Paclitaxel liposome, cisplatin and 5-fluorouracil-based induction chemotherapy followed by de-escalated intensity-modulated radiotherapy with concurrent cisplatin in stage IVA–IVB childhood nasopharyngeal carcinoma in endemic area: a phase II, single-arm trial

作者：Dong–Hua Luo, Xiaoyun Li, Shanshan Guo, Wan‐Ping Guo, Li‐Ting Liu, Hao‐Yuan Mo, Ling Guo, Xiaofei Lv, Li-Zhi Liu, Jibin Li, Qing Liu, Pan Wang, Xue-Song Sun, Sai‐Lan Liu, Qiuyan Chen, Lin‐Quan Tang, Hai‐Qiang Mai · 发表于：The Lancet Regional Health - Western Pacific · 年份：2023 · DOI：10.1016/j.lanwpc.2023.100895 · 被引用次数：9 · 研究领域：Head and Neck Cancer Studies、Head and Neck Surgical Oncology、Cleft Lip and Palate Research

Background: Previous studies demonstrated that induction chemotherapy (IC) followed by de-escalated chemoradiotherapy adapted to tumor response was effective in treating childhood nasopharyngeal carcinoma (NPC), but the toxicity profile of this treatment strategy, and whether childhood patients with advanced stages can obtain enough benefits from it requires further investigation. Methods: We conducted a single-center phase II trial (NCT03020329). All participants received 3 cycles of paclitaxel liposome, cisplatin and 5-fluorouracil (TPF)-based IC. Patients who showed complete or partial response received de-escalated radiotherapy of 60 Gy with 3 cycles of concurrent cisplatin, and those who showed stable or progressive disease received standard-dose radiotherapy of 70 Gy with concurrent cisplatin. The primary endpoint was the complete response (CR) rate at the end of concurrent chemoradiotherapy (CCRT). Findings: From November 2016 to March 2021, 44 patients were recruited in the cohort. The CR rate was 80% (35/44, 95% CI, 65-90) of the whole cohort. All patients achieved CR 3 months after CCRT. By the last follow-up, the 3-year progression-free survival and overall survival were 91% (95% CI, 82-99) and 100% respectively. Dry mouth was the most common late toxicity, with an incidence of 41% (18/44), followed by skin fibrosis and hearing impairment. No patient suffered from severe late toxicity and growth retardation. Interpretation: Our results proved the efficacy and safet...