| 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 | J C Lin, J S Jan, C Y Hsu, D Y Wong
(Affiliation: Department of Radiation Oncology, Taichung Veterans General Hospital, School of Medicine, China Medical College, Taiwan.)
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| Journal | Cancer
(Cancer)
Vol. 85
Issue 7
Pg. 1430-8
(Apr 1 1999)
ISSN: 0008-543X UNITED STATES |
| PMID | 10193931
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
|
| Chemical References |
- Cisplatin
- Fluorouracil
- Epirubicin
- Methotrexate
|
| Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use, toxicity)
- Carcinoma, Squamous Cell
(drug therapy)
- Chemotherapy, Adjuvant
- Cisplatin
(administration & dosage, toxicity)
- Drug Administration Schedule
- Epirubicin
(administration & dosage, toxicity)
- Female
- Fluorouracil
(administration & dosage, toxicity)
- Follow-Up Studies
- Humans
- Infusions, Intravenous
- Male
- Methotrexate
(administration & dosage, toxicity)
- Middle Aged
- Mouth Neoplasms
(drug therapy)
- Patient Compliance
- Prospective Studies
- Treatment Outcome
|
