In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 4020-4020
Abstract:
4020 Background: To investigate the role of esophagectomy in pts who achieved clinical complete response (cCR) with CRT for locally advanced ESCC. Methods: Pts with resectable cT3-T4a anyN M0 or anyT N+ M0 thoracic ESCC, 20-75 yrs, and ECOG PS ≤2 received 2 cycles of induction XP (capecitabine 1000 mg/m 2 bid D1-14 + cisplatin 60 mg/m 2 D1 q3w) followed by CRT (50.4 Gy/28 fx, X 800 mg/m 2 bid x 5 d/w and P 30 mg/m 2 weekly). Pts with cCR were randomized to surgery (S) or observation (O). The primary endpoint was disease-free survival (DFS). Results: From Nov 2012 to March 2016, 86 pts (17.7% of the target number) were enrolled. The slow accrual caused early closure of the study. 81 pts completed CRT, and 38 pts (44.2%) achieved cCR among whom 37 pts were randomized to S (n=19) or O (n=18). The compliance rates differed between the allocated arms (68.4% in the S arm vs 100% in the O arm; P=0.020). In both Intent-to-treat (ITT) and as-treated analysis, there were no significant differences in DFS, PFS, TTP, and OS in both arms although the S arm tended to have better DFS, PFS and TTP than the O arm (Table 1). In the as-treated analysis, the relapse rate was 23.1% (3/13) in the S arm and 45.8% (11/24) in the O arm ( P=0.288). All 10 locoregional only relapse in the O arm were considered resectable, of whom 8 pts underwent surgery (n=7) or endoscopic dissection (n=1). In the as-treated analysis, the S arm had a higher R0 resection rate (92.3% vs 42.9%; P=0.031) and lower pTNM stages ( P=0.0005) than the O arm. Conclusions: Watchful waiting might be a valuable option in pts with thoracic ESCC who have cCR to CRT. Further large-scale studies are necessary to confirm our results and to optimize treatment decision in the individual pt. Clinical trial information: NCT01740375. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2017.35.15_suppl.4020
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2017
detail.hit.zdb_id:
2005181-5
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