A Randomised Trial of Neoadjuvant Chemotherapy in Locally Advanced Oral Cancers

India accounts for more than one-fourth of the worlds burden of oral cancers.48 % of these cancers present in late stages requiring multimodality treatment with both surgery and radiation therapy and have a very poor prognosis with 5-year survival rates of 30- 40 %. A randomized, single centre study aimed at comparing the activity and toxicity of two chemotherapy regimens [5-Fluorouracil +Platin (PF regimen) versus Taxol + Platin (TP regimen)] in the neoadjuvant setting for patients with resectable squamous cell cancer of the oral cavity. Treatment was administered 3 weekly for three courses. Response assessment was done after each cycle. Patients with partial response underwent surgery. Adjuvant therapy was based on pathological status. Those who had complete response during chemotherapy received RT alone without any surgery. Patients with static or progressive disease were given radical chemoRT. Primary efficacy parameter was response rate. Secondary end points were overall survival and disease-free survival. A total of 40 patients (60 % males and 40 % females) with median age of 48 years were studied. All patients completed the study and there were no significant toxicities requiring discontinuation. Two patients on each arm (10 %) had complete response. Partial response rates were significantly different [8 patients (40 %) in the TParm and only one patient (5 %) in the PF arm (p=0.54)].9 patients (45 %) had progression in the PF arm and 4 patients progressed in the TParm (20 %) which was significant (p=0.59). Static disease was not significantly different, 8 cases in the PFarm (40 %) and 6 cases in the TP arm (15 %). The study concluded that paclitaxel/cisplatin combination chemotherapy yields significantly better response rates than 5FU/cisplatin. However, the response rates are inferior to standard three drug regimens currently recommended and preoperative chemotherapy in locally advanced resectable squamous cell carcinoma of the oral cavity is ineffective in reducing tumour volume and stage of the disease.