Abstract
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/m2, 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.
Highlights
Nasopharyngeal carcinoma (NPC) has the highest incidence among head and neck cancers in Southeast Asia
To explore the efficacy of concomitant chemotherapy in intensity-modulated radiotherapy (IMRT) to treat stage II nasopharyngeal carcinoma (NPC). 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 Intensity-modulated radiotherapy (IMRT) alone (RT group) or IMRT combined with concurrent cisplatin (40 mg/m2, weekly) (CCRT group)
The overall survival (OS), local failure-free survival (LFFS), regional failure-free survival (RFFS), disease-free survival (DFS), and distant metastasis-free survival (DMFS) for the RT group and Concurrent chemoradiotherapy (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
Summary
Nasopharyngeal carcinoma (NPC) has the highest incidence among head and neck cancers in Southeast Asia. Concurrent chemoradiotherapy (CCRT), with or without adjuvant chemoradiotherapy, has been confirmed to have a significant survival benefit vs RT alone for locally advanced NPC according to many prospective clinical trials and meta-analyses [1,2,3,4,5,6]. Based on these studies, the NCCN guidelines have recommended CCRT with/without adjuvant chemotherapy as the standard treatment modality for patients with stage II–IVb (before the AJCC 8th edition) NPC since 2010 [7]. We conducted a multicenter phase 2 trial to assess whether concurrent chemotherapy could be omitted for patients with stage II NPC without compromising the overall treatment outcomes, yet avoiding the acute treatment-related toxicities associated with chemotherapy [1, 10,11,12]
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