If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Cetuximab Does Not Improve Survival in Resected Colon Cancer Cases Where KRAS Gene Is Present: Presented at ASCO By Cameron Johnston CHICAGO -- June 7, 2010 -- Cetuximab plus standard adjuvant chemotherapy may be effective in prolonging the life expectancy of patients with metastatic stage III colon cancer, but it did not improve survival among patients with resected nonmetastatic cancer, researchers reported at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO). Previous studies have shown that adding cetuximab to the standard regimen in patients whose disease has metastasised actually improved patient survival by a significant measure, noted Steven Alberts, MD, Mayo Clinic College of Medicine, Rochester, Minnesota, speaking here on June 6 at a plenary session. He noted that 80% of patients with colon cancer can be cured through surgery and treatment with a regimen known as FOLFOX (5-fluorouracil [5-FU], leucovorin, oxaliplatin), but 20% of those cases will eventually recur. In the current study, 2,967 patients at 478 centres were enrolled. Of these, 1,864 were found to have what is known as the "wild-type" (WT) KRAS mutation. KRAS is a signalling gene that translates information from the epidermal growth factor receptor (EGFR) and instructs cells -- including cancer cells -- to grow. Cetuximab works by blocking the EGFR, which, in turn, disrupts cell growth. After their KRAS status was determined, patients were randomised to receive either the FOLFOX regimen alone (n = 902) or FOLFOX plus cetuximab (n = 945). The FOLFOX regimen consisted of oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, and 5-FU in a 400 mg/m2 IV bolus on day 1, then a 46-hour infusion of IV 5-FU 2,400 mg/m2. Cetuximab was given at 250 mg/m2 on days 1 and 8, or 400 mg/m2 on day 1 of each cycle. A preplanned data and safety analysis was conducted when 50% of the events that were anticipated in the original study protocol had occurred. This took place after a mean follow-up period of 23 months, at which time it was found that there was no difference in 3-year survival rates between the 2 arms (74.1% in the FOLFOX monotherapy arm vs 73.3% in the combination-therapy arm). In fact, patients receiving FOLFOX alone were more likely to be alive at the time of the analysis (87.3%) compared with those in the cetuximab arm (82.1%). Patients who were over 70 years of age fared worse than those who were younger than 70 years in terms of both disease-free and overall survival, although those differences were not statistically significant. Significantly more cases of any grade 3 adverse events and any grade 3 diarrhoea were also seen in the cetuximab arm. Significantly more patients in the standard-therapy arm were also able to complete 12 cycles of therapy compared with those who received additional cetuximab. Dr. Alberts concluded that, given the past experience with additional cetuximab helping to improve disease-free survival and overall survival, these results were both surprising and disappointing. "The study shows that this treatment should not be used in patients with resected stage III colon cancer," said Dr. Alberts. Funding for this study was provided by the National Institutes of Health, Bristol-Myers Squibb, ImClone, sanofi-aventis, and Pfizer Inc. [Presentation title: Adjuvant mFOLFOX6 Plus or Minus Cetuximab (Cmab) in Patients (pts) With KRAS Mutant (m) Resected Stage III Colon Cancer (CC): NCCTG Intergroup Phase III Trial N0147. Abstract 3508]
|
