Phase II trial of individualized/dynamic cisplatin regimens for definitive concurrent chemoradiation therapy in patients with head and neck squamous cell carcinoma.

The current standard cisplatin regimen for concurrent chemoradiation therapy (CCRT) involves generalized static administration of cisplatin without considering patient characteristics and patient/tumor responses during treatment. We aimed to evaluate the oncological feasibility of individualized/dynamic cisplatin regimens for definitive CCRT in patients with head and neck squamous cell carcinoma (HNSCC). This prospective, single-center study enrolled patients with biopsy-confirmed HNSCC for whom CCRT was indicated as the primary treatment. Concurrent with radiation therapy (RT), patients received individualized and dynamically modified cisplatin chemotherapy based on patient characteristics, such as age and Eastern Cooperative Oncology Group performance status (PS), and patient/tumor treatment responses. The primary endpoints of the study were grade ≥3 toxicity and progression-free survival (PFS). The study enrolled 150 patients; 146 (97.3%) received ≥2 cycles of cisplatin in addition to scheduled RT. Incidence of any grade 3-4 toxicities was 40.7% (61/150). During the 40.1 ± 25.1-month follow-up period, the 2-year locoregional control, distant control, PFS, disease-specific survival, and overall survival were 81.7%, 89.2%, 73.0%, 89.2%, and 86.1%, respectively. The treatment compliance and grade ≥3 toxicities did not differ between patients aged <70 years and ≥70 years, or those with PS 0 and PS 1-2, respectively. CCRT using individualized, dynamic cisplatin regimens based on patient age, PS, and patient/tumor responses during treatment was oncologically safe and effective for treating patients with HNSCC, including those aged ≥70 years and with PS 1-2.