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Phase II clinical trial of S-1 plus oral leucovorin in previously treated patients with non-small-cell lung cancer.
MedLine Citation:
PMID:  25453619     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
BACKGROUND: S-1, a novel oral fluoropyrimidine, has potent antitumor activity against non-small-cell lung cancer (NSCLC). Meanwhile, leucovorin enhances the efficacy of 5-fluorouracil by inhibiting thymidylate synthase. Therefore, this phase II clinical trial evaluated the safety and efficacy of S-1 plus leucovorin combination therapy for previously treated patients with NSCLC.
PATIENTS AND METHODS: Patients with stage IIIB or IV NSCLC were prospectively enrolled if they received 1 or 2 prior chemotherapy regimens. S-1 (40-60mg) and leucovorin (25mg) were administered together orally twice per day for 7 consecutive days followed by 7 days of rest. This 2-week cycle was repeated for a maximum of 25 cycles until the onset of disease progression or unacceptable adverse events. Endpoints included objective tumor response, progression-free survival, overall survival, and safety.
RESULTS: Among 33 patients, 6 (18.2%), 14 (42.4%), and 11 (33.3%) had partial response, stable disease, and progressive disease, respectively. Median progression-free and overall survival times were 3.5 and 11.7 months, respectively. The common grade 3 toxicities included stomatitis (18.2%), anorexia (12.1%), and neutropenia (9.1%). One patient had pneumatosis cystoides intestinalis, and another experienced paralytic ileus. There were no treatment-related deaths.
CONCLUSIONS: S-1 plus leucovorin combination therapy demonstrated promising efficacy and an acceptable toxicity profile in previously treated patients with NSCLC.
Authors:
T Naito; T Seto; K Takeda; K Goto; I Okamoto; K Nakagawa; T Ohba; H Murakami; T Takahashi; T Yamanaka; N Yamamoto
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Publication Detail:
Type:  Journal Article     Date:  2014-10-23
Journal Detail:
Title:  Lung cancer (Amsterdam, Netherlands)     Volume:  86     ISSN:  1872-8332     ISO Abbreviation:  Lung Cancer     Publication Date:  2014 Dec 
Date Detail:
Created Date:  2014-12-03     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8800805     Medline TA:  Lung Cancer     Country:  Ireland    
Other Details:
Languages:  eng     Pagination:  339-43     Citation Subset:  IM    
Copyright Information:
Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
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