Addition of Nimotuzumab to Standard TPF Regimen in Locally Advanced Head and Neck Cancer: A Single Institutional Study.

ABSTRACT

BACKGROUND: Induction docetaxel, cisplatin, and 5-fluorouracil (TPF) chemotherapy followed by definitive concurrent chemoradiation remains the standard of care in locally advanced squamous cell carcinoma of head and neck cancers despite which the survival remains low. So, we analyzed the efficacy and adverse effect profile of the addition of nimotuzumab to standard TPF induction chemotherapy. Methods. We included 20 patients with locally advanced squamous cell carcinoma of the head and neck. Patients were administered with induction chemotherapy with nimotuzumab plus docetaxel, cisplatin, and 5-fluorouracil (TPF + N) followed by definitive concurrent chemoradiation with carboplatin. Treatment responses were assessed by PET-CT following induction chemotherapy and concurrent chemoradiation. Response rates, survival, and adverse effects data were tabulated and analyzed using the Kaplan Meier method. RESULTS: At a minimum follow-up of two years, the median progression-free survival (PFS) and median overall survival (OS) were 16 months and 38 months, respectively. PFS and OS were not reached (NR) in patients who showed a complete radiological response (CR). Median PFS and OS in patients who had partial response were 17.6 and 34.5 months, respectively. All subsites of primary including oral cavity, hypopharynx, and oropharynx showed similar response rates and survival. Overall the treatment was well tolerated with predominantly grade 1/2 toxicities. CONCLUSIONS: Patients with locally advanced head and neck cancer could possibly have a better response and survival with nimotuzumab added to the standard TPF regimen. A complete response may serve as a good surrogate for survival irrespective of the primary site of head and neck cancer.