The addition of radiotherapy to chemotherapy prolonged survival in chemotherapy-sensitive patients with de novo metastatic nasopharyngeal carcinoma (mNPC), showed data from a randomized phase 3 trial (ClinicalTrials.gov Identifier: NCT02111460). Trial findings were recently reported in JAMA Oncology.1
A total of 126 patients with mNPC who achieved a complete or partial response after 3 cycles of cisplatin and fluorouracil chemotherapy were enrolled. Patients were randomly assigned to receive intensity-modulated radiotherapy (IMRT) after chemotherapy or chemotherapy alone. The chemotherapy regimen for both arms was cisplatin and fluorouracil.
The study authors explained that cisplatin and fluorouracil was used instead of gemcitabine and cisplatin because the study was planned before the release of the phase 3 trial results were published in The Lancet, which showed that gemcitabine and cisplatin offered superior progression-free survival to cisplatin and fluorouracil in patients with recurrent or metastatic nasopharyngeal carcinoma (ClinicalTrials.gov Identifier: NCT01528618).2
The trial described in JAMA Oncology met its primary endpoint, showing a 58% reduction in the likelihood of death for chemotherapy plus radiotherapy compared with chemotherapy alone (stratified hazard ratio [HR], 0.42; 95% CI, 0.23-0.77; P =.004). At 24 months, 76.4% (95% CI, 64.4%-88.4%) of patients on the chemotherapy plus radiotherapy arm remained alive compared with 54.5% (95% CI, 41.0%-68.0%) who were enrolled in the chemotherapy-alone arm.
Patients treated with chemotherapy plus radiotherapy also had a 64% reduced likelihood of disease progression or death compared with patients treated with chemotherapy alone (stratified HR=0.36; 95% CI, 0.23-0.57; P<0.001).
Adverse events related to radiotherapy seen in the chemotherapy plus radiotherapy arm were acute grade 3 or higher dermatitis (8.1%), mucositis (33.9%), and xerostomia (6.5%). Late adverse events seen were grade 3 or higher hearing loss (5.2%) and trismus (3.4%).
Hematologic, hepatotoxic, nephrotoxic, and gastrointestinal adverse events did not differ between treatment arms.
“These findings suggest that chemotherapy plus high-dose locoregional radiotherapy improves survival in chemotherapy-sensitive patients with de novo mNPC,” the study authors concluded.
- You R, Liu Y, Huang P, et al. Efficacy and safety of locoregional radiotherapy with chemotherapy vs chemotherapy alone in de novo metastatic nasopharyngeal carcinoma: A multicenter phase 3 randomized clinical trial. JAMA Oncol. Published online July 23, 2020. doi:10.1001/jamaoncol.2020.1808
- Zhang L, Huang Y, Hong S, et al. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: A multicentre, randomised, open-label, phase 3 trial. Lancet. 2016;388(10054):1883-1892. doi:10.1016/S0140-6736(16)31388-5