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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.

frontiers in oncology

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