A phase II study of capecitabine plus oxaliplatin (XELOX): a new first-line option in metastatic colorectal cancer.
BACKGROUND
Capecitabine and oxaliplatin are both effective and well-tolerated monotherapies for the treatment of advanced colorectal cancer (CRC). Oxaliplatin has also been shown to be very effective when combined with 5-FU/LV in the first-line setting.


OBJECTIVE
Assess the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with previously untreated advanced CRC.


METHODS
Fifty-three patients with measurable disease received capecitabine 1,000 mg/m2 twice daily on d 1-14 and oxaliplatin 130 mg/m2 on d 1, every 3 wk. Of these, 52 were evaluable for safety and 49 for antitumor response.


RESULTS
There was a low rate of grade 1/2 adverse events; grade 3/4 events included leukopenia (10%), neutropenia (6%), thrombocytopenia (2%), nausea/vomiting (4%), and diarrhea (4%). The overall response rate was 39% (95% CI, 25-54%) and median time to disease progression was 7.8 mo.


CONCLUSIONS
XELOX is an active and well-tolerated first-line treatment for advanced CRC. Randomized phase III studies are ongoing to compare XELOX with FOLFOX in view of the comparable efficacy and safety but superior convenience of XELOX therapy.
Makatsoris
Thomas
T
Hellenic Cooperative Oncology Group (HECOG), Data Office, Athens, Greece. maktom@yahoo.com
Kalofonos
Haralabos P
HP
Aravantinos
Gerasimos
G
Papadimitriou
Christos
C
Kastritis
Efstathios
E
Rigatos
Sotirios K
SK
Xiros
Nikolaos
N
Petsas
Theodore
T
Economopoulos
Theofanis
T
Sakadamis
Athanassios K
AK
Fountzilas
George
G
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome