Source:
//www.ascopost.com/News/44001
By Matthew Stenger
Key Points
• The addition of TPF induction chemotherapy to concurrent chemoradiotherapy significantly improved failure-free survival in patients with locoregionally advanced nasopharyngeal carcinoma.
• Severe hematologic adverse events were more common in the induction chemotherapy group.
In a Chinese phase III trial reported in
The Lancet Oncology, Sun et al found that adding induction treatment with cisplatin, fluorouracil (5-FU), and docetaxel (TPF) to concurrent chemoradiotherapy improved failure-free survival in locoregionally advanced nasopharyngeal carcinoma.
Study Details
In this open-label trial, 480 patients with previously untreated stage III to IVB (except T3–4N0) nasopharyngeal carcinoma aged 18 to 59 years without severe comorbidities from 10 sites in China were randomized between March 2011 and August 2013 to receive induction chemotherapy plus concurrent chemoradiotherapy (n = 241) or concurrent chemoradiotherapy alone (n = 239).
Induction chemotherapy consisted of 3 cycles of docetaxel (60 mg/m² on day 1), cisplatin (60 mg/m² on day 1), and continuous intravenous 5-FU (600 mg/m²/d from day 1 to day 5) every 3 weeks before concurrent chemoradiotherapy. Concurrent chemotherapy consisted of 3 cycles of cisplatin (100 mg/m²) every 3 weeks concurrently with intensity-modulated radiotherapy.
The primary endpoint was failure-free survival (from randomization to locoregional failure, distant failure, or death from any cause) in the intent-to-treat population.
Outcomes
After a median follow-up of 45 months, 3-year failure-free survival was 80% in the induction chemotherapy group vs 72% in the concurrent chemoradiotherapy alone group (hazard ratio [HR] = 0.68, P = .034). Three-year rates were 92% vs 86% for overall survival (HR = 0.59, P = .029), 90% vs 83% for distant failure–free survival (HR = 0.59, P = .031), and 92% vs 89% for locoregional failure–free survival (HR = 0.64, P = .12).
Adverse Events
Grade 3 or 4 adverse events occurred in 73% of the induction chemotherapy group vs 54% of the concurrent chemoradiotherapy alone group (grade 4 in 18% vs 1%, P < .0001), with the most common in the induction chemotherapy group being neutropenia (42% vs7%), leukopenia (41% vs 17%), stomatitis (41% vs 35%), vomiting (24% vs 19%), and nausea (21% vs 17%).
The investigators concluded: “Addition of TPF induction chemotherapy to concurrent chemoradiotherapy significantly improved failure-free survival in locoregionally advanced nasopharyngeal carcinoma with acceptable toxicity. Long-term follow-up is required to determine long-term efficacy and toxicities.”
The study was funded by Shenzhen Main Luck Pharmaceuticals Inc, Sun Yat-sen University Clinical Research 5010 Program, the National Science and Technology Pillar Program during the Twelfth Five-year Plan Period, Health & Medical Collaborative Innovation Project of Guangzhou City, the Planned Science and Technology Project of Guangdong Province, and the National Key Research and Development Program of China.
Jun Ma, MD, of
Sun Yat-sen University Cancer Center, is the corresponding author of
The Lancet Oncology article.
