial of the treatment of squamous-cell carcinoma of the head and neck compared induction chemotherapy with docetaxel plus cisplatin and fluorouracil (TPF) with cisplatin and fluorouracil (PF), followed by chemoradiotherapy.


METHODS
We randomly assigned 501 patients (all of whom had stage III or IV disease with no distant metastases and tumors considered to be unresectable or were candidates for organ preservation) to receive either TPF or PF induction chemotherapy, followed by chemoradiotherapy with weekly carboplatin therapy and radiotherapy for 5 days per week. The primary end point was overall survival.


RESULTS
With a minimum of 2 years of follow-up (> or =3 years for 69% of patients), significantly more patients survived in the TPF group than in the PF group (hazard ratio for death, 0.70; P=0.006). Estimates of overall survival at 3 years were 62% in the TPF group and 48% in the PF group; the median overall survival was 71 months and 30 months, respectively (P=0.006). There was better locoregional control in the TPF group than in the PF group (P=0.04), but the incidence of distant metastases in the two groups did not differ significantly (P=0.14). Rates of neutropenia and febrile neutropenia were higher in the TPF group; chemotherapy was more frequently delayed because of hematologic adverse events in the PF group.


CONCLUSIONS
Patients with squamous-cell carcinoma of the head and neck who received docetaxel plus cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy had a significantly longer survival than did patients who received cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy. (ClinicalTrials.gov number, NCT00273546 [ClinicalTrials.gov].).
Posner
Marshall R
MR
Dana-Farber Cancer Institute, Boston, MA 02115, USA.
Hershock
Diane M
DM
Blajman
Cesar R
CR
Mickiewicz
Elizabeth
E
Winquist
Eric
E
Gorbounova
Vera
V
Tjulandin
Sergei
S
Shin
Dong M
DM
Cullen
Kevin
K
Ervin
Thomas J
TJ
Murphy
Barbara A
BA
Raez
Luis E
LE
Cohen
Roger B
RB
Spaulding
Monica
M
Tishler
Roy B
RB
Roth
Berta
B
Viroglio
Rosana del Carmen
Rdel C
Venkatesan
Varagur
V
Romanov
Ilya
I
Agarwala
Sanjiv
S
Harter
K William
KW
Dugan
Matthew
M
Cmelak
Anthony
A
Markoe
Arnold M
AM
Read
Paul W
PW
Steinbrenner
Lynn
L
Colevas
A Dimitrios
AD
Norris
Charles M
CM
Haddad
Robert I
RI
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D011878:Radiotherapy / Q000009:adverse effects; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage*; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil