A multicenter randomized controlled trial (RCT) of adjuvant chemotherapy (CT) in nasopharyngeal carcinoma (NPC) with residual plasma EBV DNA (EBV DNA) following primary radiotherapy (RT) or chemoradiation (CRT)
Refereed conference paper presented and published in conference proceedings

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AbstractBackground: The benefit of adjuvant CT in NPC is unclear. Post-RT EBV DNA predicts poor survival and may be a biomarker of subclinical residual disease. We conducted a biomarker driven RCT using post-RT EBV DNA to select high risk NPC patients (pts) for adjuvant CT while sparing low risk pts from unnecessary toxicity. Methods: Eligible pts had biopsy proven NPC of AJCC (6th Ed) stage IIB-IVB, detectable EBV DNA ( > 0 copy/ml) at 6-8 weeks post-RT, no persistent locoregional disease or distant metastasis, ECOG 0 or 1, and adequate organ function. Pts were randomized with stratification for primary therapy (RT Vs CRT) and tumor stage (II/III Vs IV) to arm A (adjuvant cisplatin 40 mg/m2 and gemcitabine 1000 mg/m2, both given on D1+8 q3w x 6 cycles) or arm B (clinical follow-up). Primary endpoint was relapse free survival (RFS). With a hazard ratio (HR) of 2, 100 pts were required with a power of 0.8 and an alpha at 0.05. Results: From 9/2006 to 7/2015, 789 pts consented for EBV DNA screening, 218 (27.6%) pts had detectable EBV DNA, and 104 (13.2%) pts were randomized (arm A: 52; arm B: 52). The two arms were well balanced in baseline characteristics. 84.6% received prior neoadjuvant and/or concurrent CT and all received curative RT. Staging distribution: IIB 27.9%, III 37.5%, IVA 19.2%, IVB 15.4%. 8 pts refused adjuvant CT after randomization. Overall 69% and 50% completed 3 and 6 cycles of adjuvant CT respectively. After median follow up of 6.5 years (yr), the 3-yr and 5-yr survival outcomes were summarized in Table. Conclusions: In NPC pts who had residual EBV DNA after curative RT/CRT, adjuvant CT with cisplatin-gemcitabine did not improve survival.
All Author(s) ListChan ATC, Hui EP, Ngan RKC, Tung SY, Cheung ACK, Ng WT, Lee VHF, Ma B, Cheng HC, Wong CS, Loong HHF, Tong M, Poon DMC, Ahuja A, King AD, Wang K, Mo F, Zee BCY, Chan AKC, Lo DYM
Name of Conference53rd Annual Clinical Science Meeting of the American-Society-of-Clinical-Oncology (ASCO)
Start Date of Conference02/06/2017
End Date of Conference07/06/2017
Place of ConferenceChicago, Illinois
Country/Region of ConferenceUnited States of America
Proceedings TitleJournal of Clinical Oncology
Volume Number35
Issue NumberSuppl 15
Pages6002 - 6002
LanguagesEnglish-United States

Last updated on 2021-06-05 at 02:47