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- Title
Low-dose capecitabine plus trastuzumab as first-line treatment in patients 75 years of age or older with HER2-positive advanced gastric cancer: a pilot study.
- Authors
Kim, Young; Sym, Sun; Baek, Min; Park, Inkeun; Hong, Junshik; Ahn, Hee; Park, Jinny; Cho, Eun; Lee, Woon; Chung, Min; Kim, Hyung-Sik; Lee, Jae; Shin, Dong; Kim, Young Saing; Sym, Sun Jin; Baek, Min Young; Ahn, Hee Kyung; Cho, Eun Kyung; Lee, Woon Ki; Lee, Jae Hoon
- Abstract
<bold>Background: </bold>Single-agent chemotherapy is considered a good and safe treatment option for elderly patients with advanced gastric cancer (AGC). We investigated the efficacy and safety of trastuzumab plus low-dose capecitabine in elderly patients with previously untreated human epidermal growth factor receptor 2 (HER2)-positive AGC.<bold>Methods: </bold>Patients aged 75 years or older with tumors having HER2 overexpression defined as either immunohistochemistry (IHC) 3+ or IHC 2+ and in situ hybridization-positive were eligible for inclusion. Patients received capecitabine (1000 mg/m(2)) orally twice daily on days 1-14 and trastuzumab (8 mg/kg for cycle 1, followed by 6 mg/kg) intravenously on day 1 of a 21-day cycle. The primary endpoint was progression-free survival (PFS).<bold>Results: </bold>Twenty patients were enrolled. The median age was 79 years (range 75-91). Nine patients (45 %) had ECOG performance status 2. Median PFS was 5.2 months (95 % CI 1.9-8.4 months), and median overall survival was 9.3 months (95 % CI 4.0-14.6 months). The confirmed response rate was 40 % (95 % CI 19-64 %) with disease control rate of 80 %. Grade 3-4 toxicities were anorexia (10 %), fatigue (5 %), stomatitis (5 %), and anemia (5 %). No treatment-related deaths or symptomatic congestive heart failure were observed.<bold>Conclusions: </bold>Low-dose capecitabine plus trastuzumab is effective and well tolerated in elderly patients with HER2-positive AGC.
- Subjects
TRASTUZUMAB; DRUG dosage; HER2 gene; STOMACH cancer treatment; PILOT projects; ANEMIA; ANOREXIA nervosa; ANTINEOPLASTIC agents; CLINICAL trials; COMPARATIVE studies; DOSE-effect relationship in pharmacology; FATIGUE (Physiology); LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; NAUSEA; RESEARCH; STOMACH tumors; VOMITING; EVALUATION research; TREATMENT effectiveness; KAPLAN-Meier estimator
- Publication
Cancer Chemotherapy & Pharmacology, 2015, Vol 76, Issue 6, p1267
- ISSN
0344-5704
- Publication type
journal article
- DOI
10.1007/s00280-015-2881-x