1. 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
- Author
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Jae Hoon Lee, Young Saing Kim, Dong Bok Shin, Min Young Baek, Eun Kyung Cho, Jinny Park, Min Chung, Hee Kyung Ahn, Junshik Hong, Hyung Sik Kim, Sun Jin Sym, Woon Ki Lee, and Inkeun Park
- Subjects
Oncology ,Male ,Cancer Research ,medicine.medical_specialty ,Nausea ,Anemia ,Vomiting ,medicine.medical_treatment ,Pilot Projects ,Kaplan-Meier Estimate ,Toxicology ,Capecitabine ,Trastuzumab ,Stomach Neoplasms ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Clinical endpoint ,Humans ,Pharmacology (medical) ,Prospective Studies ,Prospective cohort study ,Fatigue ,Aged ,Pharmacology ,Aged, 80 and over ,Chemotherapy ,Dose-Response Relationship, Drug ,business.industry ,medicine.disease ,Anorexia ,Treatment Outcome ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
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. 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/m2) 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). 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. Low-dose capecitabine plus trastuzumab is effective and well tolerated in elderly patients with HER2-positive AGC.
- Published
- 2015