A phase II study of first-line biweekly capecitabine and bevacizumab in elderly patients with metastatic colorectal cancer.
OBJECTIVE
This phase II study was conducted to determine the efficacy and safety of capecitabine and bevacizumab in untreated elderly metastatic colorectal cancer patients.


METHODS
Patients received 1500 mg/m(2)/dose of capecitabine twice daily x 7 days and bevacizumab at 5mg/kg on day 1, in 2 week-cycles.


RESULTS
The study was closed early, due to poor accrual, after a total of 16 patients enrolled. Four patients had an objective response and 11 patients had stable disease. The median time to progression and overall survival were 9.5 and 21.2 months, respectively. The most common grade >or= 3 toxicities included diarrhea (13%) and hand and foot syndrome (25%). Three patients had an arterial thrombotic event and one patient developed a bowel perforation.


CONCLUSIONS
In this underpowered phase II study in elderly patients with metastatic colorectal cancer, capecitabine plus bevacizumab was associated with considerable clinical activity but at an increased risk of hand and foot syndrome and arterial thrombotic events.
Puthillath
Ajithkumar
A
Department of Medicine at Roswell Park Cancer Institute, United States. ajithkumar.puthillath@roswellpark.org
Mashtare
Terry
T
Wilding
Gregory
G
Khushalani
Nikhil
N
Steinbrenner
Lynn
L
Ross
Mary Ellen
ME
Romano
Karen
K
Wisniewski
Michelle
M
Fakih
Marwan G
MG
D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D000068258:Bevacizumab; D000069287:Capecitabine; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D020360:Neoadjuvant Therapy; D009362:Neoplasm Metastasis; D016019:Survival Analysis; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil