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Abstract
Purpose The contribution of adjuvant chemotherapy after chemoradiation therapy (CRT) in nasopharyngeal cancer (NPC) remains controversial. Plasma Epstein-Barr virus (EBV) DNA is a potential biomarker of subclinical residual disease in NPC. In this prospective, multicenter, randomized controlled trial, we used plasma EBV DNA to identify patients with NPC at a higher risk of relapse for adjuvant chemotherapy. Patients and Methods Eligible patients with histologically confirmed NPC of Union for International Cancer Control stage IIB to IVB, adequate organ function, and no locoregional disease or distant metastasis were screened by plasma EBV DNA at 6 to 8 weeks after radiotherapy (RT). Patients with undetectable plasma EBV DNA underwent standard surveillance. Patients with detectable plasma EBV DNA were randomly assigned to either adjuvant chemotherapy with cisplatin and gemcitabine for six cycles (arm 1) or observation (arm 2). Patients were stratified for primary treatment (RT v CRT) and stage (II/III v IV). The primary end point was relapse-free survival (RFS). Results Seven hundred eighty-nine patients underwent EBV DNA screening. Plasma EBV DNA was undetectable in 573 (72.6%) and detectable in 216 (27.4%); 104 (13.2%) with detectable EBV DNA were randomly assigned to arms 1 (n = 52) and 2 (n = 52). After a median follow-up of 6.6 years, no significant difference was found in 5-year RFS rate between arms 1 and 2 (49.3% v 54.7%; P = .75; hazard ratio for relapse or death, 1.09; 95% CI, 0.63 to 1.89). The level of post-RT plasma EBV DNA correlated significantly with the hazards of locoregional failure, distant metastasis, and death. Conclusion In patients with NPC with detectable post-RT plasma EBV DNA, adjuvant chemotherapy with cisplatin and gemcitabine did not improve RFS. Post-RT plasma EBV DNA level should be incorporated as the selection factor in future clinical trials of adjuvant therapy in NPC.

Author information

Chan ATC1, Hui EP1, Ngan RKC1, Tung SY1, Cheng ACK1, Ng WT1, Lee VHF1, Ma BBY1, Cheng HC1, Wong FCS1, Loong HHF1, Tong M1, Poon DMC1, Ahuja AT1, King AD1, Wang K1, Mo F1, Zee BCY1, Chan KCA1, Lo YMD1.
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Anthony T.C. Chan, Edwin P. Hui, Brigette B.Y. Ma, Herbert H.F. Loong, Macy Tong, and Darren M.C. Poon, Prince of Wales Hospital; Roger K.C. Ngan and Hoi C. Cheng, Queen Elizabeth Hospital; Stewart Y. Tung and Frank C.S. Wong, Tuen Mun Hospital; Ashley C.K. Cheng, Princess Margaret Hospital; Wai T. Ng, Pamela Youde Nethersole Eastern Hospital; Victor H.F. Lee, Queen Mary Hospital; and Anthony T.C. Chan, Edwin P. Hui, Brigette B.Y. Ma, Herbert H.F. Loong, Anil T. Ahuja, Ann D. King, Ki Wang, Frankie Mo, Benny C.Y. Zee, K.C. Allen Chan, and Y.M. Dennis Lo, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.