Concurrent chemoradiotherapy with/without induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: Long-term results of phase 3 randomized controlled trial.

Abstract

To report long-term results of a randomized controlled trial that compared cisplatin/fluorouracil/docetaxel (TPF) induction chemotherapy (IC) plus concurrent chemoradiotherapy (CCRT) with CCRT alone in locoregionally advanced nasopharyngeal carcinoma (NPC). Patients with stage III-IVB (except T3-4 N0) NPC were randomly assigned to receive IC plus CCRT (n = 241) or CCRT alone (n = 239). IC included three cycles of docetaxel (60 mg/m2 d1), cisplatin (60 mg/m2 d1), and fluorouracil (600 mg/m2 /d civ d1-5) every 3 weeks. Patients from both groups received intensity-modulated radiotherapy concurrently with three cycles of 100 mg/m2 cisplatin every 3 weeks. After a median follow-up of 71.5 months, the IC plus CCRT group showed significantly better 5-year failure-free survival (FFS, 77.4% vs. 66.4%, p = 0.019), overall survival (OS, 85.6% vs. 77.7%, p = 0.042), distant failure-free survival (88% vs. 79.8%, p = 0.030), and locoregional failure-free survival (90.7% vs. 83.8%, p = 0.044) compared to the CCRT alone group. Post hoc subgroup analyses revealed that beneficial effects on FFS were primarily observed in patients with N1, stage IVA, pretreatment lactate dehydrogenase ≥170 U/l, or pretreatment plasma Epstein-Barr virus DNA ≥6000 copies/mL. Two nomograms were further developed to predict the potential FFS and OS benefit of TPF IC. The incidence of grade 3 or 4 late toxicities was 8.8% (21/239) in the IC plus CCRT group and 9.2% (22/238) in the CCRT alone group. Long-term follow-up confirmed that TPF IC plus CCRT significantly improved survival in locoregionally advanced NPC with no marked increase in late toxicities and could be an option of treatment for these patients.

• Authors: Wen-Fei Li, Nian-Yong Chen, Ning Zhang, Guo-Qing Hu, Fang-Yun Xie, Yan Sun, Xiao-Zhong Chen, Jin-Gao Li, Xiao-Dong Zhu, Chao-Su Hu, Xiang-Ying Xu, Yuan-Yuan Chen, Wei-Han Hu, Ling Guo, Hao-Yuan Mo, Lei Chen, Yan-Ping Mao, Rui Sun, Ping Ai, Shao-Bo Liang, Guo-Xian Long, Bao-Min Zheng, Xing-Lai Feng, Xiao-Chang Gong, Ling Li, Chun-Ying Shen, Jian-Yu Xu, Ying Guo, Yu-Ming Chen, Fan Zhang, Li Lin, Ling-Long Tang, Meng-Zhong Liu, Jun Ma, Ying Sun
• Journal: International journal of cancer (Int J Cancer) Vol. 145 Issue 1 Pg. 295-305 (07 01 2019) ISSN: 1097-0215 [Electronic] United States
• PMID: 30613964 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2019 UICC.

Topics

• Adolescent
• Adult
• Chemoradiotherapy
• Disease-Free Survival
• Female
• Humans
• Male
• Middle Aged
• Nasopharyngeal Carcinoma (drug therapy, radiotherapy)
• Nasopharyngeal Neoplasms (drug therapy, radiotherapy)
• Neoplasm Staging
• Nomograms
• Prognosis
• Reproducibility of Results
• Young Adult