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A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer
Author(s) -
Patil Vijay Maruti,
Noronha Vanita,
Joshi Amit,
Agarwal Jaiprakash,
GhoshLaskar Sarbani,
Budrukkar Ashwini,
Murthy Vedang,
Gupta Tejpal,
Mahimkar Manoj,
Juvekar Shashikant,
Arya Supreeta,
Mahajan Abhishek,
Agarwal Archi,
Purandare Nilendu,
Rangarajan Venkatesh,
Balaji Arun,
Chaudhari Sameer Vasant,
Banavali Shripad,
Kannan Sadhana,
Bhattacharjee Atanu,
D’Cruz Anil K.,
Chaturvedi Pankaj,
Pai Prathamesh S.,
Chaukar Devendra,
Pantvaidya Gouri,
Nair Deepa,
Nair Sudhir,
Deshmukh Anuja,
Thiagarajan Shivakumar,
Mathrudev Vijayalakshmi,
Manjrekar Aparna,
Dhumal Sachin,
Maske Kamesh,
Bhelekar Arti Sanjay,
Nawale Kavita,
Chandrasekharan Arun,
Pande Nikhil,
Goel Alok,
Talreja Vikas,
Simha Vijai,
Srinivas Sujay,
Swami Rohit,
Vallathol Dilip Harindran,
Dsouza Hollis,
Shrirangwar Sameer,
Turkar Siddharth,
Abraham George,
Thanky Aditi Harsh,
Patel Usha,
Pandey Manish Kumar,
Prabhash Kumar
Publication year - 2019
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.32179
Subject(s) - nimotuzumab , medicine , mucositis , head and neck cancer , chemoradiotherapy , hazard ratio , clinical endpoint , oncology , phases of clinical research , radiation therapy , cancer , progression free survival , adverse effect , cisplatin , randomized controlled trial , surgery , clinical trial , chemotherapy , confidence interval , epidermal growth factor receptor
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/m 2 ) (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/m 2 cisplatin in patients with locally advanced head and neck cancer who are treated with radical‐intent CRT.