Hoffmann, R. A wiki for the life sciences where authorship matters. Nature Genetics (2008)

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Ramanathan, R.K. et al.

Ramanathan, Hwang, Zamboni, Sinicrope, Safran, Wong, Earle, Brufsky, Evans, Troetschel, Walko, Day, Chen, Finkelstein,

Low overexpression of HER-2/neu in advanced colorectal cancer limits the usefulness of trastuzumab (Herceptin) and irinotecan as therapy. A phase II trial.

BACKGROUND: To determine the response rate of trastuzumab and irinotecan in HER-2/neu overexpressing advanced colorectal cancer (CRC), determine the frequency of HER-2/neu expression in CRC, and evaluate the pharmacokinetics of trastuzumab in a phase II study. PATIENTS AND METHODS: Patients were screened for HER-2/neu by immunohistochemistry (DAKO HercepTest). Prior chemotherapy was limited to one regimen. Trastuzumab was administered weekly (loading dose of 4 mg/kg i.v. and 2 mg/kg thereafter). Irinotecan 125 mg/m2, i.v. was administered weekly for 4 weeks with a 2-week rest period. RESULTS: HER-2/neu overexpression was detected in 11 of 138 (8.0%) of screened tumors (2+ in 5 and 3+ in 6 patients). Nine patients were entered in the study; 6 had received prior chemotherapy. Partial responses were seen in 5 of 7 evaluable patients. Grade 3-4 toxicities in 31 cycles of therapy included diarrhea (19%), nausea (10%), and vomiting (6%). Leukopenia occurred in 6%, and congestive heart failure and acute renal failure (secondary to diarrhea and dehydration) were seen in 3% of cycles. The study was prematurely closed due to low accrual. CONCLUSIONS: The low overexpression rate of HER-2/neu (8.0%) in advanced CRC limits the potential for further investigation of regimens involving trastuzumab, despite evidence suggestive of activity. Irinotecan did not alter the pharmacokinetic disposition of trastuzumab.[1]

References

Low overexpression of HER-2/neu in advanced colorectal cancer limits the usefulness of trastuzumab (Herceptin) and irinotecan as therapy. A phase II trial. Ramanathan, R.K., Hwang, J.J., Zamboni, W.C., Sinicrope, F.A., Safran, H., Wong, M.K., Earle, M., Brufsky, A., Evans, T., Troetschel, M., Walko, C., Day, R., Chen, H.X., Finkelstein, S. Cancer Invest. (2004) [Pubmed]

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