Adding Concurrent Chemotherapy to Intensity-Modulated Radiotherapy Does Not Improve Treatment Outcomes for Stage II Nasopharyngeal Carcinoma: A Phase 2 Multicenter Clinical Trial

• Published in: Frontiers in oncology Vol. 10; p. 1314
• Main Authors: Huang, Xiaodong, Chen, Xiaozhong, Zhao, Chong, Wang, Jingbo, Wang, Kai, Wang, Lin, Miao, Jingjing, Cao, Caineng, Jin, Ting, Zhang, Ye, Qu, Yuan, Chen, Xuesong, Liu, Qingfeng, Zhang, Shiping, Zhang, Jianghu, Luo, Jingwei, Xiao, Jianping, Xu, Guozhen, Gao, Li, Yi, Junlin
• Format: Journal Article
• Language: English
• Published: Frontiers Media S.A 07-08-2020
• Subjects: concurrent chemoradiotherapy; intensity-modulated radiotherapy; nasopharyngeal carcinoma; Oncology; stage II; treatment outcomes
• ISSN: 2234-943X; 2234-943X
• DOI: 10.3389/fonc.2020.01314

Purpose:
To explore the efficacy of concomitant chemotherapy in intensity-modulated radiotherapy (IMRT) to treat stage II nasopharyngeal carcinoma (NPC).
Methods and Materials:
In this randomized phase 2 study [registered with ClinicalTrials.gov (NCT01187238)], eligible patients with stage II (2010 UICC/AJCC) NPC were randomly assigned to either IMRT alone (RT group) or IMRT combined with concurrent cisplatin (40 mg/m
2
, weekly) (CCRT group). The primary endpoint was overall survival (OS). The second endpoints included local failure-free survival (LFFS), regional failure-free survival (RFFS), disease-free survival (DFS), distant metastasis-free survival (DMFS), and acute toxicities.
Results:
Between May 2010 to July 2012, 84 patients who met the criteria were randomized to the RT group (
n
= 43) or the CCRT group (
n
= 41). The median follow-up time was 75 months. The OS, LFFS, RFFS, DFS, and DMFS for the RT group and CCRT group were 100% vs. 94.0% (
p
= 0.25), 93.0% vs. 89.3% (
p
= 0.79), 97.7% vs. 95.1% (
p
= 0.54), 90.4% vs. 86.6% (
p
= 0.72), and 95.2% vs. 94.5% (
p
= 0.77), respectively. A total of 14 patients experienced disease failure, 7 patients in each group. The incidence of grade 2 to 4 leukopenia was higher in the CCRT group (
p
= 0.022). No significant differences in liver, renal, skin, or mucosal toxicity was observed between the two groups.
Conclusion:
For patients with stage II NPC, concomitant chemotherapy with IMRT did not improve survival or disease control but had a detrimental effect on bone marrow function.