Effect of thalidomide on gastrointestinal toxic effects of irinotecan

Irinotecan is the only accepted second-line treatment for colorectal cancer in the USA. Doses are, however, frequently limited by associated late-onset diarrhoea. Thalidomide has antiangiogenic and immunomodulatory properties and is being investigated as an antineoplastic. We did a pilot study of combination therapy with thalidomide and irinotecan for metastatic colorectal cancer. In an interim analysis of nine patients, thalidomide had almost eliminated the dose-limiting gastrointestinal toxic effects of irinotecan, especially diarrhoea and nausea (each p<0·0001), and eight of nine patients were able to complete the chemotherapy course.