A Phase II Prospective Study about the Efficacy and Toxicity of the Locally Advanced Nasopharyngeal Carcinoma Patients Treated with Concurrent Chemoradiotherapy Followed with the Capecitabine Metronomic Chemotherapy

Abstract

The concurrent chemoradiotherapy is the standard treatment modality for nasopharyngeal carcinoma (NPC), however the adjuvant chemotherapy is still controversial in the treatment of NPC. Metronomic chemotherapy is a new dosing modality of chemotherapy which is in low-dosages with high frequency and continuous administration that has been rising in recent years. We aimed to preliminary evaluate the possible efficacy and toxicity in locally advanced NPC patients treated with concurrent chemoradiotherapy followed with the capecitabine metronomic chemotherapy. Sixty-seven III-IV stage (UICC 8th) locally advanced NPC were included in our study from April 2014 to July 2016. All the patients received definitive concurrent chemoradiotherapy followed with the capecitabine metronomic chemotherapy. For the control group, we selected 75 patients treated with definitive concurrent chemoradiotherapy. Two to 3 cycles of cisplatin-based chemotherapy and 3 cycles of capecitabine (750mg/m2, bid) was used. The Kaplan-Meier method was used to calculate the local control rate (LC), distant metastasis-free survival rate (DMFS), progression-free survival (PFS) and overall survival (OS). The acute and late toxicities were graded according to the CTCAE 3.0 scoring criteria. The median follow-up time was 24 months. The 2-year OS and LC were similar (96.0%, 98.2%; 95.9%, 97.2% respectively). Compared with the control group, the 2-year DMFS and PFS were improved in the observation group (94.9%, 89.5%; 89%, 85.3%). Because of the limited cases, there was no statistical difference about the OS, LC, DMFS and PFS. For the acute toxicities, the incidence of grade 1-2 and grade 3-4 neutropenia in observational and control group were 50.7%, 58.6% and 10.4%, 8%, the grade 1-2 and grade 3-4 thrombocytopenia were 22.4%, 25.3% and 6%, 5.3%, and the grade 1-2 and grade 3-4 oral mucous reaction were 65.7%, 61.3% and 17.9%, 20%, respectively. For the late toxicities, the incidence of grade 1-2 and grade 3-4 xerostomia were 56.7%, 54.7% and 3%, 1.3% in the observational and control group respectively; the grade 1-2 and grade 3-4 hearing impairment were 41.8%, 38.7% and 0%, 1.3%. In addition, for the specific toxicity, the toxicities were all grade 1-2. The incidence of limb numbness, rash, neuropathic headache and anaphylaxis were 32.8%, 28.3%, 17.9% and 3.0%. There was no significant difference about the toxicities between two groups (p>0.05). The concurrent chemoradiotherapy followed with the capecitabine metronomic chemotherapy was a promising modality for locally advanced NPC patients. The 2-year DMFS and PFS was improved compared with the concurrent chemoradiotherapy, and the acute and late toxicity were all tolerable. The more and long follow-up studies should be carried out in the future.