In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 3_suppl ( 2015-01-20), p. 103-103
Abstract:
103 Background: We conducted a RCT to compare splenectomy and spleen preservation in total gastrectomy and reported higher morbidity and larger blood loss in splenectomy at 2010 ASCO Annual Meeting. Survival analysis after 5-year follow-up is now complete. Methods: Proximal gastric adenocarcinoma of T2-4/N0-2/M0 not invading the greater curvature was eligible. During operation surgeons confirmed that R0 resection was possible with negative lavage cytology, and the patient was randomized into splenectomy or spleen-preserving arm. The primary endpoint was OS. The trial was designed to confirm non-inferiority of spleen preservation to splenectomy in OS with a non-inferiority margin of the hazard ratio (HR) as 1.21. The planned sample size was 500 pts with a power of 70% and a one-sided alpha of 5%. Results: Between June 2002 and March 2009, 505 patients (splenectomy 254, spleen-preservation 251) were enrolled from 36 institutions. The first 319 patients were treated without adjuvant therapy by protocol, but after the S-1 adjuvant effect was established in 2006, patients with pathological stage II and III tumors received adjuvant S-1 by amended protocol. The 5-year survivals were 75.1% and 76.4% in the splenectomy and spleen-preserving arms, respectively. The HR was 0.88 [90.7% CI 0.67-1.16] ( 〈 1.21); thus the non-inferiority of spleen preservation was confirmed (p=0.025). The 5-year RFS was 68.4% in splenectomy arm and 70.5% in spleen-preserving arm. The HR was 0.87 [95% CI 0.65-1.17]. Subset analyses showed slightly better survival of spleen preservation in patients having deeper tumors (T3/T4), lymph node metastases, tumors located mainly in the middle stomach, and in those enrolled in the first study period of no-adjuvant protocol. Conclusions: This is the largest RCT of splenectomy in gastric cancer, and demonstrated significant non-inferiority of spleen preservation for the first time. In total gastrectomy for proximal gastric cancer which does not invade the greater curvature, prophylactic splenectomy should be avoided not only for operative safety but also for survival benefit. Clinical trial information: NCT00112099.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2015.33.3_suppl.103
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2015
detail.hit.zdb_id:
2005181-5
