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 chemoradiotherapy (CRT).

Author:

Chan Anthony T. C.1,Ngan Roger K.C.2,Hui Edwin Pun3,Leung Sing Fai4,Poon Patricia2,Sin VC2,Tung Stewart Yuk5,Cheng Ashley Chi Kin6,Yau Tsz Kok7,Lee Victor8,Ma Brigette4,Cheng HC2,Yuen Kwok Keung5,Lee Conrad6,Kam Michael K.4,Yau Stephen2,Ng Alice Wan-ying5,Mo Frankie4,Zee Benny C.Y.9,Lo Dennis YM10,

Affiliation:

1. Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong

2. Queen Elizabeth Hospital, Kowloon, Hong Kong

3. State Key Laboratory in Oncology in South China, The Chinese University of Hong Kong, Shatin, Hong Kong

4. Prince of Wales Hospital, Shatin, Hong Kong

5. Tuen Mun Hospital, Tuen Mun, Hong Kong

6. Princess Margaret Hospital, Kwai Chung, Hong Kong

7. Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong

8. Queen Mary Hospital, University of Hong Kong, Hong Kong

9. Center for Clinical Trials, Chinese University of Hong Kong, Shatin, Hong Kong

10. Department of Chemical Pathology, State Key Laboratory in Oncology in South China, The Chinese University of Hong Kong, Shatin, Hong Kong

Abstract

5511 Background: The benefit of adjuvant CT in NPC is unclear. Administering CT after full-dose CRT presents challenges in treatment compliance and toxicity. Post-RT EBV DNA predicts poor survival and may be a biomarker of subclinical residual disease. We conducted a biomarker driven RCT using EBV DNA to select high risk NPC patients (pts) for adjuvant CT while sparing low risk pts from unnecessary toxicity. Methods: Biopsy proven NPC, AJCC stage IIB-IVB, detectable EBV DNA at 6-8 wks post-RT, no persistent locoregional disease or distant metastasis, ECOG 0 or 1, adequate organ function. Randomised 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 1000mg/m2, both given on D1+8 q3w x 6 cycles) or arm B (clinical follow-up). EBV DNA and PET scan were performed before and 6 months after randomization. Primary endpoint was relapse free survival and secondary endpoints included toxicity of adjuvant CT. With a hazard ratio of 2, 100 pts were required with a power of 0.8 and an alpha at 0.05. This safety analysis was approved by DMSC. Results: From 9/2006 to 12/2011, 514 pts consented for EBV DNA screening, 95 with detectable EBV DNA consented for adjuvant study. After work-up, 74 were eligible for randomization (37 to arm A; 37 to arm B). The two arms were well balanced in baseline characteristics. 80% received prior neoadjuvant and/or concurrent CT. Staging: IIB (36.5%), III (29.7%), IVA (18.9%), IVB (14.8%). Five pts refused adjuvant CT after randomization. Overall 65% and 57% completed 5 and 6 cycles respectively. Mean dose intensity (DI): 84% for cisplatin (22.5 mg/m2/wk, range 0.0-26.7), 92% for gemcitabine (612.8 mg/m2/wk, range 333.3-777.8). Treatment related adverse events above CTC G2 were summarized in Table. Conclusions: Delivery of 6 cycles of adjuvant CT is feasible with acceptable toxicity after full dose RT or CRT. [Table: see text]

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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