A prospective study to assess the efficacy and toxicity of 5-flurouracil and cisplatin versus taxane and cisplatin as induction chemotherapy in locally advanced head and neck squamous cell cancer in a regional cancer center in India

Aim: The aim of this study is to assess the efficacy and toxicity of 5-flurouracil (5-FU) and cisplatin (PF) versus taxane and cisplatin (TP) as induction chemotherapy in locally advanced head and neck squamous cell cancer. Materials And Methods: There were 50 patients in each arm, matched for age, performance state, site and stage of disease. PF arm (cisplatin - 100 mg/m2 D1, 5-FU - 1000 mg/m 2 D1-D5) TP arm (docetaxel - 75 mg/m 2 or paclitaxel - 175 mg/m 2 on D 1 , cisplatin 75 mg/m 2 on D 2 ), received once in 3 weeks for 3 cycles. Patients without progressive disease underwent either surgery or chemoradiation. The primary end point was overall response rate (ORR) and secondary endpoint was toxicity. Results: In a total of 100 patients in our study, 44 in PF and 47 in TP arm were evaluable. ORR was 86.6% in PF arm and 82.9% in TP arm ( P = 0.71).There were more Grade 3 or 4 events of neutropenia, mucositis ( P ≤ 0.05) and myelosuppression diarrhea, febrile neutropenia ( P ≥ 0.05) in PF arm compared with TP arm. Post-chemotherapy hospital admissions due to toxicity were more frequent in PF arm (38.6% vs. 19%), dropout rate due to toxicity (9% vs. 0%) and deaths (6.8% vs. 2.1%) were more common in PF arm compared with TP arm. Conclusion: TP induction chemotherapy better tolerated than PF, which has similar efficacy, further multicenter randomized controlled studies; involving a large sample size is needed to confirm our data.