Abstract
To investigate the efficacy and safety of selective radiotherapy after distant metastasis of nasopharyngeal carcinoma (NPC) treated with dose-dense cisplatin plus fluorouracil. Eligible patients were randomly assigned to a study group treated with dose-dense cisplatin plus fluorouracil following selective radiotherapy and a control group receiving traditional cisplatin plus fluorouracil following selective radiotherapy according to a 1:1 distribution using a digital random table method. The primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival (PFS), objective response rate, relapse or progression rate in the radiation field and treatment toxicity. Of 52 patients in the study group, 20 cases underwent radiotherapy., while in the control group of 51 patients, 16 underwent radiotherapy. The median PFS, median OS, survival rates in 1, 2 and 3 years in study and control group were 20.9 vs 12.7months, 28.3 vs 18.8months, 85.2%vs 65.9%, 62.2% vs 18.3%, and 36.6%vs 5.2% (p values of 0.00, 0.00, 0.04, 0.00 and 0.00, respectively). Subgroup analysis showed that the median OS and survival rates of 1, 2, 3 years for patients undergoing radiotherapy in the study group better than that in control group( 43.2vs24.1 months, 94.1% vs 86.7%, 82.4% vs 43.3%, 64.7% vs 17.3%, (p=0.00, 0.57, 0.04 and 0.01, respectively). The complete response rate, objective response rate after chemotherapy and three months after radiotherapy, relapse or progression rate in radiation field in study group and in control group were 19.2% vs 3.9%, 86.5% vs 56.9%, 85% vs 50%, 95% vs 81.3% and 41.3% vs 66.7% (p =0.03, 0.00, 0.03,0.30, 0.01 respectively). The grade 3-4 acute adverse reactions in the study group were significantly higher than in the control group (53.8% vs 9.8%, p=0.00). The survival of patients benefits from selective radiotherapy after distant metastasis of NPC treated with dose-dense cisplatin plus fluorouracil.
Highlights
The incidence of NPC is high in China and Southeast Asian countries, especially Pearl River Basin of Guangxi and Guangdong
To the best of our knowledge, this is the first clinical study on patients with distant metastases of NPC for dose-dense chemotherapy of cisplatin plus fluorouracil following selection radiotherapy to show an improvement in efficacy outcomes
The higher complete response rate was obtained in study group by using dose-dense cisplatin combined with fluorouracil chemotherapy, so more complete response patients received radiotherapy that relapse or progression rate in radiation field, median progression-free survival (PFS), median overall survival (OS), survival rate in 2 and 3 years of whole or patients undergoing radiotherapy in study group were significantly better than those of control group
Summary
The incidence of NPC is high in China and Southeast Asian countries, especially Pearl River Basin of Guangxi and Guangdong. The local area is one of the high incidence areas in China. The progress of radiotherapy technology increased the local control rate by 75-95% (Ng et al, 2010; Xiao et al, 2011; Abbasi et al, 2013). The distant metastasis occurred on about 20% of newly diagnosed patients (Xiao et al, 2011). The response rate and progression-free survival time of cisplatin in combination with docetaxel or gemcitabine scheme was not superior to those of cisplatin in combination with fluorouracil (Kertmen et al, 2015). Cisplatin in combination with fluorouracil remains the standard chemotherapy scheme of NPC. The progression-free survival and overall survival were still low. The progression-free survival was from 5.6 to 10.6 months and the overall survival was from 7.6 to 19.6 months
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