Multicenter phase 2 study of induction chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma.
OBJECTIVE
To determine the clinical and hisotological efficacy and toxicities of induction chemotherapy with docetaxel (DOC) and nedaplatin (CDGP) for oral squamous cell carcinoma (OSCC) in the preoperative setting.


METHODS
A total of 30 patients with locally advanced but operable OSCC were enrolled. Combination induction chemotherapy consisted of DOC 60 mg/m2 followed by CDGP 100 mg/m2.


RESULTS
All patients received one cycle of chemotherapy. In the clinical assessment, ten patients achieved partial response for an overall response rate of 33.3% (95% CI, 16.4-50.2%). Histological assessment of surgical specimens showed an overall response rate of 56.6% (95% CI, 38.9-74.3%). Although severe neutropenia was observed in 90% of patients, only one patient (3.3%) experienced severe infection. Toxicities associated with this regimen did not interfere with planned radical surgery.


CONCLUSIONS
A single cycle of preoperative combination chemotherapy with DOC and CDGP showed moderate histological activity with an acceptable safety profile for the planned radical surgery. Further studies testing more cycles before surgery might be more appropriate.
Kurita
Hiroshi
H
Department of Dentistry and Oral Surgery, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, 390-8621, Japan. hkurita@shinshu-u.ac.jp
Yamamoto
Etsuhide
E
Nozaki
Shinichi
S
Wada
Shigehito
S
Furuta
Isao
I
Miyata
Masaru
M
Kurashina
Kenji
K
D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000855:Anorexia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D003967:Diarrhea / Q000139:chemically induced; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
D009944:Organoplatinum Compounds; D043823:Taxoids; D000077143:Docetaxel; C053989:nedaplatin