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NIMOTUZUMAB PUBLICATIONS - NON BIOCON SPONSORED

Authors: K. Satish Srinivas, Raja Sundaram, C. V. Divyambika, and Sameer Chaudhari

Date: 2020/03

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6956585/

Abstract:

  • Background: Outcomes with conventional treatment are poor in patients with squamous cell carcinoma of head and neck (SCCHN). Treatment options are further limited for patients ineligible to receive platinum-based chemotherapy due to various factors such as geriatric age, comorbidity, and organ dysfunctions. The present study retrospectively evaluated the effectiveness of nimotuzumab when added to radiation therapy in unresectable, locally advanced SCCHN patients who were ineligible for platinum-based chemotherapy.
  • Materials and Methods: The medical records of 21 patients with unresectable, locally advanced head-and-neck cancer and histologically confirmed squamous cell carcinoma who were ineligible for platinum-based chemotherapy treated with nimotuzumab and intensity-modulated radiation therapy (IMRT) from 2012 to 2017 were retrospectively analyzed. The tumor response rate and overall survival (OS) were analyzed. Patients were assessed for toxicity and adverse events (AEs) as per CTCAE version 4. Statistical analysis was performed using SPSS software.

Authors: Shyamji Rawat, Hemu Tandan, Sanandan Patel, and Sameer Chaudhari

Date: 2019/03

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6133787/

Abstract:

  • Context: Nimotuzumab is the only anti-epidermal growth factor receptor monoclonal antibody which can be safely added to concurrent chemoradiotherapy (CRT) to improve efficacy in the management of unresectable, locally advanced squamous cell carcinoma of head and neck (LA-SCCHN). However, the evidence available on this is limited.
  • Aims: We retrospectively investigated efficacy and safety of nimotuzumab when combined with chemoradiation for LA-SCCHN.
  • Settings and Design: Hospital records of 39 patients from January 2012 to December 2016 diagnosed with locally advanced (Stage III-IVb), unresectable SCCHN, and treated with concurrent CRT with weekly nimotuzumab were reviewed retrospectively after fulfilling the inclusion/exclusion criteria.
  • Subjects and Methods: Tumor response was calculated as per response evaluation criteria in solid tumors criteria 1.1. Association of tumor response with independent variables was assessed. Overall survival (OS) and progression-free survival (PFS) were calculated. All patients were assessed for toxicity as per common terminology criteria for adverse events Common Terminology Criteria for Adverse Events v 4.0 (U.S. Department of health and human services, National Institutes of Health, National Cancer Institute).

Authors: Sundaram Subramanian, Nithya Sridharan, V Balasundaram and Sameer Chaudhari

Date: 2019/05

Link: https://pubmed.ncbi.nlm.nih.gov/31069192/

Abstract:

  • Context: Epidermal growth factor receptor (EGFR) is overly expressed in esophageal squamous cell carcinoma (ESCC) and is important prognostic and predictive biomarker. Nimotuzumab is a humanized anti-EGFR monoclonal antibody and has documented promising clinical outcomes and survival rates in various solid tumors with high EGFR expression.
  • Aims: Attempt to fill gap on paucity of data in India on the efficacy of Nimotuzumab in the treatment of locally advanced/metastatic ESCC.
  • Settings and design: Hospital records of 15 patients with unresectable, locally advanced/metastatic esophageal cancers, histologically confirmed squamous cell carcinoma being treated with Nimotuzumab along with standard treatments from October 2006 to November 2016 were retrospectively analyzed.
  • Subjects and methods: The tumor response rate and overall survival (OS) were analyzed. All patients were assessed for toxicity and adverse events (AEs) as per Common Terminology Criteria for Adverse Events (CTCAE) v4.

Authors: Sundaram Subramanian, Nithya Sridharan, V. Balasundaram and Sameer Chaudhari

Date: 2018/06

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6069342/

Abstract:

  • 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.

Authors: Shyamji Rawat

Date: 2018/08

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6133787/

Abstract:

  • Introduction: The majority of the cancers that affect the body of the uterus originate in the endometrial lining and are endometrial carcinomas. Globally, cancer of the body of the uterus is the sixth most common cancer among women, while in India, it is ranked as the tenth most common cancer accounting for 2.3% of all cancers among women and was responsible for an estimated 4773 cancer deaths (1.5% of total cancer deaths among women).Survival is very poor with conventional treatment; especially in patients with advanced disease, targeted therapies have shown limited success in endometrial cancer patients. In this case report, we are sharing our experience with nimotuzumab, a novel monoclonal antibody, in the management of a recurrent case of endometrial carcinoma.

Authors: D. Pawar, R. Ahmed, S. Chaudhari

Date: 2018/11/18

Link: https://oncologypro.esmo.org/meeting-resources/esmo-asia-2017-congress/Nimotuzumab-in-management-of-recurrent-metastatic-head-and-neck-cancer-A-pilot-study-366P

Abstract:

  • Background: Majority of the patients of head and neck cancer (HNC) that are treated with anticancer chemotherapy receive platinum based drugs. However, few patients cannot tolerate toxicity of these agents and hence are ineligible for platinum based chemotherapy. Treatment options for such patients are limited and outcomes are usually poor
  • Methods:We conducted a questionnaire based survey in 2016 among oncologists across India to understand routine clinical practice related to management of platinum ineligible patients. A questionnaire of 10 questions was prepared and circulated amongst 50 oncologists across India. Responses from 36 doctors were analysed.

Authors: S. Subramanian, N. Sridharan, S. Chaudhari, D. Pawar, V. Balasundaram

Date: 2017/09/18

Link: https://oncologypro.esmo.org/meeting-resources/esmo-asia-2017-congress/Nimotuzumab-in-management-of-recurrent-metastatic-head-and-neck-cancer-A-pilot-study-366P

Abstract:

  • Background: 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/metastatic HNC. We conducted a pilot study to evaluate efficacy and safety of nimotuzumab when added to conventional therapy in management of recurrent/metastatic HNC.
  • Methods: The hospital records of 16 patients who were diagnosed with recurrent or metastatic HNC with histologically confirmed squamous cell carcinoma and treated with nimotuzumab from December 2010 till December 2016 were evaluated. Of these, 2 patients who were treated with cetuximab were excluded and 14 patients were considered for final analysis. Demographic details, risk factors, ECOG score, tumour characteristics such as anatomical subsites, histopathological grades, TNM staging were noted. Tumour response was calculated as per RECIST criteria 1.1. Overall survival was calculated from date of diagnosis using Kaplan‐Meier method. All patients were assessed for toxicity and adverse events (AEs) were reported as per CTCAE version 4.0. Statistical analysis was done using STATA (V. 12) software.

Authors: Suresh VS Attili, Dilip Pawar, Chinnababu Sunkavalli

Year: 2017

Link: https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.e21635

Abstract:

  • Background: Nimotuzumab is a humanized IgG1 monoclonal antibody against the EGFR extracellular domain that has been evaluated in solid tumors as a single agent or in combination with chemotherapy and radiation. However when used without radiation, its always used in adjunct to chemotherapy. With encouraging results of other EGFR monoclonal antibodies as single agent therapies, we explored the possibility of using Nimotuzumab as single agent by which we could avoid chemo related side effects. In view of the limited options availability for subjects with PS 3 and more we thought of choosing this population for analysis of Nimotuzumab as single agent palliative therapy in PS 3 and above EGFR expressing tumors for safety and efficacy.
  • Methods:Details of the 38 subjects with pre-treated advanced refractory or progressive solid tumors having PS of more than 2 were evaluated. Nimotuzumab was administered weekly at 200 mg/m2 as single agent for 4 weeks (induction phase) and patients were stratified into those with improved PS and those without. The subjects without PS improvement were continued on the single agent and those with improvement were offered additional chemotherapy . Nimotuzumab could be continued beyond disease progression.

Authors: Nagraj Gururaj Huilgol, Ajit Nair, Sameer Chaudhari, Dilip Pawar

Year: 2017

Link: https://www.journalrcr.org/article.asp?issn=2588-9273;year=2017;volume=8;issue=2;spage=108;epage=111;aulast=Huilgol

Abstract:

  • Introduction: Head and neck cancer (HNC) has large worldwide prevalence and accounts for almost 5% among all types of cancers. Nimotuzumab is a humanized anti-epidermal growth factor receptor monoclonal antibody that has shown promising results in patients with HNC. The present retrospective case study aimed at investigating the response rate and adverse events (AEs) of a high dose of nimotuzumab in patients with HNC who are ineligible for platinum-based chemotherapy.
  • Materials and Methods: Patients with locally advanced HNC who refused chemotherapy or were ineligible for platinum-based chemotherapy were analyzed in the study. Patients were given nimotuzumab along with radiotherapy (RT). The duration of each treatment cycle was 6 weeks. About 200 mg nimotuzumab was administered, twice weekly for 6 weeks. The patients who received at least one treatment cycle of targeted therapy and accompanied regular follow-ups were assessed for response rate measurements.

Authors: K. S. Kirushna Kumar, P. Ananda Selvakumar, Krishna Kumar Rathinam

Year: 2017

Link: https://www.scirp.org/journal/paperinformation.aspx?paperid=74335

Abstract:

Brainstem glioma is rare tumour in adults accounting for 1% – 2% of intracranial gliomas. In this case study, a 28-year-old female diagnosed with BG, and lesions were observed in the pons and medulla region of the brain stem. She was initially treated with radiotherapy (54 Gy in 30 fractions for 6 weeks) but no change in her clinical condition and size of tumor was observed. Temozolomide (250 mg/daily for 5 days) was prescribed as first line chemotherapy. After completion of three cycles of Temozolomide, patient presented with diplopia and MRI showed increase in the size of lesions. After unsatisfactory response to radiation and chemotherapy, the patient was treated with Nimotuzumab therapy. MRI scan demonstrated the reduction of lesion size after 8 cycles of Nimotuzumab (200 mg/week). This treatment continued for another 8 cycles and the MRI scan of patients showed a significant reduction in lesion size. Nimotuzumab was found to be an effective and safe treatment option for brainstem glioma patient who was resistant to radiotherapy and chemotherapy.

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