A phase II trial of gefitinib in combination with capecitabine and oxaliplatin as first-line chemotherapy in patients with advanced colorectal cancer.
OBJECTIVE
This study was designed as a multicentre phase II trial to assess the efficacy and safety of gefitinib in association with capecitabine and oxaliplatin in patients with untreated metastatic colorectal cancer.


METHODS
Patients with metastatic colorectal cancer that had received no prior chemotherapy for advanced disease were treated with oral gefitinib (250 mg daily) plus oral capecitabine (1000 mg/m2 twice a day on Days 1-14) and intravenous oxaliplatin (120 mg/m2 on Day 1 of each 3-week cycle).


RESULTS
Thirty-five patients were enrolled. In the intention-to-treat analysis, 3 (8.6%) patients experienced a complete response (CR), 14 (40%) a partial response (PR) and 11 (31.4%) had stable disease (SD). The disease control rate (CR + PR + SD) was 80%, the median time to progression was 7.3 months (95%CI: 4.76-9.2) and the estimated median overall survival was 21.9 months (95% CI: 15.1--not reached). The most common grade 3 to 4 toxicities included diarrhoea (31%) and vomiting (5.7%).


CONCLUSIONS
The combination of capecitabine, oxaliplatin and gefitinib appears to have promising activity in chemotherapy-naïve metastatic colorectal cancer. A higher disease control rate and an increase in median overall survival were seen compared with previous reports with capecitabine and oxaliplatin in similar patient populations. The tolerability profile appears to be predictable and similar to capecitabine/oxaliplatin regimens.
Gelibter
Alain J
AJ
Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy. agelibter@yahoo.it
Gamucci
Teresa
T
Pollera
Camillo F
CF
Di Costanzo
Francesco
F
Nuzzo
Carmen
C
Gabriele
Angela
A
Signorelli
Carlo
C
Gasperoni
Silvia
S
Ferraresi
Virginia
V
Giannarelli
Diana
D
Cognetti
Francesco
F
Zeuli
Massimo
M
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077156:Gefitinib; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011799:Quinazolines / Q000008:administration & dosage; D015996:Survival Rate
D009944:Organoplatinum Compounds; D011799:Quinazolines; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D000077156:Gefitinib; D005472:Fluorouracil