Concurrent chemoradiotherapy with cisplatin and docetaxel for advanced head and neck cancer. A phase I study.
BACKGROUND
This phase I study of weekly low-dose administration of cisplatin (CDDP) and docetaxel (DOC) combined with concurrent conventionally fractionated radiotherapy was designed for locoregionally advanced head and neck cancer.


METHODS
Twelve patients were treated at varying levels of DOC (level 1: 5 mg/m2/week, level 2: 7.5 mg/m2/week, level 3: 10 mg/m2/week) with CDDP constant at 20 mg/m2/week in four cohorts of three patients. Radiation was given at 1.8-2.0 Gy/fraction to a total dose of 60-70.2 Gy.


RESULTS
Hematological toxicities, except lymphocytopenia, were minimal. Mucosal toxicities, especially grade 3 mucositis, were common. Dose-limiting toxicity was grade 3 pain, although level 3 did not reach a maximum tolerated dose. No grade 4 toxicities were observed. Complete response rate ranged from 33% to 67% in the various dose levels.


CONCLUSIONS
This concurrent chemoradiotherapy seems to be a promising treatment modality, in which level 3 is the recommended dose for a phase II study.
Inohara
Hidenori
H
Department of Otolaryngology and Sensory Organ Surgery Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan. hinohara@ent.med.osaka-u.ac.jp
Inoue
Takehiro
T
Akahani
Shiro
S
Yamamoto
Yoshifumi
Y
Takenaka
Yukinori
Y
Nakagawa
Takashi
T
Isohashi
Fumiaki
F
Kubo
Takeshi
T
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy / Q000532:radiotherapy; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin