e16006 Background: We investigated the efficacy, toxicity, and prognostic factors of salvage chemotherapy plus cetuximab in patients with recurrent/metastatic oral squamous cell carcinoma (OSCC). Methods: A total of 30 patients with recurrent/metastatic OSCC were treated by an outpatient weekly multi-drug combination chemotherapy plus cetuximab 400 mg/m2 loading in day 1, then 250 mg/m2 every week. The major chemotherapy regimen consisted of MEMOCLUB (methotrexate 30 mg/m2 d1, epirubicin 30 mg/m2 d1, alternating with mitomycin-C 4 mg/m2 d8, oncovin 1 mg/m2 d8, cisplatin 25 mg/m2 d8, leucovorin 120 mg/m2 d8, 5-fluorouracil 1000 mg/m2 d8, and bleomycin 10 mg/m2 d8) or GV (gemcitabine 1000mg/m2 d1, and vinorelbine 25 mg/m2 d8). Results: Baseline characteristics are as followings: median age=45 (range 32-73); male/female=28/2; Karnofsky performance status 80%/70%/60%/50%=7/18/3/2. Most patients had heavily treated history — first recurrence in 11 cases, second recurrence in 6, and third or more recurrence in 13. The disease extent consists of 25 (83.3%) locoregional recurrences, 3 (10.0%) distant metastasis, and 2 (6.7%) locoregional + metastatic diseases. Grade 3/4 toxicity included leucopenia (46.7%), anemia (33.3%), thrombocytopenia (6.7%), mucositis (6.7%) and skin rashes (20.0%). We obtained a high overall response rate of 66.7% (7 CR, 13 PR, 6 SD, 3 PD, and 1 unevaluable). So far, there are 22 deaths and 8 alive. The overall survival time ranges from 48-1365 days with a median of 312 days. One-year overall survival rate is 49%. Two favorable prognostic factors were found by univariate analysis- disease extent (locoregional vs. distant disease, HR=0.1509, 95%CI=0.0008-0.0592) and tumor response (CR+PR vs. SD+PD, HR=0.2255, 95%CI=0.0277-0.2984). Conclusions: Cetuximab plus weekly outpatient multi-drug chemotherapy has a high response rate and encouraging survival with acceptable toxicity in recurrent/metastatic OSCC patients.
Epigenetic Alterations Associated with the Overall Survival and Recurrence Free Survival among Oral Squamous Cell Carcinoma Patients
