In a Chinese phase III trial reported in JAMA Oncology, Xue et al found that sequential chemoradiotherapy (SCRT) was noninferior to induction chemotherapy (IC) plus concurrent chemoradiotherapy (CCRT) in terms of failure-free survival in patients with locoregionally advanced nasopharyngeal carcinoma.
Study Details
In the multicenter open-label trial, 420 patients with newly diagnosed stage III or IVA nasopharyngeal carcinoma were randomly assigned between January 2018 and September 2021 to receive SCRT (n = 210) or IC plus CCRT (n = 210). Patients received two cycles of IC with a gemcitabine and cisplatin (GP) regimen plus radiotherapy alone, followed by two cycles of adjuvant chemotherapy with a GP regimen (SCRT group) or two cycles of IC with a GP regimen followed by radiotherapy concurrent with weekly cisplatin (IC plus CCRT group).
The primary endpoints were:
- Three-year failure-free survival with noninferiority of SCRT vs IC plus CCRT defined as an upper bound of the 95% confidence interval (CI) for the hazard ratio (HR) of < 1.6
- Incidence of grade ≥ 3 acute mucositis during radiotherapy.
Key Findings
Median follow-up was 50 months (interquartile range = 40–61 months). Failure-free survival at 3 years was 83.7% (95% CI = 78.6%–88.8%) in the SCRT group vs 79.5% (95% CI = 74.0%–85.0%) in the IC plus CCRT group (HR = 0.77, 95% CI = 0.50–1.19, P = .24), with noninferiority being achieved.
The SCRT group had a significantly lower rate of grade ≥ 3 acute mucositis during radiotherapy (29.0% vs 41.9%, P < .001), as well as lower rates of grade ≥ 3 acute nausea (9.5% vs 18.1%, P = .01) and vomiting (3.8% vs 9.5%, P = .02). No differences in late toxicity were observed.
The investigators concluded: “Results from this noninferiority randomized clinical trial suggest that SCRT is noninferior to IC plus CCRT in terms of 3-year [failure-free survival] in locally advanced nasopharyngeal carcinoma, with less severe acute nonhematological toxic effects.”
Xiayun He, MD, and Chaosu Hu, MD, of the Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, are the corresponding authors for the JAMA Oncology article.
Disclosure: The study was supported by the Key Clinical Specialty Project of Shanghai and Shanghai Anticancer Association. For full disclosures of all study authors, visit jamanetwork.com.
