PMID- 30112336 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220318 IS - 2278-330X (Print) IS - 2278-4306 (Electronic) IS - 2278-330X (Linking) VI - 7 IP - 3 DP - 2018 Jul-Sep TI - Efficacy and safety of nimotuzumab in unresectable, recurrent, and/or metastatic squamous cell carcinoma of the head and neck: A hospital-based retrospective evidence. PG - 188-192 LID - 10.4103/sajc.sajc_87_18 [doi] AB - CONTEXT: Role of nimotuzumab in locally advanced head and neck cancer (HNC) is well established in India; however, no clinical evidence is available for its role in recurrent and/or metastatic HNC. AIMS: The aim of this study is to evaluate the efficacy and safety of nimotuzumab when added to standard treatment in unresectable, recurrent, and metastatic squamous cell carcinoma of the head and neck (SCCHN). SETTINGS AND DESIGN: Hospital records of 14 patients diagnosed with recurrent and/or metastatic HNC with histologically confirmed squamous cell carcinoma and being treated with nimotuzumab along with standard treatments from December 2010 to December 2016 were retrospectively evaluated. SUBJECTS AND METHODS: The tumor response rate and overall survival (OS) were analyzed. Toxicity and adverse events (AEs) were assessed as per common terminology criteria for adverse events (CTCAE) v 4. RESULTS: Oral cavity was most commonly involved region followed by hypopharynx and oropharynx. At 24 weeks after completion of treatment, overall response rate (complete response (CR) + partial response (PR)) was 75%. Survival rate at 1, 2, and 3 years was 77.80%, 64.81%, and 64.81%, respectively. At a median follow-up of 15.17 months, median OS was not reached. All AEs were either Grade I (66.7%) or Grade II (33.3%). No Grade III or Grade IV AEs were observed. No added toxicity was observed due to nimotuzumab. CONCLUSIONS: In the first of its kind study, the addition of nimotuzumab to standard treatment showed promising response rate as well as survival outcomes in recurrent and/or metastatic SCCHN patients without producing additional toxicity. FAU - Subramanian, Sundaram AU - Subramanian S AD - Department of Medical Oncology, VS Hospital and Cancer Center, Chennai, Tamil Nadu, India. FAU - Sridharan, Nithya AU - Sridharan N AD - Department of Medical Oncology, VS Hospital and Cancer Center, Chennai, Tamil Nadu, India. FAU - Balasundaram, V AU - Balasundaram V AD - Department of Radiation Oncology, VS Hospital and Cancer Center, Chennai, Tamil Nadu, India. FAU - Chaudhari, Sameer AU - Chaudhari S AD - Medical affairs, Biocon Ltd, Bengaluru, Karnataka, India. LA - eng PT - Journal Article PL - India TA - South Asian J Cancer JT - South Asian journal of cancer JID - 101618774 PMC - PMC6069342 OTO - NOTNLM OT - Antibodies OT - carcinoma OT - head and neck neoplasms OT - inoperable OT - metastatic OT - monoclonal OT - nimotuzumab OT - overall survival OT - recurrent OT - squamous cell OT - therapy OT - tumor response COIS- There are no conflicts of interest. EDAT- 2018/08/17 06:00 MHDA- 2018/08/17 06:01 PMCR- 2018/07/01 CRDT- 2018/08/17 06:00 PHST- 2018/08/17 06:00 [entrez] PHST- 2018/08/17 06:00 [pubmed] PHST- 2018/08/17 06:01 [medline] PHST- 2018/07/01 00:00 [pmc-release] AID - SAJC-7-188 [pii] AID - 10.4103/sajc.sajc_87_18 [doi] PST - ppublish SO - South Asian J Cancer. 2018 Jul-Sep;7(3):188-192. doi: 10.4103/sajc.sajc_87_18.