Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK.
BACKGROUND
To determine the activity and tolerability of adding cetuximab to the oxaliplatin and capecitabine (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC).


METHODS
In a multicenter two-arm phase II trial, patients were randomized to receive oxaliplatin 130 mg/m(2) on day 1 and capecitabine 1000 mg/m(2) twice daily on days 1-14 every 3 weeks alone or in combination with standard dose cetuximab. Treatment was limited to a maximum of six cycles.


RESULTS
Seventy-four patients with good performance status entered the trial. Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively. Stable disease has been observed in 62% and 35% of the patients, with 76% disease control in both arms. Cetuximab led to skin rash in 65% of the patients. The median overall survival was 16.5 months for arm A and 20.5 months for arm B. The median time to progression was 5.8 months for arm A and 7.2 months for arm B.


CONCLUSIONS
Differences in response rates between the treatment arms indicate that cetuximab may improve outcome with XELOX. The correct place of the cetuximab, oxaliplatin and fluoropyrimidine combinations in first-line treatment of MCC has to be assessed in phase III trials.
Borner
M
M
Institute of Medical Oncology, Inselspital, Bern, Switzerland. Electronic address: markus.borner@insel.ch.
Koeberle
D
D
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Von Moos
R
R
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Saletti
P
P
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Rauch
D
D
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Hess
V
V
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Trojan
A
A
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Helbling
D
D
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Pestalozzi
B
B
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Caspar
C
C
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Ruhstaller
T
T
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Roth
A
A
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Kappeler
A
A
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Dietrich
D
D
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Lanz
D
D
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Mingrone
W
W
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
Institute of Medical Oncology, Inselspital, Bern, Switzerland.
D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000473:pathology; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D011859:Radiography; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000068818:Cetuximab