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.
BACKGROUND
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.


METHODS
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).


RESULTS
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.


CONCLUSIONS
Low-dose capecitabine plus trastuzumab is effective and well tolerated in elderly patients with HER2-positive AGC.
Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon, 405-706, Republic of Korea.
Young Saing
YS
Kim
Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon, 405-706, Republic of Korea.
Sun Jin
SJ
Sym
Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon, 405-706, Republic of Korea.
Min Young
MY
Baek
Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon, 405-706, Republic of Korea.
Inkeun
I
Park
Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon, 405-706, Republic of Korea.
Junshik
J
Hong
Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon, 405-706, Republic of Korea.
Hee Kyung
HK
Ahn
Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon, 405-706, Republic of Korea.
Jinny
J
Park
Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon, 405-706, Republic of Korea.
Eun Kyung
EK
Cho
Department of General Surgery, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Woon Ki
WK
Lee
Department of General Surgery, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Min
M
Chung
Department of Radiology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Hyung-Sik
HS
Kim
Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon, 405-706, Republic of Korea.
Jae Hoon
JH
Lee
Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon, 405-706, Republic of Korea. dbs@gilhospital.com.
Dong Bok
DB
Shin
D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D000855:Anorexia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009325:Nausea / Q000139:chemically induced; D010865:Pilot Projects; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000068878:Trastuzumab / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
D000069287:Capecitabine; D000068878:Trastuzumab
Capecitabine; Elderly; Gastric cancer; HER2; Trastuzumab