TITLE:
Nimotuzumab with Induction Chemotherapy and Chemo-Radiation in Patients with Advanced Head and Neck Cancer
AUTHORS:
Sundaram Subramanium, Venkatanarayan Balasundaram, Sridharan Nithya, Poojar Kiran
KEYWORDS:
Nimotuzumab, Head and Neck Cancer, Chemoradiotherapy, Cisplatin, Epidermal Growth Factor Receptors, Monoclonal Antibody
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.6 No.2,
January
30,
2015
ABSTRACT: Background: Head and
neck squamous cell carcinoma (HNSCC), is a common malignancy in the Indian
Population. In locally advanced disease, chemoradiation is the standard of
care. Although induction chemotherapy has been much studied, no clear benefit
has been identified apart from laryngeal preservation. A few randomized trials
have demonstrated improved response rate, disease free survival, and overall
survival, with induction chemotherapy. Nimotuzumab is a humanized monoclonal
antibody targeting epidermal growth factor receptors (EGFR). Unlike other
Anti-EGFR monoclonal antibodies, it is demonstrated to be safer when combined
with chemotherapy and/or radiotherapy. Aim: To evaluate the safety and efficacy
of concurrently administered nimotuzumab with chemo-radiotherapy in patients
with HNSCC in usual health care setting. Methods: This was an open-label,
single arm study, with retrospective analysis of results. Patients above 18
years of age, and having histologically confirmed, advanced HNSCC were included
in the study. The patients were treated with 3 cycles of induction chemotherapy
consisting of modified TPF regimen along with nimotuzumab (200 mg IV) on Day 1,
followed by radiotherapy for a dose of 66 Gy along with concurrent weekly
cisplatin (30 mg/m2) and nimotuzumab (200 mg) throughout the course
of radiation. Patients were evaluated using RECIST criteria, 4 weeks after the
last cycle of chemotherapy. Results: Sixteen patients were included in this
study, with mean age of 54 ± 11 years.Most
common sub-site of cancer was oral cavity in 69% (n = 11), followed by pharynx
in 19% (n = 3).Four patients had
metastasis at the time of presentation. Six patients (37.5%) had progressive
disease and four patients (25%) were lost to follow-up. The combination
chemotherapy with nimotuzumab was well tolerated. Addition of nimotuzumab to
TPF regimen was not associated with added toxicity. Conclusion: Addition of
anti-EGFR monocloncal antibody (nimotuzumab) to induction chemotherapy and
chemoradiation may be a promising alternative to concurrent chemoradiotherapy
in HNSCC due to known over expression of EGFR receptors. The results of this
study need further evaluation in a larger study setting.