Abstract
Background and Purpose: Evidence for induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) in nasopharyngeal carcinoma (NPC) was derived from landmark clinical trials excluding the T3N0, T3N1, T4N0 subgroups. This study used Epstein-Barr virus (EBV) DNA to select IC beneficiaries from the three subgroups.Materials and Methods: Significant predictors of overall survival (OS) were identified using multivariate Cox analyses. Risk stratification was generated using recursive partitioning analysis (RPA). IC+CCRT was compared with CCRT in each risk stratification and in different subgroups. Individual-level data from a clinical trial (NCT01245959) was used for validation.Results: Gender and EBV DNA were included in RPA-generated risk stratification, categorizing patients into low-risk (EBV DNA <2,000 copies/mL; female and EBV DNA ≥2,000 copies/mL) and high-risk groups (male and EBV DNA ≥2,000 copies/mL). The OS superiority of IC+CCRT over CCRT was only observed in the high-risk group (HR = 0.64, 95% CI = 0.43–0.97; P = 0.032). Subgroup analysis indicated the OS benefit was exclusively from the docetaxel–cisplatin−5-fluorouracil regimen (HR = 0.41, 95% CI = 0.22–0.78; P = 0.005). The status of the T3N1 subgroup as an IC beneficiary is more explicit than the T3N0 and T4N0 subgroups. IC+CCRT showed improved OS in the validation cohort combining high-risk cases of real-world data with clinical trial data (HR = 0.62, 95% CI = 0.42–0.94; P = 0.023).Conclusion: Patients with high-risk T3N1 NPC is the definite target population for receiving IC+CCRT in real-world practice. T3N0 and T4N0 subgroups need further investigations in future IC-related studies.
Highlights
As nasopharyngeal carcinoma (NPC) has the highest incidence in endemic areas such as Southern China, randomized controlled trials (RCTs) conducted in this region are incredibly important in optimizing clinical decision-making [1, 2]
All patients received radical treatments based on intensity-modulated radiotherapy (IMRT) and complete basic data were obtained for each patient
In December 2016, the U.S Congress enacted $$The 21st Century Cures Act, which modified the Food and Drug Administration policies and inspired investigators to provide real-world evidence as supplements to clinical trials, in order to expedite the approval process for innovative research [22]. This retrospective, joint analysis based on real-world and clinical trial data is the first attempt to identify Induction chemotherapy (IC) beneficiaries among patients with T3N0, T3N1, and T4N0 NPC based on Epstein-Barr virus (EBV) DNA status (Supplementary Figure 6)
Summary
As nasopharyngeal carcinoma (NPC) has the highest incidence in endemic areas such as Southern China, randomized controlled trials (RCTs) conducted in this region are incredibly important in optimizing clinical decision-making [1, 2]. Since the INT 0099 trial successfully introduced chemotherapy for improved management of LANPC in 1998, various chemoradiotherapy schedules have been investigated using clinical trials [4,5,6,7,8]. In the past two decades, concurrent chemoradiotherapy (CCRT) followed by adjuvant chemotherapy (AC) has been recommended by the National Comprehensive Cancer Network (NCCN) clinical guidelines as the standard treatment for LANPC due to its strong therapeutic intensity [9]. Evidence for induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) in nasopharyngeal carcinoma (NPC) was derived from landmark clinical trials excluding the T3N0, T3N1, T4N0 subgroups. This study used Epstein-Barr virus (EBV) DNA to select IC beneficiaries from the three subgroups
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