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

Title
Phase II trial of S-1 monotherapy in elderly or frail patients with metastatic colorectal cancer
Author(s)
이경희신상준[신상준]정재헌[정재헌]박영숙[박영숙]심병용[심병용]김태원[김태원]오도연[오도연]이명아[이명아]김용태[김용태]김열홍[김열홍]장대영[장대영]노재경[노재경]안중배[안중배]
Keywords
MULTICENTER RANDOMIZED-TRIAL; FLUOROURACIL PLUS LEUCOVORIN; ADVANCED GASTRIC-CANCER; 1ST-LINE TREATMENT; COMBINATION CHEMOTHERAPY; ORAL CAPECITABINE; POOLED ANALYSIS; OXALIPLATIN; IRINOTECAN; CARCINOMA
Issue Date
201110
Publisher
SPRINGER
Citation
INVESTIGATIONAL NEW DRUGS, v.29, no.5, pp.1073 - 1080
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
http://hdl.handle.net/YU.REPOSITORY/24475http://dx.doi.org/10.1007/s10637-010-9418-2
ISSN
0167-6997
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의과대학 > 내과학교실 > Articles
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