Nimotuzumab with concurrent chemoradiotherapy in patients with locally advanced head and neck cancer (LASCCHN).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6084-6084 ◽  
Author(s):  
Naresh Somani ◽  
Karandikar SM ◽  
Kamlesh Bokil ◽  
Kumar Tapash Bhowmik ◽  
Shyam Agarwal
Keyword(s):  
Monoclonal Antibody ◽  
Adverse Event ◽  
Head And Neck ◽  
Squamous Cell ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Neck Region ◽  
Open Label ◽  
Term Survival ◽  
Head And Neck Region

6084 Background: Nimotuzumab is a humanized monoclonal antibody targeting EGFR receptors. Unlike other anti-EGFR monoclonal antibodies, it has demonstrated to be safe and effective when combined with chemotherapy or/and radiotherapy. We evaluated safety and efficacy of concurrently administrating nimotuzumab with chemo-radiotherapy in patients with locally advanced inoperable squamous cell carcinomas of head and neck region in a usual health care setting. Methods: Open-label single-arm study. Patients of age 18 years and above with histologically confirmed squamous cell cancer of head and neck region in an inoperable stage (stage III & IV) having an ECOG ≤ 2 were included in the study. Informed consent was obtained from all the patients. The patient were administered injection cisplatin (30 mg/m2 IV) and nimotuzumab (200 mg IV) weekly for six weeks along with radiotherapy of 6600cGy over 33 fractions. Patients were evaluated based on RECIST criteria 24 weeks after the last cycle of chemotherapy. Results: Fifty seven patients were enrolled in the study. Mean age of the patients was 51yr (29 yr-79 yr). Most common site of cancer was oral cavity 32 (56.14%). Fourty six (80.70%) patients completed 6 cycles of therapy. ORR was 80.7%, 34 with CR (59.6%), 12 with PR (21%), 8 with SD (14%), 3 with PD (5.2%). Most common adverse event seen was mucositis (33%) but there was no grade III or IV adverse event. Conclusions: Addition of anti-EGFR monoclonal antibody (nimotuzumab) is safe and efficacious based on the loco-regional response and confirms the available phase II data. The long-term survival benefits based on this encouraging response rate needs to be further evaluated especially in patients with inoperable LASCCN.

Weekly methotrexate in squamous cell cancers of head and neck

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15539-15539 ◽  
Author(s):  
A. B. Pathak ◽  
H. Kulkarni
Keyword(s):  
Head And Neck ◽  
Squamous Cell ◽  
Large Scale ◽  
Symptomatic Relief ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Neck Region ◽  
Response Duration ◽  
Outpatient Basis ◽  
Head And Neck Region

15539 Background: The aim was to evaluate response rates and toxicity of weekly methotrexate in locally advanced or recurrent squamous cell cancers of the head and neck region. Methotrexate, oldest non-platinum drugs active in squamous cell cancer of head and neck, was selected for its cost-effectiveness and ease of administration. Methods: Patients with locally advanced, inoperable or recurrent squamous cancers were selected. Sites included anterior two-third tongue, buccal mucosa, alveolus, base tongue, larynx and maxilla. Methotrexate 1 mg/Kg was given intramuscularly on outpatient basis once a week for 6 to 8 weeks along with hydration. Patients who responded well and became resectable were encouraged to undergo surgery. All patients were followed up in the clinic every monthly. Results: Total 19 patients were entered on the study over a duration of 24 months. 12 out of 19 patients had partial response (63%), 5 had stable disease (26%) and 2 patients had disease progression. Symptomatic relief ranged from 25% to 100%. Maximum response duration was 12 weeks. Treatment naïve patients had rapid response. In 5 patients disease became clearly resectable. Toxicity was grade II-III oral mucositis in patients with previous radiation. Sample size is small for a subset analysis. Conclusions: Weekly methotrexate is a simple, cost-effective regimen for palliation in advanced recurrent squamous cell cancers of head and neck region. It should also be evaluated further in large scale trials and especially in neo-adjuvant setting in locally advanced squamous cell cancers of the head and neck region given its rapidity of response and brief duration of therapy. No significant financial relationships to disclose.

scholarly journals Giant locally advanced and metastatic squamous cell skin carcinoma of head and neck region: case report

2020 ◽  
Vol 25 (1) ◽  
pp. 20-22
Author(s):  
Jan Stuk ◽  
Jaroslav Vanasek ◽  
Karel Odrazka ◽  
Martin Dolezel ◽  
Iveta Kolarova ◽  
...  
Keyword(s):  
Case Report ◽  
Head And Neck ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Neck Region ◽  
Skin Carcinoma ◽  
Head And Neck Region ◽  
Squamous Cell Skin Carcinoma

EACH: A randomised phase II study evaluating the safety and anti-tumour activity of the combination of avelumab and cetuximab relative to avelumab monotherapy in recurrent/metastatic head and neck squamous cell cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6091-TPS6091 ◽  
Author(s):  
Martin David Forster ◽  
Joseph J. Sacco ◽  
Anthony Hee Kong ◽  
Graham Wheeler ◽  
Sharon Forsyth ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Phase Ii ◽  
Squamous Cell ◽  
Cell Cancer ◽  
Single Agent ◽  
Locally Advanced ◽  
Predictive Biomarkers

TPS6091 Background: Patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) have low response rates to licensed second line therapies, including PD-1 inhibitors nivolumab and pembrolizumab, and represent an area of unmet clinical need. The chimeric IgG1 epithelial growth factor receptor (EGFR) monoclonal antibody cetuximab potentiates the activity of radiotherapy in locally advanced HNSCC and chemotherapy in R/M HNSCC and is also licensed with modest activity as a single agent. Cetuximab initiates Natural Killer (NK) cell antibody-dependent cell-mediated cytotoxicity (ADCC), resulting in an anti-tumour immune response and the potential to augment the activity of PD-1/PD-L1 inhibition. EACH aims to examine the safety and efficacy of the potentially synergistic interaction between cetuximab and avelumab, a fully human IgG1 anti-PD-L1 monoclonal antibody in R/M HNSCC. Methods: EACH is a randomised phase II trial preceded by a safety run-in phase. Eligible patients have histologically or cytologically confirmed measurable recurrent or metastatic squamous cell carcinoma of any site in the safety run-in phase, and HNSCC in phase II, that is considered incurable by local therapies. The safety run-in has a single arm de-escalating design, aiming to establish the safety of cetuximab with avelumab and determine the optimal dose of cetuximab within this combination. The safety run-in has a dosing schedule of avelumab (10 mg/kg) + cetuximab (500 mg/m2) intravenously every 2 weeks, with de-escalation of cetuximab to 400 mg/m2 and 300 mg/m2 if necessary. The safety run-in phase commenced recruitment in July 2018 and is ongoing. The phase II component will randomize 114 HNSCC patients between either avelumab + cetuximab at the dose determined by the safety run-in phase or avelumab (10 mg/kg) alone. Treatment will be in 4-week cycles for up to one year. The primary endpoint in the safety run-in phase is the occurrence of dose limiting toxicities, and in phase II is Disease Control Rate at 24 weeks, using iRECIST. Blood and fresh tissue will be collected for exploratory translational studies, which will focus on the identification of potential novel predictive biomarkers for response. Clinical trial information: NCT03494322.

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