Polaprezinc reduces the severity of radiation-induced mucositis in head and neck cancer patients

Abstract

Polaprezinc (PZ), an antiulcer drug, has been reported to have antioxidant properties. The aim of the present study was to assess the feasibility and efficacy of administering PZ for radiation-induced mucositis in head and neck cancer patients. Patients with newly diagnosed head and neck cancer were enrolled in this prospective study. PZ was prepared as an oral rinse. The PZ oral rinse was used four times per day during the course of radiotherapy. Sequential changes in radiation mucositis were assessed during and after radiotherapy according to the Common Terminology Criteria for Adverse Events, version 3.0. Furthermore, a retrospective comparison analysis was performed to assess the efficacy of PZ for radiation-induced mucositis. A total of 32 patients were enrolled in the prospective study of the PZ oral rinse. Radiotherapy was performed up to a total dose of 60-66 Gy using a conventional schedule combined with chemotherapy. Of the 32 patients, 30 (93.8%) reported no complaints due to the PZ oral rinse. In addition, PZ was not associated with severe adverse effects. Among the patients who received PZ, grade 3 mucositis was observed in 29.0% based on the mucosal findings and in 39.3% based on the symptoms. In the patients who did not receive PZ, the incidence of grade 3 mucositis was 40.0% based on the mucosal findings and 60.7% based on the symptoms. Moreover, PZ promoted the recovery from mucositis caused by chemoradiotherapy and was not associated with reduced tumor response to radiotherapy. Therefore, the PZ oral rinse was well tolerated and proved to be efficient for the treatment of radiotherapy-induced oral mucositis.

Keywords: head and neck cancer; mucositis; oral rinse; polaprezinc; radiotherapy.

Figures

Figure 1.

Polaprezinc (PZ) reduced the incidence of severe radiadion-induced mucositis, as indicated by clinical examinations, according to the Common Terminology Criteria for Adverse Events, version 3. Acute radiation mucositis developed in all the patients, as demonstrated by clinical examination in both groups by the fifth week or later after the initiation of radiotherapy. (A) The incidence of grade 3 mucositis was 29.0 and 40.0% in the PZ (+) and the PZ (-) groups, respectively (P=0.42). The PZ treatment ameliorated the mucosa l lesions, as indicated by the macroscopic findings. (B) Sequential findings of radiation mucositis during and after radiotherapy. The patients who received PZ oral rinse recovered from the radiation-induced mucositis within a shorter time period compared to those who did not.

Figure 2.

Polaprezinc (PZ) reduced the incidence of severe radiadion-induced mucositis as indicated by the improved ability to eat, according to the Common Terminology Criteria for Adverse Events, version 3. Symptomatic/functional mucositis developed in all the patients, apart from one patient in the PZ (+) group, by the fourth week and gradually worsened until the end of the radiotherapy course. (A) The incidence of grade 3 symptoms was 39.3 and 60.7% in the PZ (+) and the PZ (-) groups, respectively (P=0.18). (B) Sequential findings of radiation mucositis during and after radiotherapy. The patients who received PZ recovered from acute radiation-induced mucositis within a shorter time period compared to those who did not. The data revealed that PZ treatment improved the patient's oral ingestion ability and quality of life.

Figure 3.

Overall survival of the (PZ) (+) and PZ (-) groups. The patients treated with the PZ oral rinse exhibited a better survival compared to those who were not (P=0.15). PZ, polaprezinc.

Figure 4.

Survival outcomes at 2 years after the completion of treatment. (A) The overall survival rates were 72.7 and 60.7% in the PZ (+) and PZ (-) groups, respectively (P=0.55). (B) The disease-specific survival rates were 80.0 and 71.4% in the PZ (+) and PZ (-) groups, respectively (P=0.72). (C) The disease-free survival rates were 66.7 and 45.2% in the PZ (+) and PZ (-) groups, respectively (P=0.17). Patients who received the PZ oral rinse exhibited better survival outcomes.