Induction Chrono-Chemotherapy Plus Radiation Therapy for Nasopharyngeal Carcinoma: A Phase 2 Prospective Randomized Study: Definitive Management of Head-and-Neck Squamous Cell Carcinoma

Abstract

Purpose/Objective(s)To evaluate the efficacy and toxicities of induction chrono-chemotherapy in compare with conventional chemotherapy followed by radiation therapy for nasopharyngeal carcinoma.Materials/MethodsSubjects with pathologically confirmed NPC who had no evidence of metastasis were divided randomly into two groups: patients in chrono-chemotherapy group (CC group) and in routine-chemotherapy group (RC group). Treatment response was evaluated with chi-square test and survival was evaluated with Kaplan-Meier method and Log-Rank test. The SPSS 11.5 was used for statistical analysis. Acute/late toxicities were graded based on the common terminology criteria for the adverse events (CTC AE) version 3.0.ResultsTotally, 60 patients in this study, 30 in each group. After treatment, the complete and partial response rate was 96.7% in the CC group versus 73.3% in the RC group (P<0.05). By the end of follow-up, 5 patients (16.7%) in the CC group experienced local regional recurrence versus 12 patients (40.0%) in the RC group (P = 0.045) and 16 patients (53.3%) versus 14 patients (46.7%) experienced distant metastasis (P = 0.606), respectively. The overall survival rates at 1, 3, 6 years were 96.7%,73.3%,60.0% in CC group versus 96.7%, 66.7%, 50.0% in the RC group (P = 0.346), respectively. During induction chemotherapy, the incidence of leukocytopenia (43.3% vs 80%, P = 0.003), Thrombocytopenia (26.7% vs 56.7%, P = 0.018), nausea/vomiting (40% vs 66.7%, P = 0.038) were all significantly lower in the CC group compared with RC group. The radiation-induced complications were similar in the two groups.ConclusionsCompared with conventional chemotherapy, induction chrono-chemotherapy seems reduce chemotherapy-related toxicities and improved local regional control in patients with nasopharyngeal carcinoma treated with combined chemoradiation therapy. Purpose/Objective(s)To evaluate the efficacy and toxicities of induction chrono-chemotherapy in compare with conventional chemotherapy followed by radiation therapy for nasopharyngeal carcinoma. To evaluate the efficacy and toxicities of induction chrono-chemotherapy in compare with conventional chemotherapy followed by radiation therapy for nasopharyngeal carcinoma. Materials/MethodsSubjects with pathologically confirmed NPC who had no evidence of metastasis were divided randomly into two groups: patients in chrono-chemotherapy group (CC group) and in routine-chemotherapy group (RC group). Treatment response was evaluated with chi-square test and survival was evaluated with Kaplan-Meier method and Log-Rank test. The SPSS 11.5 was used for statistical analysis. Acute/late toxicities were graded based on the common terminology criteria for the adverse events (CTC AE) version 3.0. Subjects with pathologically confirmed NPC who had no evidence of metastasis were divided randomly into two groups: patients in chrono-chemotherapy group (CC group) and in routine-chemotherapy group (RC group). Treatment response was evaluated with chi-square test and survival was evaluated with Kaplan-Meier method and Log-Rank test. The SPSS 11.5 was used for statistical analysis. Acute/late toxicities were graded based on the common terminology criteria for the adverse events (CTC AE) version 3.0. ResultsTotally, 60 patients in this study, 30 in each group. After treatment, the complete and partial response rate was 96.7% in the CC group versus 73.3% in the RC group (P<0.05). By the end of follow-up, 5 patients (16.7%) in the CC group experienced local regional recurrence versus 12 patients (40.0%) in the RC group (P = 0.045) and 16 patients (53.3%) versus 14 patients (46.7%) experienced distant metastasis (P = 0.606), respectively. The overall survival rates at 1, 3, 6 years were 96.7%,73.3%,60.0% in CC group versus 96.7%, 66.7%, 50.0% in the RC group (P = 0.346), respectively. During induction chemotherapy, the incidence of leukocytopenia (43.3% vs 80%, P = 0.003), Thrombocytopenia (26.7% vs 56.7%, P = 0.018), nausea/vomiting (40% vs 66.7%, P = 0.038) were all significantly lower in the CC group compared with RC group. The radiation-induced complications were similar in the two groups. Totally, 60 patients in this study, 30 in each group. After treatment, the complete and partial response rate was 96.7% in the CC group versus 73.3% in the RC group (P<0.05). By the end of follow-up, 5 patients (16.7%) in the CC group experienced local regional recurrence versus 12 patients (40.0%) in the RC group (P = 0.045) and 16 patients (53.3%) versus 14 patients (46.7%) experienced distant metastasis (P = 0.606), respectively. The overall survival rates at 1, 3, 6 years were 96.7%,73.3%,60.0% in CC group versus 96.7%, 66.7%, 50.0% in the RC group (P = 0.346), respectively. During induction chemotherapy, the incidence of leukocytopenia (43.3% vs 80%, P = 0.003), Thrombocytopenia (26.7% vs 56.7%, P = 0.018), nausea/vomiting (40% vs 66.7%, P = 0.038) were all significantly lower in the CC group compared with RC group. The radiation-induced complications were similar in the two groups. ConclusionsCompared with conventional chemotherapy, induction chrono-chemotherapy seems reduce chemotherapy-related toxicities and improved local regional control in patients with nasopharyngeal carcinoma treated with combined chemoradiation therapy. Compared with conventional chemotherapy, induction chrono-chemotherapy seems reduce chemotherapy-related toxicities and improved local regional control in patients with nasopharyngeal carcinoma treated with combined chemoradiation therapy.