Concomitant chemoradiotherapy versus induction docetaxel, cisplatin and 5 fluorouracil (TPF) followed by concomitant chemoradiotherapy in locally advanced head and neck cancer: a phase II randomized study.
BACKGROUND
Concomitant chemoradiotherapy (CT/RT) is the standard treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). We evaluated the efficacy of induction docetaxel (Taxotere), cisplatin, and 5-fluorouracil (TPF) before CT/RT versus CT/RT alone.


METHODS
Patients with stage III-IVM0 SCCHN, Eastern Cooperative Oncology Group performance status of zero to one, were randomly assigned to receive CT/RT alone (arm A: two cycles of cisplatin 20 mg/m(2), days1-4, plus 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, during weeks 1 and 6 of radiotherapy) or three cycles of TPF (arm B: docetaxel 75 mg/m(2) and cisplatin 80 mg/m(2), day 1, and 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, every 3 weeks) followed by the same CT/RT. The primary end point was the rate of radiologic complete response (CR) at 6-8 weeks after the end of CT/RT.


RESULTS
A total of 101 patients were randomly allocated to the study (51 arm A; 50 arm B). CR rates were 21.2% (arm A) versus 50% (arm B). Median progression-free survival and overall survival were, respectively, 19.7 and 33.3 months (arm A) and 30.4 and 39.6 months (arm B). Hematologic and non-hematologic toxic effects during CT/RT were similar in the two arms.


CONCLUSIONS
Induction TPF followed by CT/RT was associated with higher radiologic CR in patients with locally advanced SCCHN with no negative impact on CT/RT feasibility.
Paccagnella
A
A
Department of Medical Oncology, Venezia. Electronic address: adriano.paccagnella@ulss12.ve.it.
Ghi
M G
MG
Department of Medical Oncology, Venezia.
Loreggian
L
L
Department of Radiotherapy, Istituto Oncologico Veneto, Istituto di Ricerca e Cura a Carattere Scientifico, Padova.
Buffoli
A
A
Department of Radiotherapy, Azienda Ospedaliera Universitaria, Udine.
Koussis
H
H
Department of Medical Oncology, Istituto Oncologico Veneto, IRCCS, Padova.
Mione
C A
CA
Department of Radiotherapy, Ospedale SS. Giovanni e Paolo, Venezia.
Bonetti
A
A
Department of Medical Oncology, Ospedale Mater Salutis, Legnago.
Campostrini
F
F
Department of Radiotherapy, Ospedale Mater Salutis, Legnago.
Gardani
G
G
Department of Radiotherapy, S. Gerardo Hospital, Monza.
Ardizzoia
A
A
Department of Medical Oncology, S. Gerardo Hospital, Monza.
Dondi
D
D
Sanofi-Aventis, Milano.
Guaraldi
M
M
Department of Medical Oncology, S. Orsola-Malpighi Hospital, Bologna.
Cavallo
R
R
Department of Medical Oncology, P. Cosma Hospital, Camposampiero, Padova.
Tomio
L
L
Department of Radiotherapy, S. Chiara Hospital, Trento.
Gava
A
A
Department of Radiotherapy, Ospedale Ca' Foncello, Treviso, Italy.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D000077143:Docetaxel; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D012074:Remission Induction; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil