Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation
Vijay Patil, Vanita Noronha, Nandini Menon, Ajay Singh, Sarbani Ghosh Laskar, Ashwini Budrukkar, Atanu Bhattacharjee, Monali Swain, Vijayalakshmi Mathrudev, Kavita Nawale, Arun Balaji, Zoya Peelay, Mitali Alone, Shruti Pathak, Abhishek Mahajan, Suman Kumar, Nilendu Purandare, Archi Agarwal, Ameya Puranik, Shantanu Pendse, Monica Reddy Yallala, Harsh Sahu, Venkatesh Kapu, Sayak Dey, Jatin Choudhary, Madala Ravi Krishna, Alok Shetty, Naveen Karuvandan, Rahul Ravind, Rahul Rai, Kunal Jobanputra, Pankaj Chaturvedi, Prathamesh Pai, Devendra Chaukar, Sudhir Nair, Shivakumar Thiagarajan, Kumar Prabhash
Abstract
PURPOSE There is a lack of published literature on systemic therapeutic options in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing chemoradiation. Docetaxel was assessed as a radiosensitizer in this situation. METHODS This was a randomized phase II/III study. Adult patients (age ≥ 18 years) with LAHNSCC planned for chemoradiation and an Eastern Cooperative Oncology Group performance status of 0-2 and who were cisplatin-ineligible were randomly assigned in 1:1 to either radiation alone or radiation with concurrent docetaxel 15 mg/m 2 once weekly for a maximum of seven cycles. The primary end point was 2-year disease-free survival (DFS). RESULTS The study recruited 356 patients between July 2017 and May 2021. The 2-year DFS was 30.3% (95% CI, 23.6 to 37.4) versus 42% (95% CI, 34.6 to 49.2) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.673; 95% CI, 0.521 to 0.868; P value = .002). The corresponding median overall survival (OS) was 15.3 months (95% CI, 13.1 to 22.0) and 25.5 months (95% CI, 17.6 to 32.5), respectively (log-rank P value = .035). The 2-year OS was 41.7% (95% CI, 34.1 to 49.1) versus 50.8% (95% CI, 43.1 to 58.1) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.747; 95% CI, 0.569 to 0.980; P value = .035). There was a higher incidence of grade 3 or above mucositis (22.2% v 49.7%; P < .001), odynophagia (33.5% v 52.5%; P < .001), and dysphagia (33% v 49.7%; P = .002) with the addition of docetaxel. CONCLUSION The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC. [Media: see text]