• Vijay Maruti Patil, Vanita Noronha, Amit Joshi, Jaiprakash Agarwal, Sarbani Ghosh-Laskar, Ashwini Budrukkar, Vedang Murthy, Tejpal Gupta, Manoj Mahimkar, Shashikant Juvekar, Supreeta Arya, Abhishek Mahajan, Archi Agarwal, Nilendu Purandare, Venkatesh Rangarajan, Arun Balaji, Sameer Vasant Chaudhari, Shripad Banavali, Sadhana Kannan, Atanu Bhattacharjee, Anil K D'Cruz, Pankaj Chaturvedi, Prathamesh S Pai, Devendra Chaukar, Gouri Pantvaidya, Deepa Nair, Sudhir Nair, Anuja Deshmukh, Shivakumar Thiagarajan, Vijayalakshmi Mathrudev, Aparna Manjrekar, Sachin Dhumal, Kamesh Maske, Arti Sanjay Bhelekar, Kavita Nawale, Arun Chandrasekharan, Nikhil Pande, Alok Goel, Vikas Talreja, Vijai Simha, Sujay Srinivas, Rohit Swami, Dilip Harindran Vallathol, Hollis Dsouza, Sameer Shrirangwar, Siddharth Turkar, George Abraham, Aditi Harsh Thanky, Usha Patel, Manish Kumar Pandey, and Kumar Prabhash.
• Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.
• Cancer. 2019 Sep 15; 125 (18): 3184-3197.

BackgroundBecause 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.MethodsThis 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.ResultsIn 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).ConclusionsThe 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.© 2019 American Cancer Society.

33 keywords...

hide…