title: High rate of clinical complete response to weekly outpatient neoadjuvant chemotherapy in oral carcinoma patients using a new regimen of cisplatin, 5-fluorouracil, and bleomycin alternating with methotrexate and epirubicin.
abstract: BACKGROUND
  A Phase II trial was initiated to evaluate the response to and toxicity of a new regimen of weekly outpatient neoadjuvant chemotherapy in patients with oral carcinoma.
  
  
  METHODS
  Patients with previously untreated squamous cell carcinoma of the oral cavity were eligible for this trial. The neoadjuvant chemotherapy was comprised of cisplatin, 25 mg/m2, 5-fluorouracil, 1000 mg/m2, and bleomycin, 10 mg/m2, mixed in normal saline as a 24-hour intravenous (i.v.) infusion, alternating with methotrexate, 30 mg/m2, and epirubicin, 30 mg/m2, as an i.v. bolus (PFB/ME) on a weekly schedule for 8-12 weeks. In patients with American Joint Committee on Cancer Stage IV disease who completed neoadjuvant chemotherapy, surgery was preferred to radiotherapy, unless patients refused surgery.
  
  
  RESULTS
  A total of 40 patients (82.5% with Stage IV disease) with previously untreated oral carcinoma were enrolled. The median size of the primary tumor was 7 cm (range, 3-13 cm). Fifty percent of patients had tumor penetrating through the oral mucosa to the cheek skin and 62.5% had bony destruction. Detectable cervical lymph nodes were noted in 77.5% of patients. After neoadjuvant weekly chemotherapy, 22 patients (55%) showed complete response (CR) and 15 patients (37.5%) showed partial response, for an overall response rate of 92.5%. World Health Organization Grade 3/4 toxicity included mucositis (7.5%), leukopenia (25%), anemia (10%), and thrombocytopenia (2.5%). Eleven of 33 patients with Stage IV disease underwent surgery, and pathologic CR (2 patients) or microscopic residual tumor (4 patients) was noted (54.5%).
  
  
  CONCLUSIONS
  The results of the current study indicate that a weekly PFB/ME neoadjuvant chemotherapy regimen is highly effective for the treatment of patients with oral carcinoma. In addition, this regimen has low toxicity. The authors believe that implementation of this regimen into a multimodality therapy protocol deserves further study.
authors: Department of Radiation Oncology, Taichung Veterans General Hospital, School of Medicine, China Medical College, Taiwan.
authors: J C
authors: JC
authors: Lin
authors: J S
authors: JS
authors: Jan
authors: C Y
authors: CY
authors: Hsu
authors: D Y
authors: DY
authors: Wong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000633:toxicity; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000633:toxicity; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000633:toxicity; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000633:toxicity; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy*; D010349:Patient Compliance; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D015251:Epirubicin; D002945:Cisplatin; D005472:Fluorouracil; D008727:Methotrexate