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Phase II trial of S-1 monotherapy in elderly or frail patients with metastatic colorectal cancer

Authors
 Sang Joon Shin  ;  Jae Heon Jeong  ;  Joong Bae Ahn  ;  Jae Kyung Roh  ;  Dae Young Zang  ;  Yeul Hong Kim  ;  Yong Tai Kim  ;  Myung Ah Lee  ;  Do Youn Oh  ;  Tae Won Kim  ;  Byoung Yong Shim  ;  Kyung Hee Lee  ;  Young Suk Park 
Citation
 Investigational New Drugs, Vol.29(5) : 1073-1080, 2011 
Journal Title
 Investigational New Drugs 
ISSN
 0167-6997 
Issue Date
2011
Abstract
A phase II study was conducted to evaluate S-1 monotherapy in previously untreated elderly or frail metastatic colorectal cancer patients. A total of 48 elderly (70-85 years old) and frail [Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 and 65-69 years old] patients were eligible for first-line S-1 of 35 mg/m(2) given twice daily for 2 weeks followed by 1 week of rest. The overall response rate (ORR) for all patients was 19%. Similarly, the ORR for frail and elderly patients was 22% and 18%, respectively. Median progression-free survival (PFS) and overall survival (OS) for all patients were 3.9 months (95% CI, 3.0-4.8) and 11.3 months (95% CI, 7.4-15.2), respectively. For frail patients, PFS was 1.4 (95% CI, 0.8-2.0) vs. 4.3 months (95% CI, 3.0-5.4) for the elderly (P = 0.016). OS was significantly longer for elderly patients than for frail patients (13.1 months, 95% CI, 9.5-16.7) vs. (4.1 months, 95% CI, 3.2-5.0; P = 0.01). Toxicity was mild to moderate, as only 29% of patients experienced grade 3 toxicity. Grade 4 toxicity and febrile neutropenia did not occur; however, two frail patients died from grade 5 treatment-related infections. Generally, S-1 monotherapy was well-tolerated and efficacious in the elderly patient group, but not in the frail patient group. Considering performance status and co-morbidities in patients >70 years old, S-1 monotherapy may be a first-line therapeutic option for elderly mCRC patients.
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/93852
DOI
10.1007/s10637-010-9418-2
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
Yonsei Authors
노재경(Roh, Jae Kyung) ; 신상준(Shin, Sang Joon) ; 안중배(Ahn, Joong Bae) ; 정재헌(Jung, Jae Hun)
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Full Text
http://link.springer.com/article/10.1007%2Fs10637-010-9418-2
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