title: Comparison between nedaplatin and cisplatin plus docetaxel combined with intensity-modulated radiotherapy for locoregionally advanced nasopharyngeal carcinoma: a multicenter randomized phase II clinical trial.
abstract: Nasopharyngeal carcinoma (NPC) is highly incident in southern China. Metastasis is the major cause of death in NPC patients. Concurrent chemoradiotherapy (CCRT) has been accepted as standard in the treatment of patients with locoregionally advanced nasopharyngeal carcinoma (NPC). However, induction chemotherapy (IC) also has benefits in this disease, especially in the patients with certain high-risk factors such as bulky and/or extensive nodal disease. It has been presented that adding IC to CCRT might be a reasonable approach and need more work to confirm. The optimal chemotherapeutic regimen combined with radiotherapy has not been determined so far. It is important to explore high effective and low toxic chemotherapy for the patients. In the multicenter prospective study, 223 patients with locoregionally advanced untreated NPC were randomized into experimental group and control group. The patients received two cycles of induction chemotherapy (IC) with docetaxel (DOC) plus nedaplatin (NDP) in experimental group every 3 weeks, followed by IMRT concurrent with weekly NDP for six cycles, and NDP was replaced by cisplatin (CDDP) in control group. More patients in experimental group could receive full courses of IC and concurrent chemoradiotherapy (CCRT) (P=0.013). There was no significant difference between the two groups in the percentage of reduction of GTVnx and GTVnd after IC (P=0.207 andP=0.107) and CR rate three months after completion of chemoradiotherapy (P=0.565 andP=0.738). With a mean follow-up of 35.1 months, no statistically significant difference in the 3-year OS, LRFS, RRFS, DMFS, and PFS was found. During IC, more patients suffered vomiting in control group (P=0.001). During CCRT, grade 3/4 neutropenia/thrombocytopenia were more common in experimental group (P=0.028 andP=0.035); whereas, severe anemia and vomiting were more common in control group (P=0.0001 andP=0.023). In conclusions, patients with locoregionally advanced NPC showed good tolerance and compliance with a manageable toxicity profile to the regimen of IC with DOC plus NDP followed by concomitant NDP and IMRT, which is as effective as the regimen of DOC plus CDDP as IC followed by concomitant CDDP and IMRT. This trial is registered at ClinicalTrials.gov (NCT 01479504).
authors.affiliation: Guangxi Medical Association, First Affiliated Hospital of Guangxi Medical University Nanning, China.
authors.forename: Chunyuan
authors.initials: C
authors.lastname: Tang
authors.affiliation: Department of Radiation Oncology, First Affiliated Hospital of Guangxi Medical University Nanning, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Wu
authors.affiliation: Department of Radiation Oncology, First Affiliated Hospital of Guangxi Medical University Nanning, China.
authors.forename: Rensheng
authors.initials: R
authors.lastname: Wang
authors.affiliation: Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region Nanning, China.
authors.forename: Heming
authors.initials: H
authors.lastname: Lu
authors.affiliation: Department of Radiation Oncology, Liuzhou Worker Hospital Liuzhou, Guangxi, China.
authors.forename: Guisheng
authors.initials: G
authors.lastname: Li
authors.affiliation: Department of Radiation Oncology, Affiliated Hospital of Guilin Medical University Guilin, Guangxi, China.
authors.forename: Meilian
authors.initials: M
authors.lastname: Liu
authors.affiliation: Department of Radiation Oncology, First People's Hospital of Yulin City Yulin, Guangxi, China.
authors.forename: Haisheng
authors.initials: H
authors.lastname: Zhu
authors.affiliation: Department of Radiation Oncology, Wuzhou Red Cross Hospital Wuzhou, Guangxi, China.
authors.forename: Jinxian
authors.initials: J
authors.lastname: Zhu
authors.affiliation: Department of Radiation Oncology, First Affiliated Hospital of Guangxi Medical University Nanning, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Radiation Oncology, First Affiliated Hospital of Guangxi Medical University Nanning, China.
authors.forename: Kai
authors.initials: K
authors.lastname: Hu
keywords: Nasopharyngeal carcinoma; docetaxel; efficacy; nedaplatin; toxicity