In a Chinese phase III trial reported in JAMA Oncology, Li et al found that induction chemotherapy with paclitaxel, cisplatin, and capecitabine (TPC) prior to concurrent chemoradiation was associated with improved failure-free survival vs induction therapy with cisplatin and fluorouracil (PF) in patients with previously untreated stage IVA to IVB nasopharyngeal carcinoma.
In the open-label multicenter trial, 238 patients were randomly assigned between October 2016 and August 2019 to receive induction therapy with two 21-day cycles of TPC (n = 118) or PF (n = 120). Random assignment was stratified by disease stage.
TPC consisted of paclitaxel at 150 mg/m2 on day 1, cisplatin at 60 mg/m2 on day 1, and capecitabine at 1,000 mg/m2 twice daily on days 1 to 14; PF consisted of cisplatin at 100 mg/m2 on day 1 and fluorouracil at 800 mg/m2 daily via continuous infusion on days 1 to 5. All patients then received two cycles of cisplatin at 100 mg/m2 concurrent with intensity-modulated radiotherapy.
The primary endpoint was failure-free survival (absence of recurrence or death) in the intention-to-treat population.
Median follow-up was 48.4 months (interquartile range = 39.6–53.3 months). Failure-free survival at 3 years was 83.5% (95% confidence interval [CI] = 77.0%–90.6%) in the TPC group vs 68.9% (95% CI = 61.1%–77.8%) in the PF group (stratified hazard ratio [HR] = 0.47, 95% CI = 0.28–0.79, P = .004).
At 3 years, distant metastasis–free survival was 91.4% (95% CI = 86.4%–96.6%) vs 80.4% (73.6%–87.9%; stratified HR = 0.49, 95% CI = 0.24–0.98, P = .04) and locoregional relapse–free survival was 93.8% (95% CI = 89.5%–98.4%) vs 87.4% (95% CI = 81.4%–93.8%; stratified HR = 0.40, 95% CI = 0.18–0.93, P = .03). Death occurred in 5.1% vs 10.8% of patients, with a 3-year overall survival rate of 94.7% (95% CI = 90.6%–98.9%) vs 88.9% (95% CI = 83.4%–94.8%; stratified HR = 0.45, 95% CI = 0.17–1.18, P = .10).
Acute treatment-related grade 3 or 4 adverse events occurred in 57.6% of patients in the TPC group vs 65.8% of the PF group. The most common in both groups were mucositis (28.0% vs 28.3%), vomiting (18.6% vs 15.8%), leukopenia (15.3% vs 14.2%), nausea (15.3% vs 20.8%), and neutropenia (12.7% vs 18.3%). Late treatment-related grade 3 or 4 adverse events occurred in 13.6% vs 17.9% of patients. One patient in the PF group died from treatment-related renal failure.
The investigators concluded, “This randomized clinical trial found that induction chemotherapy with two cycles of TPC for patients with stage IVA to IVB nasopharyngeal carcinoma improved failure-free survival compared with two cycles of PF, with no increase in the toxicity profile.”
Yan-Qun Xiang, MD, and Wei-Xiong Xia, MD, of the Department of Nasopharyngeal Carcinoma, Sun Yat-sen University, Guangzhou, are the corresponding authors for the JAMA Oncology article.
Disclosure: The study was supported by the National Natural Science Foundation of China. For full disclosures of the study authors, visit jamanetwork.com.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.