Long-term outcomes of a phase Ⅱ randomized controlled trial comparing intensity-modulated radiotherapy with or without weekly cisplatin for the treatment of locally recurrent nasopharyngeal carcinoma

• Published in: Ai zheng Vol. 35; no. 4; pp. 181 - 189
• Main Authors: Guan, Ying, Liu, Shuai, Wang, Han-Yu, Guo, Ying, Xiao, Wei-Wei, Chen, Chun-Yan, Zhao, Chong, Lu, Tai-Xiang, Han, Fei
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 15-02-2016; Department of Radiation 0ncology, Afliated Cancer Hospital of Guangxi Medical University, Cancer Institute of Guangxi Zhuang Autonomous Region, Nanning 530021, Guangxi, P. R. China%Department of Radiotherapy 0ncol-ogy, The Sixth Afliated Hospital of Sun Yat-sen University, Guangzhou 510655, Guangdong, P. R. China%Department of Radiotherapy 0ncology, Sun Yat-sen University Cancer Center, State Key Laboratory of 0ncology in South China, Col aborative Innovation Center for Cancer Medical, 651 Dongfeng Road East, Guangzhou 510060, Guangdong, P. R. China%Department of Clinical Trial, Sun Yat-sen University Cancer Center, State Key Laboratory of 0ncology in South China, Col aborative Innovation Center for Cancer Medical, Guang-zhou 510060, Guangdong, P. R. China; BioMed Central; BMC
• Subjects: Administration, Intravenous; Adult; Aged; Antimitotic agents; Antineoplastic agents; Cancer; Carcinoma; carcinoma;Intensity; Care and treatment; chemoradiotherapy;Cisplatin; Chemotherapy; Cisplatin; Cisplatin - administration & dosage; Cisplatin - therapeutic use; Clinical trials; Concomitant chemoradiotherapy; Disease-Free Survival; Dose-Response Relationship, Radiation; Drug Administration Schedule; Female; Humans; Intensity-modulated radiation therapy; Male; Metastasis; Middle Aged; modulated; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms - drug therapy; Nasopharyngeal Neoplasms - pathology; Nasopharyngeal Neoplasms - radiotherapy; Original; Patient outcomes; Product development; radiation; Radiation-Sensitizing Agents - administration & dosage; Radiation-Sensitizing Agents - therapeutic use; Radiotherapy; Radiotherapy, Intensity-Modulated - methods; Recurrence; Recurrence;Nasopharyngeal; Salvage Therapy; Survival Analysis; therapy;Concomitant; Treatment Outcome; Nasopharyngeal carcinoma; Recurrence; Intensity-modulated radiation therapy; Concomitant chemoradiotherapy; Cisplatin
• ISSN: 1000-467X; 1944-446X; 1944-446X
• DOI: 10.1186/s40880-016-0081-7

Background:Salvage treatment for locally recurrent nasopharyngeal carcinoma(NPC) is complicated and relatively limited.Radiotherapy,combined with effective concomitant chemotherapy,may improve clinical treatment outcomes.We conducted a phase Ⅱ randomized controlled trial to evaluate the efficacy of intensity-modulated radiotherapy with concomitant weekly cisplatin on locally recurrent NPC.Methods:Between April 2002 and January 2008,69 patients diagnosed with non-metastatic locally recurrent NPC were randomly assigned to either concomitant chemoradiotherapy group(n = 34) or radiotherapy alone group(n = 35).All patients received intensity-modulated radiotherapy.The radiotherapy dose for both groups was 60 Gy in 27 fractions for 37 days(range 23-53 days).The concomitant chemotherapy schedule was cisplatin 30 mg/m~2 by intravenous infusion weekly during radiotherapy.Results:The median follow-up period of all patients was 35 months(range 2-112 months).Between concomitant chemoradiotherapy and radiotherapy groups,there was only significant difference in the 3-year and 5-year overall survival(OS) rates(68.7%vs.42.2%,P = 0.016 and 41.8%vs.27.5%,P = 0.049,respectively).Subgroup analysis showed that concomitant chemoradiotherapy significantly improved the 5-year OS rate especially for patients in stage rT3-4(33.0%vs.13.2%,P = 0.009),stages Ⅲ-Ⅳ(34.3%vs.13.2%,P = 0.006),recurrence interval >30 months(49.0%vs.20.6%,P = 0.017),and tumor volume >26 cm~3(37.6%vs.0%,P = 0.006).Conclusion:Compared with radiotherapy alone,concomitant chemoradiotherapy can improve OS of the patients with locally recurrent NPC,especially those with advanced T category(rT3-4) and stage(lll-IV) diseases,recurrence intervals >30 months,and tumor volume >26 cm~3.