Details

Autor(en) / Beteiligte

• Noronha, Vanita
• Joshi, Amit
• Patil, Vijay Maruti
• Agarwal, Jaiprakash
• Ghosh-Laskar, Sarbani
• Budrukkar, Ashwini
• Murthy, Vedang
• Gupta, Tejpal
• D'Cruz, Anil K
• Banavali, Shripad
• Pai, Prathamesh S
• Chaturvedi, Pankaj
• Chaukar, Devendra
• Pande, Nikhil
• Chandrasekharan, Arun
• Talreja, Vikas
• Vallathol, Dilip Harindran
• Mathrudev, Vijayalakshmi
• Manjrekar, Aparna
• Maske, Kamesh
• Bhelekar, Arati Sanjay
• Nawale, Kavita
• Kannan, Sadhana
• Gota, Vikram
• Bhattacharjee, Atanu
• Kane, Shubhada
• Juvekar, Shashikant L
• Prabhash, Kumar

Titel

Once-a-Week Versus Once-Every-3-Weeks Cisplatin Chemoradiation for Locally Advanced Head and Neck Cancer: A Phase III Randomized Noninferiority Trial

Ist Teil von

• Journal of clinical oncology, 2018-04, Vol.36 (11), p.1064-1072

Ort / Verlag

United States

Erscheinungsjahr

2018

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• Purpose Chemoradiation with cisplatin 100 mg/m given once every 3 weeks is the standard of care in locally advanced head and neck squamous cell cancer (LAHNSCC). Increasingly, low-dose once-a-week cisplatin is substituted because of perceived lower toxicity and convenience. However, there is no level 1 evidence of comparable efficacy to cisplatin once every 3 weeks. Patients and Methods In this phase III randomized trial, we assessed the noninferiority of cisplatin 30 mg/m given once a week compared with cisplatin 100 mg/m given once every 3 weeks, both administered concurrently with curative intent radiotherapy in patients with LAHNSCC. The primary end point was locoregional control (LRC); secondary end points included toxicity, compliance, response, progression-free survival, and overall survival. Results Between 2013 and 2017, we randomly assigned 300 patients, 150 to each arm. Two hundred seventy-nine patients (93%) received chemoradiotherapy in the adjuvant setting. At a median follow-up of 22 months, the estimated cumulative 2-year LRC rate was 58.5% in the once-a-week arm and 73.1% in the once-every-3-weeks arm, leading to an absolute difference of 14.6% (95% CI, 5.7% to 23.5%); P = .014; hazard ratio (HR), 1.76 (95% CI, 1.11 to 2.79). Acute toxicities of grade 3 or higher occurred in 71.6% of patients in the once-a-week arm and in 84.6% of patients in the once-every-3-weeks arm ( P = .006). Estimated median progression-free survival in the once-a-week arm was 17.7 months (95% CI, 0.42 to 35.05 months) and in the once-every-3-weeks arm, 28.6 months (95% CI, 15.90 to 41.30 months); HR, 1.24 (95% CI, 0.89 to 1.73); P = .21. Estimated median overall survival in the once-a-week arm was 39.5 months and was not reached in the once-every-3-weeks arm (HR, 1.14 [95% CI, 0.79 to 1.65]; P = .48). Conclusion Once-every-3-weeks cisplatin at 100 mg/m resulted in superior LRC, albeit with more toxicity, than did once-a-week cisplatin at 30 mg/m , and should remain the preferred chemoradiotherapy regimen for LAHNSCC in the adjuvant setting.