AUTHOR=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 

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

JOURNAL=Frontiers in Oncology

VOLUME=10

YEAR=2020

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.01314

DOI=10.3389/fonc.2020.01314

ISSN=2234-943X

ABSTRACT=<p><bold>Purpose:</bold> To explore the efficacy of concomitant chemotherapy in intensity-modulated radiotherapy (IMRT) to treat stage II nasopharyngeal carcinoma (NPC).</p><p><bold>Methods and Materials:</bold> 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<sup>2</sup>, 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.</p><p><bold>Results:</bold> Between May 2010 to July 2012, 84 patients who met the criteria were randomized to the RT group (<italic>n</italic> = 43) or the CCRT group (<italic>n</italic> = 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% (<italic>p</italic> = 0.25), 93.0% vs. 89.3% (<italic>p</italic> = 0.79), 97.7% vs. 95.1% (<italic>p</italic> = 0.54), 90.4% vs. 86.6% (<italic>p</italic> = 0.72), and 95.2% vs. 94.5% (<italic>p</italic> = 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 (<italic>p</italic> = 0.022). No significant differences in liver, renal, skin, or mucosal toxicity was observed between the two groups.</p><p><bold>Conclusion:</bold> 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.</p>