A prospective comparative analysis of two neoadjuvant chemotherapy protocols in technically unresectable head and neck cancer.

In India, nearly two-thirds of patients of head and neck cancers present in advanced stages . The majority (60%) of these patients present with stage III/IV and have a poor-prognosis disease. The patients usually present in their fifth and early sixth decades of life in Asian population compared to seventh and eighth decades among Western population. Advanced head and neck cancers carry a dismal prognosis and patients usually die of uncontrolled loco-regional disease or its complications. Locally advanced oral cavity cancers with features discussed below are considered technically unresectable and selected for neoadjuvant  (1) Buccal mucosa primary, with diffuse margins and peritumoral oedema

going up to or above the level of zygomatic arch and without any satellite nodules. 2. Tongue primary {anterior 2/3rds} with the tumour extending up to or below the level of the hyoid bone. 3. Extension of tumour of anterior two third of oral tongue to the vallecula. 4. Extension of tumour into the high infratemporal fossa, as defined by the extension of tumour above an axial plane passing at the level of the sigmoid notch. 5. Extensive skin infiltration impacting the achievement of negative margins. Treatment decisions for locally advanced HNSCC, include the delivery of single versus multiple modality therapy. The sequence of administration if multi- modality therapy is indicated is based upon several factors that can be tumor-related, such as primary site and stage, as well as patient-related characteristics, such as age, performance status and pre-existent co-morbidities. TAX 323 and 324 are regarded as landmark studies that have used neoadjuvant chemotherapy in locally advanced HNC. The response rates with the three-drug regime were to the tune of 68%; however oral cavity cancers constituted a minority of the treated patient population in these studies. Results from early trials and encouraging results from meta-analyses have revived interest in the use of neoadjuvant chemotherapy prior to definitive local treatment. Based on the initial reports of the GORTEC2000-1, TAX323 and TAX324 trials, neoadjuvant chemotherapy followed by either RT or CRT is frequently used for the treatment of curable LAHNC and TPF has been approved by the Federal Drug Administration (FDA) for the treatment of LAHNC. Nonetheless, the role of neoadjuvant chemotherapy is still poorly defined and randomized trials are under way to determine whether induction chemotherapy is superior to concomitant chemo/RT. In this study we will compare two neoadjuvant chemotherapy in technically unresectable head and neck cancer.