Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2019 Sep 15;125(18):3184-3197.
doi: 10.1002/cncr.32179. Epub 2019 May 31.

A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer

Vijay Maruti Patil  1 , Vanita Noronha  1 , Amit Joshi  1 , Jaiprakash Agarwal  2 , Sarbani Ghosh-Laskar  2 , Ashwini Budrukkar  2 , Vedang Murthy  2 , Tejpal Gupta  2 , Manoj Mahimkar  3 , Shashikant Juvekar  4 , Supreeta Arya  4 , Abhishek Mahajan  4 , Archi Agarwal  5 , Nilendu Purandare  5 , Venkatesh Rangarajan  5 , Arun Balaji  6 , Sameer Vasant Chaudhari  7 , Shripad Banavali  1 , Sadhana Kannan  8 , Atanu Bhattacharjee  9 , Anil K D'Cruz  10 , Pankaj Chaturvedi  10 , Prathamesh S Pai  10 , Devendra Chaukar  10 , Gouri Pantvaidya  10 , Deepa Nair  10 , Sudhir Nair  10 , Anuja Deshmukh  10 , Shivakumar Thiagarajan  10 , Vijayalakshmi Mathrudev  1 , Aparna Manjrekar  1 , Sachin Dhumal  1 , Kamesh Maske  1 , Arti Sanjay Bhelekar  1 , Kavita Nawale  1 , Arun Chandrasekharan  1 , Nikhil Pande  1 , Alok Goel  1 , Vikas Talreja  1 , Vijai Simha  1 , Sujay Srinivas  1 , Rohit Swami  1 , Dilip Harindran Vallathol  1 , Hollis Dsouza  1 , Sameer Shrirangwar  1 , Siddharth Turkar  1 , George Abraham  1 , Aditi Harsh Thanky  1 , Usha Patel  3 , Manish Kumar Pandey  3 , Kumar Prabhash  1
Affiliations
Free article
Clinical Trial

A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer

Vijay Maruti Patil et al. Cancer. .
Free article

Abstract

Background: Because the addition of nimotuzumab to chemoradiation in patients with locally advanced head and neck cancer improved outcomes in a phase 2 study, the authors conducted a phase 3 study to confirm these findings.

Methods: This open-label, investigator-initiated, phase 3, randomized trial was conducted from 2012 to 2018. Adult patients with locally advanced head and neck cancer who were fit for radical chemoradiation were randomized 1:1 to receive either radical radiotherapy (66-70 grays) with concurrent weekly cisplatin (30 mg/m2 ) (CRT) or the same schedule of CRT with weekly nimotuzumab (200 mg) (NCRT).The primary endpoint was progression-free survival (PFS); key secondary endpoints were disease-free survival (DFS), duration of locoregional control (LRC), and overall survival (OS). An intent-to-treat analysis also was performed.

Results: In total, 536 patients were allocated equally to both treatment arms. The median follow-up was 39.13 months. The addition of nimotuzumab improved PFS (hazard ratio [HR], 0.69; 95% CI, 0.53-0.89; P = .004), LRC (HR, 0.67; 95% CI, 0.50-0.89; P = .006), and DFS (HR, 0.71; 95% CI, 0.55-0.92; P = .008) and had a trend toward improved OS (HR, 0.84; 95% CI, 0.65-1.08; P = .163). Grade 3 through 5 adverse events were similar between the 2 arms, except for a higher incidence of mucositis in the NCRT arm (66.7% vs 55.8%; P = .01).

Conclusions: The addition of nimotuzumab to concurrent weekly CRT improves PFS, LRC, and DFS. This combination provides a novel alternative therapeutic option to a 3-weekly schedule of 100 mg/m2 cisplatin in patients with locally advanced head and neck cancer who are treated with radical-intent CRT.

Keywords: Chemoradiation; epidermal growth factor receptor (EGFR); head and neck cancer; nimotuzumab.

PubMed Disclaimer

References

    1. Pfister DG, Ang KK, Brizel DM, et al. Head and neck cancers, version 2.2013. Featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2013;11:917-923.
    1. Gregoire V, Lefebvre JL, Licitra L, Felip E; EHNS-ESMO-ESTRO Guidelines Working Group. Squamous cell carcinoma of the head and neck: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21(suppl 5):v184-v186.
    1. Pignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009;92:4-14.
    1. Blanchard P, Baujat B, Holostenco V, et al. Meta-Analysis of Chemotherapy in Head and Neck Cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol. 2011;100:33-40.
    1. Forastiere AA, Goepfert H, Maor M, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003;349:2091-2098.

Publication types

MeSH terms