Multicenter phase 2 study of induction chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma

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. A total of 30 patients with locally advanced but operable OSCC were enrolled. Combination induction chemotherapy consisted of DOC 60 mg/m(2) followed by CDGP 100 mg/m(2). 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. 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.