TPF induction chemotherapy versus PF adjuvant chemotherapy plus concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma: A multicenter, randomized controlled, III trial.

6069 Background: To investigate the efficacy and safety of the two modes of concurrent chemoradiotherapy combined with induction or adjuvant chronotherapy for the treatment of locoregionally advanced nasopharyngeal carcinoma. Methods: A total of 266 patients with locoregionally advanced NPC were enrolled from May 2018 to July 2021 and randomly divided into a test (n = 133) and a control (n = 133) group. In the test group, the docetaxel and cisplatin plus fluorouracil (TPF) regimen was used to induce chronological chemotherapy for 3 cycles (docetaxel 75mg / m2, D1, cisplatin 75mg / m2, d1-d5, fluorouracil 750mg / m2 / D, d1-d5) + 3 cycles of concurrent chemoradiotherapy (cisplatin 100mg / m2; The control group was treated with three cycles of concurrent chemoradiotherapy (cisplatin 100mg / m2) + cisplatin plus fluorouracil (PF) regimen with adjuvant schedule chemotherapy for three cycles (cisplatin 80mg / m2 on days d1-d5, fluorouracil 800mg / m2 / d on days d1-d5). In both groups, intensity-modulated radiation therapy was used with a total dose of 69.96 Gy to the primary tumor at T1 and T2, 72.6 Gy to the primary tumor at T3 and T4, and 69.96 Gy to the positive lymph nodes. Acute adverse effects and survival were compared between the two groups. Results: A median follow-up of 19 months, 129 patients in the test group and 124 in the control group were evaluable for efficacy and adverse effects.Compliance was 96.99% and 90.22%, respectively. The 2-year overall survival rates were 91.7% and 90.5%, and the 2-year progression free survival rates were 92.4% and 90.4% in the test and control groups, respectively, with no significant difference ( P > 0.05). The test group had a lower incidence of radiation mucositis, dry mouth, and dysphagia than the control group ( P < 0.05), whereas the test group had a higher incidence of leukopenia, neutropenia, hemoglobin loss, vomiting ( P < 0.05), decreased radiation dermatitis, platelets There were no significant differences in the categories of creatinine elevation and transaminase elevation (P > 0.05). Conclusions: The patients' compliance was good and the toxic effects such as radiation mucositis, dry mouth and dysphagia were reduced under the treatment mode in which the TPF induced chemotherapy combined with concurrent chemoradiotherapy.Although the toxic effects such as leukopenia, neutropenia, hemoglobin reduction and vomiting were increased, the efficacy was comparable with that of the PF in which the adjuvant schedule chemotherapy combined with concurrent chemoradiotherapy. Clinical trial information: NCT-03574324.