First-line single-agent cetuximab in patients with advanced colorectal cancer.
BACKGROUND
The anti-epidermal growth factor receptor (EGFR) antibody cetuximab is active in heavily pretreated patients with metastatic colorectal cancer (mCRC) both in monotherapy and in combination with chemotherapy (CT). This study assesses the antitumor activity of single-agent cetuximab in CT-naive patients.


METHODS
Phase II clinical trial was used. Patients were EGFR positive by immunohistochemistry and were not candidate for radical surgery, even in the case of substantial tumor shrinkage. Cetuximab was administered weekly.


RESULTS
Thirty-nine patients were treated and evaluated. The most common adverse event was skin toxicity (89% any grade; 48% grade 1; 31% grade 2; 10% grade 3). One patient had a complete response and three obtained partial responses (10% overall response rate). Thirteen patients had stable disease (34%). Twenty-two patients experienced progressive disease (56%). Overall median time to progression (TTP) was 2 months, and the responders individual TTP was 12, 9, 9, and 6 months.


CONCLUSIONS
Even in chemo-naive patients, cetuximab as single agent is active only in a small fraction of mCRC, similarly to what has been reported for heavily pretreated patients. The extent of benefit when response occurs is, however, such that it is mandatory to intensify the search for the predictive markers of response to cetuximab therapy.
Pessino
A
A
Medical Oncology Unit, Ospedale S. Martino, Genoa, Italy.
Artale
S
S
Sciallero
S
S
Guglielmi
A
A
Fornarini
G
G
Andreotti
I C
IC
Mammoliti
S
S
Comandini
D
D
Caprioni
F
F
Bennicelli
E
E
Andretta
V
V
Siena
S
S
Sobrero
A
A
D000230:Adenocarcinoma / Q000737:chemistry / Q000188:drug therapy* / Q000556:secondary; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis* / Q000276:immunology; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000209:etiology; D066246:ErbB Receptors / Q000032:analysis* / Q000187:drug effects* / Q000276:immunology; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D008297:Male; D008875:Middle Aged; D009260:Nail Diseases / Q000139:chemically induced; D011237:Predictive Value of Tests; D011711:Pyoderma / Q000139:chemically induced; D012867:Skin / Q000187:drug effects; D012871:Skin Diseases / Q000139:chemically induced*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D066246:ErbB Receptors; D000068818:Cetuximab