James Shaw, MD, MPH
Does cetuximab improve overall survival in patients with colorectal cancer in whom other treatments have failed?
Randomized controlled trial.
Median 15 months.
Canada, Australia, New Zealand, and Singapore.
572 patients 29 to 88 years of age (median age 63 y, 64% men) who had been treated with a fluoropyrimidine, irinotecan, and oxaliplatin and had no response (unacceptable adverse events or progression of tumor within 6 mo) or had contraindications to these drugs; measurable disease; Eastern Cooperative Oncology Group performance status 0 to 2; adequate bone marrow, kidney, and liver function; and no serious concurrent illness. Exclusion criteria were receipt of any agent that targets the epidermal growth factor–receptor pathway and treatment with a murine monoclonal antibody.
Intravenous cetuximab and best supportive care (BSC) (palliation of symptoms and improvement of quality of life) (n = 287) or BSC alone (n = 285). Cetuximab 400 mg/m2 was initially infused over 120 minutes, followed by a weekly infusion of 250 mg/m2 over 60 minutes. Treatment continued until death in the absence of unacceptable adverse events, tumor progression, worsening symptoms, or patient request.
Overall survival. Secondary outcomes included progression-free survival, response rates, and adverse events.
100% for survival (intention-to-treat analysis).
Median overall survival was longer in the cetuximab-plus-BSC group than in the BSC-alone group (6.1 vs 4.6 mo). The cetuximab group had longer progression-free survival (hazard ratio 0.71, 95% CI 0.59 to 0.85), higher rates of partial response (8% vs 0%, P < 0.001), and more adverse events than the BSC group (Table).
Cetuximab improved survival in patients with colorectal cancer in whom other treatments had failed.
IV cetuximab (Cet) + best supportive care (BSC) vs BSC alone in patients with colorectal cancer in whom other treatments had failed†
†Abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from data in article.
‡Adjusted for Eastern Cooperative Oncology Group performance at baseline.
§Based on patients who received ≥ 1 dose of treatment (n = 562).
||n = 457.
James Shaw. Cetuximab improved overall survival in colorectal cancer patients in whom other treatments had failed. Ann Intern Med. 2008;148:JC3–8. doi: 10.7326/0003-4819-148-10-200805200-02008
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Published: Ann Intern Med. 2008;148(10):JC3-8.
Colorectal Cancer, Gastroenterology/Hepatology, Gastrointestinal Cancer, Hematology/Oncology.
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