Dose escalation study of nedaplatin with 5-fluorouracil in combination with alternating radiotherapy in patients with head and neck cancer.
BACKGROUND
This study, with a large number of patients, confirms that after administration of 5-fluorouracil (5FU), a higher dose of nedaplatin (NDP) can be safely administered rather than a single therapy of NDP, as demonstrated in a phase I study.


METHODS
The subjects were 52 patients with stage II-IV (M0) head and neck cancer other than nasopharyngeal cancer. Alternating chemoradiotherapy was performed using the following method. Initially, chemotherapy was administered. For chemotherapy, 5FU at 700 mg/m2/24 h was intravenously administered for 5 days (days 1-5), and NDP was administered on day 6. We established three dose groups: level 1, 120 mg/m2; level 2, 140 mg/m2; and level 3, 150 mg/m2 (n = 13 or more per group).


RESULTS
The maximum acceptable dose of NDP (150 mg/m2) was confirmed. The 5-year overall survival rates were 77% (95% CI: 66-90%) in all subjects and 75% (95% CI: 61-92%) in the stage III/IV patients. The 5-year progression-free survival rates were 73% (95% CI: 62-87%) in all subjects and 72% (95% CI: 57-89%) in the stage III/IV patients.


CONCLUSIONS
After administration of 5FU, a higher dose of NDP can be safely administered. This alternating chemoradiotherapy showed potent antitumor effects. The efficacy of chemotherapy with NDP and 5FU should be compared to that of chemotherapy with CDDP and 5FU.
Fuwa
Nobukazu
N
Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. nfuwa@aichi-cc.jp
Kodaira
Takesi
T
Tachibana
Hiroyuki
H
Nakamura
Tatsuya
T
Daimon
Takasi
T
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; C053989:nedaplatin; D005472:Fluorouracil