In a Chinese phase III trial reported in JAMA Oncology, You et al found that the addition of locoregional radiotherapy to chemotherapy improved overall survival in patients with chemotherapy-sensitive metastatic nasopharyngeal carcinoma.
Study Details
The open-label trial included 126 previously untreated patients from three institutions in Guangzhou who had complete or partial response after three cycles of cisplatin plus fluorouracil. Patients were randomly assigned between April 2014 and August 2018 to receive continued chemotherapy plus intensity-modulated radiotherapy (IMRT) after chemotherapy (n = 63) or chemotherapy alone (n = 63). Chemotherapy consisted of fluorouracil via continuous intravenous infusion at 5 g/m2 over 120 hours and cisplatin at 100 mg/m2 on day 1 every 3 weeks for 6 cycles. Patients assigned to the radiotherapy group received IMRT starting 3 weeks after the end of the last chemotherapy cycle.
KEY POINTS
- The addition of locoregional radiotherapy to chemotherapy significantly improved overall survival in chemotherapy-sensitive patients.
- Overall survival at 24 months was 76.4% vs 54.5%.
Overall Survival
Median follow-up was 26.7 months. Overall survival at 24 months was 76.4% (95% confidence interval [CI] = 64.4%–88.4%) in the chemotherapy plus radiotherapy group vs 54.5% (95% CI = 41.0%–68.0%) in the chemotherapy group (stratified hazard ratio [HR] = 0.42, 95% CI = 0.23–0.77, P = .004). Median progression-free survival was 12.4 vs 6.7 months; progression-free survival at 24 months was 35.0% vs 3.6% (stratified HR = 0.36, 95% CI = 0.23–0.57). Objective response at the end of chemotherapy was 80.9% vs 82.5%, with complete response in 7.9% vs 6.3% of patients.
Adverse Events
There were no significant differences between the chemotherapy plus radiotherapy vs chemotherapy groups in grade 3 or 4 hematologic toxicity, with the most common being neutropenia (56.5% vs 54.7%) and anemia (29.1% vs 25.0%). No significant differences between groups were observed in grade 3 or 4 hepatotoxicity (6.5% vs 4.7%), nephrotoxicity (0% vs 0%), or gastrointestinal toxicity (eg, nausea in 11.3% vs 12.5%). Grade ≥ 3 radiotherapy toxicity included acute effects of dermatitis (8.1%), mucositis (33.9%), and xerostomia (6.5%). Grade ≥ 3 late effects included hearing loss (5.2%) and trismus (3.4%).
The investigators concluded, “In this randomized clinical trial, radiotherapy added to chemotherapy significantly improved overall survival in chemotherapy-sensitive patients with metastatic nasopharyngeal carcinoma.”
Ming-Yuan Chen, MD, PhD, of Sun Yat-sen University, Guangzhou, and Melvin Lee Kiang Chua, MBBS, FRCR, PhD, of National Cancer Centre Singapore, are the corresponding authors for the JAMA Oncology article.
Disclosure: For full disclosures of the study authors, visit jamanetwork.com.
