Randomized study of 5 fluorouracil and cis platin as neoadjuvant therapy in head and neck cancer: a preliminary report.
A randomized prospective study of 5 fluorouracil (5-FU) and Cis platin preceding definitive local treatment for squamous cell carcinoma of the head and neck region was initiated in September 1986. Seventy-five patients were stratified by site (oral cavity-12, oropharynx-28, larynx-16, hypopharynx-19), and by Stage (Stage II-20, Stage III-43, Stage IV-12) and randomized to receive definitive local treatment (surgery and post-operative radiation or radiation alone) or chemotherapy followed by definitive local treatment. Chemotherapy consisted of three cycles of 120 hr 5-FU infusion 1 g/m2/day plus Cis platin 100 mg/m2 on day 1 on each cycle. Response to chemotherapy was complete in 17 patients (46%) for an overall response rate of 68%. All the patients have completed therapy with a median follow-up of more than 12 months. After local treatment, the complete response rate is 84% for the control group and 86% in the chemotherapy group. Actuarial disease-free survival at 1 year is 61% in the control group and 73% in the chemotherapy group (p = 0.25). These preliminary results show that in spite of initial tumor response, neoadjuvant chemotherapy does not improve long-term control and survival.
Martin
M
M
Département de Cancérologie, Centre Hospitalier Creteil, France.
Hazan
A
A
Vergnes
L
L
Peytral
C
C
Mazeron
J J
JJ
Sénéchaut
J P
JP
Lelièvre
G
G
Peynègre
R
R
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D006801:Humans; D008297:Male
D002945:Cisplatin; D005472:Fluorouracil