BACKGROUND: The mean 5-6-month survival after failed standard chemotherapy for metastatic @entity14 (mCRC) necessitates more effective treatments for refractory mCRC. For untreated mCRC, S-1   +   oral leucovorin (SL) therapy offers promising results without severe @entity137 . The ML18147 trial demonstrated that bevacizumab ( @entity1493 ) prolongs overall survival after mCRC progression. We conducted a single-centre phase-II trial to evaluate the safety and efficacy of SL/ @entity1493 combination chemotherapy as mCRC salvage therapy. METHODS: Major eligibility criteria were confirmed @entity420 diagnosis; age >20  years; Eastern Cooperative Oncology Group performance status, 0-2; and progression after administration/intolerance of/to approved drugs for mCRC. (5-FU, oxaliplatin, irinotecan, Bev, and anti- @entity470 antibody, if @entity984 wild-type). S-1 (80-120  mg/body) and leucovorin (25  mg) were orally administered in a 1-week-on/1-week-off schedule. @entity1493 (5  mg/kg) was administered on day 1 of every 2-week cycle. The primary endpoint was disease control rate (DCR). RESULTS: A total of 31 @entity1 were enrolled. DCR was 65  % [95  % confidence interval (CI), 48-100  %] and the response rate was 7  % (95  % CI, 0.7-22  %). One @entity1 showing partial response to SL/ @entity1493 had a BRAF-mutant @entity5 . Median progression-free survival and overall survivals were 5.3 [95  % CI, 2.1-9.3] and 9.9 [95  % CI, 7.4-NA] months, respectively. The most-frequent grade-3/4 adverse events were @entity33 (26  %) and @entity294 (11  %), which were manageable by dose reduction/interruption. CONCLUSIONS: SL/ @entity1493 showed impressive activity in refractory mCRC and was tolerable, suggesting its potential as an alternative chemotherapy for refractory mCRC. TRIAL REGISTRATION: This study has been registered in University Hospital Medical Information Network (UMIN) Clinical Trials Registry ( ID UMIN000009083 ) on 11 October 2012.

A single-arm phase II trial of combined chemotherapy with S-1, oral leucovorin, and bevacizumab in heavily pre-treated @entity1 with metastatic XXXX .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity470 :: ('1956', 'Gene') :: ['EGFR'] @entity984 :: ('3845', 'Gene') :: ['KRAS'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity33 :: ('MESH:D052016', 'Disease') :: ['mucositis'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity1493 :: ('12064', 'Species') :: ['Bev'] @entity14 :: ('MESH:D015179', 'Disease') :: ['colorectal cancer'] @entity420 :: ('MESH:D000230', 'Disease') :: ['adenocarcinoma']
@entity14 :: (MESH:D015179,Disease) :: ['colorectal cancer']
