A prospective phase II clinical study of different time-delivered drugs combined with intensity-modulated radiotherapy for locally advanced nasopharyngeal carcinoma.

Abstract

6061 Background: To compare the effects of combining intensity-modulated radiotherapy administered at different times on the toxic side effects, quality of life (QoL) and long-term survival of patients with locally advanced nasopharyngeal carcinoma (LA-NPC). Methods: A total of 160 patients with LA- NPC were randomized into the experimental group and the control group of 80 patients each, both groups received 2 cycles of TPF (docetaxel, cisplatin, and 5- fluorouracil) induced chemotherapy sequential synchronous radiochemotherapy, the experimental group received chrono- chemotherapy, while the control group received conventional chemotherapy. Primary study endpoints included Grade ≥ 3 acute adverse reactions, Secondary study endpoints included quality of life and 8- year overall survival (OS), progression- free survival (PFS), distant metastasis- free survival (DMFS), and local recurrence- free survival (LRFS). Results: As of October 10, 2024, the incidence rates of grade ≥ 3 acute vomiting, oral mucositis, leukopenia, and neutropenia in the experimental group were 3.75%, 6.25%, 27.5%, and 35.0%, while those in the control group were 15.0%, 16.25%, 47.5%, and 52.5%, and the differences were statistically significant (P < 0.05). In the experimental group, the incidence rates of Grade 1- 2 xenosomia and hearing impairment were 63.2% and 23.5%, respectively, compared to 80% and 48.6% in the control group, with a statistically significant difference (P < 0.05), and no Grade 3- 4 late toxicities were reported in either group. The experimental group demonstrated significantly higher overall QoL scores compared to the conventional group, with statistically significant differences in vomiting, general health status, and quality of life scores between the two groups (P < 0.05). However, no statistically significant differences were observed in 8-year OS, PFS, DMFS, or LRFS between the groups (P > 0.05). Conclusions: The integration of chronotherapy with IMRT significantly reduced adverse reactions and improved quality of life with LA-NPC, without compromising long-term survival outcomes. Clinical trial information: NCT02937519 .