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Attend this session at the
2017 ASCO Annual Meeting!


Session: Head and Neck Cancer

Type: Oral Abstract Session

Time: Monday June 5, 8:00 AM to 11:00 AM

Location: S100a

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).

Sub-category:
Advanced Disease

Category:
Head and Neck Cancer

Meeting:
2017 ASCO Annual Meeting

Abstract No:
6002

Citation:
J Clin Oncol 35, 2017 (suppl; abstr 6002)

Author(s): Anthony T. C. Chan, Edwin Pun Hui, Roger K.C. Ngan, Stewart Yuk Tung, Ashley Chi Kin Cheng, Wai Tong Ng, Victor HF Lee, Brigette Ma, Hoi Ching Cheng, Frank C.S. Wong, Herbert H. F. Loong, Macy Tong, Daren MC Poon, Anil Tejbhan Ahuja, Ann Dorothy King, Ki Wang, Frankie Mo, Benny C.Y. Zee, Allen K.C. Chan, YM Dennis Lo; Department of Clinical Oncology, State Key Laboratory of Oncology in South China, The Chinese University of Hong Kong, Hong Kong, Hong Kong; Partner State Key Laboratory of Oncology in South China, Sir Y K Pao Centre for Cancer, Department of Clinical Oncology, Hong Kong Cancer Institute and Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong; Queen Elizabeth Hospital, Department of Clinical Oncology, Hong Kong, Hong Kong; Tuen Mun Hospital, Hong Kong, Hong Kong; Department of Oncology, Princess Margaret Hospital, Kowloon, Hong Kong; Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong; Department of Clinical Oncology, Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong; State Key Laboratory of Oncology in South China, Sir Y K Pao Centre for Cancer, Department of Clinical Oncology, Hong Kong Cancer Institute and Prince of Wales Hospital, The Chinese University of Hong Kong, Sha Tin, Hong Kong; Department of Clinical Oncology, Queen Elizabeth Hospital, Kowloon, Hong Kong; Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun, Hong Kong; The Chinese University of Hong Kong, Shatin, Hong Kong; Department of Clinical Oncology, Prince of Wales Hospital, Shatin, Hong Kong; Department of Imaging and Interventional Radiology, Prince of Wales Hospital, Shatin, Hong Kong; Department of Imaging and Interventional Radiology, Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China; Sir YK Pao Center for Cancer, State Key Laboratory in Oncology in South China, Department of Clinical Oncology, The Chinese University of Hong Kong, Shatin, Hong Kong; Chinese University of Hong Kong, Sha Tin, NT, Hong Kong; Department of Chemical Pathology, The Chinese University of Hong Kong, Shatin, Hong Kong; Department of Chemical Pathology, Prince of Wales Hospital, Shatin, Hong Kong

Abstract Disclosures

Abstract:

Background: 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. Clinical trial information: NCT00370890

Arm A:
Adjuvant CT
(n = 52)
Arm B:
Clinical follow up
(n = 52)
Log rank
p-value
HR
(95% C.I)
Relapse free survival (RFS)0.790.92 (0.51-1.68)
No. of event2023
3-yr58.2%57.3%
5-yr58.2%57.3%
Overall survival (OS)0.921.04 (0.53-2.01)
No. of event1718
3-yr70.6%80.1%
5-yr66.2%67.6%
Loco-regional failure free survival0.461.42 (0.56-3.59)
No. of event108
3-yr78.0%83.6%
5-yr78.0%83.6%
Distant failure free survival0.380.72 (0.34-1.51)
No. of event1217
3-yr74.2%68.9%
5-yr74.2%68.9%

 
Other Abstracts in this Sub-Category:

 

1. Phase III randomized trial of chemotherapy with or without bevacizumab (B) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Survival analysis of E1305, an ECOG-ACRIN Cancer Research Group trial.

Meeting: 2017 ASCO Annual Meeting Abstract No: 6000 First Author: Athanassios Argiris
Category: Head and Neck Cancer - Advanced Disease

 

2. Neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: A phase III multicentre randomised controlled trial.

Meeting: 2017 ASCO Annual Meeting Abstract No: 6005 First Author: Ming-Yuan Chen
Category: Head and Neck Cancer - Advanced Disease

 

3. Genomic determinants of response to pembrolizumab in head and neck squamous cell carcinoma (HNSCC).

Meeting: 2017 ASCO Annual Meeting Abstract No: 6009 First Author: Robert I. Haddad
Category: Head and Neck Cancer - Advanced Disease

 

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